Existing drug safety information is mainly text. Patients told us that they don’t use many of the words that are common in safety information, such as “indication.” Patients also told us they would like additional details in other areas of the drug safety information.
Important Safety Information
Who should not take EVOTAZ?
Do not take EVOTAZ (atazanavir and cobicistat) if you:
- Are allergic to any of the ingredients in EVOTAZ
- Are taking the following medicines because taking them with EVOTAZ may cause serious, life-threatening side effects: alfuzosin (Uroxatral®), carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®), cisapride (Propulsid®, Propulsid® Quicksolv®), colchicine (Mitigare®, Colcrys®) if you have liver or kidney problems, dronedarone hydrochloride (Multaq®), ergot containing medicines (D.H.E. 45®, Embolex®, Migranal®, Cafergot®, Migergot®, Ergomar®, Ergostat®, Medihaler®, Wigraine®, Wigrettes®, Methergine®), indinavir (Crixivan®), irinotecan (Camptosar®), lovastatin (Advicor®, Altoprev®, Mevacor®), lurasidone (Latuda®), oral midazolam (Versed®), nevirapine (Viramune®, Viramune XR®), phenobarbital (Luminal®), phenytoin (Dilantin®, Phenytek®), pimozide (Orap®), ranolazine (Ranexa®), rifampin (Rimactane®, Rifadin®, Rifater®, Rifamate®), sildenafil (Revatio®) when used for lung problems, simvastatin (Zocor®, Vytorin®, Simcor®), triazolam (Halcion®) or products that contain St. John’s wort (Hypericum perforatum)
What should I tell my healthcare provider before taking EVOTAZ?
- If you have heart problems, liver problems, including hepatitis B or C virus infection, kidney problems, diabetes, or hemophilia or any other medical condition
- If you are pregnant or plan to become pregnant. It is not known if EVOTAZ will harm your unborn baby. Pregnant women have developed a serious condition called lactic acidosis (a buildup of lactic acid in the blood)
- If you take hormonal forms of birth control, such as injections, rings, implants, contraceptive patches or birth control pills, as some of these may not work when you are taking EVOTAZ
- After your baby is born, tell your healthcare provider if your baby’s skin or the white part of his/her eyes turns yellow
- If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed if you have HIV or if you take EVOTAZ. HIV can be passed to the baby in breast milk. It is not known if EVOTAZ passes into breast milk
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. Call your healthcare provider right away if you have any of the following:
- A change in the way your heart beats (heart rhythm change). You may feel 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 (“flu like” symptoms); fever; muscle or joint aches; red or inflamed eyes; blisters; 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. 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
- Gallbladder problems have happened in some people who take atazanavir, one of the medicines in EVOTAZ. Symptoms may include pain in the right or middle upper stomach area, fever, nausea and vomiting, 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, dark (tea colored) urine, light colored stools, nausea, itching, or stomach-area pain
- Yellowing of the skin or the white part of your eyes. This may occur due to increases in bilirubin levels in the blood
- 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 can happen or get worse in some people who take protease inhibitor medicines like EVOTAZ. Some people may need to start diabetes medicine or change their diabetes medicine
- Changes in body fat can happen in people taking HIV 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.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Please see U.S. Full Prescribing Information and Patient Information