How is apalutamide administered. What are the common side effects of apalutamide. How can patients manage potential risks associated with apalutamide treatment. What precautions should be taken when using apalutamide.

Understanding Apalutamide: A Comprehensive Overview

Apalutamide is a medication primarily used in the treatment of certain types of prostate cancer. As with any pharmaceutical, it’s crucial for patients and healthcare providers to have a thorough understanding of its uses, administration methods, and potential side effects. This article aims to provide a detailed exploration of apalutamide, offering valuable insights for those prescribed this medication or considering it as a treatment option.

Proper Administration of Apalutamide: Dosage and Instructions

Apalutamide is typically administered orally, with or without food, as directed by a healthcare professional. The standard dosage is usually once daily, but this can vary based on individual patient needs and medical conditions.

Swallowing Difficulties: Alternative Administration Methods

For patients who have difficulty swallowing tablets whole, there are alternative methods of administration:

• For 60 mg tablets: Mix whole tablets with 4 ounces (120 mL) of applesauce, following a specific stirring and waiting process.
• For 240 mg tablets: Mix the whole tablet with water, then add orange juice, applesauce, or more water before consumption.

Is it safe to crush or split apalutamide tablets? No, it’s important to note that apalutamide tablets should not be cut, chewed, or crushed. Always follow the specific instructions provided by your healthcare provider or pharmacist.

Common Side Effects of Apalutamide: What Patients Should Expect

Like many medications, apalutamide can cause various side effects. While not everyone experiences these, it’s important to be aware of potential reactions:

• Hot flashes
• Fatigue
• Joint pain
• Nausea
• Decreased appetite
• Weight loss
• Reduced sexual interest or ability

Can apalutamide cause more serious side effects? Yes, while less common, some patients may experience more severe reactions. These can include:

• Elevated blood pressure
• Signs of an underactive thyroid
• Weakening of bones and muscles
• Increased susceptibility to infections
• Symptoms resembling a heart attack or stroke
• Seizures

It’s crucial to report any persistent or worsening side effects to your healthcare provider promptly.

Managing Potential Risks: Precautions and Monitoring

To ensure safe and effective use of apalutamide, certain precautions should be taken:

1. Regular blood pressure checks
2. Monitoring for signs of infection
3. Awareness of bone health and fall risk
4. Vigilance for any allergic reactions

How often should patients on apalutamide have check-ups? The frequency of medical check-ups can vary, but regular monitoring is essential. Your healthcare provider will establish a suitable schedule based on your individual health status and response to the medication.

Special Considerations for Apalutamide Use

Certain groups require special attention when using apalutamide:

Pregnancy and Exposure Risks

Apalutamide can be harmful to unborn babies. Women who are pregnant or may become pregnant should avoid handling the medication or breathing in tablet dust.

Patients with Difficulty Swallowing

For those using feeding tubes, specific instructions from a healthcare professional are necessary for proper administration.

Are there any dietary restrictions while taking apalutamide? While apalutamide can be taken with or without food, it’s important to maintain consistency in your routine. Discuss any significant dietary changes with your healthcare provider.

Recognizing and Responding to Allergic Reactions

While rare, allergic reactions to apalutamide can occur. Patients should be aware of potential symptoms:

• Rash or itching
• Swelling, especially of the face, tongue, or throat
• Severe dizziness
• Difficulty breathing

How can patients distinguish between a mild rash and a serious allergic reaction? This can be challenging, as apalutamide commonly causes mild rashes that are usually not serious. However, due to the potential for severe reactions, it’s advisable to seek medical attention for any rash development while taking this medication.

Interactions and Contraindications: What Patients Should Know

Apalutamide may interact with other medications or medical conditions. It’s crucial to provide your healthcare provider with a comprehensive list of all medications, supplements, and health conditions before starting treatment.

Can apalutamide be used in combination with other cancer treatments? The use of apalutamide in combination with other therapies should be carefully evaluated by your oncologist. Some combinations may be beneficial, while others could increase the risk of side effects or reduce treatment efficacy.

Long-term Considerations and Follow-up Care

Patients on long-term apalutamide therapy should be aware of the importance of ongoing medical supervision:

• Regular assessments of treatment efficacy
• Monitoring for cumulative side effects
• Adjustments to dosage or treatment plan as needed
• Periodic evaluation of overall health and quality of life

How long do patients typically remain on apalutamide treatment? The duration of apalutamide therapy can vary significantly depending on individual factors such as the type and stage of cancer, response to treatment, and overall health status. Your oncologist will determine the appropriate length of treatment based on your specific situation.

Patient Education and Support Resources

Empowering patients with knowledge and support is crucial for successful apalutamide treatment:

Educational Materials

Patients should have access to comprehensive information about apalutamide, including:

• Detailed medication guides
• Instructions for proper administration
• Side effect management strategies
• FAQs addressing common concerns

Support Networks

Connecting with others can be beneficial for patients on apalutamide:

• Patient support groups
• Online forums and communities
• Counseling services for emotional support

Where can patients find reliable information about apalutamide beyond their healthcare provider? Reputable sources include cancer organizations, academic medical centers, and government health agencies. Always verify information with your healthcare team to ensure its relevance to your specific situation.

Advances in Apalutamide Research: Future Perspectives

The field of cancer treatment is continuously evolving, and research on apalutamide is ongoing:

Current Studies

• Investigations into new potential applications
• Research on combination therapies
• Long-term efficacy and safety studies

Emerging Trends

Keep an eye on developing areas in apalutamide research:

• Personalized medicine approaches
• Novel drug delivery methods
• Strategies for minimizing side effects

How might future research impact current apalutamide treatment protocols? Ongoing studies could lead to refined dosing strategies, expanded indications, or improved management of side effects. Patients should stay informed about new developments and discuss potential implications with their healthcare providers.

