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REYATAZ

What Is REYATAZ?

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What is REYATAZ?

REYATAZ is a prescription medicine used to treat HIV-1 (Human Immunodeficiency Virus type 1) infection in adults, and in children who are 3 months of age and older and weigh at least 11 pounds (5 kg). A complete treatment regimen of REYATAZ in combination with other antiretroviral medicines is important to properly treat HIV:

Ways you can take Reyatazwhatis-map whatis-map

REYATAZ will not cure HIV infection or AIDS (Acquired Immunodeficiency Syndrome), but, when taken properly, it can help reduce the amount of HIV-1 and increase the amount of infection-fighting immune cells in your blood:

You must stay on continuous HIV-1 therapy in order to control your HIV-1 infection, decrease HIV-1-related illness, and reduce the chance of viral resistance.
Do not give REYATAZ to children younger than 3 months of age.
REYATAZ may cause side effects in some people

Learn more about REYATAZ side effects

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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®), elbasvir/grazoprevir (Zepatier®), ergot medicines (Cafergot®, Migergot®, Ergomar®, Ergostat®, Medihaler®, ergotamine, Wigraine®, Wigrettes®, D.H.E.45®, Migranal®, Methergine®), glecaprevir/pibrentasvir (Mavyret®), 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:

  • Chronic kidney disease. REYATAZ may affect how well your kidneys work. Your healthcare provider will do blood and urine tests to check your kidneys before you start REYATAZ and during treatment
  • Kidney stones have happened in some people taking REYATAZ. 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 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

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

  • 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.

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®), elbasvir/grazoprevir (Zepatier®), ergot medicines (Cafergot®, Migergot®, Ergomar®, Ergostat®, Medihaler®, ergotamine, Wigraine®, Wigrettes®, D.H.E.45®, Migranal®, Methergine®), glecaprevir/pibrentasvir (Mavyret®), 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
  • Chronic kidney disease. REYATAZ may affect how well your kidneys work. Your healthcare provider will do blood and urine tests to check your kidneys before you start REYATAZ and during treatment
  • Kidney stones have happened in some people taking REYATAZ. 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 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