Important Safety Information

What are the possible side effects of INTELENCE®?

INTELENCE® can cause serious side effects including:

  • Severe skin rash and allergic reactions. Skin rash is a common side effect of INTELENCE®. Rash can be serious. Call your healthcare provider right away if you get a rash. In some cases, severe rash and allergic reaction may need to be treated in a hospital and may lead to death
  • If you get a rash with any of the following symptoms, stop taking INTELENCE® and call your healthcare provider right away:
    • fever
    • generally ill feeling
    • extreme tiredness
    • muscle or joint aches
    • blisters or sores in mouth
    • blisters or peeling of the skin
    • redness or swelling of the eyes
    • swelling of the mouth, lips, or face
    • problems breathing
  • Sometimes allergic reactions can affect body organs, such as your liver. Call your healthcare provider right away if you have any of the following signs or symptoms of liver problems:
    • yellowing of your skin or whites of your eyes
    • dark or tea-colored urine
    • pale-colored stools (bowel movements)
    • nausea or vomiting
    • loss of appetite
    • pain, aching, or tenderness on the right side of your stomach area
  • Changes in your immune system can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden
  • Changes in body fat can happen in people taking HIV-1 medicines. The cause and long-term health effects of this condition is not known
  • The most common side effects of INTELENCE® in adults include rash as well as numbness, tingling or pain in the hands or feet
  • The most common side effects of INTELENCE® in children include rash and diarrhea

This is not a complete list of all side effects. If you experience these or other symptoms, contact your healthcare provider right away.

What should I tell my healthcare provider before taking INTELENCE®?

  • Before taking INTELENCE®, tell your healthcare provider if you:
    • have liver problems, including hepatitis B or C
    • are pregnant or plan to become pregnant. Tell your healthcare provider if you become pregnant during treatment with INTELENCE®
    • are breastfeeding or plan to breastfeed. Do not breastfeed if you take INTELENCE®. INTELENCE® can pass to your baby in your breast milk. You should not breastfeed if you have HIV because of the risk of passing HIV to your baby
  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements
  • Do not start a new medicine without telling your healthcare provider

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

Please see the full Product Information in PDF format for more details.

cp-63740v2

 

 

 

About INTELENCE® (etravirine)

  • INTELENCE® is a prescription medicine that is used in combination with other antiretroviral medicines to treat human immunodeficiency virus-1 (HIV-1) infection in adults and children 2 years of age and older, who have taken HIV-1 medicines in the past. HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
  • INTELENCE® is not recommended for use in children less than 2 years of age.

INTELENCE® does not cure HIV infection or AIDS. You must stay on continuous HIV therapy to control your HIV infection and decrease HIV-related illnesses.

Ask your healthcare provider if INTELENCE® is right for you.