Frequently 
Asked 
Questions

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.

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 helps prevent cells infected by HIV from producing more HIV. This reduces the amount of the virus in your body. REYATAZ as part of combination therapy is one of several treatment options your doctor may consider. REYATAZ does not cure HIV-1 infection or AIDS (Acquired Immunodeficiency Syndrome). You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses.

HIV is a virus that multiplies quickly. Untreated, it can produce billions of copies of itself every day. But HIV cannot multiply on its own. It uses the CD4+ cells of your immune system. Normally, CD4+ cells fight bacteria and viruses to keep you healthy. As HIV multiplies, it destroys CD4+ cells.

REYATAZ is in the category of HIV drugs known as protease inhibitors (PIs). PIs prevent HIV from copying itself effectively.

REYATAZ can help raise your CD4+ cells and lower your viral load to undetectable.*

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 or life-threatening side effects, or death if taken with the following medicines:
  • alfuzosin
  • apalutamide
  • carbamazepine
  • amiodarone (when REYATAZ is used with ritonavir)
  • cisapride
  • elbasvir and grazoprevir
  • encorafenib
  • ergot medicines including:
    • dihydroergotamine
    • ergonovine
    • ergonovine ergotamine
    • methylergonovine
  • glecaprevir and pibrentasvir
  • indinavir
  • irinotecan
  • ivosidenib
  • lomitapide
  • lovastatin
  • lurasidone (when REYATAZ is used with ritonavir)
  • midazolam when taken by mouth for sedation
  • nevirapine
  • phenobarbital
  • phenytoin
  • pimozide
  • quinidine (when REYATAZ is used with ritonavir)
  • rifampin
  • sildenafil when used for pulmonary arterial hypertension
  • simvastatin
  • St. John’s wort
  • triazolam

No. REYATAZ does not cure HIV-1 infection or AIDS (Acquired Immunodeficiency Syndrome). You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses (opportunistic infections). Opportunistic infections are infections that develop because the immune system is weak. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infections. It is very important that you see your healthcare provider regularly while taking REYATAZ.

REYATAZ does not lower your chance of passing HIV to other people through sexual contact, sharing needles, or being exposed to your blood. For your health and the health of others, it is important to always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood. Never use or share dirty needles.

No. REYATAZ does not lower your chance of passing HIV to other people through sexual contact, sharing needles, or being exposed to your blood. To reduce the risks linked to sexual contact, you should get tested for sexually transmitted diseases (STDs). Let your partner know your HIV and STD status.

For your health and the health of others, it is important to always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.

Never share or reuse piercing, tattooing, or injection needles. If you are an injection drug user, consider seeking treatment for substance use.

Yes. REYATAZ in HIV combination therapy can be taken by adults who are starting HIV treatment for the first time.

Once-daily REYATAZ in combination therapy has been shown to be effective in helping to manage HIV. It can help lower your viral load to undetectable* and may raise your CD4+ cell count. REYATAZ does not cure HIV-1 infection or AIDS (Acquired Immunodeficiency Syndrome). You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses.

Doctors may change your HIV therapy for a variety of reasons. REYATAZ as part of combination therapy is one of several treatment options your doctor may consider.

Before you take REYATAZ, tell your healthcare provider:

If you are pregnant or plan to become pregnant.

• REYATAZ must be taken with ritonavir during pregnancy.
• 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.
• Pregnancy Exposure Registry. There is a pregnancy exposure registry for people who take REYATAZ 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.
• After your baby is born, tell your healthcare provider if your baby’s skin or the white part of their eyes turns yellow.
• Are breastfeeding or plan to breastfeed. Do not breastfeed if you are taking REYATAZ.
  • REYATAZ can pass into your breast milk

If you have heart or liver problems (including hepatitis B or C infection). Learn what else to discuss with your doctor

If you are receiving dialysis treatment. Learn what else to discuss with your doctor

If you have diabetes. Learn what else to discuss with your doctor

If you have hemophilia. Learn what else to discuss with your doctor

If you have any other medical conditions. Learn what else to discuss with your doctor

If you have phenylketonuria (PKU). REYATAZ oral powder contains phenylalanine as part of the artificial sweetener aspartame and can be harmful to people with PKU.

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 your medicines to show your healthcare provider and pharmacist. You can ask your healthcare provider or pharmacist for a list of medicines that interact with REYATAZ. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take REYATAZ with other medicines. Learn more about possible drug interactions

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 or life-threatening side effects, or death if taken with the following medicines:
  • alfuzosin
  • amiodarone (when REYATAZ is used with ritonavir)
  • apalutamide
  • carbamazepine
  • cisapride
  • elbasvir and grazoprevir
  • encorafenib
  • ergot medicines including:
    • dihydroergotamine
    • ergonovine
    • ergonovine ergotamine
    • methylergonovine
  • glecaprevir and pibrentasvir
  • indinavir
  • irinotecan
  • ivosidenib
  • lomitapide
  • lovastatin
  • lurasidone (when REYATAZ is used with ritonavir)
  • midazolam when taken by mouth for sedation
  • nevirapine
  • phenobarbital
  • phenytoin
  • pimozide
  • quinidine (when REYATAZ is used with ritonavir)
  • rifampin
  • sildenafil when used for pulmonary arterial hypertension
  • simvastatin
  • St. John’s wort
  • triazolam

Serious problems can happen if you or your child takes any of the medicines listed above with REYATAZ.

