Etravirine

Etravirine is a prescription medication used in combination with other medications to treat human immunodeficiency virus (HIV) in people who are at least 6 years of age. Etravirine is used when other medications have not been successful. Etravirine is a type of HIV medicine called a non-nucleoside reverse transcriptase inhibitor (NNRTI). It works by stopping HIV from dividing and spreading.

This medication comes in tablet form and is usually taken twice daily, after meals. Etravirine must be swallowed whole with a glass of water.

Common side effects include tingling, numbness, or pain in the hands or feet, and diarrhea.

Etravirine is a prescription medication used in combination with other medications to treat human immunodeficiency virus (HIV) in people who are at least 6 years of age. Etravirine is given when other medications have not been successful.

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

Etravirine may be found in some form under the following brand names:

• Intelence

Etravirine can cause serious side effects. See "Drug Precautions" section.

In adults, common side effects of etravirine include tingling, numbness, or pain in the hands or feet.

In children, diarrhea is a common side effect of etravirine.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects with etravirine. For more information, ask your doctor or pharmacist.

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

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements, including St. John's wort (Hypericum perforatum). Some medicines may interact with etravirine.

Etravirine may affect the way other medicines work, and other medicines may affect how etravirine works. Taking etravirine and certain other medicines may cause serious side effects. If you take certain medicines with etravirine, then the amount of etravirine in your body may be too low and etravirine may not work to help reduce your HIV viral load. The HIV virus in your body may become resistant to etravirine or other HIV medicines that are like it.

Tell your doctor if you take other HIV medicines. Some HIV medicines should not be taken with etravirine.

Tell your doctor if you take:

• an antiarrhythmic to treat abnormal heart rhythms-amiodarone (Cordarone, Pacerone), bepridil (Vascor), digoxin (Lanoxin), disopyramide (Norpace), flecainide (Tambocor), lidocaine (LidoPen, Xylocaine), mexiletine (Mexitil), propafenone (Rythmol SR), quinidine (Duraquin, Quinaglute)
• an anticoagulant to prevent blood clots-warfarin (Coumadin)
• an anti-seizure medicine to treat epilepsy or prevent seizures-carbamazepine (Tegretol, Tegretol-XR, Carbatrol, Equetro, Teril, Epitol), phenobarbital (Luminal, Solfoton), phenytoin (Dilantin, Dilantin-125, Phenytek)
• an antifungal to treat a fungal infection-fluconazole (Diflucan), itraconazole (Onmel, Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), voriconazole (Vfend)
• an anti-infective to treat a bacterial infection-clarithromycin (Biaxin, Biaxin XL)
• an antimycobacterial to treat a bacterial infection, including tuberculosis (TB)-rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate, Rimactane), rifapentine (Priftin)
• a benzodiazepine to treat trouble with sleeping and/or anxiety-diazepam (Diastat, Valium)
• a corticosteroid to treat inflammation or asthma-dexamethasone (Decadron)
• an HMG-CoA reductase inhibitor to lower cholesterol levels-atorvastatin (Caduet, Lipitor), fluvastatin (Lescol), lovastatin (Advicor, Altoprev, Mevacor), pitavastatin (Livalo), rosuvastatin (Crestor), simvastatin (Juvisync, Simcor, Vytorin, Zocor)
• an immunosuppressant to prevent organ transplant rejection-cyclosporine (Gengraf, Sandimmune, Neoral), sirolimus (Rapamune), tacrolimus (Prograf)
• a medicine to treat narcotic withdrawal and dependence-buprenorphine (Buprenex, Butrans, Subutex), buprenorphine/naloxone (Suboxone), methadone (Dolophine, Methadose)
• a PDE-5 inhibitor to treat erectile dysfunction and/or pulmonary arterial hypertension-sildenafil (Revatio, Viagra), tadalafil (Adcirca, Cialis), vardenafil (Levitra, Staxyn)
• a platelet aggregation inhibitor to prevent blood clots-clopidogrel (Plavix)
• dolutegravir (Tivicay)
• atazanavir/ritonavir
• boceprevir (Victrelis)

Dolutegravir should only be used with etravirine when co‑administered with atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir.

Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

Your doctor and your pharmacist can tell you if you can take these medicines with etravirine. Do not start any new medicines while you are taking etravirine without first talking with your doctor or pharmacist. You can ask your doctor or pharmacist for a list of medicines that can interact with etravirine.