Navigating Insurance and Cost Considerations

Understanding the financial aspects of apalutamide treatment is important for many patients:

Insurance Coverage

Coverage for apalutamide can vary:

• Check with your insurance provider for specific coverage details
• Be aware of any prior authorization requirements
• Understand your out-of-pocket costs and deductibles

Patient Assistance Programs

For those facing financial challenges, assistance may be available:

• Manufacturer-sponsored programs
• Non-profit organization support
• Hospital or clinic-based financial assistance

Are there generic alternatives to brand-name apalutamide? As of now, apalutamide is still under patent protection, meaning generic versions are not yet available. However, this may change in the future, potentially affecting cost and accessibility.

Lifestyle Considerations While on Apalutamide

Maintaining a healthy lifestyle can complement apalutamide treatment:

Diet and Nutrition

While there are no specific dietary restrictions with apalutamide, a balanced diet is important:

• Focus on nutrient-rich foods
• Stay hydrated
• Consult with a nutritionist if experiencing appetite changes

Exercise and Physical Activity

Regular physical activity can be beneficial, but consider these factors:

• Start slowly and gradually increase intensity
• Be aware of potential fatigue or joint pain
• Incorporate bone-strengthening exercises, if appropriate

Stress Management

Coping with cancer and treatment can be stressful. Consider these strategies:

• Mindfulness and meditation techniques
• Regular relaxation practices
• Engaging in enjoyable hobbies or activities

Can lifestyle modifications impact the effectiveness of apalutamide treatment? While lifestyle factors alone don’t determine treatment outcomes, maintaining overall health can support your body during treatment and potentially help manage side effects. Always discuss significant lifestyle changes with your healthcare team.

Apalutamide in the Context of Overall Cancer Care

Understanding how apalutamide fits into the broader landscape of cancer treatment is crucial:

Combination Therapies

Apalutamide may be used in conjunction with other treatments:

• Androgen deprivation therapy (ADT)
• Radiation therapy
• Other targeted therapies or immunotherapies

Treatment Sequencing

The timing of apalutamide treatment can vary:

• As initial therapy for certain types of prostate cancer
• Following other treatments
• In the context of recurrent or metastatic disease

How does a healthcare team determine the best treatment approach incorporating apalutamide? The decision is based on multiple factors, including the specific type and stage of cancer, overall health status, previous treatments, and individual patient preferences. It’s a collaborative process involving oncologists, urologists, and other specialists to create a personalized treatment plan.

Monitoring Treatment Efficacy and Disease Progression

Regular assessment is crucial to ensure apalutamide is effectively managing the cancer:

Diagnostic Tests

Various tests may be used to monitor treatment response:

• PSA (Prostate-Specific Antigen) levels
• Imaging studies (CT scans, bone scans, MRI)
• Physical examinations

Treatment Adjustments

Based on monitoring results, treatment may be modified:

• Dosage adjustments
• Addition or removal of complementary treatments
• Consideration of alternative therapies if needed

How frequently should patients expect to undergo monitoring tests while on apalutamide? The frequency of monitoring can vary but typically includes regular PSA tests and periodic imaging studies. Your oncologist will establish a monitoring schedule tailored to your specific situation, often with more frequent assessments in the initial phases of treatment.

Addressing Quality of Life Concerns

Maintaining a good quality of life is an important aspect of cancer treatment:

Managing Treatment-Related Symptoms

Strategies to address common issues:

• Fatigue management techniques
• Pain control methods
• Strategies for coping with hot flashes

Emotional and Psychological Support

Resources for mental health and well-being:

• Access to mental health professionals
• Support groups specific to prostate cancer patients
• Resources for partners and family members

Sexual Health Considerations

Addressing potential sexual side effects:

• Open communication with healthcare providers about sexual concerns
• Exploration of treatment options for erectile dysfunction
• Counseling for couples to address intimacy issues

How can patients balance the benefits of apalutamide treatment with potential quality of life impacts? It’s important to have ongoing discussions with your healthcare team about your priorities and concerns. Treatment plans can often be adjusted to optimize both cancer control and quality of life. Don’t hesitate to voice your concerns and ask about available supportive care options.

Future Directions in Prostate Cancer Treatment

The landscape of prostate cancer treatment, including the use of drugs like apalutamide, is continually evolving:

Emerging Therapies

New treatment options on the horizon:

• Novel hormonal therapies
• Advanced immunotherapies
• Precision medicine approaches

Clinical Trials

Opportunities for participating in research:

• Trials exploring new applications of apalutamide
• Studies on combination therapies
• Investigations into biomarkers for treatment response

How might the role of apalutamide in prostate cancer treatment change in the coming years? As research progresses, we may see expanded indications for apalutamide, refined treatment protocols, or its use in novel combination therapies. Staying informed about these developments and discussing them with your oncologist can help ensure you have access to the most current and effective treatment options.

apalutamide oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

How to use Apalutamide 60 Mg Tablet

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start taking apalutamide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow the tablets whole. Do not cut, chew, or crush the tablets.

