INDICATION

What is SUSTIVA® (efavirenz)?

SUSTIVA is a prescription medicine used with other antiretroviral medicines to help treat HIV-1 infection in adults and children 3 months or older and who weigh at least 3.5 kg (7 lbs 12 oz).

SUSTIVA does not cure HIV or AIDS. You should keep taking HIV medicines in order to control HIV infection and decrease HIV-related illnesses.

TAKING YOUR MEDICINES EVERY DAY AS
YOUR HEALTHCARE PROVIDER DIRECTS

 

In addition to following your prescribed treatment plan, it’s important to be aware that stopping your medicines inappropriately can increase the levels of the virus in your blood. This is one of the ways you may develop drug resistance, which can make the virus harder to treat. That is why it’s so important to take your medicines every day as directed and to never stop taking your medicines without talking to your healthcare provider.

Changing your HIV treatments is a decision that is made by you and your healthcare provider. There are times when changes may be needed—such as when your treatment is not working as well as it should or if you are experiencing side effects that you cannot tolerate.

Your healthcare provider will closely monitor your progress on HIV therapy with regular viral load and CD4+ cell (T-cell) count tests.

SOME FACTORS THAT MAY INFLUENCE YOUR
DOCTOR’S TREATMENT DECISIONS INCLUDE:

 
  • Virologic failure: This occurs if the amount of HIV in your blood (viral load) does not lower to undetectable levels or if your viral load increases again after being previously undetectable. Your healthcare provider can confirm the amount of HIV in your blood with viral load tests
  • Intolerable side effects (or drug toxicity): If you are experiencing side effects, including ones that are making it hard to take your medicines, tell your doctor right away. Your healthcare provider will work with you to either help you manage the side effects and/or change your HIV medicines if needed
  • Drug resistance: Antiretroviral medicines work by helping to slow replication of the virus. When HIV becomes resistant to a medicine, this means that the virus has mutated (or changed form) and may no longer be controlled by that medicine

How can I help prevent drug resistance? Remember, to reduce the risk of developing drug resistance, take your medicines every day as directed by your healthcare provider. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to your medicines and become harder to treat. When your medicine supply starts to run low, get more from your healthcare provider or pharmacy.

IMPORTANT SAFETY INFORMATION

Do not take SUSTIVA if you are allergic to efavirenz or any of the ingredients.

Before taking SUSTIVA, tell your doctor if you:

  • Have a heart condition.
  • Have ever had mental illness or used street drugs or large amounts of alcohol.
  • Have liver problems including hepatitis.
  • Have a history of seizures.
  • Are pregnant or plan to become pregnant. SUSTIVA may harm your unborn baby.
    • If you are able to become pregnant your healthcare provider should do a pregnancy test before you start SUSTIVA.
    • You should not become pregnant and should use two effective forms of birth control while taking SUSTIVA and for 12 weeks after stopping it.
    • A barrier form of birth control such as a condom, contraceptive sponge, diaphragm with spermicide, or cervical cap should always be used along with another type of birth control.
    • Hormonal forms of birth control, such
      as birth control pills, injections, vaginal rings, or implants may not work during treatment with SUSTIVA.
    • Do not breastfeed if you take SUSTIVA.
      You should not breastfeed if you have HIV because of the risk of passing HIV to your baby.

Tell your doctor and pharmacist about all the medicines you take, including prescription and over the counter medicines, vitamins, and herbal supplements. Some medicines interact with SUSTIVA.

SUSTIVA may affect the way other medicines work and other medicines may affect how SUSTIVA works, and may cause serious side effects.

You should not take SUSTIVA if you take ATRIPLA (efavirenz/emtricitabine/ tenofovir disoproxil fumarate) unless your doctor tells you to.

Keep a list of your medicines to show your doctor and pharmacist. Do not start taking a new medicine without telling your doctor.

SUSTIVA may cause serious side effects, including:

  • Serious mental health problems can happen in people who take SUSTIVA. Tell your doctor right away if you have any of the following symptoms: feeling sad or hopeless, feeling anxious or restless, having thoughts of suicide, have tried to hurt 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, or not able to move or speak normally.
  • Nervous system symptoms are common and can be severe in patients who take SUSTIVA. Symptoms usually begin during the first or second day of treatment and usually go away after 2 to 4 weeks. These symptoms may get worse if you drink alcohol, take a medicine for mental health problems, or use certain street drugs during treatment. Symptoms may include: dizziness, trouble sleeping, trouble concentrating, drowsiness, and unusual dreams. If you have dizziness, trouble concentrating or drowsiness, do not drive a car, use machinery, or do anything that needs you to be alert.
  • Skin rash is common with SUSTIVA but can sometimes be severe. The rash usually goes away without change in treatment. Tell your doctor right away if you develop a rash with any of the following symptoms: skin rash with or without itching, fever, swelling of your face, blisters or skin lesions, peeling skin, mouth sores, red or inflamed eyes.
  • Liver problems, including liver failure and death. If you have liver problems, your doctor may do blood tests to check your liver before you start SUSTIVA and during treatment. Liver problems can happen in people without a history of liver problems. Tell your doctor right away if you get any of the following symptoms: skin or white part of your eyes turns yellow, your urine turns dark, your bowel movements turn light in color, you don’t feel like eating for several days or longer, you feel nauseous, you have abdominal pain.
  • Seizures can happen in people who take SUSTIVA. Seizures are more likely to happen if you have had them in the past. Tell your doctor if you have had a seizure or if you take a medicine to help prevent seizures.
  • Changes in your immune system can happen when you start taking HIV medicines. Tell your doctor if you start having new symptoms after starting your HIV medicine.
  • Changes in body fat can happen in people taking HIV medicines. Increase of fat in the upper back and neck, breasts, and around the trunk may happen. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects are not known.

