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Side effects of atazanavir: Atazanavir: MedlinePlus Drug Information

Atazanavir – Patient | NIH

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Atazanavir

Brand Name

Reyataz

Other Names

ATV, atazanavir sulfate

Drug Class

Protease Inhibitors (PIs)

Drug Image(s): (Click to enlarge)

 

What are the most important things to know about atazanavir? What are the most important things to know about atazanavir?

What are the most important things to know about atazanavir?

Atazanavir can cause serious, life-threatening side effects. These include changes in heart rhythm, severe skin rash and allergic reactions, liver problems, and drug interactions.

Contact your health care provider right away if you have any of the following symptoms that could be signs of a change in your heart rhythm:

  • Dizziness
  • Lightheadedness

Contact your health care provider right away if you develop a rash while taking atazanavir. Stop taking atazanavir and get medical help right away if you develop a rash with any of the following symptoms:

  • General ill feeling
  • Extreme tiredness
  • Muscle or joint aches
  • Fever
  • Blistering or peeling skin
  • Blisters or sores in your mouth
  • Redness or swelling of the eyes (conjunctivitis)
  • Swelling of your face, lips, mouth, tongue, or throat
  • Trouble breathing or swallowing

Some people taking atazanavir may develop liver problems. People with a history of hepatitis B virus infection (HBV) or hepatitis C virus infection (HCV) or who have elevated results on liver function tests may have an increased risk of developing worsening liver problems while taking atazanavir. Liver function tests may be done before and during treatment with atazanavir.

Contact your health care provider right away if you have any of the following symptoms that could be signs of liver problems:

  • Yellowing of your skin or the whites of your eyes (jaundice)
  • Dark-colored urine
  • Light-colored bowel movements
  • Loss of appetite for several days or longer
  • Nausea or vomiting
  • Pain, aching, or tenderness on the right side of your stomach/abdominal area
  • Itching

Taking atazanavir with certain medicines may result in serious, life-threatening side effects. Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

While taking atazanavir, it is important to keep all of your appointments with your health care provider.

What is atazanavir?What is atazanavir?

What is atazanavir?

Atazanavir (brand name: Reyataz) is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults and children. Atazanavir comes in two different dosage forms: capsules and oral powder.

  • Atazanavir capsules are approved for use in adults and children 6 years of age and older who weigh at least 33 lb (15 kg). Atazanavir capsules may be used with a pharmacokinetic enhancer (boosting agent) – either ritonavir (brand name: Norvir) or cobicistat (brand name: Tybost). (A fixed-dose combination tablet containing atazanavir and cobicistat [brand name: Evotaz] is also available. )
  • Atazanavir oral powder is approved for use in children 3 months of age and older who weigh at least 11 lb (5 kg) and must be used with the boosting agent ritonavir.

Atazanavir is always used in combination with other HIV medicines.

For more information on the use of atazanavir in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.

HIV medicines cannot cure HIV/AIDS, but taking HIV medicines every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission. If you are taking HIV medicines, do not cut down on, skip, or stop taking them unless your health care provider tells you to.

What should I tell my health care provider before taking atazanavir?What should I tell my health care provider before taking atazanavir?

What should I tell my health care provider before taking atazanavir?

Before taking atazanavir, tell your health care provider:

  • If you are allergic to atazanavir or any other medicines.
  • If you have heart problems.
  • If you have liver problems, including hepatitis B virus infection (HBV) or hepatitis C virus infection (HCV).
  • If you have phenylketonuria (PKU). The artificial sweetener (aspartame) in atazanavir oral powder contains phenylalanine. Phenylalanine may be harmful to people with PKU.
  • If you have kidney problems.
  • If you are receiving kidney dialysis treatment.
  • If you have diabetes.
  • If you have hemophilia.
  • If you have any other medical conditions.
  • If you are pregnant or plan to become pregnant. Talk to your health care provider about the risks and benefits of taking atazanavir during pregnancy. Atazanavir must be taken with ritonavir during pregnancy. If you take atazanavir during your pregnancy, after your baby is born, tell your health care provider if your baby’s skin or the white part of their eyes turns yellow. For more information on the use of atazanavir during pregnancy, please refer to the Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States.
  • If you are breast/chestfeeding or plan to breast/chestfeed. For people with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. People with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk.
  • If you are using hormone-based birth control (such as injections, vaginal rings, implants, a contraceptive patch, or birth control pills). Atazanavir may make these forms of birth control less effective. Your health care provider can help you decide how to adjust your birth control while you are taking atazanavir. For more information about using birth control and HIV medicines at the same time, view the HIVinfo HIV and Birth Control infographic.
  • About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products (particularly St. Johns’ wort) you are taking or plan to take. Atazanavir may affect the way other medicines or products work, and other medicines and products may affect how atazanavir works. Taking atazanavir together with certain medicines or products may cause serious, life-threatening side effects.