If you are using the 60 milligram tablets and have difficulty swallowing the tablets whole, you may mix the whole tablets in 4 ounces (120 milliliters) of applesauce. Stir the mixture but make sure not to crush the tablets. Wait 15 minutes, and then stir the mixture again. Wait another 15 minutes and stir the mixture for a third time. Make sure the tablets are well mixed with no solid chunks remaining. Swallow the mixture right away using a spoon. After taking the mixture, rinse the container with 2 ounces (60 milliliters) of water and drink the mixture right away. Repeat the rinse to make sure you take the full dose of the medication. The applesauce/drug mixture should be used within 1 hour of making. Do not store for future use.

If you are using the 240 milligram tablet and have difficulty swallowing the tablet whole, you may mix the whole tablet with water as directed. Add 2 teaspoons (10 milliliters) of water to a cup with the tablet inside. Do not split or crush the tablet. Make sure that the tablet is covered with water. Wait 2 minutes for the tablet to break up and then stir the mixture. Then add 2 tablespoons (30 milliliters) of either orange juice, applesauce, or more water to the mixture and stir. Swallow the mixture right away. After taking the mixture, rinse the cup with water and drink the water to make sure you take the full dose of the medication. Do not save any of the mixture for future use.

If you are giving this medication through a feeding tube, ask your health care professional for detailed instructions on how to properly mix and give it.

The dosage is based on your medical condition and response to treatment. Do not increase your dose or take this drug more often than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Side Effects

Hot flashes, tiredness, joint pain, nausea, decreased appetite, weight loss, or decreased sexual interest/ability may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: signs of an underactive thyroid (such as unusual weight gain, cold intolerance, slow heartbeat, constipation).

Treatment with this medication can cause bones and muscles to weaken, which may increase your risk for falls and broken bones. Ask your doctor for details.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Get medical help right away if you have any signs of infection (such as sore throat that doesn’t go away, fever, swollen lymph nodes, chills, cough).

Get medical help right away if you have any very serious side effects, including: symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), signs of a stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion), seizure.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Apalutamide can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking apalutamide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as coronary artery disease, heart failure, recent heart attack), diabetes, high cholesterol, high blood pressure, stroke/transient ischemic attack (TIA), seizure, increased risk for seizure (such as brain injury, stroke, brain tumor).

Since this medication may rarely cause seizures in some people, ask your doctor if you should avoid activities where a sudden loss of consciousness may cause serious harm to you or others.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication should not be used by women, especially during pregnancy or breast-feeding. It may harm an unborn or breast-feeding baby. Consult your doctor for more details.

Older adults may be at greater risk for falls while using this drug.

Men who are sexually active with a pregnant woman must use a condom during treatment and for 3 months after stopping treatment. Men with female partners of childbearing age should use reliable forms of birth control during treatment and for 3 months after stopping treatment. If your partner becomes pregnant or thinks she may be pregnant, tell the doctor right away. Do not donate sperm during treatment and for at least 3 months after stopping treatment.

Consult your pharmacist or physician.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Apalutamide can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include artemether-lumefantrine, azole antifungals (such as isavuconazonium, voriconazole), cobicistat, lurasidone, nifedipine, ranolazine, rilpivirine, certain drugs for hepatitis C (such as asunaprevir, daclatasvir, ledipasvir, sofosbuvir), among others.

Does Apalutamide 60 Mg Tablet interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

Lab and/or medical tests (such as blood pressure, thyroid function) should be done while you are taking this medication. Keep all medical and lab appointments.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store in the original package at room temperature away from light and moisture. Do not store in the bathroom. Keep the drying agent (desiccant) in the bottle. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Apalutamide | Macmillan Cancer Support

Apalutamide (Erleada®) is a hormonal therapy drug used to treat prostate cancer. It can be used for the following:

• Prostate cancer that has not spread, but has stopped responding to other hormonal treatments (hormone resistant). This is called non-metastatic castrate-resistant prostate cancer. Apalutamide is used when there is a high risk of the cancer spreading to other parts of the body.  
• Prostate cancer that has spread to other parts of the body (advanced prostate cancer) and is still responding to hormonal treatment (hormone sensitive). It is used if the person is not having chemotherapy. It is given with other hormonal drugs. 

It is best to read this information with our general information about hormonal therapies and prostate cancer. 

Your doctor or nurse will talk to you about this treatment and its possible side effects before you agree (consent) to have treatment.

Hormones are chemicals that our bodies make. Hormones act as messengers and help control how cells and organs work. Hormonal therapies are drugs that change the way hormones are made or how they work in the body.

Prostate cancer needs the hormone testosterone to grow. Almost all testosterone is made by the testicles. A very small amount is made by the adrenal glands, which sit above the kidneys.

Apalutamide blocks the effect of testosterone on prostate cancer cells. This will usually slow down the growth of cancer cells. This can help control advanced prostate cancer or delay the spread of localised prostate cancer or locally advanced prostate cancer to other parts of the body. 

Taking apalutamide tablets

Apalutamide comes as tablets you can take at home. You may have apalutamide on its own, or with other drugs. Your nurse or doctor will talk to you about your treatment plan and tell you how many tablets you need to take. 

During treatment you will regularly see a cancer doctor, a cancer nurse or specialist nurse, and a specialist pharmacist. This is who we mean when we mention doctor, nurse or pharmacist in this information. They will ask you how you are feeling. They may check your weight and blood pressure.

Always take the tablets exactly as explained. This is important to make sure they work as well as possible for you. You usually take apalutamide tablets once a day. You can take apalutamide with or without food. 

Make sure you:

• swallow the tablets whole with a glass of water 
• do not chew, break or crush them 
• take them at the same time every day.  

