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Information

An Overview of Sustiva (Efavirenz, Stocrin)

June 12, 2017

Brand Name: Sustiva
Other Name(s): EFV
Drug Class: Non-nucleoside reverse transcriptase inhibitors


Sustiva tablet

WARNING:

Efavirenz can cause serious, life-threatening side effects. These include serious mental health problems, liver problems, and severe rash.

Contact your health care provider right away if you have any of the following symptoms that could be signs of mental health problems:

  • Feeling sad or hopeless
  • Feeling anxious or restless
  • Having thoughts about harming yourself (including suicidal thoughts) or have tried to harm yourself or others
  • Not being able to tell the difference between what is true or real and what is false or unreal
  • Not trusting other people
  • Hearing or seeing things that are not real
  • Not being able to move or speak normally

Contact your health care provider right away if you have any of the following symptoms that could be signs of liver problems:

  • Yellowing of your skin or the whites of your eyes (jaundice)
  • Dark-colored urine
  • Light-colored bowel movements
  • Loss of appetite for several days or longer
  • Nausea
  • Pain in the lower stomach area (abdominal pain)

Skin rash is common when taking efavirenz and usually goes away within 4 weeks of beginning treatment, but it can also be severe. Contact your health care provider right away if you develop a rash -- with or without itching -- and any of the following symptoms:

  • Fever
  • Swelling of your face
  • Blisters or skin lesions
  • Peeling of your skin
  • Sores in your mouth
  • Red or inflamed eyes, like "pink eye" (conjunctivitis)

Women should not become pregnant while taking efavirenz and for 12 weeks after stopping the medicine. Serious birth defects have been seen in the babies of animals and women treated with efavirenz during pregnancy. Whether efavirenz caused the birth defects is unknown.

While taking efavirenz, it is important to keep all of your appointments with your health care provider.


What Is Efavirenz?

Efavirenz is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults and in children 3 months of age and older who weigh at least 7 pounds 12 ounces (3.5 kilograms). Efavirenz is always used in combination with other HIV medicines.

Efavirenz belongs to a class (group) of HIV drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs). NNRTIs attach to and block an HIV enzyme called reverse transcriptase. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) By blocking reverse transcriptase, NNRTIs prevent HIV from multiplying and can reduce the amount of HIV in the body.

HIV medicines can't cure HIV/AIDS, but taking a combination of HIV medicines (called an HIV regimen) every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission. If you are taking HIV medicines, including efavirenz, don't cut down on, skip, or stop taking them unless your health care provider tells you to.


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What Should I Tell My Health Care Provider Before Taking Efavirenz?

Before taking efavirenz, tell your health care provider:

  • If you are allergic to efavirenz or any other medicines.
  • If you have a heart condition.
  • If you have or have ever had liver problems, including hepatitis B or C virus infection.
  • If you have ever had seizures or are taking medicine to help prevent seizures.
  • If you have any other medical conditions.
  • If you have ever had a mental health problem.
  • If you have ever used street drugs or large amounts of alcohol.
  • If you are pregnant or plan to become pregnant. Women should not become pregnant while taking efavirenz and for 12 weeks after stopping the drug. Serious birth defects have been seen in the babies of animals and women treated with efavirenz during pregnancy. Whether efavirenz caused the birth defects is unknown. Talk to your health care provider about possible risks with taking efavirenz when pregnant.
  • If you are breastfeeding or plan to breastfeed. Do not breastfeed if you have HIV or are taking efavirenz.
  • If you are using hormone-based birth control (such as pills, implants, or vaginal rings). Efavirenz may make these forms of birth control less effective. Women who are able to become pregnant must use two effective forms of birth control during treatment and for 12 weeks after stopping treatment with efavirenz. A barrier form of birth control, such as a condom or contraceptive sponge, must be used along with another type of birth control. Your health care provider can help you decide how to adjust your birth control while you are taking efavirenz. The AIDSinfo infographic on HIV and Birth Control includes information on various forms of birth control.
  • About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Efavirenz may affect the way other medicines or products work, and other medicines or products may affect how efavirenz works. Taking efavirenz together with certain medicines or products may cause serious side effects.


How Should I Take Efavirenz?

Efavirenz (brand name: Sustiva) comes in the following forms and strengths:

  • 50-mg and 200-mg capsules
  • 600-mg tablets

Take efavirenz according to your health care provider's instructions.

Take efavirenz on an empty stomach, preferably at bedtime. Swallow efavirenz tablets and capsules whole with liquid. Do not take efavirenz with food.

Tell your health care provider if you or your child is unable to swallow tablets or capsules. Your health care provider can give you instructions on how to mix the contents of efavirenz capsules with soft food (or infant formula) to make the medicine easier to take.

Always take efavirenz in combination with other HIV medicines.

If you take too much efavirenz, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room.

For more information on how to take efavirenz, see the FDA drug label from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)


What Should I Do If I Forget a Dose?

If you miss a dose of efavirenz, take the missed dose right away. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose. If you need help planning the best time to take your medicine, ask your health care provider or pharmacist.


What Side Effects Can Efavirenz Cause?

Efavirenz may cause side effects. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the AIDSinfo fact sheet on HIV Medicines and Side Effects for more information.

Some side effects of efavirenz can be serious. Serious side effects of efavirenz include serious mental health problems, liver problems, and severe rash. (See the WARNING box above.)

Other possible side effects of efavirenz include:

  • Nervous system symptoms, including dizziness, drowsiness, trouble sleeping, unusual dreams, and trouble concentrating. (These symptoms usually go away within 2 to 4 weeks of beginning treatment.)
  • Increases in the levels of certain lipids (cholesterol and triglycerides) in the blood (hyperlipidemia).
  • Seizures.
  • Changes in body fat (including gain or loss of fat).
  • Immune reconstitution inflammatory syndrome (IRIS), a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.

Tell your health care provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of efavirenz. To learn more about possible side effects of efavirenz, read the drug label or package insert or talk to your health care provider or pharmacist.

You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online at www.accessdata.fda.gov/scripts/medwatch/.


How Should Efavirenz Be Stored?

  • Store efavirenz at room temperature, 68°F to 77°F (20°C to 25°C).
  • Do not use efavirenz if the original seal over the container opening is broken or missing.
  • Throw away efavirenz that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
  • Keep efavirenz and all medicines out of reach of children.


Where Can I Find More Information About Efavirenz?

More information about efavirenz is available:


Manufacturer Information

Bristol-Myers Squibb
Main number: 800-332-2056
Patient assistance: 888-281-8981

The above Patient Version drug summary is based on the following FDA label(s): Capsule (gelatin coated), tablet (film coated).


Related Stories

More on HIV Medications
More on Sustiva (Efavirenz, Stocrin)


  
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This article was provided by AIDSinfo. Visit the AIDSinfo website to find out more about their activities and publications.
 

 

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