Sustiva LogoHome Your Sustiva Your HIV Treatment Managing Side Effects Tools & Resources
Patient Information
Full Prescribing Information
Learn more about HIV treatment

SUSTIVA in combination therapy: Together, you and your
doctor have chosen SUSTIVA as part of your HIV regimen

In HIV combination therapy, Once-Daily SUSTIVA:
  • Can help keep viral loads undetectable* for a long time†

    • * Undetectable is defined as a viral load of less than 400 copies/mL or less than
    50 copies/mL (depending on the test used).
    † Up to 168 weeks.

  • Has been shown to help increase your CD4+ cell (T-cell) count
As part of HIV combination therapy:
  • SUSTIVA has been the #1 prescribed non-nucleoside reverse transcriptase inhibitor (NNRTI)
    in the United States since 1999    1

    • — NNRTIs work by binding to and disabling a protein called reverse transcriptase that HIV needs to make more copies of itself.2

  • SUSTIVA is the only NNRTI listed in the Department of Health and Human Services (DHHS) HIV-treatment Guidelines3 as part of a preferred regimen for the initial treatment of HIV
    infection.     The preferred NNRTI-based combination includes efavirenz‡ and tenofovir + emtricitabine§

    • ‡ Do not use during first trimester of pregnancy or in those with high pregnancy potential. Use with caution in patients with unstable psychiatric disease.
    § Do not use in combination with atazanavir when atazanavir is not given with ritonavir. Use with caution with nevirapine and in patients with existing kidney problems.

  • SUSTIVA has been available since 19984

  • Hundreds of thousands of patients have used SUSTIVA in combination therapy to
    treat HIV-1 infection    5

Get tips for working with your doctor to manage your concerns about HIV treatment. Plus, sign up for a medication reminder program to receive regular e-mail or text message reminders that may help you remember to take your medicines.
Learn more

   
IMPORTANT INFORMATION ABOUT SUSTIVA® (efavirenz)

INDICATION:
SUSTIVA® (efavirenz) is a prescription medicine used in combination with other medicines to treat people who are infected with the human immunodeficiency virus type 1 (HIV-1).

SUSTIVA does not cure HIV and has not been shown to prevent passing HIV to others.

See your healthcare provider regularly.

IMPORTANT SAFETY INFORMATION:
Do not take SUSTIVA if you are taking the following medicines because serious and life-threatening side
effects may occur when taken
together: Vascor® (bepridil),
Propulsid® (cisapride),
Versed® (midazolam), Orap® (pimozide), Halcion® (triazolam), or ergot medicines (for example,Wigraine® and Cafergot®).

Taking SUSTIVA with St. John’s wort (Hypericum perforatum) is not recommended, as it may cause decreased levels of SUSTIVA, increased viral load, and possible resistance to SUSTIVA or cross-resistance to other anti-HIV drugs.

SUSTIVA should not be taken with ATRIPLA® (efavirenz 600 mg / emtricitabine 200 mg/tenofovir    disoproxil fumarate 300mg) because it contains efavirenz, the active ingredient in SUSTIVA.

If you are taking SUSTIVA with
REYATAZ® (atazanavir sulfate), your REYATAZ may need to be replaced if this is not the first time you are receiving treatment for your HIV infection. Other drugs that may also need to be replaced include
Fortovase® (saquinavir),
Invirase® (saquinavir),
Biaxin® (clarithromycin),
Carbatrol® (carbamazepine),
Tegretol® (carbamazepine),
Noxafil® (posaconazole) and
Sporonox® (itraconazole).

SUSTIVA and Vfend® (voriconazole)
must not be taken together at standard doses. Some doses of voriconazole can be taken at the same time as a lower dose of SUSTIVA, but you must check with your healthcare provider first.

These are not all the medicines that may cause problems if you take SUSTIVA® (efavirenz). Discuss with
your healthcare provider all prescription and nonprescription medicines, vitamins, and herbal supplements you are taking or plan to take.

Tell your healthcare provider right
away if you have any side effects or conditions, including the following:

  • Severe depression, strange thoughts, or angry behavior have been reported by a small number of patients taking SUSTIVA. Some patients have had thoughts of suicide and a few have actually committed suicide. These problems may occur more often in patients who have had mental illness.

