What are the common and rare side effects of Xarelto 20mg. How should Xarelto be taken and what precautions are necessary. Who should avoid taking Xarelto and what are its interactions with other medications.

Understanding Xarelto: Uses and Mechanism of Action

Xarelto, also known by its generic name rivaroxaban, is a powerful anticoagulant medication used to prevent and treat blood clots. It belongs to a class of drugs called direct factor Xa inhibitors, which work by blocking a specific clotting factor in the blood.

The primary uses of Xarelto include:

• Preventing stroke in adults with non-valvular atrial fibrillation
• Treating deep vein thrombosis (DVT) and pulmonary embolism (PE)
• Preventing recurrence of DVT and PE
• Reducing the risk of major cardiovascular events in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD)

How does Xarelto work in the body? Rivaroxaban, the active ingredient in Xarelto, directly inhibits factor Xa, a key enzyme in the blood clotting cascade. By blocking this enzyme, Xarelto effectively reduces the formation of thrombin and, consequently, the development of blood clots.

Common Side Effects of Xarelto 20mg

While Xarelto is generally well-tolerated, like all medications, it can cause side effects. It’s important to be aware of these potential effects to monitor your health effectively while taking the medication.

Common side effects of Xarelto 20mg may include:

• Bleeding (including nosebleeds and bleeding from cuts)
• Bruising
• Anemia
• Dizziness
• Headache
• Fatigue
• Nausea
• Constipation or diarrhea
• Muscle pain
• Fever

Are these side effects typically severe? Most common side effects of Xarelto are mild to moderate in severity and often resolve on their own as your body adjusts to the medication. However, if any side effect persists or worsens, it’s crucial to consult your healthcare provider.

Rare but Serious Side Effects to Watch For

While less common, some side effects of Xarelto 20mg can be severe and require immediate medical attention. Being aware of these potential complications is crucial for patient safety.

Rare but serious side effects may include:

• Severe or uncontrolled bleeding
• Signs of internal bleeding (such as unusual bruising, blood in urine or stools, coughing up blood)
• Severe headache or prolonged dizziness
• Fainting or loss of consciousness
• Unusual swelling or pain
• Difficulty breathing or chest pain
• Severe skin reactions (such as blistering or peeling)
• Signs of liver problems (such as yellowing of skin/eyes, dark urine, persistent nausea/vomiting)

When should you seek immediate medical attention while taking Xarelto? If you experience any signs of severe bleeding, such as prolonged nosebleeds, unusual bruising, blood in urine or stools, or coughing up blood, seek emergency medical care immediately. These could be signs of a serious bleeding event.

Proper Usage and Dosage Guidelines

Proper administration of Xarelto is crucial for its effectiveness and safety. The typical dosage of Xarelto 20mg is once daily, but this can vary depending on the specific condition being treated and individual patient factors.

Key points about taking Xarelto:

• Take Xarelto exactly as prescribed by your doctor
• Xarelto can be taken with or without food
• If you miss a dose, take it as soon as you remember on the same day
• Do not take a double dose to make up for a missed dose
• Do not stop taking Xarelto without consulting your doctor, as this can increase your risk of blood clots

Can Xarelto be crushed or split? Xarelto tablets should be swallowed whole. If you have difficulty swallowing the tablet, inform your healthcare provider, as there may be alternative options available.

Interactions with Other Medications and Substances

Xarelto can interact with various medications and substances, potentially altering its effectiveness or increasing the risk of side effects. It’s crucial to inform your healthcare provider about all medications, supplements, and herbal products you’re taking.

Medications and substances that may interact with Xarelto include:

• Other blood thinners (anticoagulants)
• Nonsteroidal anti-inflammatory drugs (NSAIDs)
• Certain antifungal medications
• Some HIV medications
• Certain antibiotics
• St. John’s Wort
• Grapefruit juice

How can you minimize the risk of drug interactions while taking Xarelto? Always inform your healthcare provider about all medications and supplements you’re taking. Avoid starting or stopping any new medications or supplements without consulting your doctor or pharmacist first.

Precautions and Contraindications

While Xarelto is an effective medication for many patients, it’s not suitable for everyone. Certain conditions and factors may increase the risks associated with Xarelto use.

Xarelto should be used with caution or may be contraindicated in patients with:

• Active bleeding or high risk of bleeding
• Severe kidney or liver disease
• Pregnancy or breastfeeding
• History of stomach or intestinal bleeding
• Certain types of heart valve replacements
• Antiphospholipid syndrome

Is it safe to take Xarelto during pregnancy? Xarelto is generally not recommended during pregnancy as it may harm the unborn baby. If you become pregnant while taking Xarelto, contact your healthcare provider immediately to discuss your options.

Monitoring and Follow-up While on Xarelto

Regular monitoring is essential while taking Xarelto to ensure its effectiveness and minimize potential risks. Your healthcare provider will likely schedule periodic follow-up appointments and may order certain tests.

Aspects of monitoring may include:

• Regular blood tests to check kidney and liver function
• Monitoring for signs of bleeding
• Assessing the need for continued anticoagulation therapy
• Evaluating any side effects or complications

How often should you have follow-up appointments while taking Xarelto? The frequency of follow-up appointments can vary depending on individual factors, but typically, patients on Xarelto should have at least annual check-ups with their healthcare provider. More frequent visits may be necessary for some patients.

Special Considerations for Elderly Patients

Elderly patients may be at higher risk for certain side effects of Xarelto, particularly bleeding complications. Special care and monitoring may be necessary for this population.

Considerations for elderly patients on Xarelto include:

• Increased risk of falls and subsequent bleeding
• Potential for decreased kidney function, which may affect drug clearance
• Higher likelihood of drug interactions due to multiple medications
• Possible need for dose adjustments based on age and kidney function

How can elderly patients reduce their risk of complications while on Xarelto? Elderly patients should take extra precautions to prevent falls, such as using assistive devices if needed and removing tripping hazards in the home. Regular check-ups and open communication with healthcare providers about any new symptoms or concerns are also crucial.

Lifestyle Modifications While Taking Xarelto

While Xarelto doesn’t require the strict dietary restrictions associated with some other anticoagulants, certain lifestyle modifications can help ensure the safety and effectiveness of the medication.

Recommended lifestyle adjustments may include:

• Avoiding activities with a high risk of injury or bleeding
• Using caution with sharp objects and during activities like shaving
• Maintaining a consistent diet, particularly regarding vitamin K intake
• Limiting alcohol consumption
• Quitting smoking
• Exercising regularly, but avoiding high-impact or contact sports

Can you drink alcohol while taking Xarelto? While moderate alcohol consumption is generally considered safe, excessive alcohol intake can increase the risk of bleeding and may interact with Xarelto. It’s best to discuss your alcohol consumption with your healthcare provider to determine what’s safe for you.

Dental and Surgical Procedures

If you’re taking Xarelto and need to undergo a dental or surgical procedure, special precautions may be necessary to manage bleeding risk.

Important considerations include:

• Informing all healthcare providers, including dentists, about your Xarelto use
• Discussing the need to temporarily stop Xarelto before procedures with your doctor
• Following post-procedure instructions carefully to minimize bleeding risk
• Being aware of signs of excessive bleeding after procedures

How long before a procedure should Xarelto be stopped? The timing of Xarelto discontinuation before a procedure depends on various factors, including the type of procedure and individual patient characteristics. Always follow your healthcare provider’s specific instructions regarding stopping and restarting Xarelto around procedures.

Long-term Outlook and Prognosis

For many patients, Xarelto is a long-term medication that plays a crucial role in preventing serious cardiovascular events. Understanding the long-term outlook and prognosis while on Xarelto can help patients maintain realistic expectations and adhere to their treatment plan.

Key points about the long-term use of Xarelto:

• Many patients remain on Xarelto indefinitely, especially those with chronic conditions like atrial fibrillation
• Regular follow-ups with healthcare providers are essential to assess ongoing need and effectiveness
• The risk of bleeding complications may increase with long-term use, necessitating vigilant monitoring
• Adherence to the prescribed regimen is crucial for maintaining the medication’s protective effects

What is the typical duration of Xarelto therapy? The duration of Xarelto therapy varies depending on the condition being treated. For some conditions, like DVT or PE, treatment may last 3-6 months or longer. For chronic conditions like atrial fibrillation, treatment is often indefinite. Always follow your healthcare provider’s recommendations regarding the duration of your Xarelto therapy.

Quality of Life Considerations

While Xarelto can significantly reduce the risk of serious cardiovascular events, it’s important to consider how it may impact a patient’s quality of life.

Factors that may affect quality of life include:

• The need for regular medical appointments and blood tests
• Potential lifestyle modifications to reduce bleeding risk
• Anxiety about potential bleeding complications
• Improved peace of mind due to reduced risk of blood clots
• Fewer dietary restrictions compared to some other anticoagulants

How can patients maintain a good quality of life while on Xarelto? Open communication with healthcare providers about any concerns or side effects is crucial. Patients should also focus on overall health through regular exercise, a balanced diet, and stress management techniques. Support groups or counseling may be helpful for those struggling with anxiety related to their medication regimen.

Common and Rare Side Effects for Xarelto oral

COMMON side effects

If experienced, these tend to have a Severe expression i

If experienced, these tend to have a Less Severe expression i

Sorry, we have no data available. Please contact your doctor or pharmacist.

