REYATAZ

What is HIV?

Human Immunodeficiency Virus (HIV) is the virus that causes AIDS (Acquired Immunodeficiency Syndrome). The virus can be passed from one person to another when infected blood, semen or vaginal secretions come in contact with an uninfected person’s broken skin or mucous membranes. Infected pregnant women can also pass HIV to their baby during pregnancy, delivery, or breast-feeding. HIV can also be passed by sharing needles with infected persons. Some people will develop AIDS as a result of their HIV infection.

Back to Top

What is AIDS?

Acquired Immunodeficiency Syndrome (AIDS) is a disease that develops from infection with the Human Immunodeficiency Virus (HIV). AIDS is characterized by a weakening of the immune system and a group of symptoms that includes certain infections and/or cancers.

Back to Top

What is REYATAZ?

REYATAZ is a prescription medicine used in combination with other medicines to treat people 6 years of age or older who are infected with the human immunodeficiency virus (HIV). REYATAZ has been studied in a 48-week trial in patients who have taken anti-HIV medicines and a 96-week trial in patients who have never taken anti-HIV medicines.

REYATAZ does not cure HIV or lower your chance of passing HIV to others.

People taking REYATAZ may still get opportunistic infections or other conditions that happen with HIV infection.

Do not take REYATAZ if you are allergic to REYATAZ or to any of its ingredients.

Read more REYATAZ Important Safety Information.

In clinical studies, REYATAZ in combination therapy has been shown to help raise CD4+ cell count—a measurement of important immune system cells—and lower HIV viral load to undetectable levels.* Learn how REYATAZ can help.

REYATAZ also has a low chance of diarrhea in adults (1-3% rate of moderate to severe diarrhea) as shown in clinical trials.

Other common side effects of REYATAZ^® (atazanavir sulfate) taken with other anti-HIV medicines include nausea; headache; stomach pain; vomiting; depression; fever; dizziness; trouble sleeping; numbness, tingling, or burning of the hands or feet; and muscle pain.

REYATAZ as part of combination therapy is one of several treatment options your doctor may consider.

Read more REYATAZ Important Safety Information.

*"Undetectable" is defined as a viral load that is too low to be picked up by a particular test. Typically, it is a viral load of less than 400 or 50 copies/mL (depending on test used).

Click here for Important Safety Information about REYATAZ.

Back to Top

How does REYATAZ work?

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 treatments options your doctor may consider. REYATAZ does not cure HIV or lower your chance of passing HIV to others.

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 medicines 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 levels.* Learn more about how REYATAZ works.

Selected Important Safety Information:

Do not take REYATAZ if you are taking the following medicines due to potential for serious, life-threatening side effects or death: Versed^® (midazolam) when taken by mouth, Halcion^® (triazolam), ergot medicines (dihydroergotamine, ergonovine, ergotamine, and methylergonovine such as Cafergot^®, Migranal^®, D.H.E. 45^®, ergotrate maleate, Methergine^®, and others), Propulsid^® (cisapride), or Orap^® (pimozide).

Do not take REYATAZ with the following medicines due to potential for serious side effects: Camptosar^® (irinotecan), Crixivan^® (indinavir), Mevacor^® (lovastatin), Zocor^® (simvastatin), Uroxatral^® (alfuzosin), or Revatio^® (sildenafil).

Read more REYATAZ Important Safety Information, including additional drug interactions.

*"Undetectable" is defined as a viral load that is too low to be picked up by a particular test. Typically, it is a viral load of less than 400 or 50 copies/mL (depending on test used).

Back to Top

Does REYATAZ cure HIV infection or AIDS?

No. REYATAZ does not cure HIV infection or AIDS. At present there is no cure. People taking REYATAZ may still get opportunistic infections or other conditions that can happen with HIV infection. 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 or other barrier to lower the chance of sexual contact with semen, vaginal secretions, or blood. Never use or share dirty needles.

Selected Important Safety Information:

Tell your healthcare provider if you are pregnant or plan to become pregnant. 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. After your baby is born, tell your healthcare provider if your baby's skin or the white part of his/her eyes turns yellow. You should not breast-feed if you are HIV positive.

Read more REYATAZ Important Safety Information.

