Drug Database: Atazanavir

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:

• 100-mg, 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) in children and infants who can take food.  Infants who cannot drink from a cup should be given atazanavir oral powder mixed with liquid (such as milk, infant formula, or water). For infants less than 6 months old who cannot eat solid food or drink from a cup, atazanavir oral powder should be mixed with infant formula and given using an oral dosing syringe. 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 H2 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 or online) 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/abdominal 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.)
• A list of FDA-approved HIV medicines, from HIVinfo.