Etravirine can cause serious side effects including:

• Severe skin rash and allergic reactions. Skin rash is a common side effect of etravirine. Rash can be serious. Call your doctor right away if you get a rash. In some cases, severe rash and allergic reaction may need to be treated in a hospital and may potentially lead to death.
  If you get a rash with any of the following symptoms, stop taking etravirine and call your doctor or get medical help right away:
  • hives or sores in your mouth, or your skin blisters and peels
  • trouble swallowing or breathing
  • swelling of your face, eyes, lips, tongue, or throat
  • fever, yellowing of the skin or whites of the eyes, dark urine, or pain on the right side of the stomach-area (abdominal pain).
• Changes in body fat can happen in people taking HIV medicines. These changes may include an increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the middle of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these problems are not known.
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Call your doctor right away if you start having any new symptoms after starting your HIV medicine.

Avoid doing things that can spread HIV-1 infection to others:

• Do not share or re-use needles or other injection equipment.
• Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
• Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.

Ask your doctor if you have any questions on how to prevent passing HIV to other people.

Avoid using grapefruit juice or warm (more than 104°F or 40°C) or carbonated beverages when taking this medication.

Before taking etravirine tell your doctor if you:

• have had or currently have liver problems, including hepatitis B or C.
• have any other medical conditions.
• are pregnant or breastfeeding.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Etravirine falls into category B. There are no well-done studies that have been done in humans with etravirine. But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed. Do not breastfeed if you take etravirine. You should not breastfeed if you have HIV because of the risk of passing HIV to your baby. Talk with your doctor about the best way to feed your baby.

• Stay under the care of your doctor during treatment with etravirine.
• Take etravirine tablets every day exactly as prescribed by your doctor.
• Your doctor will tell you how many etravirine tablets to take and when to take them. Talk to your doctor if you have questions about when to take etravirine.
• etravirine is taken two times each day. If your child takes etravirine, your doctor will prescribe the right dose based on your child's weight.
• Always take etravirine following a meal. Do not take etravirine on an empty stomach. etravirine may not work as well if you take it on an empty stomach.
• Do not change your dose or stop taking etravirine without first talking with your doctor. See your doctor regularly while taking etravirine.
• Swallow etravirine whole, with a glass of water. Do not chew the tablet(s).
  • If you are unable to swallow etravirine tablets whole, you may take your dose of etravirine as follows:

     

    Step 1: Measure approximately 5 mL (1 teaspoon) of water and pour into a cup.

     

    Step 2: Place the tablets in the cup containing 5 mL of water. If needed, add more water to cover the tablets. Do not put the tablets in other liquids.

     

    Step 3: Stir well until the water looks milky.

     

    Step 4: At this step, you may add a small amount of water, orange juice or milk to make it easier to take.

     

    Step 5: Drink right away.

     

    Step 6: Add more water, orange juice or milk to the cup to rinse the cup several times and completely swallow each time to make sure you take your entire dose of etravirine.

• Avoid using grapefruit juice or warm (more than 104°F or 40°C) or carbonated beverages when taking etravirine tablets.
• When your supply of etravirine starts to run low, get more from your doctor or pharmacy. It is important not to run out of etravirine. The amount of HIV in your blood may increase if the medicine is stopped even for a short time.
• If you miss a dose of etravirine within 6 hours of the time you usually take it, take your dose of etravirine following a meal as soon as possible. Then, take your next dose of etravirine at the regularly scheduled time. If you miss a dose of etravirine by more than 6 hours of the time you usually take it, wait and then take the next dose of etravirine at the regularly scheduled time.
• Do not take more than your prescribed dose to make up for a missed dose.

The recommended oral etravirine dose is 200 mg (one 200 mg tablet or two 100 mg tablets) taken twice daily following a meal.

The recommended dose for patients 6 years to less than 18 years of age and weighing at least 16 kg is based on body weight, not exceeding the recommended adult dose of 200 mg taken twice daily. The dose for children 6 years to less than 18 years of age ranges from 100 mg to 200 mg taken twice daily.

If you take too much etravirine, contact your local poison control center or go to the nearest emergency room right away.

• Store at 59°F to 86°F (15°C to 30°C).
• Keep etravirine in the original bottle given to you by your pharmacist. After opening, keep the bottle tightly closed to protect this medication from moisture.

Keep this and all medicines out of the reach of children.