How should I take atazanavir?How should I take atazanavir?

How should I take atazanavir?

Atazanavir comes in the following forms and strengths:

  • 150-mg, 200-mg, and 300-mg capsules
  • Oral powder (50 mg of atazanavir per packet)

Take atazanavir according to your health care provider’s instructions. Do not miss a dose of atazanavir, and do not change your dose or stop taking atazanavir without first talking with your health care provider.

Take atazanavir capsules with food. Swallow the capsules whole. Do not open the capsules. If your health care provider has prescribed a boosting agent (ritonavir or cobicistat) with atazanavir capsules, take the boosting agent at the same time you take atazanavir capsules.

Atazanavir oral powder must be mixed with food (such as applesauce or yogurt) or liquid (such as milk, infant formula, or water). If atazanavir oral powder is mixed with water, your child must eat food right after taking the oral powder and water mixture. Atazanavir oral powder must be taken with ritonavir. Give ritonavir right away after your child has taken atazanavir oral powder mixed with food or liquid. For information about the correct way to mix and give a dose of atazanavir oral powder to your child, see the “Instructions for Use” that comes with the medicine.

If you take antacids; buffered medicines; or h3 blockers (medicines for reducing stomach acid), carefully follow instructions on how to take them with atazanavir.

If you take proton-pump inhibitors (medicines for reducing stomach acid), check with your health care provider to find out if you can take these medicines with atazanavir. Certain people should NOT take proton pump inhibitors during treatment with atazanavir. If your health care provider tells you to continue taking proton-pump inhibitors, carefully follow instructions on how to take them with atazanavir.

Always take atazanavir in combination with other HIV medicines.

If you have taken too much atazanavir, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room.

For more information on how to take atazanavir, see the FDA drug label.

What should I do if I forget a dose?What should I do if I forget a dose?

What should I do if I forget a dose?

If you miss a dose of atazanavir, take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.

What side effects can atazanavir cause?What side effects can atazanavir cause?

What side effects can atazanavir cause?

Atazanavir may cause side effects. Some side effects of atazanavir can be serious as noted above. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the HIVinfo fact sheet on HIV Medicines and Side Effects for more information.

Other possible side effects of atazanavir include:

  • Mild rash.
  • Chronic kidney disease.
  • Kidney stones. Contact your health care provider if you have pain in your lower back or lower stomach/abdominal area, blood in your urine, or pain when urinating.
  • Gallbladder stones. Contact your health care provider right away if you develop symptoms of gallbladder problems (pain in your right or middle upper stomach area, fever, nausea and vomiting, or jaundice).
  • New or worsening diabetes and high blood sugar (hyperglycemia).
  • Changes in your immune system (called immune reconstitution inflammatory syndrome or IRIS). IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.
  • Changes in body fat (lipodystrophy syndrome).
  • Increased bleeding problems in people with hemophilia.

Tell your health care provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of atazanavir. To learn more about possible side effects of atazanavir, read the drug label or package insert or talk to your health care provider or pharmacist.

You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online.

How should atazanavir be stored?How should atazanavir be stored?

How should atazanavir be stored?

  • Store atazanavir capsules at room temperature, 68°F to 77°F (20°C to 25°C).
  • Keep atazanavir capsules in the container that they came in and keep the container tightly closed.
  • Store atazanavir oral powder at a temperature of 68°F to 86°F (20°C to 30°C).
  • Keep atazanavir oral powder in the original packet. Do not open until ready to use.
  • After atazanavir oral powder is mixed with food or liquid, it may be kept at a temperature of 68°F to 86°F (20°C to 30°C) for up to 1 hour. Use atazanavir oral powder within 1 hour after mixing with food or liquid.
  • Do not use atazanavir if the original seal over the container opening is broken or missing.
  • Throw away atazanavir that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
  • Keep atazanavir and all medicines out of reach of children.

