Etravirine

Etravirine is used along with other medications to treat human immunodeficiency virus (HIV) infection. 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 life-style changes may decrease the risk of transmitting (spreading) the HIV virus to other people.

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 a glass of water, allow to stand for a few minutes, and then stir until a milky mixture occurs. Drink the etravirine-water mixture right away. Rinse the glass with water 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.

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

Before taking etravirine,

• tell your doctor and pharmacist if you are allergic to etravirine, or any other medications.
• 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); antiarrhythmics (medications to treat abnormal heart beats) including amiodarone (Cordarone), bepridil (Vascor), disopyramide (Norpace), flecainide (Tambocor), lidocaine (Xylocaine), mexiletine (Mexitil), propafenone (Rythmol), and quinidine (Quinidex); certain medications to treat seizures such as carbamazepine (Tegretol, Carbatrol), 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 (Decadron, Dexone, others); certain medications that suppress the immune system such as cyclosporine (Sandimmune, Neoral), 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 (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); 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 breast-feed 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.

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

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.

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).

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.

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.

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

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.

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