Brand Intelence

Etravirine is used with other medications to help control your HIV infection, thereby improving your quality of life. It also lowers your risk of getting complications from HIV (e.g., new infections, cancer). This medication is usually prescribed to people who have taken other HIV medications (e.g., efavirenz, nevirapine, delavirdine) that did not work well enough to control their HIV. Etravirine is known as a non-nucleoside reverse transcriptase inhibitor (NNRTI). It blocks the virus from growing and infecting more cells. Etravirine is not a cure for HIV, and it does not prevent the spread of HIV to others through sexual contact or blood contamination (e.g., sharing used needles).

Read the Patient Information Leaflet provided by your pharmacist before you start using etravirine and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth after meals, usually 2 times daily or as directed by your doctor. Swallow the medication whole. Do not crush, chew, or break the tablets. If you have difficulty swallowing this medication whole, you may place the medication in a glass of water. Stir the mixture well until it looks milky, then drink all of the mixture immediately. To make sure you have taken the whole dose, add more water to the glass to rinse it several times, and drink all the rinse water. It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased. Do not take less of this drug than prescribed or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Doing so may cause the amount of virus to increase and/or make the infection more difficult to treat (resistant). This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same times each day.

Before taking etravirine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease (e.g., hepatitis B, hepatitis C). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is not known if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

If you miss a dose and it is within 6 hours of the time you usually take the dose, take it after a meal as soon as you remember. If it is more than 6 hours from the time you usually take the dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. This drug should not be used with the following medications because very serious interactions may occur: certain anti-seizure medicines (carbamazepine, phenobarbital, phenytoin), other HIV NNRTIs (e.g., efavirenz, nevirapine, delavirdine), certain HIV protease inhibitors (atazanavir, amprenavir, fosamprenavir, tipranavir/ritonavir), rifampin, rifapentine, St John's wort. If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting etravirine. Make sure your doctor is aware of all the HIV drugs you are taking. This medication may interact with other HIV medications. Your doctor may need to change your treatment or monitor you more closely if you are taking a certain combination of HIV medications. Consult your doctor or pharmacist for more details. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs affecting liver enzymes that remove etravirine from your body (such as rifabutin, azole antifungals including itraconazole, macrolide antibiotics including erythromycin/clarithromycin). This drug can speed up or slow down the removal of other drugs from your body by affecting certain liver enzymes. These affected drugs include clopidogrel, medications for heart rhythm (e.g., amiodarone, disopyramide, quinidine), "blood thinners" (e.g., warfarin), certain "statin" cholesterol medications (atorvastatin, fluvastatin, lovastatin, simvastatin), organ transplant drugs (e.g., cyclosporine, sirolimus, tacrolimus), drugs for male sexual ability problems (e.g., sildenafil, vardenafil, tadalafil), among others. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Nausea may occur. If this effect persists or worsens, tell your doctor or pharmacist promptly. Etravirine can commonly cause a mild rash that is usually not serious. The rash usually occurs during the second week of treatment and goes away in 1 to 2 weeks. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, seek immediate medical attention if you develop any rash. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Some people may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/persistent headaches, signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech). Tell your doctor immediately if any of these unlikely but serious side effects occur: increased thirst/urination, change in the amount of urine, mental/mood changes (e.g., nervousness, confusion), seizures. Seek immediate medical attention if any of these rare but very serious side effects occur: chest/jaw/left arm pain, persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing eyes/skin. Changes in body fat may occur while you are taking this medication (e.g., increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible role of exercise to reduce this side effect. A very serious allergic reaction to this drug is rare. However, stop taking this medication and seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, muscle/joint pain, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Store this drug in its original bottle, and keep the bottle tightly closed. Each bottle should contain small pouches of a substance (desiccant) that help keep moisture in the air from damaging the drug. Do not remove desiccant pouches from bottle. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.