This drug is used in combination with other medications to help control your HIV infection, thereby improving your quality of life. It also lowers your risk of getting HIV disease complications (e.g., new infections, cancer). Atazanavir belongs to a class of drugs known as protease inhibitors. Atazanavir is not a cure for HIV infection, and it does not prevent the spread of HIV to others through sexual contact or blood contamination (e.g., sharing used needles).

Read the Patient Information Leaflet provided by your pharmacist before you start taking atazanavir and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth, usually once daily with food, or as directed by your doctor. Do not crush or chew the medication. Swallow capsules whole.

If you are taking atazanavir and efavirenz, you should also be taking ritonavir.

If you are taking antacids or a buffered form of didanosine (e.g., chewable/dispersible buffered tablets), take atazanavir 2 hours before or 1 hour after these medicines.

Also, other acid-lowering medications for indigestion, heartburn, or ulcers (e.g., prescription or over-the-counter medications such as famotidine, omeprazole) may prevent your HIV drugs from working. Ask your doctor or pharmacist how to use these medications safely.

Do not take more or less of this drug than prescribed. Do not stop taking it unless directed to do so by your doctor.

It is very important to continue taking this medication (and other anti-HIV medications) exactly as prescribed by your doctor. Do not skip any doses.

Headache, nausea, vomiting, diarrhea, stomach pain, fatigue, fever, or trouble sleeping may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these serious side effects occur: yellowing of skin or eyes.

Tell your doctor immediately if any of these unlikely but serious side effects occur: depression, increased urination or thirst, unusual bleeding or bruising.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: change in heart rhythm, dizziness, lightheadedness, severe nausea or vomiting, severe stomach pain, extreme weakness (especially in arms and legs), trouble breathing, signs of a kidney stone (e.g., pain in side/back/abdomen, painful urination, blood in the urine).

Changes in body fat may occur while you are taking this medication (e.g., increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of therapy with your doctor, as well as the possible role of exercise to reduce this side effect.

An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

Atazanavir can commonly cause a mild/moderate rash that may not be serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, seek immediate medical attention if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking atazanavir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease (including Hepatitis B or C infections), heart problems (e.g., atrioventricular block), diabetes, blood disorders, kidney stones.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether atazanavir passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

See also How to Use section.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious interactions may occur: "ergot-type" drugs (e.g., ergotamine, dihydroergotamine, methylergonovine), etravirine, triazolam, midazolam, pimozide, cisapride, rifamycins (e.g., rifampin, rifabutin), bepridil, indinavir, irinotecan, certain "statin" drugs for cholesterol (lovastatin, simvastatin), St. John's wort, ranolazine.

If you are currently using any of these medications, tell your doctor or pharmacist before starting atazanavir.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: calcium channel blockers (e.g., diltiazem, verapamil), beta-blockers (e.g., propranolol, atenolol, metoprolol), atorvastatin, digoxin, warfarin, drugs for irregular heartbeat (e.g., antiarrhythmics such as amiodarone, lidocaine, quinidine), medicines for depression (tricyclics such as amitriptyline), drugs to treat impotence (e.g., sildenafil, tadalafil, vardenafil), immunosuppressants (e.g., cyclosporine, sirolimus, tacrolimus), temsirolimus, certain chemotherapy drugs (dasatinib, lapatinib, sunitinib), clarithromycin, ritonavir, rosuvastatin, trazodone, fluticasone (inhaled through the mouth or nose).

Tenofovir can decrease the effectiveness of atazanavir (by decreased blood levels) when the two drugs are given in combination. This can result in a worsening of your condition. According to the manufacturer, adding ritonavir to the combination of atazanavir and tenofovir may be a treatment option. Consult your doctor or pharmacist for more details.

Check the labels on all the medicines you use for heartburn, indigestion, or ulcers (including prescription or nonprescription antacids, proton pump inhibitors such as omeprazole, H2 blockers such as ranitidine). These medications may prevent your HIV drugs from working. Ask your doctor or pharmacist about using those products safely.

This medication may decrease the effectiveness of combination-type birth control pills. You may need to use an additional form of reliable birth control while using this medication. Consult your doctor or pharmacist for more details.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: severe dizziness or lightheadedness.

Do not share this medication with others.

Laboratory and/or medical tests (e.g., liver function, bilirubin, lipid/cholesterol, EKG) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

If you miss a dose, take the missed dose as soon as you remember. Do not take the missed dose if it is within 6 hours of your next dose. In that case, skip the missed dose and resume your usual dosing schedule. It is important not to miss doses of this drug.

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59 and 86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854- 1166 (USA) or 1-800-668-1507 (Canada).

Information last revised January 2009 Copyright(c) 2009 First DataBank, Inc.