If you have HIV or AIDS, you should always remain under the care of a healthcare provider and have your CD4+ cell count and viral load measured regularly.

Learn how REYATAZ can help fight HIV.

*"Undetectable" is defined as a viral load that is too low to be picked up by a particular test. Typically, it is a viral load of less than 400 or 50 copies/mL (depending on test used).

Click here for Important Safety Information about REYATAZ.

Back to Top

Does REYATAZ reduce the risk of passing HIV to others?

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 associated with 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 or other barrier 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.

Click here for Important Safety Information about REYATAZ.

Back to Top

Can I take REYATAZ if I’ve never taken an anti-HIV medication?

Yes. If you have HIV and you are beginning HIV drug therapy for the first time, your doctor may prescribe REYATAZ in combination with other HIV medications. REYATAZ as part of combination therapy is one of several treatment options your doctor may consider.

Once-daily REYATAZ in combination therapy has been shown to be effective in managing HIV. It can help lower your viral load to undetectable* levels and raise your CD4+ cell count. REYATAZ does not cure HIV or lower your chance of passing HIV to others.

Learn more about how REYATAZ can help.

Selected Important Safety Information:

Do not take REYATAZ if you are allergic to REYATAZ or to any of its ingredients.

Read more REYATAZ Important Safety Information.

*"Undetectable" is defined as a viral load that is too low to be picked up by a particular test. Typically, it is a viral load of less than 400 or 50 copies/mL (depending on test used).

Back to Top

Can I switch to REYATAZ^® (atazanavir sulfate) if I’m currently on a different HIV medication?

In general, doctors may switch your HIV therapy for a variety of reasons. REYATAZ as part of combination therapy is one of several treatment options your doctor may consider.

Learn more about how REYATAZ can help.

Selected Important Safety Information:

Do not take REYATAZ if you are taking the following medicines due to potential for serious, life-threatening side effects or death: Versed^® (midazolam) when taken by mouth, Halcion^® (triazolam), ergot medicines (dihydroergotamine, ergonovine, ergotamine, and methylergonovine such as Cafergot^®, Migranal^®, D.H.E. 45^®, ergotrate maleate, Methergine^®, and others), Propulsid^® (cisapride), or Orap^® (pimozide).

Do not take REYATAZ with the following medicines due to potential for serious side effects: Camptosar^® (irinotecan), Crixivan^® (indinavir), Mevacor^® (lovastatin), Zocor^® (simvastatin), Uroxatral^® (alfuzosin), or Revatio^® (sildenafil).

Read more REYATAZ Important Safety Information, including additional drug interactions.

*"Undetectable" is defined as a viral load that is too low to be picked up by a particular test. Typically, it is a viral load of less than 400 or 50 copies/mL (depending on test used).

Back to Top

Who should not take REYATAZ?

Do not take REYATAZ if you:

• Are taking certain medicines. Serious life-threatening side effects or death may happen. Before you take REYATAZ, tell your healthcare provider about all medicines you are taking or planning to take. These include other prescription and nonprescription medicines, vitamins, and herbal supplements.
• Are allergic to REYATAZ or to any of its ingredients. The active ingredient is atazanavir sulfate. The inactive ingredients are crospovidone, lactose monohydrate (milk sugar), magnesium stearate, gelatin, FD&C Blue #2, and titanium dioxide. Tell your healthcare provider if you think you have had an allergic reaction to any of these ingredients.

Click here for Important Safety Information about REYATAZ.

Back to Top

What should I tell my healthcare provider before I take REYATAZ?

Before you take REYATAZ, tell your healthcare provider:

• If you are pregnant or plan to become pregnant. 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.
• After your baby is born, tell your healthcare provider if your baby’s skin or the white part of his/her eyes turns yellow.
• If you are breast-feeding. You should not breast-feed if you are HIV-positive because of the chance of passing HIV to your baby. Also, it is not known if REYATAZ can pass into your breast milk and if it can harm your baby. If you are a woman who has or will have a baby, talk with your healthcare provider about the best way to feed your baby.
• If you have liver problems or are infected with the hepatitis B or C virus. Learn more about possible side effects of REYATAZ.
• If you have end stage kidney disease managed with hemodialysis.
• If you have diabetes. Learn more about possible side effects of REYATAZ.
• If you have hemophilia. Learn more about possible side effects of REYATAZ.
• About all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Keep a list of your medicines with you to show your healthcare provider. Some medicines can cause serious side effects if taken with REYATAZ. Learn more about drug interactions with REYATAZ.

