Rilpivirine
Pronunciation: (ril-pih-VIR-een).
- Generic name
- Rilpivirine
- Brand names
- Edurant, Edurant PED, Complera/Odefsey/Juluca (combination products containing rilpivirine)
- Drug class
- Non-nucleoside reverse transcriptase inhibitor (NNRTI), antiretroviral
Availability and supply rules vary by country
Trade names by country: United States · Canada
Australia: · Full directory
What Rilpivirine is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how Rilpivirine works
Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that binds directly to HIV-1 reverse transcriptase and blocks RNA-dependent and DNA-dependent DNA polymerase activity, preventing viral replication. It does not require intracellular activation. (2)
What Rilpivirine is used for
HIV-1 infection (treatment-naive patients with low baseline viral load)
Used in combination with other antiretroviral medicines to treat HIV-1 infection in antiretroviral-treatment-naive adults and pediatric patients 2 years of age and older, weighing at least 14 kg, with HIV-1 RNA 100,000 copies/mL or less at the start of therapy. (2)
Before taking Rilpivirine
Do not take / not appropriate for
- Do not take rilpivirine together with the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, or phenytoin. These medicines strongly lower rilpivirine levels in the blood, which can cause the HIV treatment to stop working and allow the virus to become resistant to rilpivirine and to the whole NNRTI class. (all countries) (2)
- Do not take rilpivirine together with the antimycobacterial medicines rifampin or rifapentine, for the same reason — they lower rilpivirine levels and risk loss of virologic control and drug resistance. (all countries) (2)
- Do not take rilpivirine together with a proton pump inhibitor — esomeprazole, lansoprazole, omeprazole, pantoprazole, or rabeprazole. By raising stomach pH they reduce how much rilpivirine is absorbed, which can cause treatment failure and resistance. (all countries) (2)
- Do not take rilpivirine together with systemic dexamethasone given as more than a single dose. A one-off single dose is not contraindicated, but repeated or ongoing systemic dexamethasone lowers rilpivirine levels. (all countries) (2)
- Do not take rilpivirine together with St John's wort (Hypericum perforatum), including herbal supplements and teas that contain it. (all countries) (2)
Tell your clinician about
- Every other medicine, herbal product, and over-the-counter remedy you take — including antacids, H2 blockers such as famotidine, rifabutin, and azole antifungals, which are not contraindicated but need specific dose timing or dose changes.
- Any history of depression or suicidal thoughts.
- Any liver problems, including hepatitis B or C infection.
- Any heart-rhythm problem, or any other medicine that can prolong the QT interval.
- Any previous severe skin or hypersensitivity reaction to a medicine.
- Pregnancy, plans for pregnancy, or breastfeeding.
How to take Rilpivirine
- Take rilpivirine exactly as prescribed, once daily, with a meal — taking it without food significantly lowers drug levels. Swallow the tablet whole with liquid; do not chew or crush. It is used together with other HIV medicines, never alone. Do not skip doses; missing doses can allow the virus to become resistant to treatment.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (2)
Missed dose
If a dose is missed and it is within 12 hours of the usual time, take it with food as soon as possible and resume the normal schedule. If more than 12 hours have passed, skip the missed dose and take the next dose with food at the regular time — do not double the dose. Contact your healthcare provider if you have questions about a missed dose.
Overdose
Seek immediate medical attention or contact a poison control center if an overdose is suspected. There is no specific antidote; treatment involves general supportive measures, including monitoring of vital signs and heart rhythm (ECG/QT interval), and clinical observation. (2)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms.