Where can I find more information about atazanavir?Where can I find more information about atazanavir?

Where can I find more information about atazanavir?

  • For more information on the use of atazanavir in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.
  • This Patient Version drug summary is based on the following FDA label(s): atazanavir capsule (gelatin coated), oral powder; cobicistat tablet (film coated); and Evotaz tablet. The Patient Package Insert, Instructions For Use, and Patient Information section include information for people taking atazanavir.
  • The American Hospital Formulary Service (AHFS) Patient Medication Information for atazanavir available from MedlinePlus.
  • Atazanavir-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests. To learn more about the ClinicalTrials.gov search features, please see How to Search.)
  • A list of FDA-approved HIV medicines, from HIVinfo.

Manufacturer Information

Bristol-Myers Squibb
Main number: 800-332-2056
Patient assistance: 800-721-8909

 

Last Reviewed: May 11, 2023

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Atazanavir Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Uses

This form of atazanavir is used with other HIV medications for infants and children to help control HIV infection. It helps to decrease the amount of HIV in the body so your child’s immune system can work better. This lowers the chance of getting HIV complications (such as new infections, cancer) and improves your child’s quality of life.Atazanavir belongs to a class of drugs known as protease inhibitors. This form of atazanavir must be given with a certain other protease inhibitor (ritonavir) to increase (“boost”) the levels of atazanavir. This helps atazanavir work better.Atazanavir is not a cure for HIV infection. To decrease the risk of spreading HIV disease to others, your child should continue to take all HIV medications exactly as prescribed by the doctor. Do not share your child’s personal items (such as needles/syringes, toothbrushes) that may have contacted blood or other body fluids. Consult the doctor or pharmacist for more details.

How to use Atazanavir 50 Mg Oral Powder Packet

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

This medication is taken by mouth. Give this medication to your child as directed by the doctor, usually once daily. Open the packet and mix its contents with food (such as applesauce, yogurt) as directed. If your child cannot eat solid food, this medication may be mixed with liquid (such as milk, infant formula, or water). If your child is younger than 6 months and cannot eat solid food or drink from a cup, mix this medication with infant formula as directed and give it to your child using an oral syringe. Do not use a baby bottle. Give the dose within 1 hour after mixing with food or liquid. Also, give your child’s ritonavir dose right after this medication.

Since this medication may cause kidney problems, give plenty of fluids during treatment to lower the risk.

The dosage is based on your child’s medical condition, weight, response to treatment, and other medications your child may be taking. Be sure to tell the doctor and pharmacist about all the products your child uses (including prescription drugs, nonprescription drugs, and herbal products).

If your child is taking antacids or buffered forms of drugs (such as didanosine solution, didanosine enteric-coated capsules), give atazanavir at least 2 hours before or 1 hour after these medications.

For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same time every day.

It is very important to continue giving this medication (and other HIV medications) exactly as prescribed by the doctor. Do not skip any doses. Do not give more or less of this drug than prescribed or stop giving it (or other HIV medicines) even for a short time unless directed to do so by the doctor. Doing so may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.

Side Effects

Headache or nausea may occur. If either of these effects lasts or gets worse, tell the doctor or pharmacist promptly.

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

As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including: unexplained weight loss, severe tiredness, muscle aches/weakness that doesn’t go away, headaches that are severe or don’t go away, joint pain, numbness/tingling of the hands/feet/arms/legs, vision changes, signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre syndrome (such as unsteadiness, loss of coordination, trouble swallowing/speaking/chewing, trouble moving your eyes).

Tell the doctor right away if your child has any serious side effects, including: increased thirst/urination, dizziness, lightheadedness, signs of kidney problems (such as pain in side/back/abdomen, painful urination, blood in the urine, change in the amount of urine), signs of liver problems (such as nausea/vomiting that doesn’t stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine).

