An Overview of Intelence (TMC125, Etravirine)

Brand Name: Intelence
Other Name(s): ETR
Drug Class: Non-nucleoside Reverse Transcriptase Inhibitors
Approved Use: Treatment of HIV Infection

What is etravirine?

Etravirine is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults and children 6 years of age and older.

Etravirine is a type of anti-HIV medicine called a non-nucleoside reverse transcriptase inhibitor (NNRTI). NNRTIs work by binding to and blocking HIV reverse transcriptase, an HIV enzyme. This prevents HIV from replicating and lowers the amount of HIV in the blood.

Etravirine is always used in combination with other anti-HIV medicines. Etravirine is used only in people who are already taking or have taken an NNRTI plus other anti-HIV medicines and in whom these medicines are not controlling their HIV infection.

Etravirine does not cure HIV/AIDS. It is not known if etravirine reduces the risk of passing HIV to other people.

What should I tell my health care provider before taking etravirine?

Before taking etravirine, tell your health care provider:

• If you are allergic to etravirine or any other medicines.
• If you have had or currently have liver problems, including hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• If you have any other medical conditions.
• If you are pregnant or plan to become pregnant. Whether etravirine can harm an unborn baby is unknown.
• If you are breastfeeding. Do not breastfeed if you are infected with HIV or are taking etravirine.
• About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Etravirine may affect the way other medicines or products work, and other medicines or products may affect how etravirine works. Taking etravirine together with certain medicines or products may cause serious side effects.

How should I take etravirine?

Etravirine comes in tablet form in three different strengths:

• 25-mg tablets (brand name: Intelence).
• 100-mg tablets (brand name: Intelence).
• 200-mg tablets (brand name: Intelence).

Take etravirine according to your health care provider's instructions.

Always take etravirine after a meal. Do not take etravirine on an empty stomach. Swallow the tablets whole with a glass of water. Do not chew the tablets.

If you are unable to swallow the etravirine tablets whole, place the tablets in a glass containing a teaspoon of water. (If needed, add more water to cover the tablets.) Do not put the tablets in other liquids. Stir well until the water looks milky. At this step, you may add a small amount of water, orange juice, or milk to make the mixture easier to drink. Then drink the mixture right away. Rinse the glass with water, orange juice, or milk several times, and completely swallow the rinse each time to make sure you take the entire dose of etravirine. Avoid using grapefruit juice or warm (104°F/40°C) or carbonated beverages when taking etravirine tablets.

Always take etravirine in combination with other anti-HIV medicines.

If you take too much etravirine, contact your local poison control center (1-800-222-1222) or go to the nearest hospital emergency room right away.

For more information on how to take etravirine, see the FDA drug label from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.).

What should I do if I forget a dose?

If you miss a dose within 6 hours of the time you usually take it, take your dose after a meal as soon as possible. Then take your next dose at the regularly scheduled time. If you miss a dose by more than 6 hours of the time you usually take it, wait and then take the next dose at the regularly scheduled time.

What side effects can etravirine cause?

Etravirine can cause serious, life-threatening side effects. These include severe rash and allergic reactions. (See the WARNING above.)

Other possible side effects of etravirine include:

• Changes in the immune system (immune reconstitution inflammatory syndrome).
• Changes in body fat (lipodystrophy).
• Tingling, numbness, or pain in your hands or feet (peripheral neuropathy).

Tell your health care provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of etravirine. Ask your health care provider or pharmacist for more information on possible side effects of etravirine.

How should etravirine be stored?

• Store etravirine at 59°F to 86°F (15°C to 30°C).
• Keep etravirine in the bottle given to you by your pharmacist.
• To protect the etravirine tablets from moisture, keep the bottle tightly closed and keep the little pouches filled with a drying agent (dessicant) in the bottle. Do not remove the desiccant packets.
• Safely throw away etravirine that is no longer needed or expired (out of date).
• Keep etravirine and all medicines out of reach of children.

Where can I find more information about etravirine?

More information about etravirine is available:

• The etravirine drug label, from DailyMed. The Patient Counseling Information section of the label includes information for people taking etravirine.
• Etravirine-related research studies, from the AIDSinfo database of ClinicalTrials.gov study summaries.
• A list of FDA-approved generics for anti-HIV medicines, from FDA.

Manufacturer Information

Janssen Pharmaceuticals, Inc.
800-526-7736