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INTELENCE® (etravirine) Information

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About INTELENCE®

  • INTELENCE® (etravirine) is a prescription HIV (human immunodeficiency virus) medicine that is used with other HIV medicines to treat HIV infection in adults and children 6 years of age and older. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). INTELENCE® is a type of HIV medicine called a non-nucleoside reverse transcriptase inhibitor (NNRTI), also known as a non-nuke
  • INTELENCE® must be taken in combination with other HIV medicines. INTELENCE® is used in people who are already taking or have taken an NNRTI and other HIV medicines and these medicines are not controlling their HIV infection
    • The use of other medicines active against your HIV in combination with INTELENCE® may increase the likelihood of your overall treatment response. If a non-nuke regimen has stopped working for you in the past, INTELENCE® should not be taken with only nucleoside/nucleotide reverse transcriptase inhibitors, also known as nukes. Your healthcare professional will work with you to find the right combination of HIV medicines to combine with INTELENCE®
    • It is important that you remain under the care of your healthcare professional during treatment with INTELENCE®
  • It is not known if INTELENCE® is safe and effective in children less than 6 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 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, in general, is a common side effect of INTELENCE® and was seen more commonly in children than adults in clinical studies. Rash was also seen more commonly in females than males. Rash can be serious and may potentially lead to death. If you get a rash with any of the following symptoms, stop taking INTELENCE® and call your healthcare professional right away: hives or sores in your mouth, or your skin blisters and peels; trouble swallowing or breathing; swelling of your face, eyes, lips, tongue, or throat; fever; yellowing of the skin or whites of the eyes; dark urine; or pain on the right side of the stomach area (abdominal pain)
  • Changes in body shape or body fat. The cause and long-term health effects of these conditions are not known at this time
  • 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
  • In adults, common side effects of INTELENCE® include tingling, numbness, or pain in hands or feet
  • In children, diarrhea is a common side effect of INTELENCE®

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 doctor before I take INTELENCE®?

  • Before taking INTELENCE®, tell your healthcare professional if you have liver problems, including hepatitis B or C, have any other medical conditions, or if you are pregnant, planning to become pregnant, or breastfeeding
    • It is not known if INTELENCE® can cause harm to 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 nonprescription medicines, vitamins, and herbal supplements
  • Taking INTELENCE® with certain medicines may cause serious side effects or may result in loss of its effectiveness (which could increase your risk for developing resistance to INTELENCE® or other HIV medicines). Dolutegravir (Tivicay®, Triumeq®) is one HIV medication that may have loss of effectiveness when taken with INTELENCE®. Tell your healthcare professional about all other HIV medications you are taking
  • Do not take INTELENCE® if you are taking the following medicines:
    • HIV: tipranavir/ritonavir (Aptivus®), fosamprenavir/ritonavir (Lexiva®), full-dose ritonavir (Norvir® 600 mg twice a day), unboosted protease inhibitors (without ritonavir), nevirapine (Viramune®), efavirenz (Sustiva®), or delavirdine (Rescriptor®)
    • Other: carbamazepine (Tegretol®, Tegretol-XR®, Carbatrol®, Equetro®, Teril®, Epitol®), phenobarbital (Luminal®, Solfoton®), phenytoin (Dilantin®, Dilantin-125®, Phenytek®), rifabutin (Mycobutin®), rifampin (Rifadin®, Rifater®, Rifamate®, Rimactane®), rifapentine (Priftin®), or products containing St. John’s wort (Hypericum perforatum)

You are encouraged to report negative 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.