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Drugs

Atazanavir / Cobicistat

Atazanavir / Cobicistat

Brand Name: Evotaz Other Names: ATV / COBI, atazanavir sulfate / cobicistat Drug Class: Combination Drugs

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WARNING:

WARNING:

Evotaz can cause serious, life-threatening side effects. These include heart rhythm problems, severe rash, liver problems, gallbladder problems, and kidney problems.

Contact your health care provider right away if you have any of the following symptoms that could be signs of heart rhythm problems:

  • Dizziness
  • Lightheadedness

Contact your health care provider or go to the nearest hospital emergency room right away if you develop a severe rash or a rash with any of the following symptoms:

  • General feeling of discomfort or “flu-like” symptoms
  • Fever
  • Muscle or joint aches
  • Swelling of your face
  • Redness or swelling of the eyes (conjunctivitis)
  • Blisters
  • Mouth sores
  • A painful, warm, or red lump under your skin

Some people taking Evotaz have had liver problems. People with a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or who have elevated results on liver function tests may have an increased risk of developing new or worsening liver problems while taking Evotaz. Liver function tests may be done before and during treatment with Evotaz. Contact your health care provider right away if you have any of the following symptoms that could be signs of liver problems:

  • Yellowing of your skin or the whites of your eyes (jaundice)
  • Dark-colored urine
  • Light-colored bowel movements
  • Nausea
  • Itching
  • Pain in your stomach area

Contact your health care provider right away if you have any of the following symptoms that could be signs of gallbladder problems:

  • Pain in your right or middle upper stomach area
  • Fever
  • Nausea and vomiting
  • Yellowing of your skin or the whites of your eyes (jaundice)

Evotaz, when taken with certain other medicines, can cause new or worse kidney problems, including kidney failure. Your health care provider should check your kidneys before and during treatment with Evotaz.

While taking Evotaz, it is important to keep all of your appointments with your health care provider.

What is Evotaz?

What is Evotaz?

Evotaz is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults. Evotaz is always used in combination with other HIV medicines.

Evotaz contains the following two different medicines combined in one pill:

PIs, such as atazanavir, block an HIV enzyme called protease. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) By blocking protease, PIs prevent HIV from multiplying and can reduce the amount of HIV in the body. Pharmacokinetic enhancers, such as cobicistat, are used in HIV treatment to increase the effectiveness of other HIV medicines. In Evotaz, cobicistat increases the effectiveness of atazanavir.

HIV medicines can’t cure HIV/AIDS, but taking a combination of HIV medicines (called an HIV regimen) 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, including Evotaz, don't 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 Evotaz?

What should I tell my health care provider before taking Evotaz?

Before taking Evotaz, tell your health care provider:

  • If you are allergic to any of the HIV medicines in Evotaz (atazanavir or cobicistat) or any other medicines.
  • If you have heart problems.
  • If you have liver problems, including hepatitis B virus (HBV) infection and hepatitis C virus (HCV) infection.
  • If you have kidney problems.
  • If you have diabetes.
  • If you have hemophilia.
  • If you have any other medical conditions.
  • If you are pregnant or plan to become pregnant. Whether Evotaz can harm an unborn baby is unknown. Some pregnant women have developed a serious condition called lactic acidosis (buildup of lactic acid in the blood) when taking Evotaz with other HIV medicines called nucleoside reverse transcriptase inhibitors (NRTIs). Talk to your health care provider about possible risks with taking Evotaz when pregnant.
  • If you are breastfeeding or plan to breastfeed. Do not breastfeed if you have HIV or are taking Evotaz.
  • If you are using hormone-based birth control (such as pills, implants, or vaginal rings). Evotaz 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 Evotaz. For more information about using birth control and HIV medicines at the same time, view the AIDSinfo HIV and Birth Control infographic.
  • About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products (particularly St. John's Wort) you are taking or plan to take. Evotaz may affect the way other medicines or products work, and other medicines or products may affect how Evotaz works. Taking Evotaz together with certain medicines or products may cause serious, life-threatening side effects.

How should I take Evotaz?

How should I take Evotaz?

Evotaz comes in tablet form. Each tablet contains:

Take Evotaz according to your health care provider’s instructions.

Take Evotaz once a day with food.

Always take Evotaz in combination with other HIV medicines.

If you take too much Evotaz, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room.

For more information on how to take Evotaz, see the FDA drug label from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)

What should I do if I forget a dose?

What should I do if I forget a dose?

If you miss a dose of Evotaz, 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 Evotaz cause?

What side effects can Evotaz cause?

Evotaz may cause side effects. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the AIDSinfo fact sheet on HIV Medicines and Side Effects for more information.

Some side effects of Evotaz can be serious. Serious side effects of Evotaz include heart rhythm problems, severe rash, liver problems, gallbladder problems, kidney problems, and life-threatening drug interactions. (See the WARNING box above.)

Other possible side effects of Evotaz include:

  • Mild rash.
  • Diabetes and high blood sugar (hyperglycemia).
  • Changes in body fat (including gain or loss of fat).
  • Yellowing of your skin or the whites of your eyes (jaundice), which may be caused by increased bilirubin levels in your blood. Contact your health care provider right away if you have this side effect.
  • Increased bleeding problems in people with hemophilia.
  • 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.
  • Kidney stones. Contact your health care provider if you have pain in your lower back or lower stomach area, blood in your urine, or pain when urinating.

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 Evotaz. To learn more about possible side effects of Evotaz, 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 at https://www.accessdata.fda.gov/scripts/medwatch/.

How should Evotaz be stored?

How should Evotaz be stored?

  • Store Evotaz at room temperature, 68°F to 77°F (20°C to 25°C)
  • Keep Evotaz in the container that it came in and keep the container tightly closed. If the container has a small packet of drying agent (called a desiccant), do not remove it. The desiccant protects the medicine from moisture.
  • Do not use Evotaz if the original seal over the container opening is broken or missing.
  • Throw away Evotaz that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
  • Keep Evotaz and all medicines out of reach of children.

Where can I find more information about Evotaz?

Where can I find more information about Evotaz?

More information about Evotaz is available:

Manufacturer Information

Bristol-Myers Squibb
Main number: 800-332-2056
Patient assistance: 888-281-8981

The above Patient Version drug summary is based on the following FDA label(s): Tablet.

Last Reviewed: September 22, 2017

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