Get medical help right away if your child has any very serious side effects, including: signs of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating).

Changes in body fat may occur while your child is taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with the doctor, as well as the possible use of exercise to reduce this side effect.

Atazanavir can commonly cause a 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 your child develops any rash.

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.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact the 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 atazanavir, tell the doctor or pharmacist if your child is allergic to it; or if your child has 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 the doctor or pharmacist your child’s medical history, especially of: liver problems (including hepatitis B or C infections), kidney problems (including kidney stones), heart problems (such as heart rhythm problems, irregular heartbeat, coronary artery disease, heart attack), a certain bleeding problem (hemophilia).

Atazanavir may increase the level of cholesterol and fats (triglycerides) in the blood. HIV infection can also cause this effect. This could increase your child’s risk for heart problems such as a heart attack. Discuss the risks and benefits of treatment with the doctor and ways to lower the risk of heart disease. Tell the doctor if your child has heart problems or other conditions that increase the risk of heart disease such as high blood pressure, diabetes, or high cholesterol/triglyceride levels.

This medication may contain aspartame. If your child has phenylketonuria (PKU) or any other condition that requires your child to limit/avoid aspartame (or phenylalanine) in the diet, ask the doctor or pharmacist about using this medication safely.

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

Atazanavir should not be given to children younger than 3 months because of the risk of very serious side effects.

This form of atazanavir is not usually used by adults. It is unlikely to be used during pregnancy or breast-feeding. Consult the doctor if you have any questions about this medication.

Interactions

See also How to Use section.

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

Some products that may interact with this drug include: certain medications used to treat chronic hepatitis C (such as elbasvir/grazoprevir, glecaprevir/pibrentasvir), a certain combination HIV medication (elvitegravir/cobicistat/emtricitabine/tenofovir), indinavir, nevirapine, orlistat, saquinavir.

Atazanavir can slow down the removal of other medications from your child’s body, which may affect how they work. Examples of affected drugs include certain alpha blockers (such as alfuzosin, silodosin), certain benzodiazepines (midazolam, triazolam), ergot alkaloids (such as dihydroergotamine, ergotamine), irinotecan, lomitapide, pimozide, a certain drug to treat erectile dysfunction-ED or pulmonary hypertension (sildenafil), certain “statin” cholesterol drugs (lovastatin, simvastatin), salmeterol, among others.

Other medications can affect the removal of atazanavir from your child’s body, which may affect how atazanavir works. Examples include apalutamide, bosentan, efavirenz, etravirine, certain rifamycins (such as rifampin, rifapentine), certain drugs used to treat seizures (such as carbamazepine, phenobarbital, phenytoin, primidone), St. John’s wort, among others.

Prescription and nonprescription drugs to treat heartburn, indigestion, or ulcers (including h3 blockers such as famotidine, proton pump inhibitors such as lansoprazole/omeprazole) reduce stomach acid and decrease the absorption of atazanavir. This may prevent atazanavir from working well. Ask the doctor or pharmacist how to use these medications safely.

If you are breast-feeding your child, ask the doctor if any medications that you are using may pass into the breast milk and interact with this medication.

Does Atazanavir 50 Mg Oral Powder Packet interact with other drugs you are taking?

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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. Symptoms of overdose may include: severe dizziness, lightheadedness.

Do not share this medication with others.

Lab and/or medical tests (such as viral load, T-cell counts, kidney/liver function, cholesterol/triglyceride levels, blood sugar levels) should be done while your child is taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

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

Store in the original packet at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

After mixing, this medication may be stored at room temperature for up to 1 hour.

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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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

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.

Atazanavir-TL instructions for use: indications, contraindications, side effects – description of Atazanavir-TL caps. 200 mg: 60 pcs. (53220)

💊 Ingredients of Atazanavir-TL

✅ Use of Atazanavir-TL

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Description of the active ingredients of the preparation

Atazanavir-TL
(Atazanavir-TL)

The scientific information provided is general and cannot be used to make decisions.
decisions about the use of a particular drug.

