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Possible Side
Effects

Not an actual patient
What side effects can REYATAZ cause?

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

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

The most common side effects include:

  • nausea
  • headache
  • stomach-area pain
  • vomiting
  • trouble sleeping
  • numbness, tingling, or burning of hands or feet
  • dizziness
  • muscle pain
  • diarrhea
  • depression
  • fever

The most severe but less common side effects of REYATAZ, and their symptoms, are:

call

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

  • A change in the way your heart beats (Arrhythmia)
    Symptoms of heart rhythm change may include: dizziness or light headedness. These could be symptoms of a heart problem
  • Skin rash
    Skin rashes are common with REYATAZ and usually 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 or a 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.
  • Yellowing of the skin or the white part of your eyes
    This may occur due to increases in bilirubin levels in your blood (bilirubin is made by the liver). It is common with REYATAZ, and usually not harmful in adults and infants older than 3 months of age, but it could also be a symptom of a serious problem. Tell your healthcare provider right away if your skin or the white part of your eyes turns yellow.
liver problems
  • Liver problems
    Liver problems, such as hepatitis B or C, may get worse. Noticeable symptoms may include: dark (“tea colored”) urine, yellowing of the skin or the white part of your eyes, light-colored stools, nausea, itching, or pain in the stomach area.
kidney stones
  • Kidney stones
    Kidney stones have occurred in some people taking REYATAZ. Symptoms may include: pain in your back or low stomach area, blood in your urine, or pain when you urinate.
gallblader
  • Gallbladder problems
    Gallbladder problems have occured in people taking REYATAZ. Symptoms may include: pain in the right or middle upper stomach area, fever, nausea and vomiting, or yellowing of the skin or the white part of your eyes.
blood sugar
  • Diabetes and high blood sugar
    Diabetes and high blood sugar have occurred, or gotten worse, in some people who take protease inhibitor medicines like REYATAZ.

    You may need to start diabetes medicine or change the diabetes medicines that you are already on.
  • Changes in your immune system (Immune Reconstitution
    Syndrome)

    General inflammatory responses and other autoimmune responses can occur when you start taking HIV-1 drugs. Tell your healthcare provider if you have any new symptoms after starting REYATAZ.
body fat
  • Changes in body fat
    Changes in the amount and distribution of body fat may appear in people taking HIV-1 drugs.
    The exact cause and long-term health effects are still unknown.
EVOTAZ
  • Hemophilia
    Protease inhibitors, such as REYATAZ, have been known to cause increased bleeding in people with hemophilia.
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More Important Safety Information

SELECTED IMPORTANT SAFETY INFORMATION

Do not take REYATAZ if you are:

  • Allergic to REYATAZ or to any of its ingredients
  • Taking certain medicines with REYATAZ that may affect how REYATAZ works. REYATAZ may cause serious, life-threatening side effects or death if taken with the following medicines: alfuzosin (Uroxatral®), cisapride (Propulsid®), ergot medicines (refer to patient information for complete list of these medicines), indinavir (Crixivan®), irinotecan (Camptosar®), lurasidone (Latuda®) if REYATAZ is used with ritonavir (Norvir®), lovastatin (Advicor®, Altoprev®, Mevacor®), midazolam (Versed®) when taken by mouth for sedation, nevirapine (Viramune®, Viramune XR®), pimozide (Orap®), rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®), sildenafil (Revatio®) when used for pulmonary arterial hypertension, simvastatin (Simcor®, Vytorin®, Zocor®), St. John’s wort (Hypericum perforatum), triazolam (Halcion®)

Before taking REYATAZ, tell your healthcare provider if you:

  • Have heart problems
  • Have liver problems including hepatitis B or C infection
  • Have phenylketonuria (PKU). REYATAZ oral powder contains phenylalanine as part of the artificial sweetener aspartame and can be harmful to people with PKU.
  • Are receiving dialysis treatment
  • Have diabetes
  • Have hemophilia
  • Have any other medical conditions

Before taking REYATAZ, tell your healthcare provider if you:

  • Are pregnant or plan to become pregnant. Talk to your healthcare provider about taking REYATAZ during your pregnancy or if you are planning to become pregnant while you are taking REYATAZ.
    • Hormonal forms of birth control, such as injections, vaginal rings or implants, contraceptive patch, and some birth control pills, may not work when you are taking REYATAZ
    • After your baby is born, tell your healthcare provider if your baby’s skin or the white part of the eyes turns yellow
  • Are breastfeeding or plan to breastfeed. Do not breastfeed if you are taking REYATAZ. REYATAZ can pass into your 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 REYATAZ. Keep a list of medicines to show your healthcare provider and pharmacist. Do not start taking a new medicine without telling your healthcare provider.

REYATAZ 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. You may feel dizzy or lightheaded. These could be symptoms of a heart problem.
  • Skin rash is common with REYATAZ and usually goes away within 2 weeks. Skin rash can sometimes be severe and may develop with other symptoms which can be serious. If you develop a severe rash with any of the following symptoms stop taking REYATAZ and call your healthcare provider 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, painful, warm or red lump under the skin.

REYATAZ can cause serious side effects. Call your healthcare provider right away if you have any of the following:

  • Yellowing of your skin or the white part of your eyes is common, and usually not harmful in adults and infants older than 3 months of age, but it could also be a symptom of a serious problem. This may occur due to increases in bilirubin levels in the blood (bilirubin is made by the liver).
  • Liver problems including hepatitis B or C may get worse when taking REYATAZ. Your healthcare provider will do blood tests before and during treatment with REYATAZ. Liver problem symptoms may include: dark “tea-colored” urine, your skin or the white part of your eyes turning yellow, light colored stools, nausea, itching, or stomach area pain.

