Atazanavir

Are there other uses for this medicine?

Atazanavir is also sometimes used to prevent infection in healthcare workers or other people who were accidentally exposed to HIV. Talk to your doctor about the risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?

Atazanavir comes as a capsule and as a powder to take by mouth. Take atazanavir capsules with food once a day.Take atazanavir powder with food. Take atazanavir at around the same time every day.

Take atazanavir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

You will take one or more other medications for HIV while you are taking atazanavir. Your doctor will tell you whether these medications should be taken at the same time as atazanavir, or several hours before or after you take atazanavir. Ask your doctor or pharmacist if you have questions about the times you should take your medications.

Swallow the capsules whole; do not open them. If you are unable to swallow the capsules, tell your doctor or pharmacist.

Atazanavir powder may be added to foods such as applesauce or yogurt, or liquids such as water, milk, or infant formula. Mix well, and take all of the mixture right away. If mixed with water, eat a snack or meal right away after taking the powder mixture. For infants (older than 3 months of age) unable to drink from a cup, the powder can be mixed with infant formula and given with an oral dosing syringe; do not give the mixture to the infant in a baby bottle. The mixture may be stored at room temperature, but must be taken within 1 hour. Carefully read the manufacturer's instructions that describe how to mix and take a dose of atazanavir. Be sure to ask your pharmacist or doctor if you have any questions about how to mix or take this medication.

Atazanavir controls HIV but does not cure it. Continue to take atazanavir even if you feel well. Do not stop taking atazanavir without talking to your doctor. If you stop taking atazanavir or skip doses, your condition may become more difficult to treat.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient. Read this information carefully and ask your doctor or pharmacist if you have any questions.

What special precautions should I follow?

Before taking atazanavir,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any otherdrugs, foods or substances. Tell your doctor or pharmacist about the allergy and whatsymptoms you had

• some medications should not be taken with atazanavir. Other medications may cause dosing changes or extra monitoring when taken with atazanavir. Make sure you have discussed any medications you are currently taking or plan to take before starting atazanavir with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking atazanavir, please get the advice of your doctor or pharmacist.

• the following nonprescription or herbal products may interact with atazanavir: medications for indigestion, heartburn, or ulcers (esomeprazole (Nexium^®), famotidine (Pepcid^®), omeprazole (Prilosec^®, Zegerid^®), ranitidine (Zantac^®)) or St. John's wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking atazanavir. Do not start any of these medications while taking atazanavir without discussing with your healthcare provider.

• if you are taking antacids, didanosine delayed-release capsules (Videx^® EC), or any other buffered medication such as buffered aspirin (Bufferin^®), take atazanavir 2 hours before or 1 hour after you take the medication. Ask your doctor or pharmacist if you are not sure if any of the medications you are taking are buffered.

• tell your doctor if you have or have ever had an irregular heartbeat, diabetes or high blood sugar, hemophilia (a condition in which the blood does not clot normally) or any other bleeding disorder, hepatitis (a viral infection of the liver) or any other liver disease, kidney or heart disease.

• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking atazanavir, call your doctor.

• tell your doctor if you are breastfeeding or plan to breastfeed. Some of the medication and HIV may be passed to your baby in your breast milk. Talk to your doctor about the risks of breastfeeding your baby if you are taking atazanavir.

• you should know that atazanavir may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, implants, and injections). Talk to your doctor about methods of birth control that will work for you while you are taking atazanavir.

• you should know that you may experience hyperglycemia (increases in your blood sugar) while you are taking this medication, even if you do not already have diabetes. Tell your doctor immediately if you have any of the following symptoms while you are taking atazanavir: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness.

• you should know that while you are taking atazanavir your body fat may increase or move to different areas of your body such as the back of your neck and upper shoulders ('buffalo hump'), stomach, and breasts. You may lose fat from your arms, legs, face, and buttocks. Talk to your doctor if you notice any of these changes in your body fat.

• if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent damage to your brain that can cause severe intellectual disability), you should know that atazanavir oral powder is sweetened with aspartame that forms phenylalanine.

• you should know that while you are taking medications to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body. This may cause you to develop symptoms of those infections. If you have new or worsening symptoms at anytime during your treatment with atazanavir, be sure to tell your doctor.

What special dietary instructions should I follow?

Talk to your doctor about eating grapefruit or drinking grapefruit juice while taking this medicine.

What should I do if I forget to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medicine cause?

Atazanavir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea, vomiting, stomach pain, diarrhea
• dizziness
• headache
• depression
• fever
• difficulty falling asleep or staying asleep
• muscle pain
• mild rash
• numbness, burning, pain, or tingling of hands or feet

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment:

• dizziness, feeling faint or lightheadedness, irregular heartbeat
• vision changes
• yellowing of skin or eyes; nausea; vomiting; loss of appetite; dark-colored urine; light-colored bowel movements
• pain in your back or side, pain or burning with urination, blood in urine

If you develop a severe rash with any of the following symptoms, stop taking atazanavir and call your doctor immediately or get emergency medical treatment:

• general ill feeling or 'flu-like' symptoms; fever; muscle or joint aches; red or swollen eyes; blisters or peeling skin; mouth sores; swelling of your face; painful, warm, or red lump under your skin

Atazanavir may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication in the container or packet it came in, tightly closed, and out of reach of children and pets. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

What should I do in case of overdose?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• yellowing of skin or eyes

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to atazanavir.

Keep a supply of atazanavir on hand. Do not wait until you run out of medication to refill your prescription.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

Brand name(s)

• Reyataz^®
• also available generically

Other name(s)

• ATZ