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.

 

 

SUSTIVA HAS DEMONSTRATED SAFETY DATA

 

Tell your doctor or healthcare provider if you notice any side effects while taking SUSTIVA. It’s important to remember to contact your doctor or healthcare provider before stopping SUSTIVA for side effects or for any other reason.

SUSTIVA may cause serious side effects, including:

Serious mental health problems can happen in people who take SUSTIVA. Tell your healthcare provider right away if you have any of the following symptoms:

  • feel sad or hopeless
  • feel anxious or restless
  • have thoughts of hurting yourself (suicide) or have tried to hurt yourself or others
  • are not able to tell the difference between what is true or real and what is false or unreal
  • do not trust other people
  • hear or see things that are not real
  • or are not able to move or speak normally

Nervous system symptoms are common in people who take SUSTIVA and can be severe. These symptoms usually begin during the first or second day of treatment with SUSTIVA and usually go away after 2 to 4 weeks of treatment. These symptoms may become worse if you drink alcohol, take a medicine for mental health problems, or use certain street drugs during treatment with SUSTIVA. Symptoms may include:

  • dizziness
  • trouble sleeping
  • trouble concentrating
  • drowsiness
  • 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. Skin rash usually goes away without any change in treatment. If you develop a rash with any of the following symptoms, tell your healthcare provider right away:

  • skin rash, with or without itching
  • fever
  • swelling of your face
  • blisters or skin lesions
  • peeling skin
  • mouth sores
  • red or inflamed eyes, like “pink eye” (conjunctivitis)

Liver problems, including liver failure and death. If you have liver problems, including hepatitis B or C infection or take another medicine that can cause liver problems, your healthcare provider may do blood tests to check your liver before you start SUSTIVA and during treatment. Liver problems can also happen in people without a history of liver problems. Tell your healthcare provider right away if you get any of the following symptoms:

  • your skin or the white part of your eyes turns yellow (jaundice)
  • your urine turns dark
  • your bowel movements (stools) turn light in color
  • you don’t feel like eating food for several days or longer
  • you feel sick to your stomach (nausea)
  • you have lower stomach area (abdominal) pain

Seizures can happen in people who take SUSTIVA. Seizures are more likely to happen if you have had seizures in the past. Tell your healthcare provider if you have had a seizure or if you take a medicine to help prevent seizures.

Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new symptoms after starting your HIV-1 medicine.

Changes in body fat can happen in people who take HIV-1 medicine. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these conditions are not known.

The most common side effects of SUSTIVA include:

  • rash
  • dizziness
  • nausea
  • headache
  • difficulty concentrating
  • abnormal dreams
  • tiredness
  • trouble sleeping
  • vomiting

Some patients taking SUSTIVA have experienced increased levels of lipids (cholesterol and triglycerides) in the blood. Tell your healthcare 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 SUSTIVA. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Here are some tips that you may want to discuss with your healthcare provider. He or she may also be able to help you manage some of your side effects. Click on the links below to learn more.

SUGGESTIONS FOR
MANAGING SOME POSSIBLE
SIDE EFFECTS

Tip: Take SUSTIVA® on an empty stomach, preferably at bedtime. Taking SUSTIVA with food increases the amount of medicine in your body, which may increase the frequency of side effects. Taking SUSTIVA at bedtime may make some side effects less bothersome. Drinking alcohol, taking a medicine for mental health problems, or using certain street drugs can worsen side effects. And when you have dizziness, trouble concentrating or drowsiness, do not drive a car, use machinery, or do anything that needs you to be alert.

For additional information, talk to your healthcare provider. He or she may be able to offer additional management tips to help with your symptoms.

Close

Tip: Take SUSTIVA on an empty stomach, preferably at bedtime. Taking SUSTIVA with food increases the amount of medicine in your body, which may increase the frequency of side effects. Taking SUSTIVA at bedtime may make some side effects less bothersome. Drinking alcohol, taking a medicine for mental health problems, or using certain street drugs can worsen side effects.

If you’re having trouble sleeping (called insomnia), here are some tips that may help:

  • Go to bed and get up at the same time each day
  • Exercise regularly
  • Avoid caffeine and/or nicotine before bedtime
  • Keep sleeping area dark, quiet, and at a comfortable temperature
  • Relax before going to bed with activities such as yoga or a bath

For additional information, talk to your healthcare provider. He or she may be able to offer additional management tips to help with your symptoms.

Close

Tip: Take SUSTIVA on an empty stomach, preferably at bedtime. Taking SUSTIVA with food increases the amount of medicine in your body, which may increase the frequency of side effects. Taking SUSTIVA at bedtime may make some side effects less bothersome.

Taking SUSTIVA with alcohol, medicine for mental health problems, or certain street drugs can worsen side effects like drowsiness. When you are drowsy, do not drive a car, use machinery, or do anything that needs you to be alert.

For additional information, talk to your healthcare provider. He or she may be able to offer additional management tips to help with your symptoms.

Close

Tip: If you have trouble concentrating, do not drive a car, use machinery, or do anything that needs you to be alert.

Take SUSTIVA on an empty stomach, preferably at bedtime. Taking SUSTIVA with food increases the amount of medicine in your body, which may increase the frequency of side effects. Taking SUSTIVA at bedtime may make some side effects less bothersome. Drinking alcohol, taking a medicine for mental health problems, or using certain street drugs can worsen side effects.

For additional information, talk to your healthcare provider. He or she may be able to offer additional management tips to help with your symptoms.

Close

Tip: Take SUSTIVA on an empty stomach, preferably at bedtime. Taking SUSTIVA with food increases the amount of medicine in your body, which may increase the frequency of side effects. Taking SUSTIVA at bedtime may make some side effects less bothersome. Drinking alcohol, taking a medicine for mental health problems, or using certain street drugs can worsen side effects.

For additional information, talk to your healthcare provider. He or she may be able to offer tips to help with your symptoms.

Close

LEARN MORE ABOUT YOUR SUSTIVA MEDICATION

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.