Medication Guide — Edurant

PATIENT INFORMATION

EDURANT ® (ee dur ant)

(rilpivirine)

tablets, for oral use

EDURANT ® PED (ee dur ant ped)

(rilpivirine)

tablets, for oral suspension

This Patient Information has been approved by the U.S. Food and Drug Administration.

• 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 and 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 Ibs (14 kg).

• carbamazepine
• phenobarbital
• rifampin
• dexamethasone (more than a single dose treatment)
• esomeprazole
• omeprazole
• rabeprazole

• oxcarbazepine
• phenytoin
• rifapentine
• St. John's wort ( Hypericum perforatum)
• lansoprazole
• pantoprazole

• 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.
  • 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. 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.

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.

• Take EDURANT or EDURANT PED 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 and 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 notcrush, chew, or swallow whole EDURANT PED tablets for oral suspension.
• If you take an H 2-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 VOCABRIA 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 VOCABRIA tablets 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.

• Severe skin rash and allergic reactions. Call your healthcare provider right away if you develop a rash with EDURANT or EDURANT PED. In some cases, rash and allergic reaction 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 changes in certain liver tests during treatment with EDURANT or EDURANT PED. Liver problems have also happened in people without a history of problems or other risk factors. Your healthcare provider may need to do tests to check your liver function 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)
• pain, aching, or tenderness on the right side of the stomach area

• loss of appetite
• dark or "tea colored" urine
• nausea or vomiting

• Depression or mood changes. Call 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.

depression, headache, trouble sleeping (insomnia) and rash.

These are not all the possible side effects of EDURANT or EDURANT PED.

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

• Store EDURANT or EDURANT PED at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep EDURANT tablets in the original bottle to protect from light.
• Keep EDURANT PED tablets in the original package to protect from light and moisture.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use EDURANT or EDURANT PED for a condition for which it was not prescribed. Do not give EDURANT or EDURANT PED 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 or EDURANT PED that is written for health professionals.

rilpivirine.

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.

croscarmellose sodium, lactose monohydrate, mannitol, microcrystalline cellulose, povidone K30, polysorbate 20, sodium lauryl sulfate and sodium stearyl fumarate.

Manufactured for: Janssen Products, LP, Horsham PA 19044, USA

For patent information: www.janssenpatents.com

© Johnson & Johnson and its affiliates 2011, 2024

For more information go to www.EDURANT.com or call 1-800-526-7736