Update date: 2020.03.02

Marketing authorization holder:

TECHNOLOGY OF DRUGS, LLC
(Russia)

Manufactured:

R-PHARM JSC

(Russia)

ATX code:

J05AE08

(Atazanavir)

Active substance:
atazanavir
(atazanavir)

Rec.INN

WHO registered

Dosage form

Atazanavir-TL

Caps. 200 mg: 60 pcs.

reg. No.: LP-004872
dated 05/30/18
– Active

Re-registration date: 07/30/19

Release form, packaging and composition
drug Atazanavir-TL

hard gelatin capsules, #0, blue body and cap; the contents of the capsules are a mixture of granules and powder from white to light yellow.

Excipients : lactose monohydrate, crospovidone, magnesium stearate.

Capsule body composition: titanium dioxide, brilliant blue dye, gelatin.
Capsule composition: titanium dioxide, brilliant blue dye, gelatin.

6 pcs. – cellular contour packings (10) – packs of cardboard.
10 pcs. – cellular contour packings (6) – packs of cardboard.
60 pcs. – polymer cans (1) – packs of cardboard.

Clinical and pharmacological group:

Antiviral drug active against HIV

Pharmacotherapeutic group:

Antiviral [HIV] agent

Pharmacological action

Antiviral agent. It is an azapeptide inhibitor of HIV protease. Selectively inhibits virus-specific processing of viral Gag-Pol proteins in HIV-infected cells, preventing the formation of mature virions and infection of other cells.

Indications of the active substances of the drug

Atazanavir-TL

Treatment of HIV infections (in combination with other antiretrovirals).

Open list of ICD-10 codes

B24 Human immunodeficiency virus [HIV] disease, unspecified

Dosing regimen

The method of administration and dosing regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. Compliance of the dosage form of a particular drug with indications for use and dosing regimen should be strictly observed.

Taken orally. The dose and treatment regimen is set depending on the composition of the combination therapy and the clinical situation.

Side effects

From the side of the central nervous system and peripheral nervous system: often – headache, insomnia, peripheral neurological symptoms; rarely – restless dreams, memory loss, confusion, drowsiness, anxiety, depression, sleep disturbances.

From the digestive system: very often – jaundice; often – abdominal pain, diarrhea, dyspepsia, nausea, vomiting; rarely – taste perversion, flatulence, gastritis, pancreatitis, aphthous stomatitis, dry mouth, anorexia, increased appetite, hepatitis; in some cases – hepatosplenomegaly.

From the musculoskeletal system: rarely – arthralgia, muscle atrophy, myalgia; rarely – myopathy.

From the urinary system: rarely – hematuria, frequent urination, proteinuria; in some cases – pain in the kidneys, urolithiasis.

Allergic reactions: rarely – urticaria.

Dermatological reactions: often – rash; rarely – baldness, itching; rarely – vasodilation, vesiculo-bullous rash.

From the side of metabolism: often – lipodystrophy; rarely – weight loss, weight gain.

From the side of laboratory parameters: increase in total bilirubin (with a predominance of increased indirect bilirubin), increased levels of amylase, CPK, ALT, AST, lipase, neutropenia.

Other: often – general weakness, scleral icterus; rarely – chest pain, fatigue, fever, general malaise, gynecomastia.

Contraindications for use

Severe hepatic insufficiency, children and adolescents under 18 years of age, concomitant use with rifampicin, hypersensitivity to atazanavir.

Use in pregnancy and lactation

Adequate and well-controlled studies of atazanavir during pregnancy have not been conducted. Application is possible in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus.

If use during lactation is necessary, breastfeeding should be discontinued.

Use in hepatic dysfunction

Contraindication: severe liver failure. Use with caution in patients with mild to moderate hepatic insufficiency, tk. Atazanavir is metabolized primarily in the liver and there is a risk of increased plasma concentrations. In patients with viral hepatitis B or C, or an increase in transaminase levels noted before treatment, the risk of a further increase in transaminase levels increases.

Use in children

Contraindication: children and adolescents under 18 years of age

Special instructions

Not recommended for use simultaneously with CYP3A4 inducers (including St. John’s wort), with drugs that are substrates of CYP3A4 with a narrow therapeutic range (including with astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, ergotamine, dihydroergotamine, ergonovine, methylergonovine).

Co-administration of atazanavir + ritonavir with other protease inhibitors is not recommended.

