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What is etravirine?

Etravirine is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Etravirine is used with other medications to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Etravirine is not a cure for HIV or AIDS.

Etravirine is usually given after other antiviral drugs have been tried without successful treatment of HIV.

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

Precautions

Instructions

Side Effects

Interactions

Precautions

Do not use this medication if you are allergic to etravirine.

You should not take etravirine together with:

• delavirdine (Rescriptor);
• efavirenz (Sustiva); or
• nevirapine (Viramune).

You should not take etravirine with ritonavir if you are also taking:

• atazanavir (Reyataz).
• tipranavir (Aptivus);
• fosamprenavir (Lexiva); or
• lopinavir (Kaletra).

You should not take etravirine without ritonavir if you are also taking:

• atazanavir (Reyataz);
• fosamprenavir (Agenerase);
• indinavir (Crixivan); or
• nelfinavir (Viracept).

Before taking etravirine, tell your doctor if you are allergic to any drugs, or if you have never taken an antiviral medication before.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. HIV can be passed to the baby if the mother is not properly treated during pregnancy. If you are pregnant, take all of your HIV medicines as directed to control your infection.

Your name may need to be listed on an antiviral pregnancy registry when you start using etravirine. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether etravirine had any effect on the baby.

You should not breast-feed while you are using etravirine. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.

Taking etravirine will not prevent you from passing HIV to other people through unprotected sex or sharing of needles. Talk with your doctor about safe methods of preventing HIV transmission during sex, such as using a condom and spermicide. Sharing drug or medicine needles is never safe, even for a healthy person.

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Instructions

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of an etravirine overdose are not known.

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
• chest pain;
• confusion, anxiety, nightmares, seizure (convulsions);
• loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• urinating less than usual;
• fever, chills, body aches, flu symptoms; or
• any other signs of new infection.

Less serious side effects may include:

• mild nausea, vomiting, stomach pain, constipation;
• dry mouth, heartburn;
• mild skin rash;
• headache, dizziness, tired feeling;
• numbness or tingly feeling in your hands or feet;
• sleep problems (insomnia), unusual dreams;
• blurred vision;
• increased sweating; 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.

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Interactions

There are many other medicines that can interact with etravirine, or make it less effective. Below is just a partial list. Tell your doctor if you are using any of the following drugs:

• a blood thinner such as warfarin (Coumadin);
• dexamethasone (Cortastat, Decadron, Dexasone, Hexadrol, Solurex, and others);
• diazepam (Valium);
• cyclosporine (Gengraf, Neoral, Sandimmune);
• a cholesterol medication such as fluvastatin (Lescol), lovastatin (Altocor, Advicor, Mevacor), atorvastatin (Lipitor) or simvastatin (Zocor);
• sirolimus (Rapamune), tacrolimus (Prograf);
• St. John's wort;
• seizure medications such as phenytoin (Dilantin), phenobarbital (Solfoton), or carbamazepine (Tegretol);
• sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra);
• an antibiotic such as clarithromycin (Biaxin), rifabutin (Mycobutin), or rifampin (Rifadin, Rifater, Rifamate, Rimactane);
• an antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), posaconazole (Noxafil), or voriconazole (Vfend); or
• a heart rhythm medication such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), flecainide (Tambocor), mexiletine (Mexitil), propafenone (Rythmol), or quinidine (Quinidex, Quin-Release Quin-G).

This list is not complete and there may be other drugs that can interact with etravirine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

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