Important Safety Information

 

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 are already taking or have taken a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other HIV-1 medicines, and
    • these medicines are not controlling their HIV-1 infection.
  • HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

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 professional if INTELENCE® is right for you.


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 professional 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 professional 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 professional 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 body fat. The cause and long-term health effects of this condition is not known
  • 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
  • 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 professional right away.

    What should I tell my healthcare professional before I take INTELENCE®?

    • Before taking INTELENCE®, tell your healthcare professional if you:
      • have severe liver problems or hepatitis B or C
      • are pregnant, planning to become pregnant, or breastfeeding. It is not known if INTELENCE® will harm your unborn baby. Do not breastfeed if you are taking INTELENCE®. You should not breastfeed if you have HIV because of the risk of passing HIV to your baby
    • Tell your healthcare professional 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 professional

    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.

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