Reyataz

DRUG DESCRIPTION

REYATAZ® (atazanavir sulfate) is an azapeptide inhibitor of HIV-1 protease.

The chemical name for atazanavir sulfate is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8- hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13- pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H52N6O7•H2SO4, which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate has the following structural formula:

REYATAZ® (atazanavir sulfate)  Structural Formula Illustration

Atazanavir sulfate is a white to pale yellow crystalline powder. It is slightly soluble in water (4–5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3° C.

REYATAZ Capsules are available for oral administration in strengths containing the equivalent of 100 mg, 150 mg, 200 mg, or 300 mg of atazanavir as atazanavir sulfate and the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: gelatin, FD&C Blue #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 #2, isopropyl alcohol, ammonium hydroxide, propylene glycol, n-butyl alcohol, simethicone, and dehydrated alcohol.

What are the possible side effects of atazanavir (Reyataz)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • increased urination or extreme thirst;
  • severe pain in your side or lower back, painful urination, blood in your urine;
  • feeling like you might pass out;
  • easy bruising or bleeding;
  • fever, sore throat, and headache with a severe blistering, peeling, and...

Read All Potential Side Effects and See Pictures of Reyataz »

What are the precautions when taking atazanavir sulfate (Reyataz)?

Before taking atazanavir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease (including Hepatitis B or C infections), heart problems (coronary artery disease, heart attack), diabetes, lipid problems (high cholesterol or triglycerides/fats), 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...

Read All Potential Precautions of Reyataz »


Reyataz Consumer (continued)

SIDE EFFECTS: 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.

Seek immediate medical attention if any of these rare but serious side effects occur: symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), 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.

PRECAUTIONS: Before taking atazanavir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease (including Hepatitis B or C infections), heart problems (coronary artery disease, heart attack), diabetes, lipid problems (high cholesterol or triglycerides/fats), 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.


Reyataz Patient Information Including Side Effects

Brand Names: Reyataz

Generic Name: atazanavir (oral) (Pronunciation: a ta ZAN a vir)

  • What is atazanavir (Reyataz)?
  • What are the possible side effects of atazanavir (Reyataz)?
  • What is the most important information I should know about atazanavir (Reyataz)?
  • What should I discuss with my healthcare provider before taking atazanavir (Reyataz)?
  • How should I take atazanavir (Reyataz)?
  • What happens if I miss a dose (Reyataz)?
  • What happens if I overdose (Reyataz)?
  • What should I avoid while taking atazanavir (Reyataz)?
  • What other drugs will affect atazanavir (Reyataz)?
  • Where can I get more information?

What is atazanavir (Reyataz)?

Atazanavir is an antiviral medication in a group of HIV medicines called protease (PRO-tee-ayz) inhibitors. Atazanavir prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Atazanavir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Atazanavir is not a cure for HIV or AIDS.

Atazanavir may also be used for other purposes not listed in this medication guide.

What are the possible side effects of atazanavir (Reyataz)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • increased urination or extreme thirst;
  • severe pain in your side or lower back, painful urination, blood in your urine;
  • feeling like you might pass out;
  • easy bruising or bleeding;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • signs of a new infection, such as fever or chills, cough, or flu symptoms; or
  • jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • nausea, vomiting, diarrhea, stomach pain;
  • numbness or tingling, especially around your mouth;
  • joint pain;
  • headache, mood changes; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about atazanavir (Reyataz)?

You should not take this medication if you are allergic to atazanavir.

Do not take atazanavir together with cisapride (Propulsid), ergotamine (Ergomar, Cafergot), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), methylergonovine (Methergine), indinavir (Crixivan), irinotecan (Camptosar), lovastatin (Mevacor, Altocor), simvastatin (Zocor), pimozide (Orap), midazolam (Versed), triazolam (Halcion), rifampin (Rifadin, Rimactane, Rifater), or St. John's wort.

There are many other medicines that can interact with atazanavir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Before using atazanavir, tell your doctor if you have liver disease (including hepatitis B or C), kidney disease (or if you are on dialysis), diabetes, a bleeding disorder such as hemophilia, a heart condition called "AV block," or if you have ever used a protease inhibitor in the past.

Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

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