Importance Safety Information

About INTELENCE®

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How to take INTELENCE®

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Patient Information

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Important Safety Information

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®. The risk of getting a skin rash is higher in females. Rarely, rash can be severe and may lead to death. Severe skin rash with blisters or peeling skin, including the area around the mouth or eyes, may happen more frequently in children less than 18 years of age who take INTELENCE® in combination with other HIV-1 medicines than in adults. Call your healthcare provider right away if a rash develops; severe cases may need to be treated in a hospital
  • 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-63740v3

Janssen CarePath Care Coordinator
866-836-0114 (toll free)
Monday - Friday, 8 AM - 8 PM ET

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