Use with caution in patients with mild to moderate hepatic impairment as Atazanavir is metabolized primarily in the liver and there is a risk of increased plasma concentrations. In patients with viral hepatitis B or C, or an increase in transaminase levels noted before treatment, the risk of a further increase in transaminase levels increases.

If severe skin rash occurs, atazanavir should be discontinued.

Bleeding has been described in patients with hemophilia type A and B treated with protease inhibitors, incl. spontaneous skin hemorrhages and hemarthroses. Some of these patients required the introduction of factor VIII. In more than half of patients, treatment with protease inhibitors was continued or resumed after a break. A causal relationship between protease inhibitor therapy and these cases has not been established.

If necessary, simultaneous use with felodipine, nifedipine, nicardipine and verapamil shows titration of the dose of calcium channel blockers and ECG monitoring.

Drug interactions

Since atazanavir is metabolized in the liver with the participation of the CYP3A4 isoenzyme, when used simultaneously with other drugs metabolized by this isoenzyme (including calcium channel blockers, HMG-CoA reductase inhibitors and PDE 5 inhibitors, including sildenafil, tadalafil, vardenafil) may increase the plasma concentration of one of the components. This may lead to an increase and prolongation of the therapeutic and side effects of the PDE5 inhibitor.

Co-administration of atazanavir with inducers of the CYP3A4 isoenzyme (including rifampin) may lead to a decrease in the concentration of atazanavir in the blood plasma and a decrease in its effectiveness.

Rifampicin reduces the activity of most protease inhibitors by about 90%.

Co-administration of atazanavir with inhibitors of the CYP3A4 isoenzyme may increase plasma concentrations of atazanavir.

Efavirenz reduces the effect of atazanavir when co-administered.

Nevirapine, as an inducer of CYP3A4, is expected to reduce the effect of atazanavir (simultaneous use is not recommended).

Indinavir is capable of causing hyperbilirubinemia, so co-administration with atazanavir is not recommended.

When co-administered with atazanavir, the efficacy of saquinavir is reduced.

When co-administered with ritonavir, plasma concentrations of atazanavir are increased.

Antacids (and preparations containing antacids) reduce the acidity of the gastric juice, so the absorption of atazanavir is reduced.

With simultaneous use with atazanavir, an increase in plasma concentrations of lidocaine (for systemic use), amiodarone (special care and control of therapeutic concentrations of these drugs is required), quinidine (the use of a combination of atazanavir + ritonavir with quinidine is contraindicated).

With simultaneous use, an increase in the toxicity of irinotecan due to a slowdown in its metabolism is possible.

Simultaneous use with simvastatin and lovastatin is not recommended.

Atazanavir may potentiate the effects of diltiazem and its metabolite desacetyl diltiazem (reduction of diltiazem dose by 50% and ECG monitoring recommended).

When used simultaneously with bepridil, it is possible to potentiate the development of severe and / or life-threatening reactions (the use of a combination of atazanavir + ritonavir with bepridil is contraindicated).

Under the influence of atazanavir, it is possible to increase the effect of atorvastatin, cerivastatin and increase the risk of myopathy, including rhabdomyolysis (special caution is required when used simultaneously).

Histamine H 2 receptor blockers and proton pump inhibitors reduce the plasma concentration of atazanavir, which may lead to a decrease in its therapeutic efficacy or the development of resistance.

Simultaneous use with cyclosporine, tacrolimus, sirolimus may increase plasma concentrations of immunosuppressants (monitoring of their therapeutic concentrations is recommended).

When used simultaneously with clarithromycin, an increase in the concentration of the latter in the blood plasma is observed, which can cause an increase in the QT interval (requires a dose reduction of 50% of the antibiotic).

With simultaneous use with atazanavir, the effectiveness of rifabutin increases (reduction of the dose of rifabutin to 75% is recommended).

Ketoconazole and itraconazole may increase plasma concentrations of atazanavir and ritonavir.

When co-administered with warfarin, there is a risk of severe and/or life-threatening bleeding due to an increase in warfarin activity (INR monitoring recommended).

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Atazanavir-TL . Description of the drug in the reference book Vidal.

