niraparib
Zejula · ATC code L01XK02
- Key facts
- Active substance
- niraparib
- ATC code
- L01XK02
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Zejula 100 mg hard capsules · Zejula 100 mg film-coated tablets
- Marketing authorisation holder
- GlaxoSmithKline Trading Services Limited
- Information as of
- 2026-10-28
Key facts
Niraparib is a poly(ADP-ribose) polymerase (PARP) inhibitor. It is used as maintenance treatment for advanced ovarian, fallopian tube or primary peritoneal cancer after response to platinum-based chemotherapy.
What it is used for
- Monotherapy maintenance in adults with advanced (FIGO Stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in response (complete or partial) after first-line platinum-based chemotherapy.
- Monotherapy maintenance in adults with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer in response to platinum-based chemotherapy.
Dosing
- Zejula (100 mg hard capsules or film-coated tablets), first-line maintenance: starting dose 200 mg once daily; for patients ≥77 kg with baseline platelets ≥150,000/μL, 300 mg once daily.
- Zejula, recurrent cancer maintenance: 300 mg (three 100 mg units) once daily; a starting dose of 200 mg may be considered for patients weighing less than 58 kg.
- For adverse reactions, first interrupt (no longer than 28 days), then resume at the same or a reduced dose; discontinue if below 100 mg/day is needed – details in the full text.
- Moderate hepatic impairment: starting dose 200 mg once daily. Mild to moderate renal impairment: no adjustment; caution in severe impairment.
- Take at about the same time each day; bedtime administration may help manage nausea.
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
- Breast-feeding.
Important warnings
- Haematologic adverse reactions (thrombocytopenia, anaemia, neutropenia): test blood counts weekly for the first month, monthly for the next 10 months, then periodically.
- Myelodysplastic syndrome/acute myeloid leukaemia, including fatal cases; discontinue if confirmed.
- Hypertension including hypertensive crisis: monitor blood pressure at least weekly for two months, then monthly for the first year.
- Posterior reversible encephalopathy syndrome (PRES) has been reported.
- Caution with anticoagulants and medicines that reduce platelets. Hard capsules contain lactose.
Side effects
- Very common (≥10%): nausea, anaemia, thrombocytopenia, fatigue, constipation, vomiting, headache, insomnia, neutropenia, abdominal pain, decreased appetite, diarrhoea, dyspnoea, hypertension, dizziness, cough, arthralgia, back pain, hot flush.
- Most common serious adverse reactions: thrombocytopenia and anaemia.
Interactions
- Niraparib induces CYP1A2: caution with narrow-therapeutic-range CYP1A2 substrates (e.g. clozapine, theophylline, ropinirole).
- Combination with vaccines, immunosuppressants or other cytotoxic medicines: caution (limited data).
Pregnancy and breastfeeding
- Pregnancy test before treatment; highly effective contraception during therapy and for 6 months after the last dose; not to be used during pregnancy.
- Breast-feeding is contraindicated.
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)
- ZejulaGlaxoSmithKline Trading Services Limited · EMEA/H/C/004249
Source: European Medicines Agency (EMA), product information
Turkey
- ZejulaGLAXOSMİTHKLİNE İLAÇLARI SAN. VE TİC. A.Ş. · 5 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 3 more European countries
- Iceland
- Zejula
- Liechtenstein
- Zejula
- Norway
- Zejula
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. Zejula – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/zejula-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-28 · 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.