Edurant and Edurant Ped

Pronunciation: ee-dur-ant and ee-dur-ant ped
Generic name: rilpivirine
Dosage form: tablets for oral use, tablets for oral suspension
Drug class: NNRTIs

Medically reviewed by Carmen Pope, BPharm. Last updated on Mar 19, 2024.

What is Edurant and Edurant Ped?

Edurant (rilpivirine tablets) and Edurant Ped (rilpivirine tablets for oral suspension) may be used to treat previously untreated HIV-1 infection in adults and children aged 2 years of age and older, weighing at least 14 kg, with HIV-1 RNA less than or equal to 100,000 copies/mL (this is called the viral load). They are used in combination with other antiretroviral agents.

Edurant is sometimes used with a medicine called cabotegravir as a daily "lead-in dose" short-term, to help determine that you can safely use a combination form of these medicines given as a monthly injection. If you can tolerate them, your doctor will switch you to Cabenuva (the injectable formulations of these drugs). When used with cabotegravir for these purposes, Edurant is only for adults and adolescents 12 years and older and weighing at least 35 kg who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

Edurant and Edurant Ped are non-nucleoside reverse transcriptase inhibitors (NNRTI) of human immunodeficiency virus type 1 (HIV-1) and work by preventing the replication of the virus by a non-competitive inhibition of HIV-1 reverse transcriptase. This enzyme forms a crucial early step in the life cycle of the virus when it catalyzes the transcription of the viral RNA genome into double-stranded DNA in infected cells.

Edurant was FDA-approved on May 20, 2011. Edurant Ped was FDA-approved on 15 March 2024.

Warnings

Edurant and Edurant Ped should not be taken with medications that interact with rilpivirine and decrease how much is in the blood. Tell each of your healthcare providers about all medicines you use now and any medicine you start or stop using.

Severe skin and hypersensitivity reactions that may require hospitalization have been reported with Edurant. Stop taking Edurant or Edurant Ped and get medical help right away if you develop a rash.

Hepatic side effects have been reported in patients with underlying liver disease, including hepatitis B or C virus co-infection, or patients with elevated liver enzymes. A few cases have occurred in patients with no previous history of liver disease. Your healthcare provider will monitor you throughout treatment.

Severe depressive disorders and immune reconstitution syndrome (a condition that results in widespread inflammation) have been reported with Edurant and Edurant Ped.

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).

Before taking

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
• have taken HIV medication in the past
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

It is not known if Edurant or Edurant Ped will harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment. There is a pregnancy registry for women who take Edurant during pregnancy that collects information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.

Breastfeeding

Edurant or Edurant Ped can pass into your breast milk. Talk with your healthcare provider about the following risks of breastfeeding during treatment, such as:

• 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.

How should I take Edurant or Edurant Ped?

Take Edurant or Edurant Ped exactly as your healthcare provider tells you to and with the other HIV medications that have been prescribed for you. Do not change your dose or skip treatment otherwise, you will not get the best results from treatment and resistance may develop.

• Take 1 time each day with a meal, not a snack, such as a protein drink or yogurt.

Edurant Ped tablets for oral suspension provided in a blister package are not the same as Edurant tablets provided in a bottle.

• They cannot be substituted for each other because they have different pharmacokinetic profiles.
• Contact your pharmacist or healthcare provider if you did not receive the correct dosage form.

Edurant Ped tablets for oral suspension must be dispersed in drinking water. Do not crush, chew, or swallow the tablets whole.

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 because the amount of HIV in your blood may increase if the medicine is stopped even for a short time.

Dosage

Adults and patients weighing at least 25kg: One 25 mg Edurant tablet taken once daily with a meal.

Children aged 2 years of age and older and weighing at least 14 kg to less than 25 kg: The dosage of Edurant Ped is based on body weight.

• Disperse Edurant Ped in drinking water and give it to the child with a meal.

Dosage of Edurant with Vocabria (cabotegravir)

Take Edurant and oral Vocabria 1 time a day with a meal. Try to take it at about the same time each day.

• You will receive this combination treatment for one month (at least 28 days) before you receive the long-acting injectable 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.

Related/similar drugs

Biktarvy, Descovy, Truvada, Atripla, Stribild, Epzicom, Complera

What happens if I miss a dose?

Do not miss a dose of Edurant or Edurant Ped. If you miss a dose and remember within 12 hours of the time you usually take it, take your dose with a meal as soon as possible. Then, take your next dose 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 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.

What happens if I overdose?

If you take too much Edurant or Edurant Ped, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the side effects of Edurant and Edurant Ped?

Edurant and Edurant Ped can cause serious side effects including:

• Severe skin rash and allergic reactions, which may need hospital treatment. Call your healthcare provider right away if you develop a rash with Edurant and Edurant Ped or stop taking them and get medical help right away if you develop a rash with any of the following signs or symptoms:
• fever
• generally ill feeling
• tiredness
• muscle or joint aches
• difficulty breathing or swallowing
• blisters or mouth sores
• skin blisters
• redness or swelling of the eyes (conjunctivitis)
• swelling of the face, lips, mouth, tongue, or throat.
• Liver problems. Call your healthcare provider right away if you develop any of the following signs or symptoms:
• 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. 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.

The most common moderate to severe side effects of Edurant or Edurant Ped affecting more than 2% of people were depressive disorders, headache, 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 the FDA at 1-800-FDA-1088.

What other drugs will affect 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. Do not take Edurant or Edurant Ped if you are taking any of the following medicines:

• carbamazepine or oxcarbazepine
• phenobarbital or phenytoin
• rifampin or rifapentine
• dexamethasone (more than a single dose
• treatment)
• St. John’s wort (Hypericum perforatum)
• proton pump inhibitors, such as esomeprazole, omeprazole, rabeprazole, lansoprazole, or pantoprazole.

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.

Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine. Do not start taking a new medicine without telling your healthcare provider. For a full list of interactions, see the prescribing information.

Storage

Store Edurant or Edurant Ped at room temperature between 68°F to 77°F (20°C to 25°C).

Keep it in the original bottle or package to protect it from light and moisture.

Keep out of the reach of children.

Ingredients

Active ingredient: rilpivirine.

Edurant 25 mg tablets 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.

Edurant Ped 2.5 mg tablets for oral suspension: croscarmellose sodium, lactose monohydrate, mannitol, microcrystalline cellulose, polysorbate 20, povidone K30, sodium lauryl sulfate, and sodium stearyl fumarate.

Manufacturer

Janssen Products, LP.

Frequently asked questions

• What is the difference between HIV treatments Odefsey and Complera?
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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer