Olaparib

Lynparza · ATC code L01XK01

Key facts
Active substance
Olaparib
ATC code
L01XK01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Lynparza 100 mg film-coated tablets / Lynparza 150 mg film-coated tablets
Marketing authorisation holder
AstraZeneca AB
Information as of
2026-10-27

Key facts

Olaparib is a PARP inhibitor. It is used in certain ovarian, breast, pancreatic, prostate and endometrial cancers, often depending on BRCA or HRD status.

What it is used for

  • Maintenance of advanced BRCA1/2-mutated high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer after response to first-line platinum chemotherapy
  • Maintenance of platinum-sensitive relapsed ovarian cancer; with bevacizumab in first-line HRD-positive disease
  • Adjuvant treatment of gBRCA1/2-mutated HER2-negative high-risk early breast cancer; gBRCA1/2-mutated HER2-negative metastatic breast cancer
  • Maintenance of gBRCA-mutated metastatic pancreatic adenocarcinoma; metastatic castration-resistant prostate cancer; further indications in the full text

Dosing

  • 300 mg (two 150 mg tablets) twice daily, as monotherapy or in combination
  • With strong CYP3A inhibitors: 100 mg twice daily; with moderate: 150 mg twice daily (co-administration should be avoided where possible)
  • Moderate renal impairment (creatinine clearance 31 to 50 ml/min): 200 mg twice daily; not recommended in severe impairment
  • Confirm mutation status with a validated test where the indication requires it

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Breast-feeding during treatment and for 1 month after the last dose

Important warnings

  • Haematological toxicity (anaemia, neutropenia, thrombocytopenia); blood counts at baseline and monthly for the first 12 months
  • Myelodysplastic syndrome/acute myeloid leukaemia
  • With durvalumab: pure red cell aplasia and autoimmune haemolytic anaemia reported
  • Do not start until recovered from haematological toxicity of previous therapy

Side effects

  • Most frequent: nausea, fatigue/asthenia, anaemia, vomiting, diarrhoea, decreased appetite, headache
  • Also: neutropenia, dysgeusia, cough, leukopenia, dizziness, dyspnoea, dyspepsia
  • Mostly mild or moderate; anaemia (14% grade ≥3) most often led to interruption or dose reduction

Interactions

  • Strong or moderate CYP3A inhibitors not recommended; reduce dose if unavoidable
  • Other myelosuppressive anticancer drugs potentiate myelosuppression
  • Vaccines and immunosuppressants: not studied, use with caution

Pregnancy and breastfeeding

  • Pregnancy test before treatment; two reliable forms of contraception before, during and for 6 months after the last dose
  • Breast-feeding contraindicated during treatment and for 1 month after

Summary of the official product information, written with AI on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

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)

  • LynparzaAstraZeneca AB · EMEA/H/C/003726

Source: European Medicines Agency (EMA), product information

Turkey

  • LynparzaASTRAZENECA İLAÇ SAN. VE TİC. LTD. ŞTİ. · 4 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Lynparza
Liechtenstein
Lynparza
Norway
Lynparza

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

  1. European Medicines Agency. Lynparza – EPAR, Product Information. 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

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.