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IMPORTANT SAFETY INFORMATION
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What are EDURANT® (rilpivirine) and EDURANT® PED?

EDURANT® and EDURANT® PED are prescription medicines that are used with:

  • other human immunodeficiency virus-1 (HIV-1) medicines to treat HIV-1 infection in people 2 years of age and older and who weigh at least 31 pounds (lbs) or 14 kilograms (kg) who:
    • have never taken HIV-1 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.
  • EDURANT® is also used with oral VOCABRIA (cabotegravir) for short term treatment of HIV-1 infection in people 12 years of age or older and who weigh at least 77 lbs (35 kg) when their healthcare provider determines that they meet certain requirements.

HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

If you take EDURANT® in combination with oral VOCABRIA (cabotegravir), you should also read the Patient Information that comes with oral VOCABRIA (cabotegravir).

It is not known if EDURANT® or EDURANT® PED is safe and effective in children less than 2 years of age or who weigh less than 31 lbs (14 kg).

IMPORTANT SAFETY INFORMATION

Who should not take EDURANT®?

Do not take EDURANT® or EDURANT® PED if you also take:

  • anti-seizure medicines:
    • carbamazepine
    • oxcarbazepine
    • phenobarbital
    • phenytoin
  • anti-tuberculosis (anti-TB) medicines:
    • rifampin
    • rifapentine
  • more than 1 dose of the steroid medicine dexamethasone
  • St. John’s wort (Hypericum perforatum)
  • proton pump inhibitor (PPI) medicine for certain stomach or intestinal problems:
    • esomeprazole
    • lansoprazole
    • omeprazole
    • pantoprazole sodium
    • rabeprazole

What should I tell my healthcare provider before taking EDURANT®?

Before taking EDURANT® or EDURANT® PED, tell your healthcare provider about all your medical conditions, including if you:

  • have ever had a severe skin rash or an allergic reaction to medicines that contain rilpivirine
  • 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® or EDURANT® PED will harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with EDURANT® or EDURANT® PED.
  • are breastfeeding or plan to breastfeed. EDURANT® or EDURANT® PED can pass into your breast milk. Talk with your healthcare provider about the following risks of breastfeeding during treatment with EDURANT® or EDURANT® PED:
    • The HIV-1 virus may pass to your baby if your baby does not have the HIV-1 infection.
    • The HIV-1 virus may become harder to treat if your baby has HIV-1 infection.
    • Your baby may get side effects from EDURANT® or EDURANT® PED.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some medicines interact with EDURANT® or EDURANT® PED. 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® or EDURANT® PED.

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® or EDURANT® PED with other medicines.

How should I take EDURANT® or EDURANT® PED?

See the “Instructions for Use” for detailed instructions on how to prepare and give a dose of EDURANT® PED tablets for oral suspension.

  • Take EDURANT® or EDURANT® PED every day exactly as your healthcare provider tells you to.
  • Take EDURANT® or EDURANT® PED 1 time each day with a meal. A protein drink or yogurt alone does not replace a meal.
  • EDURANT® or EDURANT® PED must be used with other HIV-1 medicines.
  • Do not change your dose or stop taking EDURANT® or EDURANT® PED without first talking with your healthcare provider. Stay under the care of your healthcare provider during treatment with EDURANT® or EDURANT® PED.
  • EDURANT® PED tablets for oral suspension provided in a blister package are not the same as EDURANT® tablets provided in a bottle and cannot be substituted for each other. Contact your pharmacist or healthcare provider if you did not receive the correct dosage form. Your child’s healthcare provider will prescribe EDURANT® or EDURANT® PED based on your child’s weight.
  • EDURANT® PED tablets for oral suspension must be dispersed in drinking water. Do not crush, chew, or swallow whole EDURANT® PED tablets for oral suspension.
  • If you take an H2-receptor antagonist (such as famotidine, cimetidine, nizatidine, or ranitidine), you should take these medicines at least 12 hours before or at least 4 hours after you take EDURANT® or EDURANT® PED.
  • 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® or EDURANT® PED.
  • Do not miss a dose of EDURANT® or EDURANT® PED.
  • If you miss a dose of EDURANT® or EDURANT® PED within 12 hours of the time you usually take it, take your dose of EDURANT® or EDURANT® PED with a meal as soon as possible. Then, take your next dose of EDURANT® or EDURANT® PED at the regularly scheduled time. If you miss a dose of EDURANT® or EDURANT® PED by more than 12 hours of the time you usually take it, wait and then take the next dose of EDURANT® or EDURANT® PED at the regularly scheduled time.
  • Do not take more than your prescribed dose to make up for a missed dose or take less than your prescribed dose.
  • If you take too much EDURANT® or EDURANT® PED, call your healthcare provider or go to the nearest hospital emergency room right away.
  • When your supply of EDURANT® or EDURANT® PED starts to run low, get more from your healthcare provider or pharmacy. It is important not to run out of EDURANT® or EDURANT® PED. The amount of HIV in your blood may increase if the medicine is stopped even for a short time.
  • When your healthcare provider prescribes use of EDURANT® with oral VOCABRIA (cabotegravir):
    • Take EDURANT® and oral VOCABRIA (cabotegravir) 1 time a day at about the same time each day with a meal.
    • You will receive treatment with EDURANT® tablets in combination with oral VOCABRIA (cabotegravir) tablets for one month (at least 28 days) before you receive the long-acting medicine called CABENUVA (cabotegravir; rilpivirine extended-release injectable suspensions) for the first time. This will allow your healthcare provider to assess how well you tolerate these medicines.
    • Your final dose of EDURANT® and oral VOCABRIA should be taken on the same day you receive your first CABENUVA injections.
    • If you miss or plan to miss a scheduled monthly or every 2 months injection of CABENUVA by more than 7 days, call your healthcare provider right away to discuss your treatment options.

What are the possible side effects of EDURANT® or EDURANT® PED?

EDURANT® or EDURANT® PED can cause serious side effects including:

  • Severe skin rash and allergic reactions. Skin rash is a common side effect of EDURANT® or EDURANT® PED. Skin rash can be serious. Call your healthcare provider right away if you get a rash. In some cases, rash and allergic reactions may need to be treated in a hospital.

Stop taking EDURANT® or EDURANT® PED and get medical help right away if you develop a rash with any of the following signs or symptoms:

  • fever
  • tiredness
  • difficulty breathing or swallowing
  • skin blisters
  • swelling of the face, lips, mouth, tongue or throat
  • generally ill feeling
  • muscle or joint aches
  • blisters or mouth sores
  • redness or swelling of the eyes (conjunctivitis)
  • Liver problems. 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® or EDURANT® PED. 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® or EDURANT® PED. Call your healthcare provider right away if you develop any of the following signs or symptoms of liver problems:
    • your skin or the white part of your eyes turns yellow (jaundice)
    • light-colored stools (bowel movements)
    • loss of appetite
    • dark or tea-colored urine
    • pain, aching, or tenderness on the right side of the stomach area
    • nausea or vomiting
  • 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 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® or EDURANT® PED include depression, headache, trouble sleeping (insomnia), and rash.

This is not a complete list of all side effects of EDURANT® or EDURANT® PED. If you experience these or other symptoms, contact your healthcare provider right away.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also report side effects to Janssen Products, LP, at 1-800-JANSSEN (1-800-526-7736).

Please read the full Product Information for EDURANT® and EDURANT® PED and discuss any questions you have with your healthcare provider.

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