rilpivirine
Edurant, Rekambys · ATC code J05AG05
Also known as: Rilpivirin
- Key facts
- Active substance
- rilpivirine
- Drug class
- Direct acting antiviral
- ATC code
- J05AG05
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- EDURANT 25 mg film-coated tablets · EDURANT 2.5 mg dispersible tablets · REKAMBYS 600 mg prolonged-release suspension for injection / REKAMBYS 900 mg prolonged-release suspension for injection
- Marketing authorisation holder
- 11972, Janssen-Cilag International NV
- Information as of
- 2026-10-29
Key facts
Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) against HIV-1. It is used as tablets (Edurant) or as a long-acting injection with cabotegravir (Rekambys).
What it is used for
- Edurant 25 mg film-coated tablets: with other antiretrovirals for HIV-1 infection in adults and children weighing at least 25 kg without NNRTI resistance mutations and with a viral load ≤ 100,000 HIV-1 RNA copies/ml.
- Edurant 2.5 mg dispersible tablets: children 2 to less than 18 years weighing 14 kg to less than 25 kg, under the same conditions.
- Rekambys: with cabotegravir injection in adults and adolescents (at least 12 years, at least 35 kg) who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable regimen without resistance to, or prior failure with, NNRTI and integrase inhibitors.
Dosing
- Edurant, 25 kg and above: one 25 mg tablet once daily with a meal; with rifabutin, 50 mg once daily. The 2.5 mg dispersible tablets are dosed by weight and are not interchangeable with the 25 mg tablet.
- Edurant, missed dose: take with a meal within 12 hours, otherwise skip; if vomiting within 4 hours, take another tablet.
- Rekambys monthly: initiation injection 900 mg intramuscularly, then 600 mg monthly.
- Rekambys every 2 months: 900 mg intramuscularly, a second 900 mg one month later, then 900 mg every 2 months. Optional oral lead-in of rilpivirine 25 mg plus cabotegravir 30 mg for about 1 month.
- After stopping Rekambys, start a fully suppressive regimen no later than one month (monthly schedule) or two months (every-2-months schedule) after the last injection.
Contraindications
- Hypersensitivity to the active substance or any excipient.
- Co-administration with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampicin, rifapentine, systemic dexamethasone (except single dose) or St John's wort; for Rekambys also rifabutin.
- Edurant: also proton pump inhibitors (e.g. omeprazole, pantoprazole).
Important warnings
- Edurant: higher risk of virologic failure with baseline viral load > 100,000 copies/ml; use guided by resistance testing.
- QTc prolongation at supra-therapeutic doses; caution with medicines with a known risk of torsade de pointes.
- Rekambys: residual concentrations may persist for up to 4 years; several risk factors (e.g. BMI ≥ 30 kg/m2, subtype A6/A1) increase failure risk.
- Rekambys: serious post-injection reactions within minutes (e.g. dyspnoea, bronchospasm) after accidental intravenous administration.
- Immune reactivation syndrome may occur.
Side effects
- Edurant, at least moderate intensity: depression (4.1%), headache (3.5%), insomnia (3.5%), rash (2.3%) and abdominal pain (2.0%).
- Rekambys with cabotegravir: most frequently injection site reactions, headache and pyrexia; increased cholesterol and pancreatic amylase are also very common.
Interactions
- Metabolised by CYP3A: inducers lower and inhibitors raise rilpivirine levels.
- Edurant: medicines that increase gastric pH may lower levels.
- Rekambys with cabotegravir is a complete regimen and is not combined with other antiretrovirals.
Pregnancy and breastfeeding
- Data from 300-1000 pregnancies show no malformative toxicity; exposure is lower in pregnancy, so monitor viral load closely. Rekambys in pregnancy only if benefit justifies the risk.
- Mothers receiving rilpivirine should not breast-feed.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
Source: European Medicines Agency (EMA), product information
Turkey
- EdurantJOHNSON AND JOHNSON SIHHİ MAL. SAN. VE TİC. LTD. ŞTİ. · 1 register entry
- RekambysJOHNSON AND JOHNSON SIHHİ MAL. SAN. VE TİC. LTD. ŞTİ. · 2 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 3 more European countries
- Iceland
- Edurant, Rekambys
- Liechtenstein
- Edurant, Rekambys
- Norway
- Edurant, Rekambys
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Edurant – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/edurant-epar-product-information_en.pdf
- European Medicines Agency. Rekambys – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/rekambys-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC J05AG.
Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.