If you forget to take the tablets, you should take the missed dose as soon as possible within the same day. If a full day has passed, let your doctor or nurse know. Do not take a double dose. 

Other things to remember about your tablets:

• Keep them in the original package and at room temperature, away from heat and direct sunlight.
• Keep them safe and out of sight and reach of children.
• If you are sick just after taking the tablets, contact your healthcare team. Do not take another dose.
• If your treatment is stopped, return any unused tablets to the pharmacist. 

Your nurse or pharmacist may also give you other medicines to take home. Take all your medicines exactly as they have been explained to you. Do not stop taking any of your medicines unless your doctor tells you to. 

We explain the most common side effects of this treatment here. We also include some less common side effects.

You may get some of the side effects we mention, but you are unlikely to get all of them. If you are also having treatment with other cancer drugs, you may have some side effects that we have not listed here.
Always tell your doctor, nurse or pharmacist about any side effects you have.

Your doctor can give you drugs to help control some side effects. It is important to take them exactly as your nurse or pharmacist explains. This means they will be more likely to work for you. Your nurse will give you advice about managing your side effects. After your treatment is over, most side effects start to improve.

Serious and life-threatening side effects

Some cancer treatments can cause severe side effects. Rarely, these may be life-threatening. Your cancer doctor or nurse can explain the risk of these side effects to you.

Contact the hospital

Your nurse will give you telephone numbers for the hospital. If you feel unwell or need advice, you can call them at any time of the day or night. Save these numbers in your phone or keep them somewhere safe.

More information

We cannot list every side effect for this treatment. There are some rare side effects that are not listed. You can visit the electronic Medicines Compendium (eMC) for more detailed information.

Tiredness

Feeling tired is a common side effect. Try to pace yourself and plan your day so you have time to rest. Gentle exercise, like short walks, can give you more energy. If you feel sleepy, do not drive or operate machinery.

Hot flushes and sweats

Hot flushes are a common side effect of this treatment. During a flush, your neck and face may feel warm and look red. Flushes may last from a few seconds up to 10 minutes. You may have sweats and then feel cold and clammy. Some people feel anxious or irritable during a hot flush.

There are things you can do to try to reduce flushes:

• Wear clothes made from natural fabrics, such as cotton.
• Wear layers of clothes that you can remove if you feel hot.
• Use cotton bed sheets and have layers of bedding that you can remove if you feel hot.
• Keep room temperatures cool or use a fan.
• Have cold drinks rather than hot ones. Try to avoid drinks with caffeine in them.

You may have fewer hot flushes and sweats as your body adjusts to hormonal treatment. Or your doctor can prescribe drugs to help. Flushes and sweats usually stop a few months after treatment finishes, but some people continue to have them.

You can read more about coping with hot flushes.

Loss of appetite

This treatment can affect your appetite. Don’t worry if you do not eat much for a day or 2. But if your appetite does not come back after a few days, or if you are losing weight, tell your nurse or dietitian. They can give you advice. They may give you food or drink supplements. Or they may suggest changes to your diet or eating habits to help.

Changes to your taste

You may get a bitter or metal taste in your mouth. Sucking sugar-free sweets may help with this. Some foods may taste different or have no taste. Try different foods to find out what tastes best to you. Taste changes usually get better after treatment finishes. Your nurse can give you more advice.

Muscle or joint pain

You may get pain in your muscles or joints. If this happens, tell your doctor so they can give you painkillers. Being physically active may help with the pain and keep your joints flexible. Keeping to a healthy weight may help too. Tell your doctor or nurse if the pain does not get better.

Skin changes

This treatment may affect your skin. It may cause a rash, which might be itchy. Your doctor or nurse can tell you what to expect. If your skin feels dry, try using an unperfumed moisturising cream every day.

Very rarely, this treatment may cause a more serious skin condition. You may have:

• a skin rash which then blisters 
• peeling skin 
• sores in your mouth, genitals and eyes 
• flu-like symptoms such as a high temperature and joint pain.  

If you have any of these symptoms, call your doctor or the 24-hour number the hospital has given you.

Always tell your doctor or nurse about any changes to your skin. They can give you advice and may prescribe creams or medicines to help. Skin changes usually improve when treatment finishes.

High blood pressure (hypertension)

Apalutamide may cause a rise in your blood pressure. Your doctor or nurse may check your blood pressure before you start taking apalutamide and during your treatment. They may suggest you check and record your blood pressure yourself while at home. You can show the readings to your healthcare team at your appointments.

Diarrhoea

This treatment may cause diarrhoea. Diarrhoea means passing more stools (poo) than is usual for you, or having watery or loose stools. If you have a stoma, it will be more active than usual.

If you have diarrhoea:

• try to drink at least 2 litres (3½ pints) of fluids each day
• avoid alcohol, caffeine, milk products, high-fat foods and high-fibre foods
• contact the hospital for advice.

Falls and fractures

Apalutamide can increase your risk of falling and breaking a bone (fracture). You may have scans to check your bone health before and during treatment. 

Regular exercise, such as walking, can improve your bone health. Eating a healthy diet can help too. Your doctor may prescribe drugs called bisphosphonates to help protect your bones. They may also advise you to take calcium and vitamin D supplements.

Effects on the heart

This treatment can affect the way your heart works. Your doctor may do tests to see how well your heart is working. You may have these tests before, during, and sometimes after treatment.

Contact a doctor straight away if you:

• have pain or tightness in your chest
• feel breathless or dizzy
• feel your heart is beating too fast or too slowly.

Other conditions can cause these symptoms. But it is important to get them checked by a doctor.

