Atazanavir and cobicistat

Atazanavir and Cobicistat is part of the drug class:

• Antivirals for treatment of HIV infections, combinations

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of atazanavir/cobicistat, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking atazanavir/cobicistat, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to atazanavir, cobicistat or to any of its ingredients
• have liver problems, including hepatitis B or C virus infection
• have heart problems
• have kidney problems
• have diabetes
• have hemophilia
• have had severe, life-threatening rashes in the past
• take other anti-HIV medications
• are or plan to become pregnant. Pregnant women have developed a serious condition called lactic acidosis (a build-up of lactic acid in the blood) when taking atazanavir/cobicistat with certain other HIV medicines.
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Atazanavir/cobicistat falls into category ­B. There are no well-done studies that have been done in humans with atazanavir/cobicistat. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Hormonal forms of birth control, such as injections, vaginal rings or implants, contraceptive patch, and some birth control pills may not work during treatment with atazanavir/cobicistat. Talk to your healthcare provider about forms of birth control that may be used during treatment with atazanavir/cobicistat.

Pregnancy Registry. There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.

This medicine is not a complete treatment and must be used in combination with other antiviral medicines your doctor has prescribed. However, there are certain antiviral medicines that should not be taken in combination with atazanavir and cobicistat. Follow your doctor's medication and dosing instructions very carefully.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take this medicine with food.

While using atazanavir and cobicistat, your blood may need to be tested often. Your kidney and liver function may also need to be tested.

If you take atazanavir and cobicistat with a medicine to reduce stomach acid, follow the recommendations below:

• If you take an antacid: Take the antacid at least 2 hours before or 2 hours after you take atazanavir and cobicistat.

• If you take a medicine such as cimetidine, ranitidine, Tagamet, Axid, Zantac, Pepcid, and others: You may either take the stomach medicine at the same time you take atazanavir and cobicistat; or wait at least 10 hours after taking the stomach medicine to take your atazanavir and cobicistat doses.

• If you take a proton pump inhibitor such as omeprazole, esomeprazole, Nexium, Prevacid, Prilosec, Protonix: Wait at least 12 hours after taking the stomach medicine to take your atazanavir and cobicistat doses.

Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

Store in the original container at room temperature, away from moisture and heat. Keep the bottle tightly closed when not in use.

Take the missed dose as soon as you remember. If you are more than 12 hours late, skip the missed dose and take your medicine at the next scheduled dose. Do not take extra medicine to make up the missed dose.

In the U.S.

• Evotaz

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Protease Inhibitor

• If you have an allergy to atazanavir and cobicistat or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are on dialysis, talk with your doctor.
• If you have liver disease.
• If you are taking another drug that has the same drug in it.
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with atazanavir and cobicistat, like certain drugs that are used for high cholesterol, migraines, or mood problems. There are many drugs that must not be taken with this medicine.
• If you are taking St. John's wort. Do not take St. John's wort with atazanavir and cobicistat. This medicine may not work as well.
• If you are taking sildenafil to treat pulmonary arterial hypertension (PAH).
• If you have kidney or liver disease and are taking colchicine.
• If you are also taking tenofovir and you have kidney problems or take a drug that may harm the kidneys.
• If you are breast-feeding. Do not breast-feed while you take this medicine.

This is not a list of all drugs or health problems that interact with atazanavir and cobicistat.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take atazanavir and cobicistat. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine interacts with many other drugs. The chance of this medicine's side effects may be raised or how well atazanavir and cobicistat works may be lowered. The chance of the other drugs' side effects may also be raised. This may include very bad, life-threatening, or deadly side effects. Check with your doctor and pharmacist to make sure that it is safe for you to take this medicine with all of your other drugs (prescription or OTC, natural products, vitamins).
• If you have high blood sugar (diabetes), talk with your doctor. This medicine may raise blood sugar.
• Check your blood sugar as you have been told by your doctor.
• Some people with hemophilia have had times of more bleeding when taking drugs like this one. If you have hemophilia, talk with your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine is not a cure for HIV. Stay under the care of your doctor.
• This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors. Talk with your doctor.
• Very bad kidney problems like kidney failure have happened in people taking cobicistat with tenofovir. Talk with your doctor.
• Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking atazanavir and cobicistat.
• Do not give this medicine to a child younger than 3 months of age.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using atazanavir and cobicistat while you are pregnant.

• Evotaz

Refer to adult dosing. Use with caution.

Use is not recommended (has not been studied).

Breastfeeding is not recommended during use of this drug; if replacement feeding is not an option, alternative therapy is recommended. Excreted into human milk: Yes (atazanavir); Unknown (cobicistat) Excreted into animal milk: Yes (cobicistat) Comments: -The effects in the nursing infant are unknown. -The US CDC, American Academy of Pediatrics, and manufacturer advise HIV-infected women not to breastfeed to avoid postnatal transmission of HIV to a child who may not yet be infected. -Local guidelines should be consulted if replacement feeding is not an option.

On postpartum days 5 and 14, samples of breast milk and plasma were obtained at 0, 2, 5, 8, and 24 hours postdose from 3 women taking atazanavir (dose not stated; 300 mg/day likely) as part of highly active antiretroviral therapy. Breast milk levels over 24 hours averaged 212 mcg/L on day 5 and 265 mcg/L on day 14. Peak breast milk levels averaged 419 mcg/L at 5 hours postdose. The breast milk to plasma ratio averaged 13% for atazanavir.