INFREQUENT side effects

If experienced, these tend to have a Severe expression i

• fainting
• abnormal liver function tests
• bleeding from a wound
• hematoma, a collection of blood outside of the blood vessels

If experienced, these tend to have a Less Severe expression i

• depression
• a sore throat
• inflammation of the tissue lining the sinuses
• a toothache
• irritation of the mouth
• indigestion
• urinary tract infection
• itching
• blistering of the skin
• arthritis
• backache
• muscle spasm
• dizziness
• difficulty sleeping
• low energy
• pain
• intense abdominal pain
• upper abdominal pain
• anxious feelings

RARE side effects

If experienced, these tend to have a Severe expression i

• decreased blood platelets
• very low levels of granulocytes, a type of white blood cell
• abnormal bleeding in the brain resulting in damage to brain tissue, called a hemorrhagic stroke
• subdural intracranial hemorrhage
• bleeding within the skull
• inflammation of the liver called hepatitis
• blockage of normal bile flow
• bleeding of the stomach or intestines
• abnormal bleeding from the uterus
• a skin disorder with blistering and peeling skin called Stevens-Johnson syndrome
• a significant type of allergic reaction called anaphylaxis
• a type of allergic reaction called angioedema
• a hypersensitivity reaction to a drug
• a yellowing of the eyes or skin from buildup of bilirubin called jaundice
• bleeding from the lungs
• bleeding around the spine called a spinal epidural hematoma
• bleeding in the abdomen
• hemiparesis
• a type of significant allergic skin reaction called DRESS syndrome

If experienced, these tend to have a Less Severe expression i

• abnormally long or heavy periods

Xarelto 20mg film-coated tablets – Patient Information Leaflet (PIL)

Below is a text only representation of the Patient Information Leaflet.
The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD.
For further information call emc accessibility on 0800 198 5000.
The product code(s) for this leaflet are: EU/1/08/472/020, EU/1/08/472/016, EU/1/08/472/021, EU/1/08/472/039, EU/1/08/472/018, EU/1/08/472/019, EU/1/08/472/038, EU/1/08/472/015, EU/1/08/472/036, EU/1/08/472/024, EU/1/08/472/037, EU/1/08/472/014, EU/1/08/472/023, EU/1/08/472/040, EU/1/08/472/011, EU/1/08/472/017, EU/1/08/472/012, EU/1/08/472/013.

Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the ‘Leaflet prepared/revised date’ towards the end of the leaflet to establish if there have been any changes.

If you have any doubts or queries about your medication, please contact your doctor or pharmacist.

Xarelto 15 mg film-coated tablets

Xarelto 20 mg film-coated tablets

rivaroxaban

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Xarelto is and what it is used for

2. What you need to know before you take Xarelto

3. How to take Xarelto

4. Possible side effects

5. How to store Xarelto

6. Contents of the pack and other information

Xarelto contains the active substance rivaroxaban.

Xarelto is used in adults to:

• prevent blood clots in brain (stroke) and other blood vessels in your body if you have a form of irregular heart rhythm called non-valvular atrial fibrillation.
• treat blood clots in the veins of your legs (deep vein thrombosis) and in the blood vessels of your lungs (pulmonary embolism), and to prevent blood clots from re-occurring in the blood vessels of your legs and/or lungs.

Xarelto is used in children and adolescents below 18 years and with a body weight of 30 kg or more to:

• treat blood clots and prevent re-occurrence of blood clots in the veins or in the blood vessels of the lungs, following initial treatment of at least 5 days with injectable medicines used to treat blood clots.

Xarelto belongs to a group of medicines called antithrombotic agents. It works by blocking a blood clotting factor (factor Xa) and thus reducing the tendency of the blood to form clots.

Do not take Xarelto

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)
• if you are bleeding excessively
• if you have a disease or condition in an organ of the body that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes)
• if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open.
• if you have a liver disease which leads to an increased risk of bleeding
• if you are pregnant or are breast-feeding

Do not take Xarelto and tell your doctor if any of these apply to you.

Talk to your doctor or pharmacist before taking Xarelto.

• if you have an increased risk of bleeding, as could be the case in situations such as:
  • severe kidney disease for adults, and moderate or severe kidney disease for children and adolescents, since your kidney function may affect the amount of medicine that works in your body
  • if you are taking other medicines to prevent blood clotting (e. g. warfarin, dabigatran, apixaban or heparin), when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open (see section “Other medicines and Xarelto”)
  • bleeding disorders
  • very high blood pressure, not controlled by medical treatment
  • diseases of your stomach or bowel that might result in bleeding, e.g. inflammation of the bowels or stomach, or inflammation of the oesophagus (gullet), e.g. due to gastroesophageal reflux disease (disease where stomach acid goes upwards into the oesophagus)
  • a problem with the blood vessels in the back of your eyes (retinopathy)
  • a lung disease where your bronchi are widened and filled with pus (bronchiectasis), or previous bleeding from your lung
• if you have a prosthetic heart valve
• if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed.
• if your doctor determines that your blood pressure is unstable or another treatment or surgical procedure to remove the blood clot from your lungs is planned

If any of the above apply to you, tell your doctor before you take Xarelto. Your doctor will decide, if you should be treated with this medicine and if you should be kept under closer observation.

• it is very important to take Xarelto before and after the operation exactly at the times you have been told by your doctor.
• If your operation involves a catheter or injection into your spinal column (e.g. for epidural or spinal anaesthesia or pain reduction):
  • it is very important to take Xarelto before and after the injection or removal of the catheter exactly at the times you have been told by your doctor
  • tell your doctor immediately if you get numbness or weakness of your legs or problems with your bowel or bladder after the end of anaesthesia, because urgent care is necessary.

Xarelto tablets are not recommended for children with a body weight below 30 kg.

There is not enough information on the use of Xarelto in children and adolescents in the adult indications.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

• If you are taking
  • some medicines for fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are only applied to the skin
  • ketoconazole tablets (used to treat Cushing’s syndrome – when the body produces an excess of cortisol)
  • some medicines for bacterial infections (e.g. clarithromycin, erythromycin)
  • some anti-viral medicines for HIV / AIDS (e.g. ritonavir)
  • other medicines to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol)
  • anti-inflammatory and pain relieving medicines (e. g. naproxen or acetylsalicylic acid)
  • dronedarone, a medicine to treat abnormal heart beat
  • some medicines to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs))

If any of the above apply to you, tell your doctor before taking Xarelto, because the effect of Xarelto may be increased. Your doctor will decide, if you should be treated with this medicine and if you should be kept under closer observation.

If your doctor thinks that you are at increased risk of developing stomach or bowel ulcers, he may also use a preventative ulcer treatment.

• If you are taking
  • some medicines for treatment of epilepsy (phenytoin, carbamazepine, phenobarbital)
  • St John’s Wort (Hypericum perforatum), a herbal product used for depression
  • rifampicin, an antibiotic

If any of the above apply to you, tell your doctor before taking Xarelto, because the effect of Xarelto may be reduced. Your doctor will decide, if you should be treated with Xarelto and if you should be kept under closer observation.

Do not take Xarelto if you are pregnant or breast-feeding. If there is a chance that you could become pregnant, use a reliable contraceptive while you are taking Xarelto. If you become pregnant while you are taking this medicine, tell your doctor immediately, who will decide how you should be treated.

Xarelto may cause dizziness (common side effect) or fainting (uncommon side effect) (see section 4, ”Possible side effects”). You should not drive, ride a bicycle or use any tools or machines if you are affected by these symptoms.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

You must take Xarelto together with a meal.

Swallow the tablet(s) preferably with water.

If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take Xarelto. The tablet may be crushed and mixed with water or apple puree immediately before you take it. This mixture should be immediately followed by food.

If necessary, your doctor may also give you the crushed Xarelto tablet through a stomach tube.

• Adults
  • To prevent blood clots in brain (stroke) and other blood vessels in your body
    
    The recommended dose is one tablet Xarelto 20 mg once a day.
    
    If you have kidney problems, the dose may be reduced to one tablet Xarelto 15 mg once a day.
    
    If you need a procedure to treat blocked blood vessels in your heart (called a percutaneous coronary intervention – PCI with an insertion of a stent), there is limited evidence to reduce the dose to one tablet Xarelto 15 mg once a day (or to one tablet Xarelto 10 mg once a day in case your kidneys are not working properly) in addition to an antiplatelet medicine such as clopidogrel.
  • To treat blood clots in the veins of your legs and blood clots in the blood vessels of your lungs, and for preventing blood clots from re-occurring
    
    The recommended dose is one tablet Xarelto 15 mg twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one tablet Xarelto 20 mg once a day. After at least 6 months blood clot treatment your doctor may decide to continue treatment with either one 10 mg tablet once a day or one 20 mg tablet once a day.
    
    If you have kidney problems and take one tablet Xarelto 20 mg once a day, your doctor may decide to reduce the dose for the treatment after 3 weeks to one tablet Xarelto 15 mg once a day if the risk for bleeding is greater than the risk for having another blood clot.
• Children and adolescents
  
  The dose of Xarelto depends on the body weight, and will be calculated by the doctor.
  • The recommended dose for children and adolescents with a body weight between 30 kg and less than 50 kg is one Xarelto 15 mg tablet once a day.
  • The recommended dose for children and adolescents with a body weight of 50 kg or more is one Xarelto 20 mg tablet once a day.

Take each Xarelto dose with a drink (e.g. water or juice) during a meal. Take the tablets every day at approximately the same time. Consider setting an alarm to remind you.

For parents or caregivers: please observe the child to ensure the full dose is taken.

As the Xarelto dose is based on body weight it is important to keep scheduled doctor’s visits because the dose may need to be adjusted as the weight changes.

Never adjust the dose of Xarelto by yourself. The doctor will adjust the dose if necessary.

Do not split the tablet in an attempt to provide a fraction of a tablet dose. If a lower dose is required please use the alternative presentation of Xarelto granules for oral suspension.

For children and adolescents who are unable to swallow tablets whole, please use Xarelto granules for oral suspension.

If the oral suspension is not available, you may crush the Xarelto tablet and mix with water or apple puree immediately before taking. Take some food after taking this mixture. If necessary, your doctor may also give the crushed Xarelto tablet through a stomach tube.

• less than 30 minutes after you have taken Xarelto, take a new dose.
• more than 30 minutes after you have taken Xarelto, do not take a new dose. In this case, take the next Xarelto dose at the usual time.

Contact the doctor if you repeatedly spit up the dose or vomit after taking Xarelto.

Take the tablet(s) every day until your doctor tells you to stop.

Try to take the tablet(s) at the same time every day to help you to remember it.

Your doctor will decide how long you must continue treatment.

To prevent blood clots in the brain (stroke) and other blood vessels in your body:

If your heart beat needs to be restored to normal by a procedure called cardioversion, take Xarelto at the times your doctor tells you.

• Adults, children and adolescents:
  
  If you are taking one 20 mg tablet or one 15 mg tablet once a day and have missed a dose, take it as soon as you remember. Do not take more than one tablet in a single day to make up for a forgotten dose. Take the next tablet on the following day and then carry on taking one tablet once a day.
• Adults:
  
  If you are taking one 15 mg tablet twice a day and have missed a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in a single day. If you forget to take a dose you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) on one day. On the following day you should carry on taking one 15 mg tablet twice a day.