Read more REYATAZ Important Safety Information.

Get a customized list of questions to ask your doctor.

Click here for Important Safety Information about REYATAZ.

Back to Top

What important information should I know about taking REYATAZ with other medicines?

Do not take REYATAZ if you take the following medicines (not all brands may be listed; tell your healthcare provider about all the medicines you take). REYATAZ may cause serious, life-threatening side effects or death when used with these medicines:

• Ergot medicines: dihydroergotamine, ergonovine, ergotamine and methylergonovine such as Cafergot^®, Migranal^®, D.H.E. 45^®, ergotrate maleate, Methergine^®, and others (used for migraine headaches).
• Orap^® (pimozide, used for Tourette’s disorder).
• Propulsid^® (cisapride, used for certain stomach problems).
• Triazolam, also known as Halcion^® (used for insomnia).
• Midazolam, also known as Versed^® (used for sedation), when taken by mouth.

Do not take the following medicines with REYATAZ because of possible serious side effects:

• Camptosar^® (irinotecan, used for cancer).
• Crixivan^® (indinavir, used for HIV infection). Both REYATAZ and Crixivan sometimes cause increased levels of bilirubin in the blood.
• Cholesterol-lowering medicines Mevacor^® (lovastatin) or Zocor^® (simvastatin).
• Uroxatral^® (alfuzosin, used to treat benign enlargement of the prostate).
• Revatio^® (sildenafil, used to treat pulmonary arterial hypertension).

Do not take the following medicines with REYATAZ because they may lower the amount of REYATAZ in your blood. This may lead to an increased HIV viral load. Resistance to REYATAZ or cross-resistance to other HIV medicines may develop:

• Rifampin (also known as Rimactane^®, Rifadin^®, Rifater^®, or Rifamate^®, used for tuberculosis).
• St. John's wort (Hypericum perforatum), an herbal product sold as a dietary supplement, or products containing St. John's wort.
• Viramune^® (nevirapine, used for HIV infection).

The following medicines are not recommended with REYATAZ:

• Serevent Diskus^® (salmeterol) and Advair^® (salmeterol with fluticasone), used to treat asthma, emphysema/chronic obstructive pulmonary disease also known as COPD.

Do not take the following medicine if you are taking REYATAZ and Norvir^® (ritonavir) together:

• Vfend^® (voriconazole).

The following medicines may require your healthcare provider to monitor your therapy more closely (for some medicines a change in the dose or dose schedule may be needed):

• Cialis^® (tadalafil), Levitra^® (vardenafil) or Viagra^® (sildenafil), used to treat erectile dysfunction. REYATAZ may increase the chances of serious side effects that can happen with Cialis, Levitra, or Viagra. Do not use Cialis, Levitra or Viagra while you are taking REYATAZ unless your healthcare provider tells you it is okay.
• Adcirca^® (tadalafil) or Tracleer^® (bosentan), used to treat pulmonary arterial hypertension.
• Lipitor^® (atorvastatin) or Crestor^® (rosuvastatin). There is an increased chance of serious side effects if you take REYATAZ with these cholesterol-lowering medicines.
• Medicines for abnormal heart rhythm: Cordarone^® (amiodarone), lidocaine, quinidine (also known as Cardioquin^®, Quinidex^®, and others).
• Mycobutin^® (rifabutin, an antibiotic used to treat tuberculosis).
• Buprenex^®, Subutex^®, Suboxone^® (buprenorphine or buprenorphine/naloxone, used to treat pain and addiction to narcotic painkillers).
• Vascor^® (bepridil, used for chest pain).
• Coumadin^® (warfarin).
• Tricyclic  antidepressants such as Elavil^® (amitriptyline), Norpramin^® (desipramine), Sinequan^® (doxepin), Surmontil^® (trimipramine), Tofranil^® (imipramine), or Vivactil^® (protriptyline).
• Medicines to prevent organ transplant rejection: Sandimmune^® or Neoral^® (cyclosporin), Rapamune^® (sirolimus), or Prograf^® (tacrolimus).
• The antidepressant trazodone (Desyrel^® and others).
• Fluticasone propionate (Flonase^®, Flovent^®), given by nose or inhaled to treat allergic symptoms or asthma. Your doctor may choose not to keep you on fluticasone, especially if you are also taking Norvir^®.
• Colchicine (Colcrys^®), used to prevent or treat gout or treat familial Mediterranean fever.

