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More Important Safety Information

SELECTED IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

Do not take EVOTAZ 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

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.

What are the possible side effects of EVOTAZ?

EVOTAZ can cause serious side effects, including:

  • A change in the way your heart beats (heart rhythm change). Tell your healthcare provider right away if you get dizzy or lightheaded, as these could be symptoms of a heart problem
  • Skin rash is common with EVOTAZ, and can sometimes be severe. Skin rash usually goes away within 2 weeks. Severe rash may develop with other symptoms which can be serious. If you develop a severe rash with any of the following symptoms, call your healthcare provider or go to the nearest hospital emergency room right away: general feeling of discomfort or “flu like” symptoms; red or inflamed eyes, like “pink eye”; fever; blisters; muscle or joint aches; mouth sores; swelling of your face; painful, warm, or red lump under your skin
  • Kidney problems can occur when EVOTAZ is taken with certain other medicines, as this can cause new or worse kidney problems, including kidney failure. Your healthcare provider should check your kidneys before you start and while you are taking EVOTAZ. Kidney stones have happened in some people who take atazanavir, one of the medicines in EVOTAZ. Symptoms may include pain in your low back or low stomach area, blood in your urine, pain when you urinate
  • Chronic kidney disease. EVOTAZ may affect how well your kidneys work. Your healthcare provider will do blood and urine tests to check your kidneys before you start EVOTAZ and during treatment 
  • Gallbladder problems have happened in some people who take atazanavir, one of the medicines in EVOTAZ. Tell your healthcare provider right away if you get symptoms of gallbladder problems. Symptoms may include pain in the right or middle upper stomach area, nausea and vomiting, fever, and your skin or the white part of your eyes turns yellow
  • Liver problems, including hepatitis B or C, may get worse when taking EVOTAZ. Your healthcare provider will do blood tests before and during treatment with EVOTAZ. Symptoms of liver problems may include: your skin or the white part of your eyes turns yellow, nausea, dark (tea colored) urine, itching, light colored stools, or stomach-area pain
  • Yellowing of the skin or the white part of your eyes is common with EVOTAZ but may be a symptom of a serious problem. This may occur due to increases in bilirubin levels in the blood. Tell your healthcare provider right away if your skin or the white part of your eyes turns yellow.
  • Changes in your immune system (Immune Reconstitution Syndrome). Tell your healthcare provider if you start having new symptoms after starting EVOTAZ
  • Diabetes and high blood sugar have happened and worsened in some people who take protease inhibitor medicines like EVOTAZ. Some people may need to start diabetes medicine or change their diabetes medicine. Tell your healthcare provider if you notice an increase in thirst or if you start urinating more often while taking EVOTAZ
  • Changes in body fat can happen in people taking HIV-1 medicines. The exact cause and long-term health effects are not known
  • Increased bleeding problems in people with hemophilia have happened when taking protease inhibitors including EVOTAZ

The most common side effects of EVOTAZ are yellowing of the skin and rash.

These are not all the possible side effects of EVOTAZ.

Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Please see Full Prescribing Information, including Patient Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.