Contact your doctor immediately if you have taken too many Xarelto tablets. Taking too much Xarelto increases the risk of bleeding.

Do not stop taking Xarelto without talking to your doctor first, because Xarelto treats and prevents serious conditions.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, Xarelto can cause side effects, although not everybody gets them.

Like other similar medicines to reduce the formation of blood clots, Xarelto may cause bleeding which may potentially be life threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). In some cases the bleeding may not be obvious.

• Signs of bleeding
  • bleeding into the brain or inside the skull (symptoms can include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and neck stiffness. A serious medical emergency. Seek medical attention immediately!)
  • long or excessive bleeding
  • exceptional weakness, tiredness, paleness, dizziness, headache, unexplained swelling, breathlessness, chest pain or angina pectoris

  
  Your doctor may decide to keep you under closer observation or change the treatment.
  
  

• Signs of severe skin reactions
  • spreading intense skin rash, blisters or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
  • a drug reaction that causes rash, fever, inflammation of internal organs, blood abnormalities and systemic illness (DRESS syndrome).

  
  
  The frequency of these side effects is very rare (up to 1 in 10,000 people).
  

• Signs of severe allergic reactions
  • swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and breathing difficulties; sudden drop in blood pressure.

  
  The frequencies of severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; may affect up to 1 in 10,000 people) and uncommon (angioedema and allergic oedema; may affect up to 1 in 100 people).
  
  
  

Common (may affect up to 1 in 10 people)

• reduction in red blood cells which can make the skin pale and cause weakness or breathlessness
• bleeding in the stomach or bowel, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nose bleed, bleeding in the gum
• bleeding into the eye (including bleeding from the whites of the eyes)
• bleeding into tissue or a cavity of the body (haematoma, bruising)
• coughing up blood
• bleeding from the skin or under the skin
• bleeding following an operation
• oozing of blood or fluid from surgical wound
• swelling in the limbs
• pain in the limbs
• impaired function of the kidneys (may be seen in tests performed by your doctor)
• fever
• stomach ache, indigestion, feeling or being sick, constipation, diarrhoea
• low blood pressure (symptoms may be feeling dizzy or fainting when standing up)
• decreased general strength and energy (weakness, tiredness), headache, dizziness
• rash, itchy skin
• blood tests may show an increase in some liver enzymes

Uncommon (may affect up to 1 in 100 people)

• bleeding into the brain or inside the skull (see above, signs of bleeding)
• bleeding into a joint causing pain and swelling
• thrombocytopenia (low number of platelets, which are cells that help blood to clot)
• allergic reactions, including allergic skin reactions
• impaired function of the liver (may be seen in tests performed by your doctor)
• blood tests may show an increase in bilirubin, some pancreatic or liver enzymes or in the number of platelets
• fainting
• feeling unwell
• faster heartbeat
• dry mouth
• hives

Rare (may affect up to 1 in 1,000 people)

• bleeding into a muscle
• cholestasis (decreased bile flow), hepatitis incl. hepatocellular injury (inflamed liver incl. liver injury)
• yellowing of the skin and eye (jaundice)
• localised swelling
• collection of blood (haematoma) in the groin as a complication of the cardiac procedure where a catheter is inserted in your leg artery (pseudoaneurysm)

Not known (frequency cannot be estimated from the available data)

• kidney failure after a severe bleeding
• increased pressure within muscles of the legs or arms after a bleeding, which leads to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome after a bleeding)

In general, the side effects observed in children and adolescents treated with Xarelto were similar in type to those observed in adults and were primarily mild to moderate in severity.

Side effects that were observed more often in children and adolescents:

Very common (may affect more than 1 in 10 people)

• headache
• fever
• nose bleeding
• vomiting

Common (may affect up to 1 in 10 people)

• raised heartbeat
• blood tests may show an increase in bilirubin (bile pigment)
• thrombocytopenia (low number of platelets which are cells that help blood to clot)
• heavy menstrual bleeding

Uncommon (may affect up to 1 in 100 people)

• blood tests may show an increase in a subcategory of bilirubin (direct bilirubin, bile pigment)

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store.

Ireland

HPRA Pharmacovigilance
Earlsfort Terrace
IRL – Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

Malta

ADR Reporting

Website: www.medicinesauthority.gov.mt/adrportal

By reporting side effects, you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on each blister or bottle after EXP.

The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Crushed tablets

Crushed tablets are stable in water or apple puree for up to 4 hours.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

• The active substance is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
• The other ingredients are:
  
  Tablet core: microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, hypromellose (2910), sodium laurilsulfate, magnesium stearate. See section 2 “Xarelto contains lactose and sodium”
  
  Tablet film coat: macrogol (3350), hypromellose (2910), titanium dioxide (E 171), iron oxide red (E 172).

Xarelto 15 mg film-coated tablets are red, round, biconvex and marked with the BAYER-cross on one side and “15” and a triangle on the other side.

They come

• in blisters in cartons of 10, 14, 28, 42 or 98 film-coated tablets or
• in unit dose blisters in cartons of 10 x 1 or 100 x 1 or
• in multipacks comprising 10 cartons, each containing 10 x 1 film-coated tablets or
• in bottles of 100 film-coated tablets.

Xarelto 20 mg film-coated tablets are brown-red, round, biconvex and marked with the BAYER-cross on one side and “20” and a triangle on the other.

They come

• in blisters in cartons of 10, 14, 28 or 98 film-coated tablets or
• in unit dose blisters in cartons of 10 x 1 or 100 x 1 or
• in multipacks comprising 10 cartons, each containing 10 x 1 film-coated tablets or
• in bottles of 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Bayer AG
51368 Leverkusen
Germany

The manufacturer can be identified by the batch number printed on the side flap of the carton and on each blister or bottle:

• If the first and second characters are BX, the manufacturer is

  Bayer AG
  Kaiser-Wilhelm-Allee
  51368 Leverkusen
  Germany

• If the first and second characters are IT, the manufacturer is

  Bayer HealthCare Manufacturing Srl.
  Via delle Groane, 126
  20024 Garbagnate Milanese
  Italy

• If the first and second characters are BT, the manufacturer is

  Bayer Bitterfeld GmbH
  Ortsteil Greppin
  Salegaster Chaussee 1
  06803 Bitterfeld-Wolfen
  Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom

Bayer plc

Tel: +44-(0) 118 206 3000

This leaflet was last revised in 01/2021

Detailed information on this medicine is available on the European Medicines Agency website: http://www. ema.europa.eu.

v023_0

Rivaroxaban: a blood-thinning medicine to treat and prevent blood clots

It’s very important to take rivaroxaban as your doctor has told you.

It’s usual to take it once a day just after you have eaten a meal or snack.

It’s important to take rivaroxaban with some food to help your body absorb the whole dose. Try to take it at the same time every day.

People who are taking rivaroxaban to treat DVT or a pulmonary embolism may need to take it twice a day for the first few weeks. Your doctor will tell you if you need to do this.

If you have trouble swallowing pills, speak to your doctor or pharmacist.

You can crush rivaroxaban tablets and mix them with water or apple purée. Swallow this mixture, then eat some food straight away.

Dosage

Your dose of rivaroxaban depends on why you’re taking it.

If you have:

• a heart condition called atrial fibrillation – the usual dose is 20mg a day. But your doctor might prescribe a lower dose if you have kidney disease and are at a higher risk of bleeding.
• had a blood clot (DVT or pulmonary embolism) – the usual dose is 20mg a day. You might need to take a dose of 15mg twice a day for the first few weeks of taking rivaroxaban. If you have kidney disease and are at a higher risk of bleeding, your doctor may prescribe a lower dose.
• had an operation to replace a hip or knee joint – the usual dose is 10mg a day.
• had a heart attack or have a heart condition called unstable angina – the usual dose is 2.5mg twice a day.

If you’re unsure what dose you need to take, check with your doctor or pharmacist.

What if I forget to take it?

What you need to do depends on the dose you take.

If you usually take:

• 10mg, 15mg or 20mg once a day – take a dose as soon as you remember, unless it’s nearly time for your next one. Take your next dose at the usual time and then carry on as normal. Never take more than 1 dose in a single day.
• 15mg twice a day – take a dose as soon as you remember. You can take 2 x 15mg tablets at the same time to get a total of 2 doses in 1 day. Never take more than 2 doses in 1 day.
• 2.5mg twice a day – take a dose as soon as you remember, unless it’s nearly time for your next one. Do not take a double dose to make up for a missed one. Take your next dose at the usual time, and then carry on as normal.

It’s very important that you remember to take rivaroxaban every day.

If you forget doses often, it may help to set an alarm to remind you.

You could also ask your pharmacist for advice on other ways to help you remember to take your medicine.

If you’re worried, contact your doctor or pharmacist.

What if I take too much?

Ask your doctor or pharmacist for advice straight away, as overdose puts you at risk of bleeding.

How long will I take it for?

How long you need to take rivaroxaban will depend on why you’re taking it.

If you have had an operation to replace your knee or hip joint, you’ll probably take rivaroxaban for 2 to 5 weeks.

If you have had a blood clot (DVT or pulmonary embolism), you’ll normally take rivaroxaban for at least 3 months. Depending on what caused the blood clot, you might need to take it for longer.

If you have a heart problem like atrial fibrillation or have had a heart attack, you might need to take rivaroxaban long term or even for the rest of your life.

Anticoagulant alert card

Your doctor or pharmacist will give you an anticoagulant alert card.

Carry this with you all the time. It tells healthcare professionals that you’re taking an anticoagulant. This can be useful for them to know in case of a medical emergency.

If you need any medical or dental treatment, show your anticoagulant alert card to the nurse, doctor or dentist.

This includes before you have vaccinations and routine sessions with the dental hygienist.

Your doctor may advise you to stop taking rivaroxaban or reduce your dose for a short time.

Switching from warfarin to rivaroxaban

If you need to switch from warfarin to rivaroxaban, your doctor will advise you when to stop taking warfarin. This will probably be a few days before you start rivaroxaban.

Your doctor or anticoagulant clinic will do a blood test called the international normalised ratio (INR) to check how quickly your blood’s clotting.