Nausea
Incidence: Common
Headache
Incidence: Common
Insomnia or abnormal dreams
Incidence: Common
Rash
Incidence: Common
New or worsening depression or mood changes
Incidence: Uncommon; seek medical attention
Signs of liver problems
Incidence: Uncommon; seek medical attention
Severe rash or hypersensitivity signs
Incidence: Rare; seek immediate medical attention
Serious warnings
Severe skin and hypersensitivity reactions, including cases with organ dysfunction and DRESS syndrome (drug reaction with eosinophilia and systemic symptoms), have been reported — serious
Symptoms: Severe skin and hypersensitivity reactions, including cases with organ dysfunction and DRESS syndrome (drug reaction with eosinophilia and systemic symptoms), have been reported. Seek medical attention promptly for any new or worsening rash, especially with fever, blistering, mouth sores, eye irritation, facial swelling, or feeling generally unwell — let the clinician you see advise on whether to continue or stop treatment.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Hepatotoxicity has been reported, including in patients without pre-existing liver disease — serious
Symptoms: Hepatotoxicity has been reported, including in patients without pre-existing liver disease; the risk is higher in those with hepatitis B or C co-infection. Liver function is monitored during treatment. Seek medical attention promptly for signs of liver problems such as yellowing skin/eyes, dark urine, or unusual tiredness.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Severe depressive disorders, including suicidal ideation, have been reported — serious
Symptoms: Severe depressive disorders, including suicidal ideation, have been reported. Seek medical attention promptly for new or worsening depression, unusual mood changes, or thoughts of self-harm.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Coadministration with proton pump inhibitors (e — serious
Symptoms: Coadministration with proton pump inhibitors (e.g. omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole) is contraindicated — these significantly reduce rilpivirine absorption and can cause treatment failure. Other acid-reducing medicines (H2-blockers) require strict dose-timing separation. Tell your prescriber about all medicines, including over-the-counter antacids and heartburn remedies, before starting rilpivirine.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Proton pump inhibitors | Contraindicated — significantly reduces rilpivirine absorption, risking treatment failure and resistance. | (2) |
| Strong CYP3A inducers (rifampin, rifapentine, carbamazepine, phenytoin, phenobarbital, oxcarbazepine, St. John's wort, systemic dexamethasone beyond a single dose) | Contraindicated — significantly lowers rilpivirine levels and can cause loss of virologic response and resistance. | (2) |
| H2-receptor antagonists (e.g. famotidine, ranitidine-type agents) | Must be dosed at least 12 hours before or at least 4 hours after rilpivirine to avoid reduced absorption. | (2) |
| QT-prolonging medicines | Use with caution; rilpivirine has been associated with QT prolongation at supratherapeutic doses. Discuss all other medications with your prescriber. | (2) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
For patients already virologically suppressed and stable on rilpivirine, no dose adjustment is needed during pregnancy, but total rilpivirine exposure is generally lower during pregnancy, so more frequent viral load monitoring is recommended. Discuss any pregnancy or plan for pregnancy with the treating HIV specialist. (2)
Breastfeeding
The FDA label notes rilpivirine is present in breast milk, and potential risks of breastfeeding for a person with HIV include HIV transmission to the infant (even with viral suppression) and the possibility of viral resistance developing. Current guidance in the country of care regarding infant feeding for people with HIV should be followed; discuss with the treating specialist. (2)
Children
Approved for pediatric patients 2 years of age and older weighing at least 14 kg, who are antiretroviral-treatment-naive with HIV-1 RNA of 100,000 copies/mL or less. Dosing below 25 kg body weight uses a weight-based Edurant PED oral suspension/tablet regimen rather than the standard 25 mg adult tablet. (2)
Renal_impairment
Renal impairment: no dose adjustment is needed for mild or moderate renal impairment. In severe renal impairment or end-stage renal disease, rilpivirine should be used with caution and increased monitoring, as concentrations may rise due to renal dysfunction affecting drug absorption, distribution, and metabolism; because rilpivirine is highly protein-bound, it is unlikely to be significantly removed by hemodialysis or peritoneal dialysis. Hepatic impairment: no dose adjustment is needed for mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment, though drug exposure was somewhat higher in these groups (about 47% higher in mild, 5% higher in moderate impairment); rilpivirine has not been studied in severe hepatic impairment (Child-Pugh C), so caution and specialist input are needed in that group. (2)
Hepatic_impairment
Renal impairment: no dose adjustment is needed for mild or moderate renal impairment. In severe renal impairment or end-stage renal disease, rilpivirine should be used with caution and increased monitoring, as concentrations may rise due to renal dysfunction affecting drug absorption, distribution, and metabolism; because rilpivirine is highly protein-bound, it is unlikely to be significantly removed by hemodialysis or peritoneal dialysis. Hepatic impairment: no dose adjustment is needed for mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment, though drug exposure was somewhat higher in these groups (about 47% higher in mild, 5% higher in moderate impairment); rilpivirine has not been studied in severe hepatic impairment (Child-Pugh C), so caution and specialist input are needed in that group. (2)
Monitoring
(2)Storage
Store at room temperature (20°C-25°C / 68°F-77°F). Keep the container tightly closed. Keep out of reach of children.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
United States (Edurant)
Indication: HIV-1 infection, treatment-naive with baseline HIV-1 RNA ≤100,000 copies/mL
Dose summary: Adults and pediatric patients ≥25 kg: one 25 mg tablet once daily with a meal, in combination with other antiretrovirals. Pediatric patients 14 kg to <25 kg: weight-based Edurant PED dosing (12.5-15 mg once daily with food). If coadministered with rifabutin: 50 mg (two 25 mg tablets) once daily with food for the duration of rifabutin co-therapy.