  • Dizziness, trouble sleeping or concentrating, drowsiness, and/or unusual dreams, are
    common, and tend to go away after taking SUSTIVA for a few weeks. Symptoms were severe in a few patients, and some patients discontinued therapy. These symptoms may become more severe with the use of alcohol and/or mood-altering (street) drugs. If you are dizzy, have trouble concentrating, and/or are drowsy, avoid activities that may be dangerous, such as driving or operating machinery.

  • If you have ever had mental illness
    or are using drugs or alcohol.

  • Pregnancy: Women should not become pregnant while taking SUSTIVA® (efavirenz) and for 12 weeks after stopping SUSTIVA. Serious birth defects have been seen in children of women treated with SUSTIVA during pregnancy.
    Therefore, women must use a
    reliable form of barrier contraception, such as a condom or diaphragm,
    even if they also use other methods of birth control.

  • Breast-feeding: Women with HIV should not breast-feed because they can pass HIV through their milk to the baby. Also, SUSTIVA may pass through breast milk and cause serious harm to the baby.

  • Rash is a common side effect that usually goes away without any
    change in your medicines, but may be serious in a small number of patients. Rash may be a serious problem in some children.

  • Liver problems: Some patients taking SUSTIVA have experienced serious liver problems including liver failure resulting in transplantation or death. Most of these serious side effects occurred in patients with a chronic
    liver disease such as hepatitis infection, but there have also been reports in patients without any existing liver disease. Your healthcare
    provider may want to do tests to check your liver.

  • Seizures have occurred in patients taking SUSTIVA, usually in those with a history of seizures. If you have ever had seizures or take medicines for seizures, your healthcare provider
    may want to switch you to another medicine or monitor you.

Changes in body fat have been seen in some patients taking anti-HIV
medicines. The cause and long-term health effects are not known.

Other common side effects of
SUSTIVA® (efavirenz) taken with other anti-HIV medicines include: tiredness, upset stomach, vomiting, and diarrhea. Some patients taking SUSTIVA have experienced increased levels of lipids (cholesterol and triglycerides) in the blood.

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

Continue reading below
 
 
  Patient Information
Full Prescribing Information
   
   
Get information that may help you with possible HIV treatment concerns

It's important to work with your doctor to develop a plan that works for you.

GET TIPS, TOOLS, AND RESOURCES

   
   
What you need to know about your doctor's treatment decisions

Learn more about your doctor's treatment decisions.

LEARN MORE

   
REFERENCES
  1. IMS Health, IMS National Prescription Audit (NPA), 1999 – February 2009. Data derived from total number of prescriptions of SUSTIVA.
  2. AIDSinfo. Glossary. Department of Health and Human Services. June 19, 2009. Available at
    http://aidsinfo.nih.gov/Glossary/GlossaryDefaultCenterPage.aspx.
    Accessed July 8, 2009.
  3. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in
    HIV-1-infected adults and adolescents. Department of Health and Human Services. December 1, 2009; 1-161. Available at http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf.
    Accessed June 1, 2010.
  4. AIDSinfo. HIV and Its Treatment: What You Should Know. Department of Health and Human Services. December, 2008;1-15. Available at http://aidsinfo.nih.gov/contentfiles/HIVandItsTreatment_cbrochure_en.pdf.
    Accessed June 23, 2009.
  5. SDI's Total Patient Tracker, January 2002 – February 2009.
CD4+ cell: A type of white blood cell that fights infection and can be attacked by HIV (sometimes called a T-cell).1
Viral load: How much virus is in a sample of your blood; usually measured as the number of copies of virus per milliliter of blood. It may be used to judge how well your treatment is working.1

IMPORTANT INFORMATION ABOUT SUSTIVA® (efavirenz)

INDICATION: SUSTIVA® (efavirenz) is a prescription medicine used in combination with other medicines to treat people who are infected with the human immunodeficiency virus
type 1 (HIV-1).

SUSTIVA does not cure HIV and has not been shown to prevent passing HIV to others.

See your healthcare provider regularly.

