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Patient Information
US Full Prescribing Information
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* Undetectable is defined as a viral load of less than 400 copies/mL or less than 50 copies/mL (depending on the test used).

Find out more about SUSTIVA (efavirenz) as part of your HIV combination therapy

You want to know more about your HIV medicine—and we want to help. This site may help answer some of your questions about SUSTIVA—and assist you in working with your doctor to better understand your HIV treatment.

SUSTIVA is a prescription medicine used in combination with other medicines to treat HIV-1 infection. In HIV combination therapy, SUSTIVA can help lower viral loads to undetectable* and has been shown to help improve the body’s immune system by raising CD4+ cell (T-cell) counts. SUSTIVA may not have these effects in every patient. SUSTIVA does not cure HIV or AIDS. You must keep taking HIV medicines in order to control HIV infection and decrease HIV-related illnesses.


Who should not take SUSTIVA (efavirenz)?

Do not take SUSTIVA if you are allergic to the active ingredient, efavirenz, or to any of the inactive ingredients. Your doctor and pharmacist have a list of the inactive ingredients.

LEARN MORE ABOUT YOUR SUSTIVA MEDICATION

INDICATIONS:
SUSTIVA® (efavirenz) 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 must keep taking HIV medicines in order to control HIV infection and decrease HIV-related illnesses.


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 ever had mental illness or used street drugs or large amounts of alcohol.
  • Have problems with your liver including hepatitis.
  • Have a history of seizures.
  • Are pregnant or plan to become pregnant. SUSTIVA may harm your unborn baby.

You should not become pregnant and must 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, and cervical cap must 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.

  • Are breastfeeding or plan to breastfeed. Women can pass HIV or SUSTIVA through their breast milk to the baby. It is not known if SUSTIVA can harm your baby.

Tell your doctor about all the medicines you take, including prescription and over the counter medicines, vitamins, and herbal supplements.

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.

The following medicines may need to be replaced with another medicine during your treatment with SUSTIVA: boceprevir (Victrelis®), carbamazepine (Carbatrol®, Tegretol®, Tegretol-XR®, Equetro®, Teril®, Epitol®), clarithromycin (Biaxin®, Biaxin XL®), itraconazole (Sporanox®, Onmel®), posaconazole (Noxafil®), saquinavir mesylate (Invirase®), atazanavir (Reyataz®).

Please refer to the Patient Information for a list of medicines that may require a change in the dose of either SUSTIVA or the other medicine.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

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, thoughts of hurting 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.
  • 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 increase 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.

US Full Prescribing Information

CD4+ cell: A type of white blood cell that fights infection and can be attacked by HIV. May also be called a T-cell.
Viral load: How much virus is in a sample of blood; usually measured as the number of copies of HIV RNA per milliliter of blood. It may be used to judge how well your treatment is working.
Drug resistance: Antiretroviral medicines work by helping to slow replication of the virus.1 When HIV becomes resistant to a medicine, this means that the virus has mutated (or changed form) and its replication may no longer be controlled by that medicine.1
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