Remember:

1. Know all the drugs you take.
2. Tell your healthcare provider about all the drugs you take.
3. Do not start a new drug without talking to your healthcare provider. When you get a new drug, show it to your healthcare provider and your pharmacist.

• Take REYATAZ exactly as your healthcare provider tells you to.
• Do not change your dose or stop taking REYATAZ unless your healthcare provider tells you to.
• Stay under the care of your healthcare provider during treatment with REYATAZ.
• REYATAZ must be used with other antiretroviral medicines.
• Take REYATAZ 1 time each day.
• REYATAZ comes as capsules and oral powder.
• Take REYATAZ capsules and oral powder with food.
• Swallow the capsules whole. Do not open the capsules.
• REYATAZ oral powder must be mixed with food or liquid. Your child’s healthcare provider will prescribe the right dose of REYATAZ based on your child’s weight.
• REYATAZ oral powder must be taken with ritonavir.
• If you miss a dose of REYATAZ, take it as soon as you remember. Then take the next dose at your regular time. Do not take 2 doses at the same time.
• If you take too much REYATAZ, call your healthcare provider or go to the nearest hospital emergency room right away.

When your supply of REYATAZ starts to run low, get more from your healthcare provider or pharmacy. It is important not to run out of REYATAZ. The amount of HIV-1 in your blood may increase if the medicine is stopped for even a short time. The virus may become resistant to REYATAZ and harder to treat.

The following list of side effects is not complete. Report any new or continuing symptoms to your healthcare provider. If you have questions about side effects, ask your healthcare provider. Your healthcare provider may be able to help you manage these side effects.

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 but can sometimes be severe and may develop with other symptoms which can be serious. If you develop a severe rash or a rash with any of the following symptoms, stop taking REYATAZ and 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, painful, warm or red lump under the skin.
• 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. Drink plenty of fluids during treatment with REYATAZ.
• Kidney stones have happened in some people taking REYATAZ and sometimes may lead to hospitalization. Symptoms may include pain in your low back or low stomach-area, blood in your urine, pain when you urinate.
• Gallbladder stones have happened in some people who take REYATAZ, and sometimes may lead to hospitalization. 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.
• 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).
• New or worsening diabetes and high blood sugar have happened in some people who take protease inhibitor medicines like REYATAZ. Some people may need to start diabetes medicine or change their dose of 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.
• If you experience any side effects while on REYATAZ, talk to your healthcare provider right away.

REYATAZ use during pregnancy has not been associated with an increase in birth defects. Pregnant women have experienced serious side effects when taking REYATAZ with other HIV medicines called nucleoside analogues. You and your healthcare provider will need to decide if REYATAZ is right for you. If you use REYATAZ while you are pregnant, talk to your healthcare provider about the Antiretroviral Pregnancy Registry. And after your baby is born, tell your healthcare provider if your baby's skin or the white part of his/her eyes turns yellow.

Do not breastfeed. REYATAZ can be passed to your baby in your breast milk and it is not known whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.

Over time, HIV can become resistant to HIV drugs. When patients develop resistance to a drug in a certain class (for example, REYATAZ, which is a protease inhibitor [PI]), they often become resistant to many or all of the drugs in that class.

Learn more about how REYATAZ works

Taking certain medicines with REYATAZ that may affect how REYATAZ works. REYATAZ may cause serious or life-threatening side effects, or death if taken with the following medicines:

• alfuzosin
• amiodarone (when REYATAZ is used with ritonavir)
• apalutamide
• carbamazepine
• cisapride
• elbasvir and grazoprevir
• encorafenib
• ergot medicines including:
  • dihydroergotamine
  • ergonovine
  • ergonovine ergotamine
  • methylergonovine
• glecaprevir and pibrentasvir
• indinavir
• irinotecan
• ivosidenib
• lomitapide
• lovastatin
• lurasidone (when REYATAZ is used with ritonavir)
• midazolam when taken by mouth for sedation
• nevirapine
• phenobarbital
• phenytoin
• pimozide
• quinidine (when REYATAZ is used with ritonavir)
• rifampin
• sildenafil when used for pulmonary arterial hypertension
• simvastatin
• St. John's wort
• triazolam

• Store REYATAZ capsules at room temperature, between 68°F to 77°F (20°C to 25°C). Keep capsules in a tightly closed container.
• Store REYATAZ oral powder below 86°F (30°C). Store REYATAZ oral powder in the original packet. Do not open until ready to use. After REYATAZ oral powder is mixed with food or liquid it may be kept at room temperature 68°F to 86°F (20°C to 30°C) for up to 1 hour. Take REYATAZ oral powder within 1 hour after mixing with food or liquid.
• Keep all medicines out of the reach of children and pets at all times. Do not keep medicine that is out of date or that you no longer need. Dispose of unused medicines through community take-back disposal programs when available or place REYATAZ in an unrecognizable, closed container in the household trash.

Active Ingredients: atazanavir sulfate

Inactive Ingredients:

• REYATAZ capsules: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain gelatin, FD&C Blue No. 2, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. The capsules are printed with ink containing shellac, titanium dioxide, FD&C Blue No. 2, isopropyl alcohol, ammonium hydroxide, propylene glycol, n-butyl alcohol, simethicone, and dehydrated alcohol.
• REYATAZ oral powder: aspartame, sucrose, and orange-vanilla flavor.