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Evotaz

Generic name: atazanavir and cobicistat
Drug class: Antiviral combinations

Medically reviewed by  A Ras MD.

What is Evotaz used for?

Evotaz is a prescription medicine that is used to treat HIV infection.

Description

EVOTAZ® is a fixed-dose tablet for oral administration containing the active ingredients atazanavir and cobicistat. Atazanavir is an HIV-1 protease inhibitor. Cobicistat is a mechanism-based inhibitor of cytochrome P450 (CYP) enzymes of the CYP3A family. EVOTAZ tablets contain 342 mg of atazanavir sulfate, equivalent to 300 mg of atazanavir, and 150 mg of cobicistat, as well as the following inactive ingredients in the tablet core: croscarmellose sodium, crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium starch glycolate, and stearic acid. The tablets are film-coated with a coating material containing the following inactive ingredients: hypromellose, red iron oxide, talc, titanium dioxide, triacetin.

Atazanavir: Atazanavir is present as the sulfate salt. 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:

atazanavir chemical structure

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.

Cobicistat: The chemical name for cobicistat is 1,3-thiazol-5-ylmethyl [(2R,5R)-5-{[(2S)-2-[(methyl{[2-(propan-2-yl)-1,3-thiazol-4-yl]methyl}carbamoyl)amino]-4-(morpholin-4-yl)butanoyl]amino}-1,6-diphenylhexan-2-yl]carbamate. It has a molecular formula of C40H53N7O5S2 and a molecular weight of 776.0. It has the following structural formula:

cobicistat chemical structure

Cobicistat is adsorbed onto silicon dioxide. Cobicistat on silicon dioxide is a white to pale yellow solid with a solubility of 0.1 mg/mL in water at 20°C.

 Mechanism of Action

EVOTAZ is a fixed-dose tablet consisting of the HIV-1 antiretroviral drug, atazanavir and the CYP3A inhibitor, cobicista

Before taking Evotaz, tell your doctor:

  • If you are allergic to Evotaz; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • If you have kidney disease or are on dialysis.
  • If you are also taking tenofovir and you have kidney problems or take a drug that may harm the kidneys.
  • If you have liver disease.
  • If you are taking another drug that has the same drug in it.
  • If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with Evotaz, like certain drugs that are used for high cholesterol, migraines, or mood problems. There are many drugs that must not be taken with Evotaz.
  • If you are taking St. John’s wort. Do not take St. John’s wort with Evotaz. This medicine may not work as well.
  • If you are breast-feeding. Do not breast-feed while you take Evotaz.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Evotaz with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Evotaz?

  • Tell all of your health care providers that you take Evotaz. This includes your doctors, nurses, pharmacists, and dentists.
  • This medicine interacts with many other drugs. The chance of Evotaz’s side effects may be raised or how well Evotaz works may be lowered. The chance of the other drugs’ side effects may also be raised. This may include very bad, life-threatening, or deadly side effects. Check with your doctor and pharmacist to make sure that it is safe for you to take Evotaz with all of your other drugs (prescription or OTC, natural products, vitamins).
  • High blood sugar has happened with Evotaz. This includes diabetes that is new or worse.
  • Check your blood sugar as you have been told by your doctor.
  • Some people with hemophilia have had times of more bleeding when taking drugs like this one. If you have hemophilia, talk with your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • This medicine is not a cure for HIV. Stay under the care of your doctor.
  • This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors.
  • Very bad kidney problems like kidney failure have happened in people taking cobicistat with tenofovir.
  • Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking Evotaz.
  • Do not give Evotaz to a child younger than 3 months of age.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Evotaz while you are pregnant.
  • If you used Evotaz when you were pregnant, tell the doctor if your baby has yellow skin or eyes after your baby is born.

How is Evotaz best taken?

Use Evotaz as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take Evotaz with food.
  • Do not take antacids within 2 hours before or 2 hours after taking Evotaz.
  • If you are also taking didanosine, take it at least 1 hour before or 2 hours after Evotaz.
  • If you take cimetidine, dexlansoprazole, esomeprazole, famotidine, lansoprazole, nizatidine, omeprazole, pantoprazole, rabeprazole, or ranitidine, ask your doctor or pharmacist how to take it with Evotaz.
  • It is important that you do not miss or skip a dose of Evotaz during treatment.
  • Keep taking Evotaz as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it, with food.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • If you are not sure what to do if you miss a dose, call your doctor.

What are the side effects of Evotaz that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of gallstones like sudden pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; or fever with chills.
  • Dizziness or passing out.
  • Fever.
  • Muscle or joint pain.
  • Pain when passing urine.
  • Back pain, belly pain, or blood in the urine. May be signs of a kidney stone.
  • A heartbeat that does not feel normal.
  • Very upset stomach or throwing up.
  • Change in body fat.
  • Yellow skin or eyes.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • Changes in your immune system can happen when you start taking drugs to treat HIV. If you have an infection that you did not know you had, it may show up when you take Evotaz. Tell your doctor right away if you have any new signs after you start Evotaz, even after taking it for several months. This includes signs of infection like fever, sore throat, weakness, cough, or shortness of breath.
  • If you have liver problems like hepatitis B or C, talk with your doctor. Liver problems have gotten worse with Evotaz. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

What are some other side effects of Evotaz?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Evotaz?

  • Store at room temperature.
  • Keep lid tightly closed.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

 

Label

EVOTAZ (ATAZANAVIR AND COBICISTAT) TABLET REPRESENTATIVE PACKAGING

  • See HOW SUPPLIED section for a complete list of available packages of EVOTAZ.
  • NDC 0003-3641-11
    30 Tablets
    EVOTAZ™
    (atazanavir and cobicistat) tablets
    300 mg/150 mg
    Rx only
    Take with food.
    Note to pharmacist: Do not cover ALERT box with pharmacy label.

    ALERT: Find out about medicines that should NOT be taken with EVOTAZ™
EVOTAZ 300 mg/150 mg 30 count bottle label

SRC: NLM .

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