Possible Side
Effects

Possible Side Effects

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What side effects can EVOTAZ cause?

EVOTAZ may cause side effects in some people. Some of the side effects caused by EVOTAZ can be serious.

EVOTAZ

Talk to your prescribing physician about any side effect that may be bothering you. Your prescribing physician can work with you to manage side effects throughout your treatment.

The common moderate-to-severe side effects of EVOTAZ seen in a clinical study are:

6% or 21 of 344 patients experienced yellowing of the skin

5% or 17 of 344 patients experienced a skin rash

4% or 14 of 344 patients experienced yellowing of the white parts of the eyes

2% or 7 of 344 patients experienced nausea

2% or 7 of 344 patients experienced diarrhea

2% or 7 of 344 patients experienced headache

EVOTAZ can cause serious side effects, including:

EVOTAZ

If you develop any of these symptoms call a healthcare provider right away:

EVOTAZ
  • A change in the way your heart beats (Arrhythmia)
    Symptoms of heart rhythm change may include: dizziness or light headedness.
EVOTAZ
  • Skin rash
    Skin rashes are common with EVOTAZ and can be severe. Skin rashes often go away within two weeks without any change in treatment. Severe rash may develop with other symptoms which could 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; fever; muscle or joint aches; red or inflamed eyes; blisters; mouth sores; swelling of your face; or a painful, warm, or red lump under your skin.
EVOTAZ
  • Kidney problems
    Taking EVOTAZ with certain drugs can cause kidney problems, including kidney failure, to appear or get worse. Kidney stones have also happened in people taking atazanavir, which is a part of EVOTAZ. Symptoms of kidney problems may include: pain in your low back or low stomach area, blood in your urine, or pain when you urinate.
EVOTAZ
  • Gallbladder problems
    Gallbladder problems have appeared in people taking atazanavir. Noticeable symptoms may include: Yellowing of the skin or the white part of your eyes, pain in the right or middle upper stomach area, fever, nausea and vomiting.
EVOTAZ
  • Liver problems
    Liver problems, such as hepatitis B or C may get worse. Noticeable symptoms may include: Yellowing of the skin or the white part of your eyes, dark (“tea colored”) urine, light colored stools, itching, pain in the stomach area, and nausea.
    Your prescribing physician will do blood tests before and during your treatment on EVOTAZ to check liver function.
EVOTAZ
  • Yellowing of the skin or the white part of your eyes
    This may happen due to increases in bilirubin levels (a byproduct of the liver).
EVOTAZ
  • Changes in your immune system (Immune Reconstitution
    Syndrome)

    General inflammatory responses and other autoimmune responses can appear when you start taking HIV medicines.
EVOTAZ
  • Diabetes and high blood sugar (hyperglycemia)
    Diabetes and high blood sugar have appeared, or gotten worse, in some people who take protease inhibitor drugs like atazanavir in EVOTAZ.
    You may need to start using a diabetes drug or change diabetes drugs that you are already on.
EVOTAZ
  • Changes in body fat
    Changes in the amount and distribution of body fat may appear in people taking HIV drugs.
    The exact cause and long-term health effects are still unknown.
EVOTAZ
  • If you have hemophilia
    Protease inhibitors, such as atazanavir in EVOTAZ, have been known to cause increased bleeding in hemophilia patients.
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More Important Safety Information

SELECTED IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

Who should not take EVOTAZ (atazanavir and cobicistat)?

Do not take EVOTAZ 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

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.