Side Effects

About INTELENCE

• INTELENCE is a prescription HIV medicine that helps to control HIV (human immunodeficiency virus) infection in adults. INTELENCE is a type of anti-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 for patients who are already taking or have taken HIV medicines, have resistance to non-nukes and other HIV medicines and whose HIV infection is not under control
  • 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, 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 other HIV medicines
  • It is important that you remain under the care of your healthcare professional during treatment with INTELENCE
• The safety and effectiveness of INTELENCE have not been studied in children or patients who have never taken HIV medications before

INTELENCE does not cure HIV infection or AIDS.  You should remain on your HIV medications without stopping to control your HIV infection and decrease the risk of HIV-related illnesses.

Ask your healthcare professional if INTELENCE is right for you

Important Safety Information

What are the possible side effects of INTELENCE?

• Skin rash is a common side effect of INTELENCE. Rash can be serious and potentially life-threatening. Contact your healthcare professional right away if you get a rash. Your healthcare professional will decide if INTELENCE must be stopped
  • Patients taking INTELENCE may have severe skin rashes or rashes with an allergic reaction (hypersensitivity reactions). Sometimes these allergic reactions can affect body organs, like the liver. These allergic reactions usually include a rash with other symptoms such as fever, generally ill feeling, extreme tiredness, muscle or joint aches, blisters, oral sores, irritated eyes, facial swelling, swelling of eyes, lips, or mouth, breathing difficulty, and/or signs and symptoms of liver problems (eg, yellowing of your skin or whites of your eyes, dark or tea- colored urine, pale colored stools/bowel movements, nausea, vomiting, loss of appetite, or pain, aching or sensitivity on your right side below your ribs)
  • If you get a rash, contact your healthcare professional right away to determine if you should stop taking INTELENCE

• Other common side effects of INTELENCE include tingling or pain in hands or feet, and numbness
• Other side effects of INTELENCE, which can be serious, include muscle pain, tenderness or weakness
• As with other HIV medicines, INTELENCE may cause side effects, including:
  • Changes in body shape or body fat. The cause and long-term health effects of these conditions are not known at this time
  • Immune reconstitution syndrome. Signs and symptoms of inflammation from opportunistic infections that a person has or had may occur as the medicines work to control the HIV infection and strengthen the immune system. Call your healthcare professional right away if you experience any signs or symptoms of an infection

This is not a complete list of all side effects. If you experience these or other symptoms, contact your healthcare professional right away. Do not stop taking INTELENCE or any other medications without first talking to your healthcare professional

What should I tell my doctor before I take INTELENCE?

• Before taking INTELENCE, tell your healthcare professional if you have any medical conditions such as liver problems (including hepatitis B or C) or if you are pregnant, planning to become pregnant, or breastfeeding
  • The effects of INTELENCE on pregnant women are not known. It is not known if INTELENCE can cause harm to your unborn baby. You and your healthcare professional will need to decide if taking INTELENCE is right for you
  • Do not breastfeed if you are taking INTELENCE. You should not breastfeed if you have HIV because of the chance of passing HIV to your baby

Can INTELENCE be taken with other medicines?

• Taking INTELENCE with certain medicines could cause side effects or may result in loss of its effectiveness (which could increase your risk for developing resistance to INTELENCE or other HIV medicines). Do not take INTELENCE if you are taking the following medicines:
  • HIV: tipranavir/ritonavir (Aptivus^®), fosamprenavir/ritonavir (Lexiva^®), atazanavir/ritonavir (Reyataz^®), full-dose ritonavir (Norvir^® 600 mg twice a day), unboosted protease inhibitors (without ritonavir), nevirapine (Viramune^®), efavirenz (Sustiva^®), or delavirdine (Rescriptor^®)
  • Other: carbamazepine (Tegretol^®, Carbatrol^®), phenobarbital (Luminal^®), phenytoin (Dilantin^®, Phenytek^®), rifabutin (Mycobutin^®), rifampin (Rifadin^®, Rifater^®, Rifamate^®), rifapentine (Priftin^®), or products containing St. John’s wort (Hypericum perforatum)
• Before starting INTELENCE, tell your healthcare professional about all medicines you are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Please see full product information for more details

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.