Active substance ATAZANAVIR (ATAZANAVIRUM) | Compendium – drug reference book

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  • Pharmacological properties
  • Indications ATAZANAVIR
  • Application of ATAZANAVIR
  • Contraindications
  • Side effects
  • Special instructions
  • Interactions
  • Overdose
  • Diagnosis
  • Recommended alternatives
  • Trade names

Atazanavir is an azapeptide inhibitor of the HIV-1 protease. Selectively inhibits virus-specific processing of viral Gag-Pol proteins in HIV-1-infected cells, preventing the formation of mature virions and infection of other cells.

Peak plasma concentrations of atazanavir are reached approximately 2.7 hours after ingestion. Steady-state concentrations of atazanavir are reached between days 4 and 8 of dosing. The use of atazanavir with food increases its bioavailability and reduces pharmacokinetic variability. Atazanavir is 86% bound to plasma proteins, the degree of protein binding does not depend on concentration. Equally, atazanavir binds to alpha-1 glycoprotein and albumin. Atazanavir is detected in CSF and seminal fluid. Basically, atazanavir is metabolized by the CYP 3A4 isoenzyme to oxidized metabolites. Metabolites are excreted into bile both in free and glucuronized form. A minor portion of atazanavir is metabolized by N-dealkylation and hydrolysis. After a single dose of atazanavir at a dose of 400 mg, 79and 13% of the administered dose, respectively. The proportion of unchanged drug in feces and urine is about 20% and 7%, respectively. The mean elimination half-life of atazanavir in healthy volunteers and HIV-infected adults is about 7 hours when atazanavir is administered at a dose of 400 mg/day with a light meal.

is indicated for the treatment of HIV-1 infections in combination with other antiretrovirals in patients previously treated with antiretroviral therapy and in previously untreated patients.

by mouth with meals. Adults – 400 mg once a day or 300 mg in combination with ritonavir (100 mg once a day). In case of moderate hepatic insufficiency, the dose should be reduced to 300 mg 1 time per day. In renal failure and elderly patients, dose adjustment is not required.

hypersensitivity to atazanavir, severe liver failure, hereditary metabolic disorders (galactose intolerance, lactose deficiency and malabsorption of glucose and galactose), phenylketonuria, concomitant therapy with inducers of the cytochrome P450 system, CYP 3A4 isoenzyme (including rifampicin, animal drugs wallpaper, astemizole , terfenadine, cisapride, pimozide, quinidine, bepridil, ergot alkaloids, especially ergotamine, dihydroergotamine, ergonovine, methylergonovine), lactation period, age up to 18 years.

often – general weakness, headache, insomnia, peripheral neurological symptoms; infrequently – nightmares, amnesia, confusion, drowsiness or sleep disturbances, anxiety, depression; dyspepsia (often – abdominal pain, diarrhea, nausea, vomiting, infrequently – changes in taste sensations, flatulence), often – jaundice, infrequently – anorexia or increased appetite, gastritis, pancreatitis, aphthous stomatitis, dry mouth, hepatitis, rarely – hepatosplenomegaly ; infrequently – arthralgia, muscle atrophy, myalgia, rarely – myopathy; infrequently – hematuria, pollakiuria, proteinuria, rarely – pain in the kidney area, nephrolithiasis; often – skin rash, infrequently – alopecia, itching, urticaria, rarely – vasodilation, maculopapular rash; hyperbilirubinemia (increased level of indirect bilirubin), increased activity of amylase, lipase, CPK, AlAT, AsAT, neutropenia; often – icterus of the sclera, lipodystrophy, infrequently – chest pain, fatigue, fever, general malaise, decrease or increase in body weight, gynecomastia, allergic reactions, in some cases – hyperglycemia, diabetes mellitus or its decompensation (up to diabetic ketoacidosis), in patients with hemophilia type A and B – bleeding, spontaneous skin hemorrhage and hemarthrosis.

is used with caution in mild and moderate liver failure, viral hepatitis B and C, diabetes mellitus, during pregnancy.

Patients should be informed that antiretroviral therapy does not prevent the risk of transmission of HIV through blood or sexual intercourse.

Adequate and well-controlled studies of atazanavir in pregnant women have not been conducted, so it should be prescribed during pregnancy only if the benefit to the mother outweighs the potential risk to the fetus.