The following medicines may require a change in dose or dose schedule of either REYATAZ or the other medicine:

• Invirase^® (saquinavir).
• Norvir^® (ritonavir).
• Sustiva^® (efavirenz).
• Antacids or buffered medicines.
• Videx^® (didanosine).
• Viread^® (tenofovir disoproxil fumarate).
• Mycobutin^® (rifabutin).
• Calcium channel blockers such as Cardizem^® or Tiazac^® (diltiazem),
  Covera-HS^® or Isoptin SR^® (verapamil), and others.
• Biaxin^® (clarithromycin).
• Medicines for indigestion, heartburn, or ulcers such as Axid^® (nizatidine),
  Pepcid AC^® (famotidine), Tagamet^® (cimetidine), or Zantac^® (ranitidine).

Talk to your healthcare provider about choosing an effective method of contraception. REYATAZ may affect the safety and effectiveness of hormonal contraceptives such as birth control pills or the contraceptive patch. Hormonal contraceptives do not prevent the spread of HIV to others.

Remember:

1. Know all the medicines you take.

2. Tell your healthcare provider about all the medicines you take.

3. Do not start a new medicine without talking to your healthcare provider.

Click here for Important Safety Information about REYATAZ.

Back to Top

How do I take REYATAZ^® (atazanavir sulfate)?

Take REYATAZ once every day exactly as instructed by your healthcare provider. Your healthcare provider will prescribe the amount of REYATAZ that is right for you.

• Always take REYATAZ with food (a meal or snack) to help it work better. Swallow the capsules whole. Do not open the capsules. Take REYATAZ at the same time each day.
• If you are taking antacids or didanosine (Videx^® or Videx^® EC), take REYATAZ 2 hours before or 1 hour after these medicines.
• If you are taking medicines for indigestion, heartburn, or ulcers such as Axid^® (nizatidine), Pepcid AC^® (famotidine), Tagamet^® (cimetidine), Zantac^® (ranitidine), AcipHex^® (rabeprazole), Nexium^® (esomeprazole), Prevacid^® (lansoprazole), Prilosec^® (omeprazole), or Protonix^® (pantoprazole), talk to your healthcare provider.
• Do not change your dose or stop taking REYATAZ without first talking with your healthcare provider. It is important to stay under a healthcare provider’s care while taking REYATAZ.
• 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 in your blood may increase if the medicine is stopped for even a short time.
• If you miss a dose of REYATAZ, take it as soon as possible and then take your next scheduled dose at its regular time. If, however, it is within 6 hours of your next dose, do not take the missed dose. Wait and take the next dose at the regular time. Do not double the next dose. It is important that you do not miss any doses of REYATAZ or your other anti-HIV medicines.
• If you take more than the prescribed dose of REYATAZ, call your healthcare provider or poison control center right away.

Click here for Important Safety Information about REYATAZ.

Back to Top

What if I forget to take a dose of REYATAZ?

If you miss a dose of REYATAZ, take it as soon as possible and then take your next scheduled dose at its regular time. If, however, it is within 6 hours of your next dose, do not take the missed dose. Wait and take the next dose at the regular time. Do not double the next dose. It is important that you do not miss any doses of REYATAZ or your other anti-HIV medicines.

If you take more than the prescribed dose of REYATAZ, call your healthcare provider or poison control center right away.

You should take REYATAZ once daily with food (a meal or snack). Swallow the capsules whole; do not open the capsules. You should take REYATAZ and your other anti-HIV medicines exactly as instructed by your healthcare provider.

Click here for Important Safety Information about REYATAZ.

Back to Top

What are the possible side effects of REYATAZ?

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.