Seizures

Rarely, apalutamide can cause seizures (fits). If you have a seizure, stop taking apalutamide and see a doctor straight away.

Tell your doctor before you start treatment if you:

• have ever had a seizure
• are taking medication for seizures
• have had a stroke, brain tumour or other brain injury.

Contact the hospital straight away if you suddenly feel unwell or: 

• have a headache that gets worse
• feel confused
• have problems with your sight.

Raised cholesterol level

This treatment can raise the level of cholesterol (a fatty substance) in the blood. You may have a blood test to check the level of cholesterol.
Your doctor may give you medicines to control your cholesterol levels.

Hair thinning

Your hair may become thinner when you are taking this treatment. This is usually mild. Ask your nurse for advice if you are worried about this.

Effects on the thyroid gland

Apalutamide may cause your thyroid gland to become underactive (hypothyroidism). This means it will not produce the thyroid hormones your body needs. Symptoms of an underactive thyroid include:

• feeling tired
• being sensitive to cold
• putting on weight
• being constipated 
• having a low mood
• thinking and moving slowly. 

Your doctors can check how well your thyroid gland is working with a blood test. They can give you thyroid hormone tablets if needed. 

Blood clot risk

Cancer and some cancer treatments can increase the risk of a blood clot. Symptoms of a blood clot include:

• throbbing pain, redness or swelling in a leg or arm
• suddenly feeling breathless or coughing
• sharp chest pain, which may be worse when you cough or take a deep breath.

If you have any of these symptoms, contact the hospital straight away on the 24-hour contact number you have been given. If you cannot get through to your doctor, call the NHS urgent advice number on 111.

A blood clot is serious, but it can be treated with drugs that thin the blood (anticoagulants). Your doctor or nurse can give you more information.

You can help reduce the risk of developing a blood clot by:

• staying active during treatment
• drinking plenty of fluids, especially water.

You may be given anticoagulants to help prevent a clot.

Fertility

Some cancer drugs can affect whether you can make someone pregnant. If you are worried about this, it is important to talk with your doctor before you start treatment.

Contraception

Your doctor will advise you not to make someone pregnant while having this treatment. The drug may harm the developing baby. It is important to use effective contraception during your treatment, and for 3 months after stopping.

Medical and dental treatment

If you need medical treatment for any reason other than cancer, always tell the doctors and nurses you are having cancer treatment. Give them the contact details for your cancer doctor so they can ask for advice.

If you think you need dental treatment, talk to your cancer doctor or nurse. Always tell your dentist you are having cancer treatment.

Other medicines

Some medicines can affect how this treatment works or be harmful when you are having it. Always tell your cancer doctor about any drugs you are taking or planning to take, such as:

• medicines you have been prescribed
• medicines you buy in a shop or chemist
• vitamins, herbal drugs and complementary therapies.

Tell other doctors, pharmacists or dentists who prescribe or give you medicines that you are having this cancer treatment.

You can visit the electronic Medicines Compendium (eMC) for more detailed information about your treatment.

• Visit the electronic Medicines Compendium (eMC) to download a Patient Information Leaflet (PIL) for more detailed information. The leaflet lists all known side effects.

• This information has been written, revised and edited by Macmillan Cancer Support’s Cancer Information Development team. It has been reviewed by expert health professionals and people living with cancer.

  Our cancer information has been awarded the PIF TICK. Created by the Patient Information Forum, this quality mark shows we meet PIF’s 10 criteria for trustworthy health information.

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Erleada (apalutamide) showed a significant increase in overall survival in metastatic hormone-sensitive prostate cancer

Erleada (apalutamide) showed a significant increase in overall survival in metastatic hormone-sensitive prostate cancer

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survival among patients with metastatic hormone-sensitive prostate cancer

Moscow, March 5, 2021 — Janssen, the pharmaceuticals division of Johnson & Johnson LLC, announces the results of the final analysis of the Phase 3 TITAN study, in which apalutamide therapy in combination with androgen deprivation therapy ( ADT) demonstrated higher overall survival rates in patients with metastatic hormone-sensitive prostate cancer (mHRPC) compared with placebo in combination with ADT ¹ . The results of the analysis were presented during the online conference of the American Society of Clinical Oncology (ASCO), held from February 11 to 13.

TITAN phase 3 final analysis data, obtained at a median follow-up of 44 months, confirmed an increase in overall survival (OS) and a 35% reduction in the risk of death in patients who used apalutamide in combination with androgen deprivation therapy (ADT) in compared with the group using only ADT (RR = 0. 65; 95% CI: 0.53-0.79; p<0.0001) ¹ . This result was almost similar to the OS achieved in the primary analysis of the TITAN study, despite the subsequent conversion of almost 40% of placebo patients to treatment with apalutamide ¹ . After adjusting the results for the transition of some patients from the placebo group to receiving apalutamide, the reduction in the risk of death increased to 48% (RR = 0.52; 95% CI: 0.42-0.64; p<0.0001) ¹ .

