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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 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 and methylergonovine, glecaprevir and pibrentasvir, indinavir, irinotecan, lurasidone (when REYATAZ is used with ritonavir), lomitapide, lovastatin, 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

Before taking REYATAZ, tell your healthcare provider about all of your medical conditions, including if you:

• Have heart problems
• Have liver problems including hepatitis B or C infection
• Have phenylketonuria (PKU). The artificial sweetener aspartame in REYATAZ oral powder contains phenylalanine, which can be harmful to people with PKU
• Have kidney problems
• Are receiving dialysis treatment
• Have diabetes
• Have hemophilia
• 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

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 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.

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.

Please see Patient Information in the Full Prescribing Information.