This is to help decide exactly when you should start taking rivaroxaban.

Switching from rivaroxaban to warfarin

If you need to switch from rivaroxaban to warfarin, you may need to take both medicines together for a few days.

Your doctor or anticoagulant clinic will do a blood test called the international normalised ratio (INR) to check how quickly your blood’s clotting.

This is to help decide exactly when you should stop taking rivaroxaban.

Xarelto – Uses, Side Effects, Interactions

How does this medication work? What will it do for me?

Rivaroxaban belongs to the family of medications called anticoagulants.  Anticoagulants prevent harmful blood clots from forming in the blood vessels by reducing the ability of the blood to clot. Rivaroxaban is used to prevent blood clots for people who have had total hip replacement or knee replacement surgery. It is used to treat blood clots for people who have had a deep vein thrombosis (DVT; a blood clot in a major blood vessel, particularly the leg) or pulmonary embolism (blood clot in the lung), and to prevent these clots from happening again.

Rivaroxaban is also used to prevent stroke or blood clots for people with atrial fibrillation.

The low dose of rivaroxaban (2.5 mg) is used in combination with low-doses of acetylsalicylic acid (ASA) to prevent stroke, heart attack, blood clots in the arms and legs, and death for people with coronary artery disease. This combination is also used for people with confirmed peripheral artery disease who are at increased risk for stroke, heart attack or a blockage of blood flow to the arms or legs.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

2. 5 mg
Each round, biconvex, film-coated, light yellow, immediate-release tablet of 6 mm diameter, with the Bayer Cross on one side and “2.5” and a triangle on the other side, contains 2.5 mg of rivaroxaban. Nonmedicinal ingredients: cellulose microcrystalline, croscarmellose sodium, hypromellose 5 cP, lactose monohydrate, magnesium stearate, and sodium lauryl sulfate; film coating: ferric oxide yellow, hypromellose 15 cP, polyethylene glycol, and titanium dioxide.

10 mg
Each round, biconvex, light red, film-coated tablet, marked with the Bayer Cross on one side and “10” and a triangle on the other side, contains rivaroxaban 10 mg. Nonmedicinal ingredients: croscarmellose sodium, hypromellose 5 cP, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, ferric oxide red, hypromellose 15 cP, polyethylene glycol, and titanium dioxide.

15 mg
Each round, biconvex, red, film-coated tablet, marked with the Bayer Cross on one side and “15” and a triangle on the other side contains rivaroxaban 15 mg.  Nonmedicinal ingredients: croscarmellose sodium, hypromellose 5 cP, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, ferric oxide red, hypromellose 15 cP, polyethylene glycol, and titanium dioxide.

20 mg
Each round, biconvex, brown-red, film-coated tablet, marked with the Bayer Cross on one side and “20” and a triangle on the other side contains rivaroxaban 20 mg. Nonmedicinal ingredients: croscarmellose sodium, hypromellose 5 cP, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, ferric oxide red, hypromellose 15 cP, polyethylene glycol, and titanium dioxide.

Granules for Oral Suspension
Following reconstitution, each mL of the oral suspension contains 1 mg of rivaroxaban. Nonmedicinal ingredients: citric acid, anhydrous, flavour sweet and creamy, hypromellose 5 cp, mannitol, microcrystalline cellulose and carmellose sodium (syn. : microcrystalline cellulose and carboxymethylcellulose sodium), sodium benzoate, sucralose, and xanthan gum.

Supplied as 2.625 g bottle and 5.25 g bottle.

How should I use this medication?

For knee replacement surgery or hip replacement surgery, the usual dose of rivaroxaban is 10 mg taken by mouth, once daily with or without food. This medication is generally started within 6 to 10 hours after the surgery. For hip replacement surgery, the treatment should continue for 35 days. For knee replacement surgery, the treatment should continue for 14 days.

To treat blood clots in the veins of the legs or prevent recurrent blood clots in the lungs or veins of your legs, the recommended starting dose is 15 mg taken two times a day, with food, for 3 weeks. After 3 weeks, the recommended dose is 20 mg taken once a day. The treatments should continue until your physician decides otherwise. After 6 months of treatment for blood clots in the lungs or legs, the dose to continue to prevent blood clots from forming again is 10 mg or 20 mg taken once daily. Your doctor will decide on the dose, depending on your risk of experiencing a new blood clot.

For stroke and clot prevention for people with atrial fibrillation, the usual dose is 20 mg taken by mouth, once daily with food.

To prevent stroke, heart attack, risk of sudden death, or clots blocking blood flow to the legs or arms for people with coronary artery disease, or for people with symptomatic peripheral artery disease the usual dose is 2.5 mg taken by mouth twice daily. One of these doses should be taken at the same time as low-dose ASA.

If you are taking 15 mg or 20 mg at a time, it is suggested that you take this medication with or immediately after food. If you cannot swallow tablets whole, rivaroxaban may be crushed and mixed with a small amount of applesauce immediately before taking the medication.

For infants and children under the age of 18 years, rivaroxaban oral suspension may be used for the treatment of blood clots in the legs or lungs, or to prevent recurrence of clots in the legs or lungs. The dose is based on body weight. Your doctor will calculate the correct dose and the number of times per day it needs to be given. This medication should be given with feeding or with food.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose of rivaroxaban and you are taking the medication once daily, take it as soon as possible and continue with your regular schedule. If you are taking rivaroxaban 2.5 mg two times a day, skip the missed dose and continue with your normal schedule. Do not take two doses at once to make up for the missed dose.

If you are taking rivaroxaban 15 mg two times a day, take the dose as soon as you remember and continue with your normal schedule. If it is time for your next dose already take 2 tablets (30 mg total) at once, then continue with your normal dosing schedule. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

If your child takes rivaroxaban suspension twice daily and has missed the morning dose, take the dose as soon as you remember and continue with your normal schedule. If it is already time for the evening dose, you may give the forgotten dose together with the evening dose. A missed evening dose can only be given if you remember on the same evening.

If your child takes rivaroxaban suspension three times daily and has missed a dose, skip the missed dose and continue with your regular dosing schedule. Do not take an extra dose to make up for the missed dose.

If you or your child vomits after taking a dose of rivaroxaban, and it is less than 30 minutes since taking the dose, take another dose. If you or your child vomit and it is more than 30 minutes since you took the dose, do not take another dose. Take your next dose at its regular time.

Store rivaroxaban tablets at room temperature and keep them out of the reach of children. Rivaroxaban suspension may be stored at room temperature or in the refrigerator for 14 days after being prepared. If storing in the refrigerator, allow it to warm to room temperature before administering it to your child.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take rivaroxaban if you:

• are allergic to rivaroxaban or any ingredients of the medication
• are bleeding actively or have a high risk of bleeds
• are pregnant or breast-feeding
• are taking certain medications such as ketoconazole, itraconazole, voriconazole, posaconazole, or ritonavir
• are taking other anticoagulants (blood thinners, e. g., warfarin, heparin, low molecular weight heparin, apixaban)
• have a body lesion at risk of bleeding, including bleeding in the brain within the last 6 months, or bleeding in your stomach or gut
• have liver disease associated with an increased risk of bleeding

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• bleeding
• bruising
• constipation
• decreased energy
• diarrhea
• fluid buildup in legs or ankles
• headache
• heartburn
• increased menstrual bleeding
• nausea
• stomach ache
• vomiting

Although most of these side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• bleeding or oozing from the surgical wound
• decreased urine production
• fast heartbeat
• fever
• itchy skin or skin rash
• pain, swelling, or numbness in the legs or arms
• reddish colour in the urine
• signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of bleeding (e. g., bloody nose that lasts for more than 5 minutes, blood in urine, coughing blood, cuts that don’t stop bleeding, gums that bleed for longer than 5 minutes when brushing teeth, bleeding into the rectum or from hemorrhoids, excessive menstrual bleeding)
• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• signs of low blood pressure (e.g., dizziness, lightheadedness, fainting)
• stiff, sore, hot, or painful joints
• symptoms of unidentified bleeding (e.g., weakness, paleness, dizziness, headache, unexplained swelling)
• unexpected bruising or bleeding after surgery
• vaginal bleeding (women after menopause)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of bleeding in the stomach (e. g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)
• signs of a serious allergic reaction (i.e., hives, difficulty breathing, or swelling of the face and throat)
• signs of severe skin reactions (e.g., blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort)
• signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

HEALTH CANADA ADVISORY

December 20, 2018

Health Canada has issued new restrictions concerning the use of Xarelto (rivaroxaban). To read the full Health Canada Advisory, visit Health Canada’s web site at healthycanadians.gc.ca.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Heart valve disease: Rivaroxaban is not recommended for people who have artificial heart valves or have had artificial aortic valve replacement.

Increased bleeding risk: If you have conditions that are associated with an increased risk of bleeding (e.g., bleeding problems; uncontrolled very high blood pressure; a problem with the blood vessels in the back of the eye called retinopathy; current or past ulcer of the stomach or intestines; recent stroke; or recent surgery of the brain, spinal column, or eye), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney disease: Decreased kidney function or kidney disease can cause rivaroxaban to build up in the body, causing side effects. If you have kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Lactose: This medication contains lactose. People with certain rare problems associated with lactose or galactose intolerance (e.g., Lapp lactase deficiency, glucose-galactose malabsorption) should not take this medication.

Liver disease: If you have liver disease or decreased liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Spinal or epidural injection or catheters: If you have a spinal or epidural catheter, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Surgery: Inform all health care professionals involved in your care that you are taking rivaroxaban. Rivaroxaban may need to be stopped temporarily before dental or surgical procedures to reduce your risk of bleeding heavily during or after the procedure.

Pregnancy: This medication should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: Rivaroxaban may pass into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. This medication should not be taken while breast-feeding.

Children: The safety and effectiveness of using this medication for conditions other than the treatment of blood clots in the legs or lungs, or to prevent the recurrence of clots in the legs or lungs have not been established for children less than 18 years of age.

Seniors: The side effects of this medication may be more noticeable in seniors. People who are over 65 years old should discuss with their doctor how this medication may affect them and whether any special monitoring is needed.

What other drugs could interact with this medication?

