relugolix
Orgovyx · ATC code L02BX
- Key facts
- Active substance
- relugolix
- ATC code
- L02BX
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Orgovyx 120 mg film-coated tablets
- Marketing authorisation holder
- Accord Healthcare S.L.U.
- Information as of
- 2026-10-27
Key facts
Relugolix is an oral GnRH receptor antagonist (Orgovyx) that lowers testosterone. It is used in adult patients with advanced hormone-sensitive prostate cancer.
What it is used for
- Advanced hormone-sensitive prostate cancer in adults
Dosing
- Loading dose 360 mg (three tablets) on day one, then 120 mg once daily at about the same time
- No anti-androgen surge protection needed at initiation, as testosterone does not rise
- Oral P-gp inhibitors not recommended; if required, take relugolix first and separate by at least 6 hours
- With combined P-gp and strong CYP3A inducers: if unavoidable, 240 mg once daily
- Missed dose: take unless more than 12 hours have passed; after an interruption of more than 7 days, restart with 360 mg
- No dose adjustment in the elderly or in mild to moderate renal or hepatic impairment
Contraindications
- Hypersensitivity to the active substance or any of the excipients
Important warnings
- Androgen deprivation may prolong the QT interval; assess benefit-risk with QT risk factors
- Cardiovascular disease such as myocardial infarction and stroke reported with androgen deprivation
- Decreased bone density, with risk of osteoporosis and fracture
- Caution in severe renal impairment
Side effects
- Hot flushes (54%), musculoskeletal pain (30%), fatigue (26%)
- Diarrhoea and constipation (12% each)
- Effects of testosterone suppression, including decreased bone density
Interactions
- P-gp inhibitors (e.g., erythromycin, azithromycin) increase exposure; co-administration not recommended
- Rifampicin (combined P-gp and strong CYP3A4 inducer) decreases exposure
- Caution with QT-prolonging medicines
Pregnancy and breastfeeding
- Not indicated in women of childbearing potential
- Men: effective contraception with a partner of childbearing potential during treatment and for 2 weeks after the last dose
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. 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
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)
- OrgovyxAccord Healthcare S.L.U. · EMEA/H/C/005353
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Orgovyx
- Liechtenstein
- Orgovyx
- Norway
- Orgovyx
EMA – Article 57 product data (EU/EEA), 2026-10-28
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. Orgovyx – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/orgovyx-epar-product-information_en.pdf
Editorial: Medelix editorial team · last updated 2026-10-27 · 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.