The most common side effects with SUSTIVA include: rash, dizziness, nausea, headache, difficulty concentrating, abnormal dreams, tiredness, trouble sleeping, and vomiting.

Some patients have experienced increased levels of lipids (cholesterol and triglyceride) in the blood. Tell your doctor if you have any side effect that bothers you or that does not go away.

You should take SUSTIVA on an empty stomach, preferably at bedtime, which may make some side effects less bothersome.

Please see U.S. Full Prescribing Information and Patient Information for SUSTIVA.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch
or call 1-800-FDA-1088.

SELECTED IMPORTANT SAFETY INFORMATION

SELECTED IMPORTANT SAFETY INFORMATION

Do not take SUSTIVA if you are
allergic
 to efavirenz or any of the ingredients.

Before taking SUSTIVA, tell your doctor if you:

  • Have a heart condition.
  • Have ever had mental illness or used street drugs or large amounts of alcohol.
  • Have liver problems including hepatitis.
  • Have a history of seizures.
  • Are pregnant or plan to become pregnant. SUSTIVA may harm your unborn baby.
    • If you are able to become pregnant your healthcare provider should do a pregnancy test before you start SUSTIVA.
    • You should not become pregnant and should use two effective forms of birth control while taking SUSTIVA and for 12 weeks after stopping it.
    • A barrier form of birth control such as a condom, contraceptive sponge, diaphragm with spermicide, or cervical cap should always be used along with another type of birth control.
    • Hormonal forms of birth control, such
      as birth control pills, injections, vaginal rings, or implants may not work during treatment with SUSTIVA.
    • Do not breastfeed if you take SUSTIVA.
      You should not breastfeed if you have HIV because of the risk of passing HIV to your baby.

Tell your doctor and pharmacist about all the medicines you take, including prescription and over the counter medicines, vitamins, and herbal supplements. Some medicines interact with SUSTIVA.

SUSTIVA may cause serious side effects, including:

  • Serious mental health problems can happen in people who take SUSTIVA. Tell your doctor right away if you have any of the following symptoms: feeling sad or hopeless, feeling anxious or restless, having thoughts of suicide, have tried to hurt 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, or not able to move or speak normally.
  • Nervous system symptoms are common and can be severe in patients who take SUSTIVA. Symptoms usually begin during the first or second day of treatment and usually go away after 2 to 4 weeks. These symptoms may get worse if you drink alcohol, take a medicine for mental health problems, or use certain street drugs during treatment. Symptoms may include: dizziness, trouble sleeping, trouble concentrating, drowsiness, and unusual dreams. If you have dizziness, trouble concentrating or drowsiness, do not drive a car, use machinery, or do anything that needs you to be alert.
  • Skin rash is common with SUSTIVA but can sometimes be severe. The rash usually goes away without change in treatment. Tell your doctor right away if you develop a rash with any of the following symptoms: skin rash with or without itching, fever, swelling of your face, blisters or skin lesions, peeling skin, mouth sores, red or inflamed eyes.
  • Liver problems, including liver failure and death. If you have liver problems, your doctor may do blood tests to check your liver before you start SUSTIVA and during treatment. Liver problems can happen in people without a history of liver problems. Tell your doctor right away if you get any of the following symptoms: skin or white part of your eyes turns yellow, your urine turns dark, your bowel movements turn light in color, you don’t feel like eating for several days or longer, you feel nauseous, you have abdominal pain.
  • Seizures can happen in people who take SUSTIVA. Seizures are more likely to happen if you have had them in the past. Tell your doctor if you have had a seizure or if you take a medicine to help prevent seizures.
  • Changes in your immune system can happen when you start taking HIV medicines. Tell your doctor if you start having new symptoms after starting your HIV medicine.
  • Changes in body fat can happen in people taking HIV medicines. Increase of fat in the upper back and neck, breasts, and around the trunk may happen. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects are not known.

Tell your doctor and pharmacist about all the medicines you take, including prescription and over the counter medicines, vitamins, and herbal supplements. Some medicines interact with SUSTIVA.