There may be an interaction between rivaroxaban and any of the following:

• acetylsalicylic acid (ASA)
• anagrelide
• other anticoagulant medications (e.g., apixaban, dabigatran, edoxaban, fondaparinux, heparin, and low-molecular weight heparins [e.g., enoxaparin, dalteparin], warfarin)
• apalutamide
• “azole” antifungal medications (e.g., ketoconazole, itraconazole, voriconazole)
• carbamazepine
• celecoxib
• clopidogrel
• cobicistat
• deferasirox
• dipyridamole
• dronedarone
• enzalutamide
• estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
• garlic
• ginger
• ginkgo biloba
• ginseng
• HIV protease inhibitors (e. g., darunavir, indinavir, ritonavir)
• lumacaftor and ivacaftor
• macrolides (e.g., erythromycin, clarithromycin)
• medications to break down blood clots (e.g., alteplase, defibrotide, streptokinase, urokinase)
• mifepristone
• nonsteroidal anti-inflammatory medications (NSAIDs; e.g., diclofenac, ibuprofen, naproxen)
• obinutuzumab
• omega-3 fatty acids
• oxcarbazepine
• phenobarbital
• phenytoin
• prasugrel
• primidone
• progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
• protein kinase inhibitors (e.g., dabrafenib, dasatinib, imatinib, lapatinib, sunitinib)
• red clover
• rifampin
• sarilumab
• selective serotonin reuptake inhibitors (SSRIs; (e.g., citalopram, escitalopram, fluoxetine, paroxetine)
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)
• siltuximab
• St. John’s wort
• ticagrelor
• ticlopidine
• tocilizumab
• verapamil
• vitamin E

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2021. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Xarelto

Xarelto – NPS MedicineWise

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about XARELTO. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking XARELTO against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.
You may need to read it again.

WHAT XARELTO IS USED FOR

The active substance is rivaroxaban. It belongs to a group of medicines called anticoagulants. It works by inhibiting the blood clotting protein called Factor Xa, thus reducing the tendency of blood to form clots.

XARELTO has been prescribed to you for one of the following uses:

• Prevention of blood clots in your veins after a hip or knee replacement operation because after an operation you are at an increased risk of getting blood clots
• Prevention of blood clots in your brain (stroke) and/or other blood vessels in your body if you have a form of irregular heart rhythm called non-valvular atrial fibrillation
• Treatment of blood clots in the veins of your legs (deep vein thrombosis, DVT) and clots in your lung (pulmonary embolism, PE) and to prevent blood clots from re-occurring in your legs and/or lungs.

XARELTO 2.5 mg tablets twice daily along with aspirin 100 mg once daily, has been prescribed to you for:

• prevention of major heart related events (stroke, heart attack and death from heart related conditions) if you have poor blood flow in the blood vessels of your heart (coronary artery disease or CAD) and/or arms and legs (peripheral artery disease or PAD).

Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed XARELTO for another reason.

XARELTO is a prescription medicine. It should only be used in adults under medical supervision.

BEFORE YOU TAKE XARELTO

When you must not take it

Do not take XARELTO if you have an allergy to:

• any medicine containing rivaroxaban
• any of the ingredients listed at the end of this leaflet

Some of the symptoms of an allergic reaction may include:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin

Do not take XARELTO:

• if you are bleeding excessively or at an increased risk of bleeding
• if you have liver disease which leads to an increased risk of bleeding
• if you have end stage kidney disease or if you are undergoing dialysis (a procedure used to remove waste products from the blood). Your doctor will know how to determine your kidney function.
• If you are taking medicines for fungal infections e.g. ketoconazole, or itraconazole, voriconazole, or posaconazole, unless they are only applied to the skin
• if you are taking anti-viral medicines for HIV/AIDS e.g. ritonavir
• if you had bleeding in the brain within the last 6 months.

If you are not sure whether you should start using XARELTO, talk to your doctor or pharmacist.

Do not use this medicine if you are pregnant or intend to become pregnant.
Women should use a reliable contraceptive while taking XARELTO.

Do not use XARELTO if you are breastfeeding.
It is not known whether rivaroxaban passes into human breast milk.

Tell your doctor if you have a mechanical heart valve

• XARELTO may not be suitable for you because it has not been studied in patients with mechanical heart valve.

This medicine should not be used in a child under the age of 18 years.

Do not take this medicine after the expiry date printed on the pack and blister.
The expiry date is printed on the carton and on each blister after “EXP” (e.g. 11 18 refers to November 2018). The expiry date refers to the last day of that month. If it has expired, return it to your pharmacist for disposal.

Do not take this medicine if the packaging is torn or shows signs of tampering.
If the packaging is damaged, return it to your pharmacist for disposal.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

• if you have kidney disease.
  
  Doctor will need to take special care in patients with moderate or severe kidney disease. Your doctor will do tests to determine how severe your kidney disease is.
• if you have kidney disease and undergoing dialysis (a procedure used to remove waste products from the blood)
• if you have prosthetic heart valves
• if you have liver disease
• if a doctor has told you that you have a severe form of antiphospholipid syndrome (a disease which can cause blood clots)
• if you have an increased risk of bleeding such as:
  
  – bleeding disorders
  
  – very high blood pressure, not controlled by medical treatment
  
  – an active ulcer or a recent ulcer of your stomach or bowel
  
  – a problem with the blood vessels in the back of your eyes
  
  – recent bleeding in your brain
  
  – a recent operation on your brain, spinal column or eye
  
  – abnormalities in blood vessels of your spine or brain
  
  – a lung disease where your bronchi are widened (bronchiectasis), or history of bleeding in the lungs
• If you have CAD and/or PAD and had the following:
  
  – a bleed in your brain (stroke) or
  
  – a blood clot in your brain (ischaemic, non-lacunar stroke) in the previous month or
  
  – a blockage of the small arteries in the brain (lacunar stroke).

Your doctor may decide to keep you under closer observation.

In the event of a surgery

Tell your doctor, dentist or pharmacist if you need to have an operation (including dental work) while you are taking XARELTO.
It is very important to take XARELTO and any other medications you might be on, before and after the operation exactly at the times you have been told by your doctor.

During any invasive procedure or operation, if it involves a catheter or injection into your spinal column (e.g. for epidural or spinal anaesthesia or pain reduction):

• it is very important to take XARELTO before and after the injection or removal of the catheter exactly at the times you have been told by your doctor
• tell your doctor immediately if you get numbness or weakness of your legs or problems with your bowel or bladder after the end of anaesthesia, because urgent care is necessary

If you have not told your doctor about any of the above, tell them before you start taking XARELTO.

XARELTO contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking it.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Your doctor or pharmacist may have more information on medicines to be careful with or to avoid while taking XARELTO because its effect may be increased.

Some medicines and XARELTO may interfere with each other. These include:

• other medicines to reduce blood clotting e.g. enoxaparin, clopidogrel or warfarin
• some medicines to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs))

These medicines may be affected by XARELTO, may increase the effect of XARELTO or mayaffect how well XARELTO works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking XARELTO.

Tell your doctor if you are taking anti-inflammatory and pain relieving medicines e.g. naproxen or medicines used for the protection of heart disease e.g. acetylsalicylic acid (aspirin).

Your doctor may decide to keep you under closer observation. If your doctor thinks that you are at increased risk of developing stomach or bowel ulcers, he may also use a preventative ulcer treatment.

If you have CAD and/or PAD, your doctor may ask you to take your XARELTO 2.5 mg tablet twice daily with aspirin 100 mg once daily.

If you are taking

• medicines for treatment of epilepsy (phenytoin, carbamazepine)
• St John’s Wort, a herbal product used for depression
• Rifampicin, an antibiotic

Tell your doctor before taking XARELTO, because its effect may be reduced.

HOW TO TAKE XARELTO

Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.

If you do not understand the instructions on the pharmacist label, ask your doctor or pharmacist for help.

How much to take

To prevent clots in your veins after a hip or knee replacement operation, the dose is one XARELTO 10 mg tablet once a day with or without food.

To prevent blood clots in brain (stroke) and other blood vessels, the usual dose is one XARELTO 20 mg tablet once daily. If your kidneys are not working properly, your doctor may reduce your dose to one XARELTO 15 mg tablet once daily. The tablet packs are marked with days of the week to help you remember if you have taken your daily dose. XARELTO 15 mg and 20 mg tablets are to be taken with food.

To treat blood clots in your legs and clots in your lungs and for preventing blood clots from re-occurring, the usual dose is one XARELTO 15 mg tablet TWICE daily for the first three weeks, followed by one XARELTO 20 mg tablet ONCE daily. The initial treatment pack (42 tablet pack) is marked with days of the week and “am” for the morning dose and “pm” for the evening dose. This will help you remember if you have taken the required dose. After 6 to 12 months treatment your doctor may decide to continue treatment with either one XARELTO 20 mg tablet ONCE a day or one XARELTO 10 mg tablet ONCE a day. XARELTO 15 mg and 20 mg tablets are to be taken with food.

To prevent major heart related events if you have CAD and/or PAD, the dose is one XARELTO 2.5 mg tablet twice daily. You must also take one 100 mg aspirin tablet once a day. XARELTO 2.5 mg tablets can be taken with or without food. Swallow the tablets preferably with water.

If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take XARELTO. The tablet may be crushed and mixed with water or apple puree immediately before you take it. This drink should be immediately followed by food.

If necessary, the crushed XARELTO tablet may be given to you through a stomach tube.

After giving the crushed XARELTO tablet via the stomach tube, you or your carer should flush the tube with water. If you are taking the 15 or 20 mg XARELTO tablet, you should be fed via the stomach tube straight after your dose of XARELTO.

When to take it

Following hip or knee replacement operation: Take the first tablet 6 to10 hours after your operation or as advised by your doctor. Then take a tablet every day for the duration prescribed, unless your doctor tells you to stop.

If you have had a hip replacement you will usually take the tablets for 5 weeks. If you have had a knee replacement you will usually take the tablets for 2 weeks. Your doctor will advise you about the exact duration.

For prevention of stroke or treatment or prevention of blood clots in your legs and/or lungs, take the tablet(s) every day until your doctor tells you to stop. Your doctor will decide how long you must continue your treatment.

If your heart beat needs to be restored to normal by a procedure called cardioversion, take XARELTO according to your doctor’s instructions.

