Etravirine is an antiviral medicine that is used with other medicines to treat human immunodeficiency virus (HIV). HIV causes the acquired immunodeficiency syndrome (AIDS). Etravirine is not a cure for HIV or AIDS.

Etravirine is for use in adults and children who are at least 2 years old.

Etravirine may also be used for purposes not listed in this medication guide.

Etravirine must be taken in combination with other HIV medications. However, some drugs can raise or lower your blood levels of etravirine. Etravirine can also affect blood levels of certain other drugs. This can make your medicines less effective or increase side effects. TELL YOUR DOCTOR ABOUT ALL OTHER MEDICINES YOU USE.

Etravirine must be given in combination with other antiviral medications and it should not be used alone.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Etravirine works best if you take it after a meal. Do not take it on an empty stomach.

Etravirine doses are based on weight in children. Your child's dose needs may change if the child gains or loses weight.

Do not crush, chew, or break an etravirine tablet. Swallow it whole with liquid such as water.

If you cannot swallow a tablet whole, place it into a glass with a teaspoon of water. Stir until the water looks milky. Add a tablespoon more water (or a tablespoon of orange juice, milk, or sports drink). Drink this mixture right away. Add more liquid to the glass, swirl gently and drink right away. Keep adding and drinking liquid until the entire dose is rinsed from the glass.

You will need frequent medical tests.

Store the tablets in their original container at room temperature, away from moisture and heat.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with HIV should remain under the care of a doctor.

Usual Adult Dose for HIV Infection:

200 mg orally twice a day after a meal

Comments:
-The same dosage is recommended for adult and pregnant patients.

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection in antiretroviral therapy-experienced patients

Usual Pediatric Dose for HIV Infection:

2 to less than 18 years:
-Weight 10 to less than 20 kg: 100 mg orally twice a day after a meal
-Weight 20 to less than 25 kg: 125 mg orally twice a day after a meal
-Weight 25 to less than 30 kg: 150 mg orally twice a day after a meal
-Weight at least 30 kg: 200 mg orally twice a day after a meal

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection in antiretroviral therapy-experienced patients

You should not take etravirine if you are allergic to it.

Tell your doctor if you have ever had liver disease, including hepatitis B or C.

Etravirine must be taken in combination with other HIV medications. However, there are certain combinations of medicines that should not be used together with etravirine. Tell your doctor about all your current medicines and any medicine you start or stop using.

Tell your doctor if you are pregnant. Your dose needs may be different during pregnancy. Use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy.

Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Take the medicine after your next meal, but skip the missed dose if you are more than 6 hours late for the dose. Do not use two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Keep the three desiccant (drying agent) pouches in the bottle of medication to keep the tablets dry. Do not eat the desiccant pouches.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.

Using etravirine will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Etravirine may cause serious side effects. Call your doctor at once if you have:

• unexplained muscle pain, tenderness, or weakness;

• fever, unusual tiredness;

• dark colored urine; or

• any type of skin rash, no matter how mild.

Etravirine affects your immune system, which may cause certain side effects (even weeks or months after you've taken etravirine). Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects of etravirine may include:

• diarrhea;

• numbness or tingly feeling in your hands or feet;

• rash; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can affect etravirine, especially:

• other drugs to treat HIV;

• an antibiotic or antifungal medicine;

• a blood thinner;

• heart rhythm medicine;

• medicine for erectile dysfunction or pulmonary arterial hypertension;

• medicine to prevent organ transplant rejection;

• medicine to treat hepatitis C;

• medicine to treat opioid addiction;

• medicine to treat or prevent malaria;

• seizure medication;

• "statin" cholesterol medication; or

• St. John's wort.

This list is not complete and many other drugs may affect etravirine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to etravirine.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking etravirine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a list of your medications and show it to your doctor and pharmacist when you get a new medication.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.