IMPORTANT SAFETY INFORMATION:

Do not take SUSTIVA if you are taking the following medicines because serious and life-threatening side effects may occur when taken together: Vascor® (bepridil), Propulsid® (cisapride), Versed® (midazolam), Orap® (pimozide), Halcion® (triazolam), or ergot medicines (for example, Wigraine® and Cafergot®).

Taking SUSTIVA with St. John’s wort (Hypericum perforatum) is not recommended, as it may cause decreased levels of SUSTIVA, increased viral load, and possible resistance to SUSTIVA or cross-resistance to other anti-HIV drugs.

SUSTIVA should not be taken with ATRIPLA® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) because it contains efavirenz, the active ingredient in SUSTIVA.

If you are taking SUSTIVA with REYATAZ® (atazanavir sulfate), your REYATAZ may need to be replaced if this is not the first time you are receiving treatment for your HIV infection. Other drugs that may also need to be replaced include Fortovase® (saquinavir), Invirase® (saquinavir), Biaxin® (clarithromycin), Carbatrol® (carbamazepine), Tegretol® (carbamazepine),
Noxafil® (posaconazole) and Sporonox® (itraconazole).

SUSTIVA and Vfend® (voriconazole) must not be taken together at standard doses. Some doses of voriconazole can be taken at the same time as a lower dose of SUSTIVA, but you must check with your healthcare provider first.

These are not all the medicines that may cause problems if you take SUSTIVA. Discuss with your healthcare provider all prescription and nonprescription medicines, vitamins, and herbal supplements you are taking or plan to take.

Tell your healthcare provider right away if you have any side effects or conditions, including the following:

  • Severe depression, strange thoughts, or angry behavior have been reported by a small number of patients taking SUSTIVA. Some patients have had thoughts of suicide and a few have actually committed suicide. These problems may occur more often in patients who have had mental illness.
  • Dizziness, trouble sleeping or concentrating, drowsiness, and/or unusual dreams, are common, and tend to go away after taking SUSTIVA for a few weeks. Symptoms were severe in a few patients, and some patients discontinued therapy. These symptoms may become more severe with the use of alcohol and/or mood-altering (street) drugs. If you are dizzy, have trouble concentrating, and/or are drowsy, avoid activities that may be dangerous, such as driving or operating machinery.
  • If you have ever had mental illness or are using drugs or alcohol.
  • Pregnancy: Women should not become pregnant while taking SUSTIVA® (efavirenz) and for 12 weeks after stopping SUSTIVA. Serious birth defects have been seen in children of women treated with SUSTIVA during pregnancy. Therefore, women must use a reliable form of barrier contraception, such as a condom or diaphragm, even if they also use other methods of birth control.
  • Breast-feeding: Women with HIV should not breast-feed because they can pass HIV through their milk to the baby. Also, SUSTIVA may pass through breast milk and cause serious harm to the baby.
  • Rash is a common side effect that usually goes away without any change in your medicines, but may be serious in a small number of patients. Rash may be a serious problem in some children
  • Liver problems: Some patients taking SUSTIVA have experienced serious liver problems including liver failure resulting in transplantation or death. Most of these serious side effects occurred in patients with a chronic liver disease such as hepatitis infection, but there have also been reports in patients without any existing liver disease. Your healthcare provider may want to do tests to check your liver.
  • Seizures have occurred in patients taking SUSTIVA, usually in those with a history of seizures. If you have ever had seizures or take medicines for seizures, your healthcare provider may want to switch you to another medicine or monitor you.

Changes in body fat have been seen in some patients taking anti-HIV medicines. The cause and long-term health effects are not known.

Other common side effects of SUSTIVA® (efavirenz) taken with other anti-HIV medicines include: tiredness, upset stomach, vomiting, and diarrhea. Some patients taking SUSTIVA have experienced increased levels of lipids (cholesterol and triglycerides) in the blood.

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

Full Prescribing Information

Bristol-Myers Squibb SUSTIVA and the SUNRISE logo are registered trademarks of Bristol-Myers Squibb.
ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC.
All other trademarks are owned by third parties.
© 2009 Bristol-Myers Squibb, Princeton, NJ 08543 U.S.A
Legal Policy Privacy Policy Cancel Reminder
692US09WA04201 06/10 		Partnership for Prescription AssistanceIf you or someone you know needs help paying for medicine,
click here.