If you need a procedure to treat blocked blood vessels in your heart (called a percutaneous coronary intervention – PCI with an insertion of a stent), the dose may be changed by your doctor. Your doctor will advise you about any changes to the amount of XARELTO you should take.

For prevention of major heart related events if you have CAD and/or PAD, your doctor will tell you when to start treatment with XARELTO 2.5 mg twice daily with aspirin 100 mg once daily. Your doctor will decide how long you must continue treatment.

It is important that you follow instructions from your doctor and not to miss or stop taking your medicine or lower the dosage without checking with your doctor. XARELTO has been prescribed to you by your doctor to treat and/or prevent a serious medical condition.

Try to take the tablet(s) at the same time every day to help you remember.

If you forget to take it

If you are taking one XARELTO 10 mg, or one 15 mg, or one 20 mg tablet ONCE a day: If you have missed a dose, take it as soon as you remember. Do not take more than one tablet in a single day to make up for a forgotten dose. Take the next tablet on the following day and then carry on taking a tablet once a day as normal. Do not take a double dose to make up for a forgotten tablet.

If you are taking one XARELTO 15 mg tablet TWICE a day and have misseda dose, take it as soon as you remember.
If you forget to take a dose; you can take two XARELTO 15 mg tablets at the same time to get a total dose of 30 mg in one day. The following day onwards, you should take one XARELTO 15 mg tablet twice a day as normal, until required.

If you are taking XARELTO 2.5 mg tablet TWICE a day and have missed a dose, you can take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (Australia: 13 11 26 or New Zealand: 0800 POISON or 0800 764 766) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much XARELTO. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.

Taking too much XARELTO increases the risk of bleeding.

WHILE YOU ARE TAKING XARELTO

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking XARELTO.

Take XARELTO exactly as your doctor has prescribed.

Remember to carry your patient alert card in your wallet with you at all times.

Tell all doctors, dentists and pharmacists who are treating you that you are taking XARELTO.

Tell your doctor if you need to have a surgical or dental procedure.
Tell your doctor that you are using XARELTO, if your doctor is planning for you to have an anaesthetic injection in your back (spinal or epidural injection).

Tell your doctor if other medications are prescribed to you during the course of therapy with XARELTO.

If you become pregnant while you are taking XARELTO, immediately tell your doctor.

Things you must not do

Do not take XARELTO to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not stop taking your medicine or lower the dosage without checking with your doctor first because XARELTO treats and prevents serious conditions.

Things to be careful of

If this medicine makes you feel faint or dizzy, do not drive or use machinery.

SIDE EFFECTS

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking XARELTO.

All medicines have side effects. Sometimes they are serious, most of the time they are not. In serious cases, you may need medical attention.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Your doctor may need to monitor and conduct blood tests, as XARELTO can affect your liver or pancreatic enzymes. You may not experience any specific symptoms.

Like other similar medicines (anticoagulants), XARELTO may cause bleeding, which may potentially be life threatening. In some cases this bleeding may not be obvious. There is no antidote available to reverse the effects of XARELTO, however there are measures your health professional can take to control / stop the bleeding. Please see your doctor if you experience any symptoms of bleeding.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

• exceptional weakness, unexplained swelling
• breathlessness, chest pain
• signs of allergy such as rash, itching or hives on skin, swelling of the face, lips, tongue, or other parts of the body, shortness of breath, wheezing or trouble breathing
• signs of liver problems such as yellowing of the skin and/or eyes (jaundice)
• prolonged or excessive bleeding from gums, nose etc
• numbness in the arms and legs
• dizziness, fainting
• oozing from a surgical wound
• vomiting or coughing up blood
• blood in the urine or stool
• heavy menstrual bleeding
• skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals

Your doctor may decide to keep you under observation or change how you should be treated.

Tell your doctor as soon as possible if you experience any of the following side effects and they worry you.

• tiredness, pale skin and breathlessness
• bruising
• feeling sick (nausea)
• headache
• diarrhoea, indigestion, or stomach pain
• pain in the arms or legs
• constipation
• fever
• frequent infections such as severe chills, sore throat and mouth ulcers
• mild rash, itchy skin
• fast heart beat

These side effects are usually mild.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people. If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

AFTER USING XARELTO

Storage

Keep your tablets in their blister pack until it is time to take them.
If you take the tablets out of the box or blister pack, they may not keep well.

Store the tablets in a cool dry place where the temperature stays below 30°C.

Do not store it or any other medicine in the bathroom, near a sink, or on a window sill.

Do not leave it in the car.
Heat and damp can destroy some medicines.

Keep out of the reach and sight of children.
A locked cupboard at least one and a half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking the tablets, or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

Return any unused medicine to your pharmacist.

PRODUCT DESCRIPTION

What it looks like

XARELTO 2.5 mg film-coated tablets are light yellow, round, film-coated tablets marked with the BAYER cross on one side and “2.5” and a triangle on the other side. It is packed in blister packs in cartons of 14, 56, 60 and 100 tablets.

XARELTO 10 mg film-coated tablets are light red, round, film-coated tablets marked with the BAYER-cross on one side and “10” and a triangle on the other side. It is packed in blister packs in cartons of 3, 10, 15, 30 and 100 tablets.

XARELTO 15 mg film-coated tablets are red, round, film-coated tablets marked with the BAYER-cross on one side and “15” and a triangle on the other side. It is packed in blister packs in cartons of 7, 14, 28, 42, 84, 98 and 100 tablets.

XARELTO 20 mg film-coated tablets are brown- red, round, film-coated tablets marked with the BAYER-cross on one side and “20” and a triangle on the other side. It is packed in blister packs in cartons of 7, 28, 84, 98 and 100 tablets.

Not all pack sizes may be marketed.

Ingredients

Active ingredient per tablet:

• XARELTO 2.5 mg contains 2.5 mg rivaroxaban
• XARELTO 10 mg contains 10 mg rivaroxaban
• XARELTO 15 mg contains 15 mg rivaroxaban
• XARELTO 20 mg contains 20 mg rivaroxaban

Inactive ingredients:

• microcrystalline cellulose
• croscarmellose sodium
• hypromellose
• lactose monohydrate
• magnesium stearate
• sodium lauryl sulfate
• iron oxide red (10 mg, 15 mg and 20 mg tablets)
• iron oxide yellow (2.5 mg tablets)
• macrogol 3350
• titanium dioxide

Supplier

Made in Germany or Italy for:

Bayer Australia Ltd

ABN 22 000 138 714

875 Pacific Highway

Pymble NSW 2073

Bayer New Zealand Limited

3 Argus Place, Hillcrest,

North Shore

Auckland 0627

Telephone: 0800 229 376

Australian Registration Number

XARELTO 2.5 mg – AUST R 298198

XARELTO 10 mg – AUST R 147400

XARELTO 15 mg – AUST R 181185

XARELTO 20 mg – AUST R 181186

Date of Preparation

02 June 2020

See TGA website (www.ebs.tga.gov.au) for latest Australian Consumer Medicine Information.

See MEDSAFE website (www.medsafe.govt.nz) for latest New Zealand Consumer Medicine Information.

® Registered Trademark of Bayer Group, Germany

© Bayer Australia Ltd All rights reserved.

Published by MIMS July 2020

Xarelto 20 MG Tablet (14) – Uses, Side Effects, Dosage, Composition & Price

Uses of Xarelto 20mg 14’S Tab

• Xarelto 20mg tablet is indicated for the treatment and prevention of blood clotting conditions associated with deep vein thrombosis, pulmonary embolism and stroke prevention.

• It is also used for the prevention of blood clotting resulting after a hip or knee surgery and atrial fibrillation.

Contraindications of Xarelto 20mg 14’S Tab

• If you are allergic to this medicine of any of the ingredient of Xarelto 20mg tablet.

• If you are bleeding.

• If you are suffering from a condition of increased risk of bleeding.

• If you are pregnant or breastfeeding.

• If you are already taking any other anti coagulating medicines.

• If you have liver disease.

Side effects of Xarelto 20mg 14’S Tab

• Headache

• Dizziness

• Allergic skin reactions like rashes, itching, swelling

• Increased liver enzymes

• Eye and nose bleeding

• Low blood pressure

• Body and muscular pain, bleeding in joints

• Dry mouth

• Bloodstains in cough

• Lightheadedness

• Fainting

• Nausea, vomiting

• Anaemia

• Fever, weakness

• Stomach discomfort like diarrhoea, indigestion, constipation

Precautions and Warnings of Xarelto 20mg 14’S Tab

Pregnancy

Q:

Can I take Xarelto 20mg tablet during pregnancy?

A:

It is not recommended to be used during pregnancy. If you think you are a woman of childbearing age and might become pregnant, discontinue the treatment and seek a safer alternative.

Breast Feeding

Q:

Can I take Xarelto 20mg tablet while breastfeeding?

A:

Components of this medicine pass in breast milk. Breastfeeding is not advised when you are taking this medicine. Breastfeeding women should consult a doctor before starting the treatment.

Driving

Q:

Can I drive if I have consumed this medicine?

A:

Dizziness and weakness are prominent side effects of rivaroxaban. It is advised to only go for a drive if the individual feels completely fit and in their senses.

Alcohol

Q:

Can I consume alcohol with Xarelto 20mg tablet?

A:

Consumption of alcohol has no adverse effect on the working of the medicine; however, it is advised to consult a doctor first.

Other General Warnings

Talk to your doctor if

• You have any kind of medical condition like kidney problem, bleeding disorder, lungs disease, heart-related problem, high blood pressure.

• You are elderly because the risk of excessive bleeding increases with age.

• People with surgery appointments are advised to stop the medication at least 3–4 days before the due date. The dosage set by the doctor is to be strictly followed.

Mode of Action of Xarelto 20mg 14’S Tab

Directions for Use of Xarelto 20mg 14’S Tab

• The tablets are to be taken as prescribed by the doctor.

• There are usually swallowed with water. Also, they are not supposed to be chewed or broken.

• It would be best if you took it at a fixed time for optimal results.

• You should not consume it more than that prescribed by your doctor.

Interactions of Xarelto 20mg 14’S Tab

Interactions with other medicines

• Sometimes Xarelto 20mg tablet may affect the way other medicines work, and other medicines may affect how Xarelto 20mg tablet works if taken at the same time.

• Tell your doctor about all the medicines, supplements, or herbals you are currently taking or might take to avoid any possible interaction.

