Etravirine

WHY is this medicine prescribed?

Etravirine is used along with other medications to treat human immunodeficiency virus (HIV) infection in adults and children 2 years of age and older who no longer benefit from taking other HIV medications. Etravirine is in a class of medications called non-nucleoside reverse transcriptase inhibitors (NNRTIs). It works by decreasing the amount of HIV in the blood. Although etravirine does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other lifestyle changes may decrease the risk of transmitting (spreading) the HIV virus to other people.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Etravirine comes as a tablet to take by mouth. It is usually taken after a meal two times a day. Take etravirine at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take etravirine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole with liquid, such as water; do not split, chew, or crush them.

If you have trouble swallowing the tablets, they may be dissolved in water. To prepare, add the tablets to one teaspoon (5 mL) of water (only water, do not use any other type of liquid) or at least enough liquid to cover the medication, and stir until a milky mixture occurs. Then add one tablespoon (15 mL) of a liquid such as water or you can use a beverage such as orange juice or milk to improve the taste. Do not mix the tablets with a warm or hot liquid or a carbonated beverage such as a soda. Drink the mixture right away. Rinse the glass with water, orange juice, or milk and swallow the entire contents. Repeat process of rinsing and swallowing the rinse mixture several times to make sure that the entire dose is taken.

Etravirine helps to control HIV infection but does not cure it. Continue to take etravirine even if you feel well. Do not stop taking etravirine without talking to your doctor. If you stop taking etravirine or miss doses, your condition may become more difficult to treat. When your supply of etravirine starts to run low, get more from your doctor or pharmacist.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking etravirine,

• tell your doctor and pharmacist if you are allergic to etravirine, any other medications, or any of the ingredients in etravirine tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention the following: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); antiarrhythmics (medications to treat abnormal heartbeats) including amiodarone (Nexterone, Pacerone), bepridil (Vascor), disopyramide (Norpace), flecainide (Tambocor), lidocaine (Xylocaine), mexiletine (Mexitil), propafenone (Rythmol), and quinidine (Quinidex); certain medications to treat seizures such as carbamazepine (Carbatrol, Tegretol, Teril), phenobarbital (Luminal), and phenytoin (Dilantin, Phenytek); clarithromycin (Biaxin, in Prevpac); cholesterol-lowering medications (statins) including atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Advicor, Altoprev, Mevacor), rosuvastatin (Crestor), and simvastatin (Vytorin, Zocor); clopidogrel (Plavix); diazepam (Valium); dexamethasone; certain medications that suppress the immune system such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Prograf); medications to treat erectile dysfunction including sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra); medications to treat fungal infections including fluconazole (Diflucan), itraconazole (Onmel, Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend); methadone (Dolophine); other medications to treat HIV including amprenavir (Agenerase), atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva, in Atripla), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), and nevirapine (Viramune) ritonavir (Norvir, in Kaletra), and tipranavir (Aptivus); rifabutin (Mycobutin); rifampin (Rifadin, Rifater, Rifamate); and rifapentine (Priftin). Many other medications may also interact with etravirine, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Do not start taking any new medications while you are taking etravirine without first talking with your doctor or pharmacist.

• tell your doctor what herbal products you are taking, especially St. John's wort.

• tell your doctor if you have or have ever had liver disease, including hepatitis.

• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking etravirine, call your doctor.

• you should not breastfeed if you are infected with HIV or are taking etravirine.

• you should know that your body fat may increase or move to different areas of your body such as your breasts, neck, chest, stomach, and upper back. Loss of fat from your legs, arms, and face may also happen.

• you should know that while you are taking medications to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body. This may cause you to develop symptoms of those infections. If you have new or worsening symptoms after starting treatment with etravirine, be sure to tell your doctor.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

If you remember that you have missed taking a dose within 6 hours of the time you usually take etravirine, take the missed dose following a meal as soon as possible, and take the next dose at the regularly scheduled time. However, if you remember more than 6 hours after the time you usually take your dose, wait and take the next dose of etravirine according to your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Etravirine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• abdominal pain
• diarrhea
• headache
• increase in blood pressure
• pain, burning, numbness, or tingling in the hands or feet

Some side effects can be serious. If you experience any of these symptoms, stop taking etravirine and call your doctor immediately:

• rash
• redness, bumps, or blisters on the skin or in the mouth
• redness or swelling of the eyes
• swelling of the face
• sore throat, cough, fever, chills, or other signs of infection
• general ill feeling
• tiredness
• muscle or joint aches
• yellowing of the skin or eyes
• dark-colored urine
• pale-colored stools
• pain in the upper right part of the stomach
• loss of appetite

Etravirine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

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.