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Etravirine

Generic Name: etravirine (E-tra-VIR-een)
Brand Name: Intelence

Etravirine is used for:

Treating HIV infection in certain patients. It is used in combination with other medicines.

Etravirine is a nonnucleoside reverse transcriptase inhibitor (NNRTI). It works by blocking the growth of HIV.

Do NOT use etravirine if:

  • you are allergic to any ingredient in etravirine
  • you are taking another NNRTI (eg, delavirdine, efavirenz)
  • you are taking certain protease inhibitors (eg, indinavir) without ritonavir
  • you are taking certain doses of ritonavir, or certain protease inhibitor and ritonavir combinations (eg, tipranavir/ritonavir, atazanavir/ritonavir)
  • you are taking carbamazepine, a hydantoin (eg, phenytoin), phenobarbital, primidone, a rifamycin (eg, rifampin, rifapentine), or St. John's wort

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using etravirine:

Some medical conditions may interact with etravirine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of liver problems (eg, hepatitis), diabetes, or high blood cholesterol or triglyceride levels

Some MEDICINES MAY INTERACT with etravirine. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many prescription and nonprescription medicines (eg, used for anxiety, blood vessel problems, cancer, erectile problems, irregular heartbeat or other heart problems, bacterial infections, fungal infections, immune suppression, inflammation, aches and pains, high cholesterol, HIV, malaria, narcotic or other substance dependence and withdrawal, seizures, sleep, thinning the blood), multivitamin products, and herbal or dietary supplements (eg, St. John's wort) because they may interact with etravirine. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with etravirine

This may not be a complete list of all interactions that may occur. Ask your health care provider if etravirine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use etravirine:

Use etravirine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with etravirine. Talk to your pharmacist if you have questions about this information.
  • Take etravirine by mouth following a meal.
  • Swallow etravirine whole with a liquid such as water. Do not chew before swallowing.
  • If you cannot swallow the tablet(s) whole, you may mix the tablet(s) in a glass of water. Measure 1 teaspoon (5 mL) of water and pour into a glass. Place the tablet(s) in the glass containing the water. If needed, add more water to cover the tablet(s). Do NOT place the tablet(s) in other liquids. Stir well until the water looks milky. At this point, you may add more water, orange juice, or milk to the mixture to make it easier to take. Do not add grapefruit juice, or warm (above 104°F [40°C]) or carbonated beverages to the mixture. Drink all of the liquid right away. Rinse the glass with water, orange juice, or milk several times and completely swallow the rinse each time to ensure the entire dose is taken. Do not store the mixture for future use.
  • Taking etravirine at the same time each day will help you remember to take it.
  • Continue to use etravirine even if you feel well. Do not miss any doses.
  • If you miss a dose of etravirine by less than 6 hours, take the missed dose as soon as possible following a meal, then go back to your regular dosing schedule. If you miss your dose by more than 6 hours, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use etravirine.

Important safety information:

  • Etravirine may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use etravirine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not change your dose or stop taking etravirine without talking to your doctor first.
  • Etravirine is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking etravirine, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
  • Keep a list of all the medicines that you take. Make a new list each time medicines are added or stopped. Find out about medicines that should not be taken while you are using etravirine. Be sure that each of your health care providers knows all the medicines that you are taking.
  • Etravirine does not stop the spread of HIV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HIV to others.
  • Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking etravirine. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
  • Etravirine may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start etravirine.
  • Etravirine may cause serious, potentially life-threatening, and fatal skin reactions. The risk may be greater in women. Symptoms may include red, swollen, blistered, or peeling skin; severe rash or rash with fever, mouth sores, red and irritated eyes, or swelling of the face; muscle or joint pain; unusual tiredness; or unusual hoarseness. These reactions can sometimes be associated with organ failure (eg, liver failure). Contact your doctor at once if you develop a rash or any of these symptoms.
  • Some strengths of etravirine contain lactose. If you are lactose intolerant, ask your doctor or pharmacist if your strength contains lactose.
  • Lab tests, including liver function, CD4 count, complete blood cell counts, and blood cholesterol and triglyceride levels, may be performed while you use etravirine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Caution is advised when using etravirine in CHILDREN; they may be more sensitive to its effects, especially rash.
  • Etravirine should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using etravirine while you are pregnant. It is not known if etravirine is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing HIV infection or etravirine to the baby.

Possible side effects of etravirine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; mild burning, numbness, or tingling of the arms, hands, legs, or feet; mild nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the eyes, mouth, face, lips, throat, or tongue; unusual hoarseness); bloody vomit or vomit that looks like coffee grounds; blurred vision or other vision changes; change in amount of urine produced; chest, jaw, or arm pain; fainting; fever or general feeling of being unwell; irregular heartbeat; joint pain; mood or mental changes (eg, anxiety, confusion, memory loss); muscle pain, tenderness, or weakness; reddened, blistered, swollen, or peeling skin; seizures; severe or persistent burning, numbness, pain, or tingling of the arms, legs, hands, or feet; severe or persistent dizziness, drowsiness, or headache; severe rash or rash with fever, mouth sores, or red and irritated eyes; severe stomach or back pain (with or without nausea or vomiting); shortness of breath; symptoms of high blood sugar (eg, increased hunger, thirst, or urination; confusion; flushing; rapid breathing; fruit-like breath odor); symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe stomach pain, yellowing of the skin or eyes); tremors; unusual bruising or bleeding; unusual sweating; unusual tiredness or weakness; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of etravirine:

Store etravirine between 59 and 86 degrees F (15 and 30 degrees C). Store in original bottle, away from heat, moisture, and light. Do not remove the desiccant pouches from the bottle. Do not store in the bathroom. Keep etravirine out of the reach of children and away from pets.

General information:

  • If you have any questions about etravirine, please talk with your doctor, pharmacist, or other health care provider.
  • Etravirine is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take etravirine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about etravirine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to etravirine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using etravirine.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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