Drug Database: Rilpivirine

What is rilpivirine?What is rilpivirine?

What is rilpivirine?

Rilpivirine (brand names: Edurant and Edurant PED) is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for use with other HIV medicines for the treatment of HIV infection in adults and children 2 years of age and older who weigh at least 31 lb (14 kg) who have never taken HIV medicines before and who meet certain requirements, as determined by a health care provider.

Rilpivirine (brand name: Edurant) is also FDA-approved for use with oral cabotegravir (brand name: Vocabria) for the short-term treatment of HIV infection in adults and children 12 years of age and older who weigh at least 77 lb (35 kg) and who meet certain requirements, as determined by a health care provider.

For more information on the use of rilpivirine in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. 

HIV medicines cannot cure HIV/AIDS, but taking HIV medicines every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission. If you are taking HIV medicines, do not cut down on, skip, or stop taking them unless your health care provider tells you to.

What should I tell my health care provider before taking rilpivirine?What should I tell my health care provider before taking rilpivirine?

What should I tell my health care provider before taking rilpivirine?

Before taking rilpivirine, tell your health care provider:

• If you are allergic to rilpivirine or any other medicines.
• If you have or have had liver problems, including hepatitis B virus infection (HBV) or hepatitis C virus infection (HCV).
• If you have kidney problems.
• If you have ever had a mental health problem.
• If you have any other medical conditions.  
• If you are pregnant or plan to become pregnant. Talk to your health care provider about the risks and benefits of taking rilpivirine during pregnancy. For more information on the use of rilpivirine during pregnancy, please refer to the Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States. 
• If you are breast/chestfeeding or plan to breast/chestfeed. For people with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. People with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk. 
• If you are using hormone-based birth control (such as pills, implants, or vaginal rings). For more information about using birth control and HIV medicines at the same time, view the HIVinfo HIV and Birth Control infographic.
• About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products (including St. John's wort) you are taking or plan to take. Rilpivirine may affect the way other medicines or products work, and other medicines or products may affect how rilpivirine works. Taking rilpivirine together with certain medicines or products may cause serious side effects.

How should I take rilpivirine?How should I take rilpivirine?

How should I take rilpivirine?

Rilpivirine comes in the following forms and strengths:

• Tablets (brand name: Edurant): 25 mg
• Tablets for oral suspension (brand name: Edurant PED): 2.5 mg

Take rilpivirine according to your health care provider’s instructions. Do not miss a dose of rilpivirine, and do not change your dose or stop taking rilpivirine without first talking with your health care provider.

Take rilpivirine by mouth and with a meal. (A protein drink or yogurt alone does not replace a meal.)

If you are taking any other medicines or supplements, including H2 blockers or antacids (medicines for reducing stomach acid) or other products containing aluminum, calcium carbonate, or magnesium hydroxide, carefully follow instructions on how to take them with rilpivirine.

Proton pump inhibitors (medicines for reducing stomach acid) should NOT be taken with rilpivirine.

Rilpivirine tablets for oral suspension (Edurant PED) must be dispersed in drinking water. Do not crush, chew, or swallow whole rilpivirine tablets for oral suspension. Read the “Instructions for Use” at the end of the rilpivirine drug label for detailed instructions on how to prepare these tablets for oral suspension.

Rilpivirine tablets for oral suspension (Edurant PED) are not the same as rilpivirine tablets (Edurant) and cannot be substituted for each other. Check to make sure you receive the correct dosage form each time you or your child’s prescription is filled.

Always take rilpivirine in combination with other HIV medicines.

If your health care provider is prescribing oral rilpivirine with oral cabotegravir, take rilpivirine and cabotegravir by mouth at approximately the same time each day with a meal. Before receiving the long-acting injectable regimen of cabotegravir and rilpivirine (brand name: Cabenuva), your health care provider may have you take oral rilpivirine tablets in combination with oral cabotegravir tablets for 1 month to assess your tolerance of these medicines.

If you plan to miss a scheduled injection of Cabenuva by more than 7 days, call your healthcare provider right away to discuss your treatment options. Your health care provider may have you take cabotegravir tablets in combination with rilpivirine tablets to replace missed injections. 

If you have taken too much rilpivirine, contact your health care provider or local poison control center (1-800-222-1222 or online) right away, or go to the nearest hospital emergency room. 

For more information on how to take rilpivirine, see the FDA drug label.

What should I do if I forget a dose?What should I do if I forget a dose?

What should I do if I forget a dose?

If you miss a dose of rilpivirine 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 by more than 12 hours from 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.

What side effects can rilpivirine cause?What side effects can rilpivirine cause?

What side effects can rilpivirine cause?

Rilpivirine may cause side effects. Some side effects of rilpivirine can be serious as noted above. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the HIVinfo fact sheet on HIV Medicines and Side Effects for more information.

Another possible side effect of rilpivirine is a change in your immune system (called immune reconstitution inflammatory syndrome or IRIS). IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.

Tell your health care provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of rilpivirine. To learn more about possible side effects of rilpivirine, read the drug label or package insert or talk to your health care provider or pharmacist.

You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online.

How should rilpivirine be stored?How should rilpivirine be stored?

How should rilpivirine be stored?

• Store rilpivirine at room temperature, 68°F to 77°F (20°C to 25°C).
• Keep rilpivirine tablets in the container that it came in to protect the drug from light. Keep the container tightly closed.
• Keep rilpivirine tablets for oral suspension in the original blister package to protect the drug from moisture.
• Do not use rilpivirine if the original seal over the container opening is broken or missing. 
• Throw away rilpivirine that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
• Keep rilpivirine and all medicines out of reach of children.

Where can I find more information about rilpivirine?Where can I find more information about rilpivirine?

Where can I find more information about rilpivirine?

• For more information on the use of rilpivirine in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. 
• This Patient Version drug summary is based on the following FDA label(s): Tablet (film coated), tablet (for suspension). The Patient Package Insert and Instructions for Use include information for people taking rilpivirine.
• The American Hospital Formulary Service (AHFS) Patient Medication Information for rilpivirine available from MedlinePlus.
• Rilpivirine-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests.) 
• A list of FDA-approved HIV medicines, from HIVinfo.