Patient Package Insert

PATIENT INFORMATION

REYATAZ® (RAY-ah-taz)
(atazanavir)
capsules

REYATAZ® (RAY-ah-taz)
(atazanavir)
oral powder

Important: Ask your healthcare provider or pharmacist about medicines that should not be taken with REYATAZ. For more information, see “Do not take REYATAZ if you” and “Before taking REYATAZ”.

What is REYATAZ?

REYATAZ is a prescription medicine that is used to treat human immunodeficiency virus-1 (HIV-1) infection, in combination with other HIV-1 medicines in adults and children 3 months of age and older and who weigh at least 11 pounds (5 kg).

HIV-1 is the virus that causes AIDS (Acquired Immunodeficiency Syndrome).

REYATAZ should not be used in children younger than 3 months of age.

Do not take REYATAZ if you:

• •are allergic to atazanavir or any of the ingredients in REYATAZ. See the end of this leaflet for a complete list of ingredients in REYATAZ.
• •are taking any of the following medicines. Taking REYATAZ with these medicines may affect how REYATAZ works. REYATAZ may cause serious or life-threatening side effects, or death when used with these medicines:

• oalfuzosin
• oamiodarone (when REYATAZ is used with ritonavir)
• oapalutamide
• ocarbamazepine
• ocisapride
• oelbasvir and grazoprevir
• oencorafenib
• oergot medicines including:
  • ▪dihydroergotamine
  • ▪ergonovine
  • ▪ergonovine ergotamine
  • ▪methylergonovine
• oglecaprevir and pibrentasvir
• oindinavir
• oirinotecan
• oivosidenib

• olurasidone (when REYATAZ is used with ritonavir)
• olomitapide
• olovastatin
• omidazolam, when taken by mouth for sedation
• onevirapine
• ophenobarbital
• ophenytoin
• opimozide
• oquinidine (when REYATAZ is used with ritonavir)
• orifampin
• osildenafil, when used for the treatment of pulmonary arterial hypertension
• osimvastatin
• oSt. John’s wort
• otriazolam

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 virus
• •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.
  • o REYATAZ must be taken with ritonavir during pregnancy.
  • o Hormonal forms of birth control, such as injections, vaginal rings or implants, contraceptive patch, and some birth control pills may not work during treatment with REYATAZ. Talk to your healthcare provider about forms of birth control that may be used during treatment with REYATAZ.
  • o 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.
  • o 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. REYATAZ can pass into your breast milk.
  • oTalk to your healthcare provider about the following risks of breastfeeding during treatment with REYATAZ:
• •The HIV-1 virus may pass to your baby if your baby does not have the HIV-1 virus.
• •The HIV-1 virus may become harder to treat if your baby has the HIV-1 virus.
• •Your baby may get side effects from REYATAZ.

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 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.

How should I take REYATAZ?

• • 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 HIV-1 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. See the detailed “Instructions for Use” that comes with REYATAZ oral powder for information about the correct way to mix and give a dose of REYATAZ oral powder to your child.
• •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.

What are the possible side effects of REYATAZ?

REYATAZ can cause serious side effects, including:

• • A change in the way your heart beats (heart rhythm change). Tell your healthcare provider right away if you get dizzy or lightheaded. These could be symptoms of a heart problem.
• • Skin rash. Skin rash is common with REYATAZ but can sometimes be severe. 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, stop taking REYATAZ and call your healthcare provider or go to the nearest hospital emergency room right away:

• ogeneral feeling of discomfort or “flu-like” symptoms
• ofever
• omuscle or joint aches
• ored or inflamed eyes, like “pink eye” (conjunctivitis)

• oblisters
• omouth sores
• oswelling of your face
• opainful, warm, or red lump under your skin

• • Liver problems. If you have liver problems, including hepatitis B or C virus, your liver problems may get worse when you take REYATAZ. Your healthcare provider will do blood tests to check your liver before you start REYATAZ and during treatment. Tell your healthcare provider right away if you get any of the following symptoms:

• odark “tea-colored” urine
• oyour skin or the white part of your eyes turns yellow
• olight colored stools

• onausea
• oitching
• ostomach-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 who take REYATAZ, and sometimes may lead to hospitalization. Tell your healthcare provider right away if you get symptoms of kidney stones which may include pain in your low back or low stomach area, blood in your urine, or pain when you urinate.
• • Gallbladder stones have happened in some people who take REYATAZ, and sometimes may lead to hospitalization. Tell your healthcare provider right away if you get symptoms of a gallbladder problem which may include:

• opain in the right or middle upper stomach area
• ofever

• onausea and vomiting
• oyour skin or the white part of your eyes turns yellow

• • Yellowing of your skin or the white part of your eyes is common with REYATAZ but may be a symptom of a serious problem. These symptoms may be due to increases in bilirubin levels in your blood (bilirubin is made by the liver). Tell your healthcare provider right away if your skin or the white part of your eyes turns yellow.
• • New or worsening diabetes and high blood sugar (hyperglycemia) have happened in some people who take protease inhibitor medicines like REYATAZ. Some people have had to start taking medicine to treat diabetes or have changes to their dose of their diabetes medicine. Tell your healthcare provider if you notice an increase in thirst or if you start urinating more often while taking REYATAZ.
• • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new symptoms after starting REYATAZ.
• • Changes in body fat can happen in people taking HIV-1 medicines. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions 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
• •fever

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of REYATAZ. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store REYATAZ?

REYATAZ capsules:

• •Store REYATAZ capsules at room temperature, between 68°F to 77°F (20°C to 25°C).
• •Keep capsules in a tightly closed container.
• •The REYATAZ bottle comes with a child-resistant closure.

REYATAZ oral powder:

• •Store REYATAZ oral powder at a temperature of 68°F to 86°F (20°C to 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 a temperature of 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 REYATAZ and all medicines out of the reach of children.

General information about the safe and effective use of REYATAZ

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use REYATAZ for a condition for which it was not prescribed. Do not give REYATAZ to other people, even if they have the o same symptoms that you have. It may harm them. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about REYATAZ that is written for health professionals.

For more information, go to www.reyataz.com or call 1-800-321-1335.

What are the ingredients in REYATAZ?

Active ingredient: 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.

Distributed by:

Bristol-Myers Squibb Company, Princeton, NJ 08543 USA.

REYATAZ® is a registered trademark of Bristol-Myers Squibb Company. Other brands listed are the trademarks of their respective owners and are not trademarks of Bristol-Myers Squibb Company.

This Patient Information has been approved by the U.S. Food and Drug Administration.

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