EVOTAZ is a prescription medicine used with other HIV-1 medicines to treat HIV-1 infection in adults and children weighing at least 77 pounds (35 kg). EVOTAZ contains the prescription medicines atazanavir and cobicistat.

It is not known if EVOTAZ is safe and effective in children who weigh less than 77 pounds (35 kg).

EVOTAZ helps prevent cells infected by HIV from producing more HIV. This reduces the amount of the virus in your body. EVOTAZ is one of several treatment options your doctor may consider. EVOTAZ does not cure HIV infection or AIDS. You must stay on continuous HIV therapy to help control HIV infection and reduce the chance of HIV-related illnesses.

HIV is a virus that multiplies quickly. Untreated, it can make billions of copies of itself every day. But HIV cannot multiply on its own. It uses the CD4+ cells of your immune system. Normally, CD4+ cells fight bacteria and viruses to keep you healthy. As HIV multiplies, it wipes out CD4+ cells.

EVOTAZ is in the class of HIV drugs known as protease inhibitors (PIs). PIs prevent HIV from copying itself effectively. EVOTAZ should be used as part of an HIV regimen.

EVOTAZ may help raise your CD4+ cell count and lower your viral load to undetectable.

Do not take EVOTAZ (atazanavir and cobicistat) if you:

• Are allergic to any of the ingredients in EVOTAZ
• Are taking any of the following medicines because taking them with EVOTAZ may cause serious, life-threatening side effects or death: alfuzosin, carbamazepine, cisapride, colchicine if you have liver or kidney problems, dronedarone hydrochloride, drospirenone and ethinyl estradiol, elbasvir and grazoprevir, ergot-containing medicines (dihydroergotamine, ergotamine, and methylergonovine), glecaprevir and pibrentasvir, indinavir, irinotecan, lovastatin, lomitapide, lurasidone, oral midazolam, nevirapine, phenobarbital, phenytoin, pimozide, ranolazine, rifampin, sildenafil when used for lung problems, simvastatin, products that contain St. John’s wort (Hypericum perforatum), triazolam

EVOTAZ does not cure HIV infection or AIDS (Acquired Immunodeficiency Syndrome). You must keep taking HIV drugs to control HIV infection and decrease HIV-related illnesses.

No. EVOTAZ does not lower your chance of passing HIV to other people through sexual contact, sharing needles, or being exposed to your blood. To reduce the risks linked to sexual contact, you should get tested for sexually transmitted diseases (STDs). Let your partner know your HIV and STD status.

For your health and the health of others, it is important to always practice safer sex by using a latex or polyurethane condom or other barrier to lower the chance of sexual contact with semen, vaginal secretions, or blood.

Never share or reuse piercing, tattooing, or injection needles. If you are an injection drug user, consider seeking treatment for substance use.

Yes. EVOTAZ in HIV combination therapy can be taken by adults who are starting HIV treatment for the first time.

Once-daily EVOTAZ in combination therapy has been shown to be effective in helping to manage HIV. It can help lower your viral load to undetectable and may raise your CD4+ cell count. EVOTAZ does not cure HIV infection or AIDS. You must stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses.

Doctors may change your HIV therapy for a variety of reasons. EVOTAZ as part of combination therapy is one of several treatment options your doctor may consider.

Before taking EVOTAZ, tell your healthcare provider about all of your medical conditions, including if you:

• have heart problems
• have liver problems, including hepatitis B or C virus infection
• have kidney problems
• have diabetes
• have hemophilia
• are pregnant or plan to become pregnant. It is not known if EVOTAZ will harm your unborn baby.
• EVOTAZ should not be used during pregnancy, because the EVOTAZ levels in your blood may be lower during pregnancy and may not control your HIV-1.
• Tell your healthcare provider right away if you become pregnant during treatment with EVOTAZ.
• Your healthcare provider may prescribe different medicines if you become pregnant during treatment with EVOTAZ.
• 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-1 medicines called nucleoside analogues.
• Hormonal forms of birth control, such as injections, vaginal rings or implants, contraceptive patches, and birth control pills, as some of these may not work when you are taking EVOTAZ. Talk to your healthcare provider about forms of birth control that may be used during treatment with EVOTAZ.
• Pregnancy Registry. There is a pregnancy registry for people who take HIV-1 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.
• are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed if you take EVOTAZ or if you have HIV-1. HIV-1 can be passed to the baby in breast milk. Talk to your healthcare provider about the best way to feed your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements. Some medicines interact with EVOTAZ. Keep a list of your medicines and show it to your healthcare provider and pharmacist. Do not start taking any new medicines without first talking to your healthcare provider.

