Evotaz contains a combination of atazanavir and cobicistat. Aatazanavir is a protease inhibitor antiviral medication that prevents human immunodeficiency virus (HIV) from multiplying in your body. Cobicistat reduces the action of enzymes in your liver that break down certain antiviral medicines. This allows the antiviral medicines to be used more safely and effectively at lower doses.

Evotaz is a prescription 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). This medicine is not a cure for HIV or AIDS.

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

Serious drug interactions can occur when certain medicines are used together with Evotaz. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

Evotaz should not be used during pregnancy. People who are pregnant have developed a serious condition called lactic acidosis (a build-up of lactic acid in the blood) when taking Evotaz with other HIV medicines.

Take Evotaz exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Evotaz 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 Evotaz. 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 Evotaz if you are allergic to atazanavir and cobicistat.

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with Evotaz. 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.

To make sure Evotaz is safe for you, 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. Evotaz may not work as well if you take it during pregnancy. You may also develop a serious condition called lactic acidosis if you take Evotaz 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 this medicine, 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.

Using this medicine 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 to Evotaz: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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.

Evotaz 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 Evotaz side effects 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 Evotaz much less effective when taken at the same time. If you take any of the following medicines, take them separately from your dose of Evotaz:

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

• Enteric-coated didanosine: Take your Evotaz 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 Evotaz least 10 hours after taking the stomach medicine.

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

Many other drugs can interact with 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.