Atazanavir and cobicistat is a combination medicine given together with other antiviral medicines to treat human immunodeficiency virus (HIV) in adults. HIV is the virus that can cause acquired immunodeficiency syndrome (AIDS). atazanavir and cobicistat is not a cure for HIV or AIDS.

Atazanavir and cobicistat is for use in adults and children who weigh at least 77 pounds (35 kilograms).

Atazanavir and cobicistat may also be used for purposes not listed in this medication guide.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact with atazanavir and cobicistat, and some drugs should not be used together.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Atazanavir and cobicistat must be given in combination with other antiviral medications and should not be used alone. However, there are certain antiviral medicines you should not take with atazanavir and cobicistat. Follow your doctor's medication and dosing instructions very carefully.

Take this medicine with food.

You will need frequent medical tests.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or stop using a medicine without your doctor's advice. Every person with HIV 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.

Usual Adult Dose for HIV Infection:

1 tablet orally once a day with food

Comments:
-For therapy-naive and therapy-experienced patients
-The number of baseline primary protease inhibitor resistance substitutions should guide use in therapy-experienced patients.
-Use of this drug during pregnancy results in considerably lower exposures of cobicistat (and thus lower exposures of atazanavir) during the second and third trimesters. This drug is not recommended for use during pregnancy and should not be started in pregnant patients; an alternative regimen is recommended for patients who become pregnant during therapy with this drug.

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Usual Pediatric Dose for HIV Infection:

At least 35 kg: 1 tablet orally once a day with food

Comments:
-For therapy-naive and therapy-experienced patients
-The number of baseline primary protease inhibitor resistance substitutions should guide use in therapy-experienced patients.
-Use of this drug during pregnancy results in considerably lower exposures of cobicistat (and thus lower exposures of atazanavir) during the second and third trimesters. This drug is not recommended for use during pregnancy and should not be started in pregnant patients; an alternative regimen is recommended for patients who become pregnant during therapy with this drug.

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

You should not take atazanavir and cobicistat if you are allergic to it.

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with atazanavir and cobicistat. Your doctor may change your treatment plan if you also use:

• alfuzosin;

• cisapride;

• colchicine;

• drospirenone and ethinyl estradiol (birth control pills);

• irinotecan;

• oral midazolam, triazolam;

• pimozide;

• rifampin;

• sildenafil (Revatio, for treating pulmonary arterial hypertension);

• St. John's wort;

• antipsychotic medicine--lurasidone, pimozide;

• cholesterol lowering medicine--lomitapide, lovastatin, simvastatin;

• ergot medicine--dihydroergotamine, ergotamine, ergonovine, methylergonovine;

• heart medication--dronedarone, ranolazine;

• hepatitis C antivirals--elbasvir and grazoprevir, glecaprevir and pibrentasvir;

• other HIV medicines--indinavir, nevirapine; or

• seizure medicine--carbamazepine, phenobarbital, phenytoin.

Tell your doctor if you have ever had:

• heart disease;

• liver disease (especially hepatitis B or C);

• a bleeding or blood clotting disorder such as hemophilia;

• diabetes; or

• kidney disease (or if you are on dialysis).

Do not use if you are pregnant. Atazanavir and cobicistat may not work as well if you take it during pregnancy. You may also develop a serious condition called lactic acidosis if you take atazanavir and cobicistat with certain other HIV medicines during pregnancy. Tell your doctor right away if you become pregnant. You may need to use a different antiviral medicine.

Use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

Atazanavir and cobicistat can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using atazanavir and cobicistat, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.

Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely. Missing doses may increase the risk of your virus becoming resistant to medication.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

Using atazanavir and cobicistat may not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Atazanavir and cobicistat may cause serious side effects. Call your doctor at once if you have:

• severe dizziness, irregular heartbeats;

• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;

• liver or gallbladder problems--upper stomach pain, nausea, vomiting, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• a severe skin reaction--fever, flu-like symptoms, mouth sores, muscle or joint pain, swelling in your face, burning eyes, skin pain, blistering, warmth or redness under your skin; or

• signs of a kidney stone--pain in your side or lower back, painful or difficult urination, blood in your urine.

You may need to stop taking this medicine permanently if you have a severe skin reaction.

Atazanavir and cobicistat affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects of atazanavir and cobicistat may include:

• rash;

• jaundice; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Some medicines can make atazanavir and cobicistat much less effective when taken at the same time. If you take any of the following medicines, take them separately from your dose of atazanavir and cobicistat:

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

• Enteric-coated didanosine: Take your atazanavir and cobicistat dose with food 2 hours before or 1 hour after you take didanosine.

• Medicine to reduce stomach acid (such as cimetidine, ranitidine, Tagamet, Pepcid, or Zantac): Either take the medicines at the same time, or take atazanavir and cobicistat least 10 hours after taking the stomach medicine.

• A proton pump inhibitor (such as omeprazole, esomeprazole, Nexium, Prevacid, Prilosec, or Protonix): take your atazanavir and cobicistat dose at least 12 hours after taking the other medicine.

Many other drugs can affect atazanavir and cobicistat, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor will/may order certain lab tests to check your body's response to atazanavir and cobicistat.

Keep a supply of atazanavir and cobicistat on hand. Do not wait until you run out of medication to refill your prescription.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.