When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to etravirine.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Etravirine is used with other medicines to treat HIV infection. 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 your medicine run out.
• Take this medicine after a meal.
• Swallow the tablet whole with a glass of water. Do not chew it.
• If you cannot swallow the tablet, you may dissolve it in a glass with a small amount of water. You may then add more water, orange juice, or milk to make it easier to take. Do not use grapefruit juice or warm or carbonated drinks. Drink the entire mixture right away. Then refill your glass with water, orange juice, or milk and drink it so that none of the medicine is left in the glass.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose and your next dose is due in less than 6 hours, skip the missed dose and take your next dose when you normally do. If your next dose is more than 6 hours away, then take the missed dose as soon as you remember. Take your next dose when you normally do.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

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

• Some medicines can affect how etravirine works. Tell your doctor if you are using any of the following:
  
  • Artemether/lumefantrine, boceprevir, clopidogrel, diazepam, St John's wort
  • Blood thinner (such as warfarin)
  • Cholesterol medicine (atorvastatin, fluvastatin, lovastatin, pitavastatin, simvastatin)
  • Medicine for a heart rhythm problem (amiodarone, bepridil, digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone, quinidine)
  • Medicine that weakens the immune system (cyclosporine, sirolimus, tacrolimus)
  • Medicine to treat a fungal infection (fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole) or other infection (clarithromycin, rifabutin, rifampin, rifapentine)
  • Medicine to treat erectile dysfunction (sildenafil, tadalafil, vardenafil)
  • Other medicine to treat HIV or AIDS (such as atazanavir, atazanavir/ritonavir, darunavir/ritonavir, delavirdine, dolutegravir, efavirenz, fosamprenavir, fosamprenavir/ritonavir, indinavir, lopinavir/ritonavir, nelfinavir, nevirapine, rilpivirine, ritonavir, saquinavir/ritonavir, tipranavir/ritonavir)
  • Pain medicine (buprenorphine, buprenorphine/naloxone, methadone)
  • Seizure medicine (carbamazepine, phenobarbital, phenytoin)
  • Steroid medicine (dexamethasone, hydrocortisone, methylprednisolone, prednisone, prednisolone)

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or if you have liver disease (including hepatitis B or C).
• This medicine will not keep you from giving HIV to others. Always practice safe sex, even if your partner also has HIV. Do not share needles or other items that may have blood or body fluids on them.
• Do not breastfeed. You can spread HIV or AIDS to your baby through your breast milk.
• This medicine may cause serious skin reactions.
• Your immune system may get stronger when you start taking this medicine. This could cause a hidden infection in your body to become active. Tell your doctor right away if you notice any changes in your health.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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 urine or pale stools, nausea, vomiting, loss or appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, sore throat, and body aches
• Swelling of your face, hands, or feet
• Unusual tiredness or weakness

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

• Weight gain around your neck, upper back, breast, 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