Etravirine (By mouth)

When This Medicine Should Not Be Used

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• Etravirine is used with other medicines to treat HIV infection. Make sure you take all of your medicines as your doctor has prescribed. Do not change your dose or stop taking this medicine unless your doctor tells you to.
• This medicine works best if there is a constant amount in the blood. Take this medicine at the same time each day and do not miss any doses. Contact your doctor or pharmacist when your supply of this medicine is running low. Do not let this medicine run out.
• It is best to take this medicine with food or milk.
• Swallow the tablet whole with a liquid such as water. Do not chew it.
• If you cannot swallow the tablet whole, you may dissolve it in a glass with a small amount of water. Be sure to drink or swallow the entire mixture right away. Then add more water to your glass and drink it so that none of the medicine is left in the glass.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• If you miss a dose or forget to take your medicine and it is less than 6 hours from the time your regular dose was scheduled, take the tablet as soon as you can. If you miss a dose and it is more than 6 hours from the time your regular dose was scheduled, skip the missed dose and take your next dose at the regular time. Do not use extra medicine to make up for a missed dose. Call your doctor if you have questions about this.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you use other medicines to treat HIV or AIDS (such as atazanavir, darunavir, delavirdine, efavirenz, fosamprenavir, indinavir, lopinavir, nelfinavir, nevirapine, ritonavir, saquinavir, tipranavir, Aptivus®, Crixivan®, Fortovase®, Invirase®, Kaletra®, Lexiva®, Norvir®, Prezista®, Rescriptor®, Reyataz®, Stocrin®, Sustiva®, Telzir®, Viracept®, or Viramune®), medicine to prevent blood clots (such as clopidogrel, Plavix®), or St John's wort.
• Tell your doctor if you use medicine for a heart rhythm problem (such as amiodarone, bepridil, digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone, quinidine, Cordarone®, Lanoxin®, Mexitil®, Norpace®, Quinidex®, Rythmol SR®, Tambocor?, Vascor®, or Xylocaine®), a blood thinner (such as warfarin, Coumadin®), medicine to treat seizures (such as carbamazepine, diazepam, phenobarbital, phenytoin, Carbatrol®, Dilantin®, Luminal®, Phenytek®, Tegretol®, or Valium®), medicine to treat a fungal infection (such as fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole, Diflucan®, Nizoral®, Noxafil®, Sporanox®, or Vfend®), or medicine to treat an infection (such as clarithromycin, rifabutin, rifampin, rifapentine, Biaxin®, Mycobutin®, Priftin®, Rifadin®, Rifamate®, or Rifater®).
• Make sure your doctor knows if you use a steroid medicine (such as dexamethasone, Decadron®), medicine to lower cholesterol (such as atorvastatin, fluvastatin, lovastatin, simvastatin, Advicor®, Altoprev®, Lescol®, Lipitor®, Mevacor®, Vytorin®, or Zocor®), medicine that weakens the immune system (such as cyclosporine, sirolimus, tacrolimus, Neoral®, Prograf®, Rapamune®, or Sandimmune®), a pain medicine (such as buprenorphine, buprenorphine/naloxone, methadone, Buprenex®, Dolophine®, or Suboxone®), or medicine to treat impotence (such as sildenafil, tadalafil, vardenafil, Cialis®, Levitra®, or Viagra®).

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or if you have liver disease (including hepatitis B or C).
• You should not breast feed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk.
• This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand and practice safe sex, even if your partner also has HIV. Do not share needles with anyone.
• Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia, herpes, or tuberculosis.
• Serious skin reactions can occur with this medicine. Check with your doctor right away if you have more than one of the following symptoms: blistering, peeling, or loosening of the skin; fever; chills; itching; joint or muscle pain; rash; sores, ulcers, or red skin lesions; sore throat; or swelling of your hands, face, tongue, or throat.
• This medicine may cause changes to your body fat. Tell your doctor if you notice changes in your body shape, such as more fat in your upper back and neck or around your chest and stomach area. You may also lose of fat from your legs, arms, and face.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for side effects.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Dark-colored urine or pale stools
• Fever, chills, cough, sore throat, and body aches
• Nausea, vomiting, loss or appetite or pain in your upper stomach
• Swelling of your face, hands, or feet
• Trouble breathing
• Unusual tiredness or weakness
• Yellowing of your skin or the whites of your eyes

If you notice these less serious side effects, talk with your doctor:

• Mild skin rash
• Weight gain around your neck, upper back, breast, face, or waist

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Introduction

Etravirine (e-tra-VIR-een)

Treats human immunodeficiency virus (HIV) infection. HIV causes acquired immune deficiency syndrome (AIDS). Etravirine does not cure HIV or AIDS, but it may slow the progress of the disease.

Brand Name(s)

Intelence