What are the most important things to know about rilpivirine?
Rilpivirine can cause serious, life-threatening side effects. These include severe skin rash and allergic reactions,, mood changes, and problems.
Contact your health care provider right away if you develop a rash while taking rilpivirine. Stop taking rilpivirine and get medical help right away if you develop a rash with any of the following symptoms:
- General ill feeling
- Extreme tiredness
- Muscle or joint aches
- Blistering or peeling skin
- Blisters or sores in your mouth
- Redness or swelling of your eyes ( )
- Swelling of your face, lips, mouth, tongue, or throat
- Trouble breathing or swallowing
Contact your health care provider right away if you have any of the following symptoms that could be signs of depression or mood changes:
- Feeling sad or hopeless
- Feeling anxious or restless
- Harming yourself or having thoughts about harming yourself (including suicidal thoughts)
Some people taking rilpivirine have had liver problems. People with a history of(HBV) or (HCV) or who have elevated results on liver function tests may have an increased risk of developing new or worsening liver problems while taking rilpivirine. Liver problems have also occurred in people taking rilpivirine who have no history of liver disease. Liver function tests may be done before and during treatment with rilpivirine.
Contact your health care provider right away if you have any of the following symptoms that could be signs of liver problems:
- Yellowing of your skin or the whites of your eyes ( )
- Dark-colored urine
- Light-colored bowel movements
- Loss of appetite for several days or longer
- Nausea or vomiting
- Pain, aching, or tenderness on the right side of your stomach area
What is rilpivirine?
Rilpivirine is a prescription medicine approved by the U.S.(FDA) for use with:
- other HIV medicines for the treatment of HIV in adults and in children 12 years of age and older who weigh at least 77 lb (35 kg), who have never taken HIV medicines before, and who meet certain requirements, as determined by a health care provider.
- cabotegravir (brand name: Vocabria) for the short-term treatment of HIV infection in adults 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 Living with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.
HIV medicines can’t 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. If you are taking HIV medicines, don’t 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?
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 HBV infection or HCV infection.
- 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 in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States.
- If you are breastfeeding or plan to breastfeed. For women with HIV in the United States, the Guideline does not recommend breastfeeding. Before your baby is born, or if you are already breastfeeding, talk to your health care provider to discuss alternative options for feeding your baby.
- If you are using HIV and Birth Control infographic. -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
- 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?
Rilpivirine (brand name: Edurant) comes in 25-mg tablets.
Take rilpivirine according to your health care provider’s instructions.
Take rilpivirine with a meal. (Adrink alone does not replace a meal.) If you are taking any other medicines or supplements, including antacids, carefully follow instructions on how to take them with rilpivirine.
Always take rilpivirine in combination with other HIV medicines.
If your health care provider is prescribing rilpivirine with oral cabotegravir (brand name: Vocabria), take rilpivirine and oral cabotegravir by mouth at approximately the same time each day with a meal.
If you take too much rilpivirine, contact your health care provider or local poison control center (1-800-222-1222) 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?
If you miss aof 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?
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.
Other possible side effects of rilpivirine include:
- Changes in body fat ( ).
- Changes in your (called 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 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?
- Store rilpivirine at room temperature, 68°F to 77°F (20°C to 25°C).
- Keep rilpivirine in the container that it came in to protect the drug from light. Keep the container tightly closed.
- 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?
More information about rilpivirine is available:
- 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 Living with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.
- The rilpivirine drug label. The Patient Counseling Information section of the label includes information for people taking rilpivirine.
- Rilpivirine-related research studies, from .
- A list of FDA-approved HIV medicines, from HIVinfo.
Main number: 800-526-7736
Patient assistance: 800-652-6227
Janssen CarePath: 866-836-0114
The above Patient Version drug summary is based on the following FDA label(s): Tablet (film coated).
Last Reviewed: February 18, 2021