The following side effects have been reported with REYATAZ:

• Mild Rash (redness and itching) without other symptoms sometimes occurs in patients taking REYATAZ, most often in the first few weeks after the medicine is started. Rashes usually go away within 2 weeks with no change in treatment. Tell your healthcare provider if rash occurs.
• Severe Rash—Rash may develop in association with other symptoms which could be serious and potentially cause death.

If you develop a rash with any of the following symptoms, stop using REYATAZ and call your healthcare provider right away:

• – Shortness of breath
• – General ill-feeling or "flu-like" symptoms
• – Fever
• – Muscle or joint aches
• – Conjunctivitis (red or inflamed eyes, like "pink-eye")
• – Blisters
• – Mouth sores
• – Swelling of your face

• Yellowing of the skin or eyes. These effects may be due to increases in bilirubin levels in the blood (bilirubin is made by the liver). Although these effects may not be damaging to your liver, skin, or eyes, call your healthcare provider promptly if your skin or the white part of your eyes turn yellow.
• A change in the way your heart beats (heart rhythm change). Call your healthcare provider right away if you get dizzy or lightheaded. These could be symptoms of a heart problem.
• Diabetes and high blood sugar (hyperglycemia) sometimes happen in patients taking protease inhibitor medicines like REYATAZ. Some patients had diabetes before taking protease inhibitors while others did not. Some patients may need changes in their diabetes medicines.
• If you have liver disease including hepatitis B or C, your liver disease may get worse when you take anti-HIV medicines like REYATAZ.
• Kidney stones have been reported in patients taking REYATAZ. If you develop signs or symptoms of kidney stones (pain in your side, blood in your urine, pain when you urinate), tell your healthcare provider promptly.
• Some patients with hemophilia have increased bleeding problems with protease inhibitors like REYATAZ.
• Changes in body fat. These changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the trunk. Loss of fat from the legs, arms and face may also happen. The cause and long-term health effects of these conditions are not known at this time.
• Immune reconstitution syndrome. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment, including REYATAZ, is started.
• Gallbladder disorders (which include gallstones and gallbladder inflammation) have been reported in patients taking REYATAZ.

Other common side effects of REYATAZ, include nausea; headache; stomach pain; vomiting; diarrhea; depression; fever; dizziness; trouble sleeping; numbness, tingling or burning of the hands or feet; and muscle pain.

If you experience any side effects while on REYATAZ, talk to your healthcare provider right away.

Click here for Important Safety Information about REYATAZ.

Back to Top

Can I take REYATAZ^® (atazanavir sulfate) if I am pregnant?

It is not known if REYATAZ can harm your unborn baby. 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.

Back to Top

Can I take REYATAZ^® (atazanavir sulfate) if I'm breast-feeding?

You should not breast-feed if you are HIV-positive because of the chance of passing HIV to your baby. Also, it is not known if REYATAZ can pass into your breast milk and if it can harm your baby. If you are a woman who has or will have a baby, talk with your healthcare provider about the best way to feed your baby.

Back to Top

Can HIV become resistant to REYATAZ?

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.

Do not take REYATAZ with the following medicines as they may lower the amount of REYATAZ in your blood, which may lead to increased HIV viral load and resistance to REYATAZ or other anti-HIV medicines: rifampin (also known as Rimactane^®, Rifadin^®, Rifater^®, or Rifamate^®), St. John's wort (Hypericum perforatum)-containing products, or Viramune^® (nevirapine).

Click here for Important Safety Information about REYATAZ, including additional drug interactions.

Back to Top

How should I store REYATAZ?

• Store REYATAZ capsules at room temperature, 59° to 86° F (15° to 30° C). Do not store this medicine in a damp place such as a bathroom medicine cabinet or near the kitchen sink.
• Keep your medicine in a tightly closed container.
• 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.

Click here for Important Safety Information about REYATAZ.

Back to Top

What are the ingredients in REYATAZ?

Active Ingredient: atazanavir sulfate

Inactive Ingredients: Crospovidone, lactose monohydrate (milk sugar), magnesium stearate, gelatin, FD&C Blue #2, and titanium dioxide.

Click here for Important Safety Information about REYATAZ.

Back to Top

*"Undetectable” is defined as a viral load that is too low to be picked up by a particular test. Typically, it is a viral load of less than 400 or 50 copies/mL (depending on the test used).