Edurant

Generic Name: rilpivirine (RIL-pi-VIR-een)
Brand Name: Edurant

Edurant is used for:

Treating HIV infection in combination with other medicines. If Edurant is taken alone to treat HIV, it may stop working.

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

Do NOT use Edurant if:

  • you are allergic to any ingredient in Edurant
  • you have previously taken other medicine to treat your HIV infection
  • you are taking carbamazepine, dexamethasone, oxcarbazepine, phenobarbital, phenytoin, proton pump inhibitors (PPIs) (eg, omeprazole), rifampin, rifapentine, or St. John's wort
  • you are taking another NNRTI (eg, delavirdine, efavirenz)

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

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Edurant:

Some medical conditions may interact with Edurant. 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 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 kidney problems, a certain type of irregular heartbeat (QT prolongation), or liver problems (eg, hepatitis, abnormal liver function tests)
  • if you have a history of mental or mood problems (eg, depression), or suicidal thoughts or actions
  • if you are taking any medicine that may increase the risk of a certain type of irregular heartbeat (QT prolongation). Check with your doctor or pharmacist if you are uncertain if any of your medicines may increase this risk

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

  • Azole antifungals (eg, fluconazole, ketoconazole), HIV protease inhibitors (eg, darunavir, lopinavir, ritonavir), macrolide antibiotics (eg, clarithromycin, erythromycin) or telithromycin because they may increase the risk of Edurant's side effects
  • Carbamazepine, dexamethasone, an acid blocker (eg, famotidine, ranitidine), oxcarbazepine, phenobarbital, phenytoin, PPIs (eg, omeprazole), a rifamycin (eg, rifampin, rifabutin, rifapentine), or St. John's wort because they may decrease Edurant's effectiveness
  • Other NNRTIs (eg, delavirdine, efavirenz) because they may decrease Edurant's effectiveness or increase the risk of its side effects
  • Methadone because its effectiveness may be decreased by Edurant

This may not be a complete list of all interactions that may occur. Ask your health care provider if Edurant 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 Edurant:

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

  • An extra patient leaflet is available with Edurant. Talk to your pharmacist if you have questions about this information.
  • Take Edurant by mouth with a meal. Do not substitute a protein drink for a meal.
  • If you are also taking didanosine, take it on an empty stomach at least 2 hours before or 4 hours after you take Edurant.
  • If you are also taking an antacid (eg, that contains magnesium, aluminum, calcium), take it at least 2 hours before or 4 hours after you take Edurant.
  • If you are also taking an acid blocker (eg, ranitidine, famotidine, cimetidine, nizatidine), take it at least 12 hours before or 4 hours after you take Edurant.
  • Take Edurant at the same time every day.
  • Continue to use Edurant even if you feel well. Do not miss any doses.
  • If you miss a dose of Edurant and you remember within 12 hours of the time you usually take it, take it with a meal as soon as possible and then go back to your regular dosing schedule. If you miss your dose by more than 12 hours of the time you usually take it, 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 Edurant.

Important safety information:

  • Do NOT take more than the recommended dose, change your dose, or stop taking Edurant without checking with your doctor. Taking more than the recommended dose may not provide additional benefits and may increase the risk of side effects.
  • Edurant 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 Edurant.
  • Depression has been reported with the use of Edurant. Contact your doctor right away if you experience any mental or mood changes (eg, depressed mood, unusual negative thoughts, anxiety, restlessness). Contact your doctor right away if any signs of suicidal thoughts or actions occur.
  • 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 Edurant. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
  • Edurant is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
  • Edurant 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.
  • Edurant will not prevent you from getting sexually transmitted diseases (STDs). Always use a condom during sexual intercourse.
  • If your health changes, check with your doctor.
  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Edurant, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
  • Edurant should not be used in CHILDREN younger than 18 years old; safety and effectiveness in 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 Edurant while you are pregnant. It is not known if Edurant is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Edurant to the baby.

Possible side effects of Edurant:

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:

Headache; trouble sleeping.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); irregular heartbeat; mental or mood changes (eg, depression, unusual negative thoughts, anxiety, restlessness); severe or persistent stomach pain; suicidal thoughts or behaviors; symptoms of liver problems (eg, dark urine; pale stools; persistent loss of appetite; unusual nausea or vomiting; yellowing of the eyes or skin).

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 Edurant:

Store Edurant between 68 and 77 degrees F (20 and 25 degrees C). Store in the original bottle, away from heat, moisture, and light. Do not store in the bathroom. Keep Edurant out of the reach of children and away from pets.

General information:

  • If you have any questions about Edurant, please talk with your doctor, pharmacist, or other health care provider.
  • Edurant 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 Edurant 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 Edurant. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Edurant. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Edurant.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
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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