REYATAZ can cause serious side effects. Call your healthcare provider right away if you have any of the following:

  • Kidney problemshappened in some people taking REYATAZ. Symptoms may include pain in your back or low stomach area, blood in your urine, pain when you urinate.
  • Gallbladder problems have happened in some people who take REYATAZ. Symptoms may include pain in the right or middle upper stomach area, fever, nausea and vomiting, or your skin or the white part of your eyes turning yellow.
  • Diabetes and high blood sugar have happened or worsened in some people who take protease inhibitor medicines like REYATAZ. Some people may need to start diabetes medicine or change their diabetes medicine.

REYATAZ can cause serious side effects. Call your healthcare provider right away if you have any of the following:

  • Changes in your immune system (Immune Reconstitution Syndrome). can happen when you start taking HIV-1 medicines. Tell your healthcare provider if you have any new symptoms after starting REYATAZ.
  • 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 like REYATAZ.

The most common side effects of REYATAZ include: nausea, headache, stomach-area pain, vomiting, trouble sleeping, numbness, tingling, or burning of hands or feet, dizziness, muscle pain, diarrhea, depression, and fever.

You should take REYATAZ capsules and oral powder once daily with food. Swallow the capsules whole; do not open the capsules. REYATAZ oral powder must be mixed with food or liquid and taken with ritonavir. Take REYATAZ exactly as your healthcare provider tells you to.

IMPORTANT SAFETY INFORMATION

Do not take REYATAZ if you are:

  • Allergic to REYATAZ or to any of its ingredients
  • Taking certain medicines with REYATAZ that may affect how REYATAZ works. REYATAZ may cause serious, life-threatening side effects or death if taken with the following medicines: alfuzosin (Uroxatral®), cisapride (Propulsid®), ergot medicines (refer to patient information for complete list of these medicines), indinavir (Crixivan®), irinotecan (Camptosar®), lurasidone (Latuda®) if REYATAZ is used with ritonavir (Norvir®), lovastatin (Advicor®, Altoprev®, Mevacor®), midazolam (Versed®) when taken by mouth for sedation, nevirapine (Viramune®, Viramune XR®), pimozide (Orap®), rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®), sildenafil (Revatio®) when used for pulmonary arterial hypertension, simvastatin (Simcor®, Vytorin®, Zocor®), St. John’s wort (Hypericum perforatum), triazolam (Halcion®)

Before taking REYATAZ, tell your healthcare provider if you:

  • Have heart problems
  • Have liver problems including hepatitis B or C infection
  • Have phenylketonuria (PKU). REYATAZ oral powder contains phenylalanine as part of the artificial sweetener aspartame and can be harmful to people with PKU.
  • Are receiving dialysis treatment
  • Have diabetes
  • Have hemophilia
  • Have any other medical conditions
  • Are pregnant or plan to become pregnant. Talk to your healthcare provider about taking REYATAZ during your pregnancy or if you are planning to become pregnant while you are taking REYATAZ.
    • Hormonal forms of birth control, such as injections, vaginal rings or implants, contraceptive patch, and some birth control pills, may not work when you are taking REYATAZ
    • After your baby is born, tell your healthcare provider if your baby’s skin or the white part of the eyes turns yellow
  • Are breastfeeding or plan to breastfeed. Do not breastfeed if you are taking REYATAZ. REYATAZ can pass into your 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 REYATAZ. Keep a list of medicines to show your healthcare provider and pharmacist. Do not start taking a new medicine without telling your healthcare provider.

REYATAZ 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. You may feel dizzy or lightheaded. These could be symptoms of a heart problem.
  • Skin rash is common with REYATAZ and usually goes away within 2 weeks. Skin rash can sometimes be severe and may develop with other symptoms which can be serious. If you develop a severe rash with any of the following symptoms stop taking REYATAZ and call your healthcare provider 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, painful, warm or red lump under the skin.
  • Yellowing of your skin or the white part of your eyes is common, and usually not harmful in adults and infants older than 3 months of age, but it could also be a symptom of a serious problem. This may occur due to increases in bilirubin levels in the blood (bilirubin is made by the liver).
  • Liver problems including hepatitis B or C may get worse when taking REYATAZ. Your healthcare provider will do blood tests before and during treatment with REYATAZ. Liver problem symptoms may include: dark “tea-colored” urine, your skin or the white part of your eyes turning yellow, light colored stools, nausea, itching, or stomach area pain.
  • Kidney stones have happened in some people taking REYATAZ. Symptoms may include pain in your back or low stomach area, blood in your urine, pain when you urinate.
  • Gallbladder problems have happened in some people who take REYATAZ. Symptoms may include pain in the right or middle upper stomach area, fever, nausea and vomiting, or your skin or the white part of your eyes turning yellow.
  • Diabetes and high blood sugar have happened or worsened in some people who take protease inhibitor medicines like REYATAZ. Some people may need to start diabetes medicine or change their diabetes medicine.
  • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Tell your healthcare provider if you have any new symptoms after starting REYATAZ.
  • 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 like REYATAZ.

The most common side effects of REYATAZ include: nausea, headache, stomach-area pain, vomiting, trouble sleeping, numbness, tingling, or burning of hands or feet, dizziness, muscle pain, diarrhea, depression, and fever.

You should take REYATAZ capsules and oral powder once daily with food. Swallow the capsules whole; do not open the capsules. REYATAZ oral powder must be mixed with food or liquid and taken with ritonavir. Take REYATAZ exactly as your healthcare provider tells you to.

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.

Please see U.S. Full Prescribing Information and Patient Information

687US1602781-02-01  10/16