• Especially/In particular if you are taking medicines like antibiotics like erythromycin, ketoconazole, itraconazole, anti-HIV medicines like ritonavir, medicines used for heart-related disorders like dronedarone or any other blood thinners etc.

  Read less

Storage and disposal of Xarelto 20mg 14’S Tab

• The medicine is to be kept at room temperature and away from extremities like heat or moisture.

• Keep it out of reach of children.

• Do not take this medicine after the expiry date which is mentioned in the medicine.

Dosage of Xarelto 20mg 14’S Tab

Overdose

Symptoms of overdose may increase the risk of bleeding. If you have taken too much of this medicine then contact your doctor or reach out to the nearest hospital immediately.

Missed a Dose

A missed dose is advised to be taken as soon as possible. However, it is advised not to take the missed dose if the next dose is near and can result in a double dose.

Frequently Asked Questions (FAQs)

Q: Is this medicine prescribed only to prevent blood clots?

A: Xarelto 20mg tablet is an anticoagulant that is used to prevent blood clots and also as a blood-thinning drug for individuals with heart conditions.

Q: How long does it take for this medicine to start working?

A: It usually takes two to four hours before the drug starts to show its effects.

Q: How long after getting off Xarelto 20mg tablet can a mother resume breastfeeding?

A: A mother should wait for at least two days after getting off the medication to resume breastfeeding. Consult the doctor for more information.

Q: Is it recommended to take the medicine on an empty stomach?

A: Individuals can take the medicine either after a meal or on an empty stomach.

Q: Is there a diet an individual is required to follow when on prescription for rivaroxaban?

A: There are no reported complications with any food products. The individual is free to eat what they feel like, but healthy diet.

Differences, similarities, and which is better for you

Drug overview & main differences | Conditions treated | Efficacy | Insurance coverage and cost comparison | Side effects | Drug interactions | Warnings | FAQ

Eliquis and Xarelto are two brand-name medications used to treat various clotting disorders. Both drugs are oral anticoagulants classified in a group of medications called factor Xa inhibitors. They work by blocking factor Xa, which produces thrombin, a necessary ingredient in clot production. By blocking factor Xa, the medications decrease the production of clots. Continue reading below to learn more about Eliquis and Xarelto. 

What are the main differences between Eliquis and Xarelto?

Eliquis (apixaban) and Xarelto (rivaroxaban) are NOACs (novel oral anticoagulants), which are a group of newer blood thinners. They are also known as DOAC (direct oral anticoagulants). Unlike Coumadin (warfarin), a popular and older anticoagulant, patients taking Eliquis or Xarelto do not need regular blood tests to monitor levels. Both Eliquis and Xarelto are known as factor Xa inhibitors, but they have some differences.

Eliquis and Xarelto are both approved by the FDA for prescription use and are available in brand name only. No generic is available yet for either drug; however, a generic Eliquis should be available soon. Eliquis is made by Bristol-Myers Squibb. Xarelto is made by Janssen Pharmaceuticals. Both drugs are used by adults, and the dosage varies by indication.

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Conditions treated by Eliquis and Xarelto

Eliquis and Xarelto have several indications that are the same—to reduce the risk of stroke and embolism in patients with nonvalvular atrial fibrillation (AFib, or irregular heartbeat), prevent deep vein thrombosis (DVT) in patients who have had hip or knee replacement, treat DVT, treat PE, and to reduce the risk of recurrent DVT or PE following initial therapy.

Additionally, Xarelto has two more indications. Xarelto can prevent venous thromboembolism (VTE) and VTE-related death. Xarelto may be prescribed during hospitalization and after discharge in adult patients who are at risk for complications due to restricted mobility and other risk factors. However, Xarelto should not be prescribed to patients who are at high risk of bleeding. Xarelto is also used with aspirin to lower the risk of major cardiovascular events such as death, heart attack, and stroke in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD).

Is Eliquis or Xarelto more effective?

A review and meta-analysis of Eliquis and Xarelto for acute venous thromboembolism (VTE) concluded that both drugs were similarly effective but that Eliquis may be safer. The patients treated with Xarelto experienced more bleeding—both major and minor.

Another study reviewed Eliquis and Xarelto, and also Pradaxa (another newer anticoagulant) and Coumadin (warfarin, an older anticoagulant). The authors concluded that Eliquis had the most favorable efficacy, safety, and patient compliance.

The best drug for you can only be determined by your healthcare provider, who can take into account the full picture of your medical condition(s), medical history, and other medications you take that could interact with Eliquis or Xarelto.

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Coverage and cost comparison of Eliquis vs. Xarelto

Eliquis is typically covered by insurance and Medicare Part D, but the copays vary widely. A typical Eliquis prescription for a one-month supply (60 tablets of 5 mg) would cost nearly $700 if you pay out-of-pocket. You can use a SingleCare card purchase Eliquis for under $450.

Xarelto is usually covered by insurance and Medicare Part D, but the copays vary. A typical Xarelto prescription for a one-month supply (30 tablets of 20 mg) would cost about $620 at retail price. You can use a SingleCare coupon to purchase Xarelto for about $430.

Common side effects of Eliquis vs. Xarelto

The most common side effects of both drugs are related to bleeding, such as nosebleed, contusions (bruising), blood in the urine, or bleeding gums. The incidence of bleeding side effects can vary. On rare occasions, bleeding can be serious or even life-threatening.

Other side effects that may occur with Eliquis include fatigue, loss of energy, weakness, shortness of breath, and nausea.

Other side effects that may occur with Xarelto include abdominal or back pain, fatigue, dizziness, itching, anxiety, depression, and/or insomnia.

This is not a complete list of side effects. Consult your healthcare provider for more information on adverse reactions of Eliquis and Xarelto.

Source: DailyMed (Eliquis), Product Monograph (Eliquis), DailyMed (Xarelto)

Drug interactions of Eliquis and Xarelto

Eliquis and Xarelto interact with certain drugs that are metabolized by the same enzyme. When enzyme inhibitor drugs are used with Eliquis or Xarelto, the levels of Eliquis or Xarelto in your body would increase, which would put you at increased risk for bleeding. If you have to take this combination of drugs, it is likely that your doctor will decrease your dose of Eliquis or Xarelto while on both medications.

On the other hand, when enzyme inducers are taken with Eliquis or Xarelto, there is an interaction where those drugs make Eliquis or Xarelto metabolize faster, and you will not get enough of the Eliquis or Xarelto dose.

Also, using Eliquis or Xarelto with other anticoagulants, antiplatelet drugs, NSAIDs (nonsteroidal anti-inflammatory drugs), and certain antidepressants may increase the risk of bleeding.

This is not a full list of drug interactions. Consult your healthcare provider for more information.

Warnings of Eliquis and Xarelto

Eliquis and Xarelto have a boxed (black box) warning, which is the strongest warning required by the FDA. Other warnings include:

• Discontinuing Eliquis or Xarelto prematurely increases the risk of a clotting event.
• Epidural or spinal hematoma may occur in patients who are receiving neuraxial (between vertebrae) anesthesia or spinal puncture. The hematoma could result in long-term or permanent paralysis. The risk is higher in patients with epidural catheters, patients taking other medications that affect blood flow, patients with a history of traumatic/repeated punctures, and/or patients with a history of spinal deformity or surgery. Patients should be frequently monitored for signs/symptoms of neurological impairment (numbness/weakness of the legs, bowel/bladder problems), and if any issues occur, the patient should seek emergency medical attention.
• Bleeding may occur and could be serious (major bleeding) or potentially fatal. Using Eliquis or Xarelto with certain drugs (anticoagulants, antiplatelet drugs, NSAIDs, SSRI and SNRI antidepressants) increases the risk of bleeding. Patients with bleeding should seek emergency medical attention. The drug should be stopped in patients with active hemorrhage.
• A reversal agent is available, to reverse the effects of factor Xa inhibition.
• Eliquis or Xarelto are not recommended in patients with prosthetic heart valves.
• Eliquis or Xarelto are not recommended as an alternative to heparin for initial treatment of PE patients who have hemodynamic instability (shock/heart failure).
• Eliquis or Xarelto should not be used in patients with triple-positive antiphospholipid syndrome (APS) due to an increased risk of clotting.
• If you have liver or kidney problems, talk to your healthcare provider before taking Eliquis or Xarelto.

Pregnancy use:

• There is limited data on the use of Eliquis or Xarelto in pregnancy. Treatment with Eliquis or Xarelto may increase the risk of bleeding during both pregnancy and delivery, and increase the risk of bleeding in the fetus/newborn. Using Eliquis or Xarelto during labor or delivery in women receiving an epidural may cause epidural or spinal hematoma A shorter-acting anticoagulant may be used if needed. Consult your OB-GYN about the use of Eliquis or Xarelto during pregnancy. Generally, the drug is only used if benefits outweigh risks (for example, in certain high-risk pregnancies), and with careful monitoring. If you are already using Eliquis or Xarelto and find out that you are pregnant, consult your OB-GYN for guidance.

Frequently asked questions about Eliquis vs. Xarelto

What is Eliquis?

Eliquis is a brand-name anticoagulant (blood thinner) used to prevent or treat blood clots.

What is Xarelto?

Xarelto is a brand-name anticoagulant, and it helps to prevent or treat blood clots.

Are Eliquis and Xarelto the same?

Eliquis and Xarelto are both known as factor Xa inhibitors. They are very similar, but not exactly the same. Differences are outlined above. Other factor Xa inhibitors are Pradaxa (dabigatran), Arixtra (fondaparinux), Savaysa (edoxaban), and Bevyxxa (betrixaban).

Is Eliquis or Xarelto better?

Studies (see above for details) have shown that Eliquis and Xarelto are similarly effective, or that Eliquis may be slightly more effective. Eliquis seems to have a lower risk of bleeding than Xarelto. Ask your doctor if Eliquis or Xarelto is appropriate for you.

Can I use Eliquis or Xarelto while pregnant?

Generally, Eliquis and Xarelto are not used in pregnancy. However, some exceptions may occur in certain patients who are at high risk for clots. Consult your healthcare provider.

Can I use Eliquis or Xarelto with alcohol?