“At Janssen, we are committed to finding new solutions for prostate cancer patients because, until recently, significant progress has not been made in the treatment of people with metastatic hormone-sensitive prostate cancer ² ,” commented Dr. Katherine Taylor, Vice President of Medical Affairs for EMEA at Johnson & Johnson. “According to the results of the final analysis of the TITAN study, the use of apalutamide in combination with androgen deprivation therapy provides new therapeutic options for patients with advanced hormone-sensitive prostate cancer. ”

A sustained effect was observed for other endpoints, including an increase in relapse-free survival (PFS2) (RR = 0.62; 95% CI: 0.51-0.75; p<0.0001), as well as the time to development of castration resistance (RR = 0.34; 95% CI: 0.29-0.41; p<0.0001). ¹ In addition, health-related quality of life, as assessed by the Functional Assessment of Cancer Therapy – Prostate Cancer (FACT-P) questionnaire, did not differ between the two groups of patients. The safety of apalutamide is consistent with data from previous studies. ¹ Side effects observed with the drug included skin rash, fractures, and weakness. ¹

“The final review of the TITAN study is a welcome development in the treatment of metastatic hormone-sensitive prostate cancer ² as its results demonstrate that apalutamide in combination with ADT improves long-term clinical efficacy and increases overall survival without compromising patient quality of life — said Professor Axel Merseburger, Chairman of the Urological Clinic of the University of Schleswig-Holstein and participant in the TITAN study. “The results of the analysis also confirmed the safety profile of the drug, which allows us to provide effective and safe treatment for patients with advanced forms of prostate cancer.”

Initial results from the TITAN study, presented at the 2019 annual meeting of the American Society of Clinical Oncology (ASCO) and published in The New England Journal of Medicine, showed that the use of apalutamide in combination with androgen deprivation therapy significantly improved rates of double primary endpoints of OS and radiographic progression-free survival (rFSD) in patients with mHRPC. ³

To date, published results from studies of apalutamide include more than 2,000 patients in phase 3 clinical trials. ³ Apalutamide showed a statistically significant improvement in OS with a robust safety profile in both patients with metastatic hormone-sensitive prostate cancer (TITAN) and non-metastatic castration-resistant prostate cancer (SPARTAN). ³

*Professor Axel Merseburger is a researcher who participated in the TITAN study and received a corresponding compensation for his work with the media.

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About the TITAN study ³ , ⁴

TITAN ( NCT02489318 ) is a phase 3, randomized, double-blind, placebo-controlled study conducted with participation of patients with metastatic hormone-sensitive prostate cancer. The study involved 1,052 patients in 23 countries and 260 clinical centers in North America, Latin America, South America, Europe including Russia, and the Asia-Pacific region. Patients with mHRPC were divided into two groups: one group received apalutamide (240 mg/day) plus ADT (n=525), and the other received placebo plus ADT (n=527). Groups of participants were recruited from December 2015 to July 2017. ³ , ⁴ The study included patients with mHRPC with both large and small metastatic lesions, patients with initially diagnosed mHRPC, as well as those who had previously received radical local treatment or chemotherapy in the amount of up to six cycles docetaxel. ³ , ⁴

The Independent Data Monitoring Committee (IDMC) was selected as the study sponsor to monitor the safety and efficacy of ⁵ therapy. The two primary endpoints of the study were OS and radiographic progression-free survival (rFSD) ¹ . Secondary endpoints included time to cytostatic chemotherapy, time to pain progression, time to chronic use of opiate analgesics, and time to bone complications ³ , ⁴ . Exploratory endpoints included time to prostate specific antigen (PSA) progression, relapse-free survival (PFS2), and time to symptomatic progression. ³ , ⁴ For more information about the trial, visit ClinicalTrials.gov.

About metastatic hormone-responsive prostate cancer

Metastatic hormone-responsive prostate cancer, also known as metastatic castration-sensitive prostate cancer, is prostate cancer that still responds to hormone therapy but has already spread beyond the prostate by others tissues and organs. ⁵

About Erleada (apalutamide)

Apalutamide is an oral selective androgen receptor inhibitor approved in Europe for the treatment of adult men with non-metastatic castration-resistant prostate cancer with high the risk of developing metastases, as well as with metastatic hormone-sensitive prostate cancer in combination with ADT. ⁶

About Janssen, Pharmaceutical Companies Johnson & Johnson

At Janssen, we are creating a future where disease is a thing of the past. We are the Pharmaceutical Companies of Johnson & Johnson and we spare no effort to make this future a reality for patients around the world. We defeat diseases with advanced science. We invent how to help those who need help. We heal hopelessness with human warmth.

We work in areas of medicine where we can bring the most benefit: cardiovascular diseases, immune-mediated diseases and metabolic disorders, infectious diseases and vaccines, diseases of the central nervous system, oncology, pulmonary arterial hypertension.

Learn more at janssen.com. Follow: twitter.com/JanssenGlobal. Johnson & Johnson LLC is part of the Janssen Pharmaceutical Companies, Johnson & Johnson.

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PROSUCTION measures for forecast statements

This press release contains “Forecast Information”, in accordance with the definition contained in the law on the proceedings on private securities for 1995, in relation further development and study of the potential benefits of apalutamide (Erleada). We emphasize that the reader should not be guided by forward-looking information. These statements are based on current expectations regarding future events. If underlying assumptions prove inaccurate or risks or uncertainties known or unknown to us arise, actual results may differ materially from the expectations and projections of Janssen, Johnson & Johnson Pharmaceuticals, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, the following: problems and uncertainties associated with research and development of new products, including the uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success; production difficulties and delays; competition, including technological advances, new products and patents obtained by competitors; difficulties with patents; drug efficacy or safety concerns that require a drug recall or regulatory action; changes in the behavior and spending patterns of consumers of health care products and services; changing relevant laws and regulations, including international health reforms; and trends towards containment of health care costs. An additional list of these risks, uncertainties, and other factors, along with a description of them, is provided in Johnson & Johnson’s Annual Report Form 10-K for the financial year ended 29December 2019, including under the heading “Forward-Looking Statements Warning” and “Item 1A. Risk Factors”, as well as in the company’s subsequent quarterly reports on Form 10-Q and other company documents filed with the Securities and Exchange Commission. Copies of these documents are available online at www.sec.gov, www.jnj.com or upon request to Johnson & Johnson. None of the Janssen pharmaceutical companies or Johnson & Johnson undertakes to update any forward-looking statements in the light of new information, future events or developments.

