An Overview of Intelence (TMC125, Etravirine)

Brand Name: Intelence
Other Name(s): ETR, ETV, TMC 125, TMC-125, TMC125

Drug Class: Non-nucleoside Reverse Transcriptase Inhibitors

Patient Information

INTELENCE^® (in-tel-ence)
etravirine
Tablets

Important: Ask your doctor or pharmacist about medicines that should NOT be taken with INTELENCE^®. For more information, read the section "Can INTELENCE^® be taken with other medicines?".

Read this information carefully before you start taking INTELENCE^® and each time you renew your prescription, as new information may be available. This leaflet does not take the place of talking with your doctor. You and your doctor should discuss your treatment with INTELENCE^® when you start taking it and at regular checkups. You should not change or stop treatment without first talking with your doctor.

What is INTELENCE^®?

• INTELENCE^® is a prescription anti-HIV medicine that helps to control HIV (Human Immunodeficiency Virus) infection in adults. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). INTELENCE^® is a type of anti-HIV medicine called a non-nucleoside reverse transcriptase inhibitor (NNRTI).
• INTELENCE^® is used with other anti-HIV medicines in patients who are already taking or have taken NNRTI and other anti-HIV medicines and these medicines are not controlling their HIV infection.
• It is important that you remain under the care of your doctor during treatment with INTELENCE^®.
• The safety and effectiveness of INTELENCE^® have not been studied in children.

INTELENCE^® must be taken in combination with other anti-HIV medicines.

• INTELENCE^® blocks an enzyme which the virus (HIV) needs in order to make more virus. The enzyme that INTELENCE^® blocks is called HIV reverse transcriptase.
• When used with other anti-HIV medicines, INTELENCE^® can help:
  • reduce the amount of HIV in your blood. This is called your "viral load".
  • increase the number of white blood cells called CD4+ (T) cells that help fight off other infections.

Reducing the amount of HIV and increasing the CD4+ (T) cell count may improve your immune system and, as a result, reduce the risk of death or infections that can happen when your immune system is weak (opportunistic infections).

INTELENCE^® does not cure HIV infection or AIDS.

Patients must stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses.

• Always practice safer sex.
• Use latex or polyurethane condoms to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood.
• Never re-use or share needles.

Ask your doctor if you have any questions on how to prevent passing HIV to other people.

What should I tell my doctor before I take INTELENCE^®?

Together with your doctor, you need to decide whether taking INTELENCE® is right for you.

Tell your doctor about all of your medical conditions, including if you:

• have had or currently have liver problems, including hepatitis B or C.
• are pregnant or planning to become pregnant. It is not known if INTELENCE^® can harm your unborn baby. You and your doctor will need to decide if taking INTELENCE^® is right for you. If you take INTELENCE^® while you are pregnant, talk to your doctor about how you can be included in the Antiretroviral Pregnancy Registry.
• are breastfeeding. 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. Talk with your doctor about the best way to feed your baby.

Can INTELENCE^® be taken with other medicines?

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements, including St. John’s wort (Hypericum perforatum).
Some medicines may interact with INTELENCE^®.

• Sometimes serious side effects happen if INTELENCE^® is taken with some medicines.
• INTELENCE^® should not be taken with some medicines which may lower the amount of INTELENCE^® in your blood. This may lead to an increased HIV viral load. Resistance to INTELENCE^® or cross resistance to other HIV medicines may develop.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine. Your doctor and your pharmacist can tell you if you can take these medicines with INTELENCE^®. Do not start any new medicines while you are taking INTELENCE^® without first talking with your doctor or pharmacist. You can ask your doctor or pharmacist for a list of medicines that can interact with INTELENCE^®.

Tell your doctor if you take other HIV medicines. INTELENCE^® can be combined with most HIV medicines while some HIV medicines are not recommended.

Tell your doctor if you are taking any of the following medicines:

• Antiarrhythmics (to treat abnormal heart rhythms):
  Amiodarone (Cordarone^®), bepridil (Vascor^®), digoxin (Lanoxin^®), disopyramide (Norpace^®), flecainide (Tambocor^™), lidocaine (Xylocaine^®), mexiletine (Mexitil^®), propafenone (Rythmol SR^®), quinidine (Quinidex^®)
• Anticoagulants (to prevent blood clots):
  Warfarin (Coumadin^®)
• Anticonvulsants (to treat epilepsy and prevent seizures):
  Carbamazepine (Tegretol^®, Carbatrol^®), phenobarbital (Luminal^®), phenytoin (Dilantin^®, Phenytek^®)
• Antifungals (to treat fungal infections):
  Fluconazole (Diflucan^®), itraconazole (Sporanox^®), ketoconazole (Nizoral^®), posaconazole (Noxafil^®), voriconazole (Vfend^®)
• Anti-infectives (to treat bacterial infections):
  Clarithromycin (Biaxin^®)
• Antimycobacterials (to treat bacterial infections, including tuberculosis [TB]):
  Rifabutin (Mycobutin^®), rifampin (Rifadin^®, Rifater^®, Rifamate^®), rifapentine (Priftin^®)
• Benzodiazepines (to treat trouble with sleeping and/or anxiety):
  Diazepam (Valium^®)
• Corticosteroids (to treat inflammation or asthma):
  Dexamethasone (Decadron^®)
• HMG-CoA Reductase Inhibitors (to lower cholesterol levels):
  Atorvastatin (Lipitor^®), fluvastatin (Lescol^®), lovastatin (Advicor^®, Altoprev^®, Mevacor^®), rosuvastatin (Crestor^®), simvastatin (Vytorin^®, Zocor^®)
• Immunosuppressants (to prevent organ transplant rejection):
  Cyclosporine (Sandimmune^®, Neoral^®), sirolimus (Rapamune^®), tacrolimus (Prograf^®)
• Narcotic Analgesic/Treatment of Opioid Dependence (to treat narcotic withdrawal and dependence):
   Buprenorphine (Buprenex^®, Subutex^®), buprenorphine/naloxone (Suboxone^®), methadone (Dolophine^®)
• PDE-5 Inhibitors (to treat erectile dysfunction):
  Sildenafil (Viagra^®), vardenafil (Levitra^®)
• Platelet Aggregation Inhibitors (to prevent blood clots):
  Clopidogrel (Plavix^®)

This is not a complete list of medicines that you should tell your doctor about. Know and keep track of all the medicines you take and have a list of them with you. Show this list to all of your doctors and pharmacists any time you get a new medicine. Both your doctor and your pharmacist can tell you if you can take these other medicines with INTELENCE^®.