INTELENCE®: An important option

INTELENCE® is a prescription medicine that is used to treat human immunodeficiency virus-1 (HIV-1) infection in combination with other HIV-1 medicines, in adults and children 2 years of age and older who have taken HIV-1 medicines in the past. HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). INTELENCE® is not recommended for use in children less than 2 years of age.

How to take INTELENCE®

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Patient Information

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INTELENCE® (etravirine) Dosing Information

How should I take INTELENCE®?

  • Stay under the care of your healthcare provider during treatment with INTELENCE®.
  • Take INTELENCE® tablets every day exactly as prescribed by your healthcare provider.
  • Your healthcare provider will tell you how many INTELENCE® tablets to take and when to take them. Talk to your healthcare provider if you have questions about when to take INTELENCE®.
  • Take INTELENCE® 2 times each day.
  • If your child takes INTELENCE®, your healthcare provider will prescribe the right dose based on your child’s weight.
  • Always take INTELENCE® following a meal. Do not take INTELENCE® on an empty stomach. INTELENCE® may not work as well if you take it on an empty stomach.
  • Do not change your dose or stop taking INTELENCE® without first talking with your healthcare provider.
  • Swallow INTELENCE® tablets whole, with liquid, such as water. Do not chew the tablet(s).
  • It is important that you do not miss or skip doses of INTELENCE® during treatment.
  • When your supply of INTELENCE® starts to run low, get more from your healthcare provider or pharmacy. It is important not to run out of INTELENCE®. The amount of HIV in your blood may increase if the medicine is stopped even for a short time.
  • If you take too much INTELENCE®, call your healthcare provider or go to the nearest emergency room right away.

Recommended Dosage in Adult Patients
The recommended oral dosage of INTELENCE® for adult patients is 200 mg (one 200 mg tablet or two 100 mg tablets) taken twice daily following a meal. The type of food does not affect the exposure to INTELENCE®.

Recommended Dosage During Pregnancy
The recommended oral dosage of INTELENCE® for pregnant individuals is 200 mg (one 200 mg tablet or two 100 mg tablets) taken twice daily following a meal.

Recommended Dosage in Pediatric Patients (2 Years to Less Than 18 Years of Age)
The recommended dosage of INTELENCE® for pediatric patients 2 years to less than 18 years of age and weighing at least 10 kg is based on body weight (see Table 1 in the Prescribing Information) not exceeding the recommended adult dosage. INTELENCE® should be taken orally, following a meal. The type of food does not affect the exposure to INTELENCE®.

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For patients unable to swallow the INTELENCE® tablets whole:

INTELENCE® can be taken another way–in water

If you are unable to swallow INTELENCE® tablets whole, you may take your dose of INTELENCE® as follows:


Step
1

Measure approximately 5 mL (1 teaspoon) of water and pour into a cup.


Step
2

Place the tablets in the cup containing 5 mL of water. If needed, add more water to cover the tablets. Do not put the tablets in other liquids.


Step
3

Stir well until the water looks milky.


Step
4

Add a small amount (approximately 15 mL or 1 tablespoon) of liquid. Water may be used, but adding orange juice or milk rather than water may make it easier to take. Do not use warm (temperature more than 104°F or 40°C) or carbonated beverages.


Step
5

Drink the mixture right away.


Step
6

Add more orange juice, milk, or water to the cup to rinse the cup several times and completely swallow each time to make sure you take your entire dose of INTELENCE®.


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

About INTELENCE® (etravirine)
  • INTELENCE® is a prescription medicine that is used in combination with other antiretroviral medicines to treat human immunodeficiency virus-1 (HIV-1) infection in adults and children 2 years of age and older, who have taken HIV-1 medicines in the past. HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
  • INTELENCE® is not recommended for use in children less than 2 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 provider 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 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

+
About INTELENCE® (etravirine)
  • INTELENCE® is a prescription medicine that is used in combination with other antiretroviral medicines to treat human immunodeficiency virus-1 (HIV-1) infection in adults and children 2 years of age and older, who have taken HIV-1 medicines in the past. HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
  • INTELENCE® is not recommended for use in children less than 2 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 provider if INTELENCE® is right for you.