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.

TIPS FOR STAYING ON TRACK WITH YOUR TREATMENT

 

Explore this section to get helpful tips that may help you remember to take SUSTIVA® and manage some possible concerns about HIV treatment. Plus, learn more about the reasons why your healthcare provider may change your HIV treatment.

GENERAL TIPS
FOR TAKING SUSTIVA

 
  • Take SUSTIVA exactly as your healthcare provider tells you to. Do not change your dose or stop taking SUSTIVA unless your healthcare provider tells you to. Stay under the care of your healthcare provider during treatment with SUSTIVA
  • SUSTIVA must be used with other anti-HIV medicines
  • Take SUSTIVA 1 time each day
  • SUSTIVA comes as tablets or capsules
  • SUSTIVA tablets must not be broken
  • Swallow SUSTIVA tablets or capsules whole with liquid
  • You should take SUSTIVA on an empty stomach at bedtime. Taking SUSTIVA with food increases the amount of medicine in your body. Some side effects may bother you less if you take SUSTIVA on an empty stomach and at bedtime
  • If you have difficulty swallowing tablets or capsules, tell your healthcare provider. If your healthcare provider recommends opening the SUSTIVA capsule and mixing the contents with food or infant formula, see the detailed “Instructions for Use” at the end of the Patient Information to learn the right way to take a dose of SUSTIVA using the capsule sprinkle method
  • Ask your healthcare provider or pharmacist if you have any questions about how to take a dose of SUSTIVA using the capsule sprinkle method
  • The dose of SUSTIVA for children may be lower than the dose for adults. Capsules containing lower amounts of SUSTIVA are available. Your child’s healthcare provider will prescribe the right dose based on your child’s weight
  • Adults and children who take SUSTIVA using the capsule sprinkle method should not eat for 2 hours after taking a dose of SUSTIVA
  • Babies should not be given infant formula for 2 hours after taking a dose of SUSTIVA using the capsule sprinkle method
  • Talk with your healthcare provider to help decide the best schedule for giving your baby SUSTIVA mixed with infant formula using the capsule sprinkle method
  • Do not miss a dose of SUSTIVA. If you forget to take SUSTIVA, take the missed dose right away, unless it is almost time for your next dose. Do not take 2 doses at one time. Just take your next dose at your regularly scheduled time. If you need help in planning the best times to take your medicine, ask your healthcare provider or pharmacist
  • If you take too much SUSTIVA, call your healthcare provider or go to the nearest hospital emergency room right away
  • Tell your healthcare provider if you start any new medicine or change how you take any of your current medicines. Your doses may need to be changed
  • When your SUSTIVA supply starts to run low, get more from your healthcare provider or pharmacy. It is important not to run out of SUSTIVA. The amount of HIV in your blood may increase if the medicine is stopped for even a short time. The virus may become resistant to SUSTIVA and harder to treat
  • Your healthcare provider may want to do blood tests to check for certain side effects while you take SUSTIVA.

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.