¹ Chi, K. Final Analysis Results From TITAN: A Phase 3 Study of Apalutamide (APA) vs Placebo (PBO) in Patients (pts) With Metastatic Castration-Sensitive Prostate Cancer (mCSPC) Receiving Androgen Deprivation Therapy (ADT). ASCO GU 2021 oral presentation.
² Hall, M, E. et al. Metastatic Hormone-sensitive Prostate Cancer: Current Perspective on the Evolving Therapeutic Landscape. NCBI . 2020; 13:3571–3581. Electronic resource: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7201221/. Retrieved: February 2021.
³ ERLEADA ^® Prescribing Information, September 17, 2019.
⁴ ClinicalTrials.gov. A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC (TITAN). Electronic resource: https://clinicaltrials.gov/ct2/show/NCT02489318. Accessed February 2021.
⁵ American Society of Clinical Oncology. ASCO Answers: Prostate Cancer (2018). Electronic resource: http://www.cancer.net/sites/cancer.net/files/asco_answers_guide_prostate.pdf. Retrieved: February 2021.
⁶ European Medicines Agency. ERLEADA. Electronic resource: https://www.ema.europa.eu/en/documents/product-information/erleada-epar-product-information_en. pdf. Accessed February 2021

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According to long-term patient survey results, the use of Erleada® (apalutamide) in metastatic hormone-sensitive prostate cancer improves the quality of life of patients

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According to long-term results of a patient survey, the use of Erleada® (apalutamide) in metastatic hormone-sensitive prostate cancer helps to maintain the quality of life of patients 9

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Results of the final analysis of the 3rd phase of the study TITAN presented by the American Society of Clinical Oncology (ASCO), confirm increased survival and improved quality of life when apalutamide is added to androgen deprivation therapy

Moscow, June 8, 2021 – Janssen, Pharmaceuticals Division of Johnson & Johnson LLC, presents the results of an analysis of the TITAN Phase 3 study in patients with metastatic hormone-responsive prostate cancer (mHRPC). ). The TITAN study has previously demonstrated an improvement in overall survival (OS) in patients treated with apalutamide in combination with androgen deprivation therapy (ADT) at a median follow-up of 44 months ¹ . New Patient Therapy Evaluation (PRO) results showed that the addition of apalutamide to ADT maintained patients’ quality of life and did not worsen the burden of side effects when compared with ADT alone ² . These data will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting June 4-8, 2021 (document #5068).

“Patients are often concerned about the side effects of treatment for a disease,” said Prof. Axel Merseburger, MD, Chairman of the Urological Clinic of the University of Schleswig-Holstein and participant in the TITAN study.* –The latest results from the TITAN clinical study show how we can improve overall patient survival without compromising quality of life, which is an important step towards improving the treatment of advanced prostate cancer. ”

A study found that apalutamide in combination with ADT delayed disease progression to metastatic castration-resistant prostate cancer (mCRPC) by more than 4.5 years. The median time to development of castration resistance was 11.4 months in the placebo plus ADT group, while the median was not reached in the apalutamide plus ADT group at 55 months (4.5 years) of follow-up. The reduction in the risk of developing castration resistance was 66% ¹ .

Quality of life in patients treated with apalutamide in combination with ADT and in patients treated with placebo plus ADT was maintained throughout the study. Overall, patients in both groups reported that quality of life did not decrease; results were assessed using the Brief Pain Intensity Inventory (BPI-SF) and the Functional Evaluation of Cancer Therapy – Prostate Cancer (FACT-P) questionnaire ² . On a pain score ranging from zero (no pain/discomfort with daily activities) to 10 (worst pain/discomfort), the mean patient scores were 1. 1 in the apalutamide group and 1 in the placebo group plus ADT. On the FACT-P quality of life score for prostate cancer patients (1-156, higher score = better quality of life), mean patient scores were 113 in the apalutamide group and 113.3 in the placebo plus ADT group ² . Apalutamide therapy in combination with ADT was also found to maintain physical, social, family, emotional, functional and mental well-being for two years, as assessed by the FACT-P scale. There were no significant differences between groups in the time to deterioration on any BPI or FACT-P measures, further confirming that quality of life was maintained with apalutamide ² .

Previously, apalutamide has been shown to increase OS in both patients with metastatic hormone-sensitive prostate cancer (TITAN) and patients with non-metastatic castration-resistant prostate cancer (SPARTAN) ³ . Data from the final analysis of the results of the TITAN study, presented in 2021 at the American Society of Clinical Oncology (ASCO) Genitourinary Cancer Congress and recently in the Journal of Clinical Oncology, confirmed that the addition of apalutamide to ADT continues to show a significant increase in OS with median follow-up of 44 months in patients with mHRPC. Apalutamide in combination with ADT reduces the risk of death by 35% compared with ADT alone (hazard ratio [HR]=0.65; 95% confidence interval [CI], 0.53-0.79; P<0.0001) ¹ .