Patients with hemophilia type A and B treated with protease inhibitors have reported bleeding, including spontaneous skin hemorrhage and hemarthrosis. Some of these patients required clotting factor VIII. In more than 50% of patients, treatment with protease inhibitors was continued or resumed after a break. A causal relationship with protease inhibitor therapy has not been established. Patients with hemophilia should be informed of the possibility of such complications.

During treatment, jaundice may occur (after a few days or months of therapy), which in most cases does not require discontinuation of the drug.

is not recommended for use with drugs that induce CYP 3A4 (including St. ergot, especially ergotamine, dihydroergotamine, ergonovine , methylergonovine). Nucleoside reverse transcriptase inhibitors (including didanosine, tenofovir, ifavirenz) reduce the effect of atazanavir.

Nevirapine, as a CYP 3A4 inducer, may reduce the effect of atazanavir; their combined use is not recommended. Indinavir is capable of causing hyperbilirubinemia (increased concentration of indirect bilirubin) by inhibiting glucuronosyl transferase, therefore, simultaneous use with protease inhibitors (indinavir) is not recommended. The effect of saquinavir is reduced when combined with atazanavir.

Ritonavir enhances the effect of atazanavir (increases its concentration). Co-administration of a combination of atazanavir and ritonavir with other protease inhibitors is not recommended.

Antacids reduce the acidity of gastric contents and the absorption of atazanavir (the drug should be administered 2 hours before or 1 hour after taking antacids).

Increases the concentration of amiodarone, lidocaine for systemic use, quinidine (the use of drugs in such combinations requires increased caution, it is recommended to control the therapeutic concentration of these drugs).

Quinidine is contraindicated when atazanavir is co-administered with ritonavir. Atazanavir inhibits glucuronosyl transferase and may interfere with the metabolism of irinotecan, increasing its toxicity.

Simultaneous use with simvastatin and lovastatin is not recommended. Enhances the action of diltiazem and its metabolite, deacetyldilthiazem (it is recommended to reduce the dose of diltiazem by 50% and control the ECG). Bepridil may exacerbate severe and/or life-threatening reactions (contraindicated when using atazanavir in combination with ritonavir). When administered simultaneously with other calcium channel blockers (including felodipine, nifedipine, nicardipine and verapamil), dose adjustment of the latter and ECG monitoring are indicated. Enhances the effect of HMG-CoA reductase inhibitors (including simvastatin, lovastatin, atorvastatin, cerivastatin), increases the risk of myopathy, including rhabdomyolysis (greater caution must be observed).

H 2 receptor blockers and proton pump inhibitors reduce the concentration of atazanavir in the blood, which can lead to a decrease in the therapeutic activity of the drug or to the development of resistance (these drugs should not be taken simultaneously to avoid unwanted interactions, it is recommended to take atazanavir at night before sleep). Increases the effect of immunosuppressants (including cyclosporine, tacrolimus, sirolimus), it is recommended to monitor their concentrations.

Increases the concentration of macrolide antibiotics (including clarithromycin), which can cause an increase in the interval Q-T on ECG (the antibiotic dose should be reduced by 50%), as well as the concentration of oral contraceptives (including ethinyl estradiol, norethindrone), their simultaneous use is not recommended.

With an increase in the concentration of norethindrone, a decrease in HDL concentration or an increase in insulin resistance is possible, especially in women with diabetes mellitus (it is recommended to use the lowest effective dose of each component of an oral contraceptive, it is also advisable to use other reliable methods of contraception). Increases the effect of rifabutin (the dose of the latter should be reduced to 75% – 150 mg every other day or 3 times a week). Rifampicin reduces the activity of most protease inhibitors by about 90% (simultaneous use is not recommended). Potentiates the effect of PDE-5 inhibitors (including sildenafil, tadalafil, vardenafil), increases the risk of their side effects. Ketoconazole and itraconazole slightly increase the concentration of atazanavir, but caution should be exercised in combination with ritonavir. Simultaneous use with warfarin can cause significant and / or life-threatening bleeding due to an increase in the activity of the latter (it is recommended to monitor the coagulogram).