Do not take EVOTAZ if you

• Are allergic to any of the ingredients in EVOTAZ
• Are taking any of the following medicines. EVOTAZ may cause serious life-threatening side effects or death when used with these medicines:
  • alfuzosin
  • carbamazepine
  • cisapride
  • colchicine, if you have liver or kidney problems
  • dronedarone hydrochloride
  • drospirenone and ethinyl estradiol
  • elbasvir and grazoprevir
  • ergot-containing medicines:
    • dihydroergotamine
    • ergotamine
    • methylergonovine
  • glecaprevir and pibrentasvir
  • indinavir
  • irinotecan
  • lovastatin
  • lomitapide
  • lurasidone
  • midazolam, when taken by mouth for sedation
  • nevirapine
  • phenobarbital
  • phenytoin
  • pimozide
  • ranolazine
  • rifampin
  • sildenafil, when used for the treatment of pulmonary arterial hypertension (PAH)
  • simvastatin
  • St. John’s wort (Hypericum perforatum), or a product that contains St. John’s wort
  • triazolam

The above list of drugs is not complete. Please refer to Patient Information for a list of drugs that may call for your therapy to be watched more closely or may call for a change in dose or dose schedule of EVOTAZ or the other drug. Know the drugs you take. Keep a list of your drugs and show it to your healthcare provider and pharmacist when you get a new drug.

Remember:

1. Know all the drugs you take.
2. Tell your healthcare provider about all the drugs you take.
3. Do not start a new drug without talking to your healthcare provider.
   When you get a new drug, show it to your healthcare provider and your pharmacist.

Take EVOTAZ once every day exactly as told by your healthcare provider. Your healthcare provider will prescribe the amount of EVOTAZ that is right for you.

Do not change your dose or stop taking EVOTAZ without talking to your healthcare provider.

• Stay under the care of your healthcare provider during treatment with EVOTAZ
• EVOTAZ must be used with other antiretroviral drugs
• Take EVOTAZ 1 time each day with food
• If you miss a dose of EVOTAZ, take the dose as soon as possible and then return to your normal schedule.
• If a dose of EVOTAZ is missed, do not double the next dose
• If you take too much EVOTAZ, call your healthcare provider or go to the nearest hospital emergency room right away
• When your supply of EVOTAZ starts to run low, get more from your healthcare provider or pharmacy. It is important not to run out of EVOTAZ. The amount of HIV-1 in your blood may increase if the drug is stopped for even a short time. The virus may become resistant to EVOTAZ and harder to treat

• EVOTAZ should not be used during pregnancy, because the EVOTAZ levels in your blood may be lower during pregnancy and may not control your HIV-1.
• Tell your healthcare provider right away if you become pregnant during treatment with EVOTAZ.
• Your healthcare provider may prescribe different medicines if you become pregnant during treatment with EVOTAZ.
• 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-1 medicines called nucleoside analogues.
• Hormonal forms of birth control, such as injections, vaginal rings or implants, contraceptive patches, and birth control pills, as some of these may not work when you are taking EVOTAZ. Talk to your healthcare provider about forms of birth control that may be used during treatment with EVOTAZ.
• Pregnancy Registry. There is a pregnancy registry for people who take HIV-1 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.

Do not breastfeed if you take EVOTAZ or if you have HIV-1. HIV-1 can be passed to the baby in breast milk. Talk to your healthcare provider about the best way to feed your baby.

Over time, HIV can become resistant to HIV drugs. When patients develop drug resistance to a drug in a certain class (such as EVOTAZ, which is a protease inhibitor [PI]), they often become resistant to many or all of the drugs in that class.

Learn more about how EVOTAZ works

Do not store this drug in a damp place.

• Store EVOTAZ tablets at room temperature between 68°F and 77°F (20°C and 25°C)
• Keep tablets in a tightly closed container
• Keep EVOTAZ and all drugs out of the reach of children

Active Ingredients: atazanavir and cobicistat
Inactive Ingredients: croscarmellose sodium, crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium starch glycolate, and stearic acid. The film-coating contains hypromellose, red iron oxide, talc, titanium dioxide, and triacetin.

Tell your healthcare provider if you think you have had an allergic reaction to any of these ingredients.