“We are delighted to be able to share the results of the TITAN study at this year’s American Society of Clinical Oncology (ASCO) congress. We know they are needed to provide a complete picture of the patient experience with apalutamide in combination with androgen deprivation therapy for metastatic hormone-sensitive prostate cancer. The results of the study will guide physicians in prescribing the right therapy for a particular patient, said Dr. Katherine Taylor, Vice President of Medical Affairs and Therapeutic Strategy for Janssen Europe, Middle East and Africa. “These results, along with a significant increase in OS, provide additional evidence for apalutamide in combination with ADT for patients with mHRPC as first-line therapy.”

*Professor Axel Merseburger – company consultant Janssen unpaid media work.

About metastatic hormone-sensitive prostate cancer

Metastatic hormone-responsive prostate cancer, also known as metastatic castration-sensitive prostate cancer, is prostate cancer that is still responsive to hormone therapy , but has already spread beyond limits of the prostate to other tissues and organs ⁴ .

About the study TITAN ^{3.5 oe with the participation of patients with metastatic hormone-sensitive prostate cancer. The study involved 1052 patients in 23 countries and 260 clinical centers in North America, Latin America, South America, Europe, including Russia, and countries in the Asia-Pacific region. Patients with mHRPC were divided into two groups: one group received apalutamide (240 mg/day) plus ADT (n=525) and the other received placebo plus ADT (n=527). Participant groups were recruited between December 2015 and July 2017 3.6 . The study included patients with mHRPC with both large and small metastatic lesions, patients with initially diagnosed mHRPC, as well as those who had previously received radical local treatment or chemotherapy in the amount of up to six cycles of docetaxel 3.6 .}

The Independent Data Monitoring Committee (IDMC) was selected as the study sponsor to monitor the safety and efficacy of therapy ⁵ . The two primary endpoints of the study were OS and radiographic progression-free survival (rFSD) ⁵ . Secondary endpoints included time to cytotoxic chemotherapy, time to pain progression, time to permanent opioid analgesics, and time to bone complications ^3.6 . Exploratory endpoints included time to prostate-specific antigen (PSA) progression, survival to relapse (FSD2), and time to symptomatic progression ^3.6. For more information about the trial, visit ClinicalTrials.gov.

About Erleada (apalutamide)

Apalutamide is an oral selective androgen receptor inhibitor approved in Russia, the United States and Europe for the treatment of adult men with non-metastatic castration-resistant prostate cancer with a high risk of developing metastases, as well as with metastatic hormone-sensitive prostate cancer in combination with ADT ^7,8,9 .

About Janssen Pharmaceutical companies Johnson & Johnson

At Janssen, we are creating a future where disease is a thing of the past. We are the pharmaceutical companies of Johnson & Johnson, and we spare no effort to make this future a reality for patients around the world. We defeat diseases with advanced science. Inventing how to help those who need help. We heal hopelessness with human warmth.

We work in the areas of medicine where we can make the most difference: cardiovascular diseases, immune-mediated and metabolic diseases, infectious diseases and vaccines, diseases of the central nervous system, oncology, pulmonary arterial hypertension.

Find out more at janssen.com. Follow: twitter.com/JanssenGlobal. Johnson & Johnson LLC is part of the Janssen Pharmaceutical Companies, Johnson & Johnson.

Caution regarding forward-looking statements

This press release contains “forward-looking information” as defined in the Private Securities Litigation Reform Act of 1995 year, in regarding the further development and study of the potential benefits of apalutamide (Erleada). We emphasize that the reader should not be guided by forward-looking information. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or risks or uncertainties known or unknown to us arise, actual results could differ materially from expectations and forecasts Janssen , pharmaceutical companies Johnson & Johnson , and/or companies Johnson 90 196 & Johnson . Risks and uncertainties include, but are not limited to, the following: problems and uncertainties associated with the research and development of new products, including the uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success; production difficulties and delays; competition, including technological advances, new products and patents obtained by competitors; difficulties with patents; drug efficacy or safety concerns that require a drug recall or regulatory action; changes in behavior and spending patterns of consumers of health products and services; changing relevant laws and regulations, including international health reforms; and trends towards containment of health care costs. An additional list of these risks, uncertainties and other factors, together with their description, is presented in the company’s annual report Johnson & Johnson on Form 10- K for the fiscal year ended January 3, 2021, including under the heading “Forward-Looking Statements Warning” and “ Item 1 A . Risk Factors”, as well as in subsequent quarterly reports of the company in the form 10- Q and other company documents filed with the Securities and Exchange Commission. None of the pharmaceutical companies Janssen or the company Johnson & Johnson does not undertake to update any forward-looking statements in the light of new information, future events or developments.

1. Chi, K, et al. Apalutamide in Patients with Metastatic Castration-Sensitive Prostate Cancer: Final Survival Analysis of the Randomized, Double-Blind, Phase III TITAN Study. Journal of Clinical Oncology. Electronic resource: https://ascopubs.org/doi/full/10.1200/JCO.20.03488. Entry date: May 2021

2. Agarwal, N. et al. Health-related quality of life (HRQoL) and patient-reported outcomes at final analysis of the TITAN study of apalutamide (APA) versus placebo (PBO) in patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC) receiving androgen deprivation therapy (ADT). Electronic resource: https://meetinglibrary.asco.org/record/197750/abstract. Entry date: May 2021

3. ERLEADA. Summary of Product Characteristics, December 2020.

4. American Society of Clinical Oncology. ASCO Answers: Prostate Cancer (2018). Electronic resource: http://www.cancer.net/sites/cancer.net/files/asco_answers_guide_prostate.pdf. Date of entry: May 2021

5. ClinicalTrials.gov. A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC (TITAN). Online: https://clinicaltrials.