Alcohol can thin the blood. If you take Eliquis or Xarelto and drink alcohol, this could increase the risk for bleeds. Also, alcohol can aggravate certain medical conditions. You can ask your healthcare provider if it is safe to drink, and how much, with the medication you take and the medical condition(s) you have.

Is Xarelto cheaper than Eliquis?

For a one-month supply, the price of Xarelto and the price of Eliquis are very similar. The price of Eliquis and Xarelto with a SingleCare coupon start at $447 and $428. A generic for Eliquis should be available soon.

What is the safest blood thinner to use?

Blood thinners are safe when used as prescribed. However, with any blood thinner, there is a risk of bleeding, even a major or life-threatening bleed. Blood thinners can also interact with certain medications. Consult your healthcare provider to find out which blood thinner is most appropriate for you.

Does Eliquis affect the liver?

Less than 1% of patients on Eliquis in clinical trials had abnormal liver tests. You should notify your doctor before taking Eliquis or Xarelto if you have liver problems.

Ksarelto (Rivaroxaban) – Republican Hospital named after I. V.A.Baranova

34 reviews, instructions for use

Application during pregnancy and breastfeeding

The efficacy and safety of using Xarelto ^® in pregnant women have not been established.

Data obtained in experimental animals showed a pronounced toxicity of rivaroxaban for the maternal organism, associated with the pharmacological action of the drug (for example, complications in the form of hemorrhages) and leading to reproductive toxicity.

Due to the possible risk of bleeding and the ability to penetrate the placental barrier, Xarelto ^® is contraindicated in pregnancy.

In women of childbearing age, Xarelto ^® should only be used if effective contraceptive methods are used.

The efficacy and safety of Xarelto ^® in women during lactation have not been established. Data obtained in experimental animals show that rivaroxaban is excreted in breast milk.Xarelto ^® can only be used after breastfeeding has been stopped.

Application for violations of liver function

Xarelto ^® is contraindicated in patients with liver disease, occurring with coagulopathy, leading to a clinically significant risk of bleeding. No dose adjustment is required in patients with other liver diseases.

Application for impaired renal function

In patients with impaired renal function of mild (CC 50-80 ml / min) or moderate (CC 30-49 ml / min) severity, dose adjustment of Xarelto ^® is not required.

In patients with severe renal impairment (CC 15-29 ml / min) Xarelto ^® should be used with caution, because Limited clinical data indicate that plasma concentrations of rivaroxaban are significantly increased in this patient population. The use of Xarelto ^® is contraindicated in patients with CC <15 ml / min.

Use in children

Contraindication: children and adolescents under 18 years of age (efficacy and safety for patients of this age group have not been established).

Use in elderly patients

No dose adjustment depending on the patient’s age (over 65 years) is required.

Special instructions

The use of Xarelto ^® is not recommended in patients receiving concomitant systemic treatment with azole antifungal drugs (eg ketoconazole) or HIV protease inhibitors (eg ritonavir). These drugs are potent inhibitors of CYP3A4 and P-glycoprotein. Thus, these drugs can increase the plasma concentration of rivaroxaban to clinically significant values ​​(on average, 2.6 times), which can lead to an increased risk of bleeding.

However, the azole antifungal fluconazole, a moderate inhibitor of CYP3A4, has a less pronounced effect on rivaroxaban exposure and can be used concomitantly.

No effect of Xarelto ^® on the duration of the QT interval _from was found.

Renal failure

Xarelto ^® should be used with caution in patients with moderate renal impairment (CC 30-49 ml / min) receiving concomitant drugs that can lead to an increase in plasma rivaroxaban concentration.

In patients with severe renal impairment (CC <30 ml / min), the plasma concentration of rivaroxaban can be significantly increased (1.6 times on average), which can lead to an increased risk of bleeding. Therefore, due to the presence of the specified underlying disease, such patients have an increased risk of developing both bleeding and thrombosis. Due to the limited amount of clinical data, Xarelto ^® should be used with caution in patients with CC 15-29 ml / min.

Clinical data for patients with severe renal impairment (CC <15 ml / min) are not available. Therefore, in this category of patients, the use of Xarelto ^® is contraindicated.

Patients with severe renal impairment or an increased risk of bleeding, as well as patients receiving concomitant systemic treatment with azole antifungals or HIV protease inhibitors, should be closely monitored for signs of bleeding after starting treatment.Observation can be carried out through regular physical examination of patients, careful monitoring of the drainage of the postoperative wound, as well as by periodic determination of hemoglobin.

Patients with a history of stroke or transient ischemic attack (TIA)

Taking Xarelto ^® at a dose of 2.5 mg 2 times / day is contraindicated in patients with ACS who have a history of stroke or TIA. Only a few patients with ACS with a history of stroke or TIA have been studied, therefore, data on the effectiveness of the drug in such patients are extremely limited.

Risk of bleeding

Xarelto ^® , like other antithrombotic agents, should be used with caution in diseases and conditions associated with an increased risk of bleeding, such as:

• congenital or acquired coagulation disorders;
• uncontrolled severe arterial hypertension;
• active gastrointestinal pathology with ulceration;
• recent acute gastrointestinal ulcer;
• Vascular retinopathy;
• Recent intracranial or intracerebral hemorrhage;
• Intraspinal or intracerebral vascular abnormalities;
• Recent brain, spinal or ophthalmic surgery;
• History of bronchiectasis or episode of pulmonary hemorrhage.

Caution should be exercised if the patient is simultaneously receiving medications that affect hemostasis, such as NSAIDs, platelet aggregation inhibitors or other antithrombotic drugs.

Patients after ACS receiving Xarelto ^® in combination with acetylsalicylic acid or Xarelto ^® in combination with acetylsalicylic acid and clopidogrel / ticlopidine can receive NSAIDs as long-term concomitant treatment only if the positive effects of treatment are justified bleeding.

In patients at risk of developing gastrointestinal ulcers, appropriate prophylactic treatment can be used.

For any unexplained decrease in hemoglobin or blood pressure, the source of the bleeding must be identified.

The efficacy and safety of Xarelto ^® have been studied in combination with the antiplatelet agent acetylsalicylic acid and clopidogrel / ticlopidine. The use as part of combination therapy with other antiplatelet agents (for example, prasugrel or ticagrelor) has not been studied, for this reason it is not recommended for use.

Spinal anesthesia

When performing epidural / spinal anesthesia or lumbar puncture in patients receiving platelet aggregation inhibitors to prevent thromboembolic complications, there is a risk of developing epidural or spinal hematoma, which can lead to long-term paralysis.

The risk of these events is further increased with the use of an indwelling epidural catheter or concomitant therapy with drugs that affect hemostasis.Traumatic epidural or lumbar puncture or re-puncture may also increase the risk. Patients should be monitored for signs or symptoms of neurological disorders (eg, numbness or weakness in the legs, bowel or bladder dysfunction). If neurological disorders are detected, urgent diagnosis and treatment is required. The clinician should weigh the potential benefit and relative risk before undergoing spinal cord intervention in patients receiving anticoagulants or who are planning to prescribe anticoagulants to prevent thrombosis.The epidural catheter is removed no earlier than 18 hours after the last dose of rivaroxaban is administered. Rivaroxaban should be administered no earlier than 6 hours after removal of the epidural catheter. In the case of a traumatic puncture, the appointment of rivaroxaban should be postponed for 24 hours.

Surgical operations and interventions

If an invasive procedure or surgery is required, Xarelto ^® 2.5 mg should be discontinued at least 24 hours before the intervention. if possible, and based on a clinician’s clinical judgment.

If the patient undergoing planned surgery does not need an antiplatelet effect, the use of platelet aggregation inhibitors should be discontinued, as indicated in the instructions for use of the drug provided by the manufacturer.

If the procedure cannot be postponed, then a comparative assessment of the increased risk of bleeding should be carried out and the question of the need for urgent intervention should be decided.

Xarelto ^® should be resumed after an invasive procedure or surgery as soon as possible, provided that clinical parameters allow and adequate hemostasis is achieved.

Influence on the ability to drive vehicles and use mechanisms

While taking the drug, the occurrence of fainting and dizziness was noted, which can affect the ability to drive vehicles or other mechanisms. Patients who experience such adverse reactions should not drive vehicles or other mechanisms.

Medicines from WhatsApp. Kazakh scientists disassembled drugs from mailing lists: July 13, 2020, 18:36

In medicine and in protocols, the trade name of the drugs is never indicated, and “Xarelto” is the trade name of rivaroxaban, an anticoagulant (doctors know that it is a direct factor Xa inhibitor), which is prescribed after acute coronary syndrome.

Properties

This is a very serious drug used in patients with strokes, atrial fibrillation, and peripheral arterial disease to reduce the risk of recurrent deep vein thrombosis.

The drug is prescribed only in conjunction with a doctor when the entire medical history and associated pathologies, diseases and even the history of surgical operations are known.

The drug interrupts the internal and external pathways of blood coagulation, prevents the formation of thrombin and the development of blood clots.However, it has no effect on platelets. This allows for easy dose adjustments in anticoagulant therapy, as well as avoiding dietary restrictions.

Side effects

Scientific studies have shown that rivaroxaban caused epidural hematomas, spinal hematomas and even paralysis in patients with spinal surgery or lumbar puncture.

It is highly recommended not to take this drug together with aspirin and other coagulants. Simultaneous administration with paracetamol or ibuprofen can lead to internal bleeding, especially for people with stomach and duodenal ulcers. All this can lead to a load on the surgical link, and there is no guarantee that there will be places in the hospital.

If, for any reason, you began to take rivaroxaban on your own for prophylaxis, it is recommended to contact your doctor online for further action, since an independent abrupt withdrawal of this drug can lead to a worsening of the condition and to dangerous consequences.It is very important to tell your doctors about any medications you have taken with rivaroxaban.

The same applies to all patients with diabetes mellitus. German studies have shown that abrupt withdrawal of rivaroxaban in diabetic patients results in extensive bleeding . Strokes are also possible.

For persons over 60 years of age, this drug should be prescribed with extreme caution, as kidney function decreases, which affects the effects of various drugs in the body.Rivaroxaban should be administered with caution to pregnant women, as it can cross the placenta and even cause bleeding in the fetus . And also for lactating women, since this substance can pass into breast milk. In women taking progestins as a contraceptive and rivaroxaban at the same time, effects may be counteracted by .

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