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EDURANT- rilpivirine hydrochloride tablet, film coated


  1. Patient Information
  2. Edurant Is A Prescription Medicine That Is Used With Other Antiretroviral Medicines To Treat Human Immunodeficiency Virus (hiv-1) In People 12 Years Of Age And Older And Who Weigh At Least 77 Lbs (35 Kg) Who:
  3. Do Not Take Edurant If You Also Take:
  4. Before Taking Edurant, Tell Your Healthcare Provider About All Your Medical Conditions, Including If You:
  5. Are Pregnant Or Plan To Become Pregnant. It Is Not Known If Edurant Will Harm Your Unborn Baby. Tell Your Healthcare Provider If You Become Pregnant During Treatment With Edurant.pregnancy Registry:
  6. How Should I Take Edurant?
  7. Edurant Can Cause Serious Side Effects Including:
  8. Depression Or Mood Changes. Tell Your Healthcare Provider Right Away If You Have Any Of The Following Symptoms:
  9. How Should I Store Edurant?
  10. Active Ingredient:
  11. Inactive Ingredients:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Severe Skin and Hypersensitivity Reactions

Advise patients to immediately contact their healthcare provider if they develop a rash. Instruct patients to immediately stop taking EDURANT and

Edurant Is A Prescription Medicine That Is Used With Other Antiretroviral Medicines To Treat Human Immunodeficiency Virus (hiv-1) In People 12 Years Of Age And Older And Who Weigh At Least 77 Lbs (35 Kg) Who: 

  • havenevertaken HIV medicines before,and
  • have an amount of HIV-1 in their blood (this is called 'viral load') that is no more than 100,000 copies/mL.
HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
It is not known if EDURANT is safe and effective in children less than 12 years of age or who weigh less than 77 lbs (35 kg).

Do Not Take Edurant If You Also Take: 

  • anti-seizure medicines:
    • carbamazepine
    • oxcarbazepine
    • phenobarbital
    • phenytoin
  • anti-tuberculosis (anti-TB) medicines:
    • rifampin
    • rifapentine
  • proton pump inhibitor (PPI) medicine for certain stomach or intestinal problems:
    • esomeprazole
    • lansoprazole
    • omeprazole
    • pantoprazole sodium
    • rabeprazole
  • more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate
  • St. John's wort (Hypericum perforatum)
What should I tell my healthcare provider before taking EDURANT?

Before Taking Edurant, Tell Your Healthcare Provider About All Your Medical Conditions, Including If You: 

  • have or had liver problems, including hepatitis B or C virus infection.
  • have kidney problems
  • have ever had a mental health problem.

Are Pregnant Or Plan To Become Pregnant. It Is Not Known If Edurant Will Harm Your Unborn Baby. Tell Your Healthcare Provider If You Become Pregnant During Treatment With Edurant.pregnancy Registry: 

There is a pregnancy registry for women who take EDURANT during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.
  • are breastfeeding or plan to breastfeed.Do not breastfeed if you take EDURANT.
    • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
    • It is not known if EDURANT passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby during EDURANT treatment.
  • Tell your healthcare provider about all the medicines you take, includingprescription and over-the-counter medicines, vitamins, and herbal supplements.Some medicines interact with EDURANT. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine. You can ask your healthcare provider or pharmacist for a list of medicines that interact with EDURANT.
    Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take EDURANT with other medicines.

    How Should I Take Edurant? 

    • Take EDURANT every day exactly as your healthcare provider tells you to.
    • Take EDURANT 1 time each day with a meal.A protein drink alone does not replace a meal.
    • Do not change your dose or stop taking EDURANT without first talking with your healthcare provider. Stay under the care of your healthcare provider during treatment with EDURANT.
    • Do not miss a dose of EDURANT.
    • If you take an H2-receptor antagonist (famotidine, cimetidine, nizatidine, or ranitidine), you should take these medicines at least 12 hours before or at least 4 hours after you take EDURANT.
    • If you take antacids, or other products that contain aluminum, calcium carbonate, or magnesium hydroxide, you should take these medicines at least 2 hours before or at least 4 hours after you take EDURANT.
    • If you miss a dose of EDURANT within 12 hours of the time you usually take it, take your dose of EDURANT with a meal as soon as possible. Then, take your next dose of EDURANT at the regularly scheduled time. If you miss a dose of EDURANT by more than 12 hours of the time you usually take it, wait and then take the next dose of EDURANT at the regularly scheduled time.
    • Do not take more than your prescribed dose to make up for a missed dose.
    • If you take too much EDURANT, call your healthcare provider or go to the nearest hospital emergency room right away.
    • When your supply of EDURANT starts to run low, get more from your healthcare provider or pharmacy. It is important not to run out of EDURANT. The amount of HIV in your blood may increase if the medicine is stopped even for a short time.

    Edurant Can Cause Serious Side Effects Including: 

    • Severe skin rash and allergic reactions.Skin rash is a common side effect of EDURANT. Skin rash can be serious. Call your healthcare provider right away if you get a rash. In some cases, rash and allergic reaction may need to be treated in a hospital.
      If you get a rash with any of the following symptoms,stop taking EDURANT and get medical help right away:
      • fever
      • skin blisters
      • mouth sores
      • redness or swelling of the eyes (conjunctivitis)
      • swelling of the face, lips, mouth, tongue, or throat
      • trouble breathing or swallowing
      • pain on the right side of the stomach (abdominal) area
      • dark colored urine "tea colored"
    • Change in liver enzymes.People with a history of hepatitis B or C virus infection or who have certain liver function test changes may have an increased risk of developing new or worsening liver problems during treatment with EDURANT. Liver problems have also happened during treatment with EDURANT in people without a history of liver disease. Your healthcare provider may need to do tests to check your liver enzymes before and during treatment with EDURANT.

    Depression Or Mood Changes. Tell Your Healthcare Provider Right Away If You Have Any Of The Following Symptoms: 

    • feeling sad or hopeless
    • feeling anxious or restless
    • have thoughts of hurting yourself (suicide) or have tried to hurt yourself
  • Changes in body fatcan happen in people who take HIV medicine. These changes may include 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. Tell your healthcare provider right away if you start having any new symptoms after starting your HIV-1 medicine.
  • The most common side effects of EDURANT includedepression, headache, trouble sleeping (insomnia) and rash.
    These are not all the possible side effects with EDURANT.
    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    How Should I Store Edurant? 

    • Store EDURANT at room temperature between 68 F to 77 F (20 C to 25 C).
    • Keep EDURANT in the original bottle to protect from light.
    Keep EDURANT and all medicines out of the reach of children.General information about the safe and effective use of EDURANTMedicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use EDURANT for a condition for which it was not prescribed. Do not give EDURANT to other people even if they have the same condition you have. It may harm them.You can ask your healthcare provider or pharmacist for information about EDURANT that is written for health professionals.

    Active Ingredient: 

    rilpivirine.

    Inactive Ingredients: 

    croscarmellose sodium, lactose monohydrate, magnesium stearate, polysorbate 20, povidone K30 and silicified microcrystalline cellulose. The tablet coating contains hypromellose 2910 6 mPa.s, lactose monohydrate, PEG 3000, titanium dioxide, and triacetin.Manufactured by: Janssen-Cilag SpA, Latina, Italy
    Manufactured for: Janssen Therapeutics, Division of Janssen Products, LP, Titusville NJ 08560
    EDURANTis a registered trademark of Johnson & Johnson
    Janssen Products, LP 2011
    For more information go to www.EDURANT.com or call 1-800-526-7736



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