Renal context: No dose adjustment needed for mild or moderate renal impairment. In severe renal impairment or end-stage renal disease, use with caution and increased monitoring; rilpivirine is unlikely to be significantly removed by hemodialysis or peritoneal dialysis due to high protein binding. (1) (2)
Hepatic guidance
No dose adjustment needed for mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment, though exposure is somewhat increased (~47% in mild, ~5% in moderate impairment). Rilpivirine has not been studied in severe hepatic impairment (Child-Pugh C); use in this group requires specialist caution.
Frequently asked questions
What is Rilpivirine used for?
Rilpivirine (Edurant) is used with other HIV medicines to treat HIV-1 infection in people who have not previously taken antiretroviral treatment and whose viral load is 100,000 copies/mL or less at the start of therapy.
Why must Rilpivirine be taken with food?
Taking rilpivirine on an empty stomach significantly lowers blood levels of the drug, which can reduce its effectiveness against HIV and increase the risk of treatment resistance. Always take it with a meal.
What are the side effects of Rilpivirine?
Common side effects include nausea, headache, insomnia or abnormal dreams, and rash. Seek prompt medical attention for signs of depression, liver problems, or a severe rash.
Can I take antacids or heartburn medicine with Rilpivirine?
Proton pump inhibitors (like omeprazole) must not be used with rilpivirine. H2-blockers must be timed at least 12 hours before or 4 hours after rilpivirine. Discuss any acid-reducing medicine, including over-the-counter antacids, with your prescriber.
Is Rilpivirine safe with kidney or liver disease?
No dose change is needed for mild-to-moderate kidney or liver impairment. Severe kidney impairment or dialysis, and severe liver impairment (which has not been studied), both require extra caution and close specialist monitoring.
What is the mechanism of action of Rilpivirine?
Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that binds directly to HIV-1 reverse transcriptase and blocks RNA-dependent and DNA-dependent DNA polymerase activity, preventing viral replication. It does not require intracellular activation. (2)
What is the generic name of Rilpivirine?
The generic name is Rilpivirine. It is sold under brand names including Edurant, Edurant PED, Complera/Odefsey/Juluca (combination products containing rilpivirine).
What class of drug is Rilpivirine?
Rilpivirine is classed as: Non-nucleoside reverse transcriptase inhibitor (NNRTI), antiretroviral.
References
- Rilpivirine — MedGuideGlobal internal product recordMedGuideGlobal · Internal database · accessed 2026-08-03 · source 1
- EDURANT / EDURANT PED (rilpivirine) tablets — FDA prescribing informationUS FDA (prescribing information via DailyMed) · United States · accessed 2026-08-07 · source 2
- JULUCA (DOLUTEGRAVIR SODIUM AND RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 3
- Rilpivirine — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 4
- EDURANT — FDA approval record (Drugs@FDA NDA202022)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 5
- Rilpivirine — RxNorm normalized drug concept (RXCUI 1102270)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 6
Brand names by country
Single-ingredient Rilpivirine names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- EDURANT PED2.5 mg · janssen products, lp
- EDURANT25 mg · janssen products, lp
Canada
- EDURANT