Abbreviated Prescribing Information
Lynparza

Presentation: Lynparza film‑coated tablet 100 mg or 150 mg. Indications: Monotherapy for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy; monotherapy for the maintenance treatment of adult patients with platinum‑sensitive relapsed high‑grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum‑based chemotherapy; in combination with bevacizumab for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability; monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy; monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy; monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen; monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent; in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated. Dosage: 300mg bd oral; for first-line maintenance treatment of BRCA-mutated advanced ovarian cancer, continue until radiological disease progression, unacceptable toxicity or for up to 2 years if there is no radiological evidence of disease after 2 years of treatment. Patients with evidence of disease at 2 years can be treated beyond 2 years; for combination with bevacizumab for the first-line maintenance treatment of high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer following completion of first-line platinum-based therapy with bevacizumab, the dose of bevacizumab is 15 mg/kg once every 3 weeks. Patients can continue treatment with Lynparza until radiological disease progression, unacceptable toxicity or for up to 2 years if there is no radiological evidence of disease after 2 years of treatment. Patients with evidence of disease at 2 years, who in the opinion of the treating physician can derive further benefit from continuous Lynparza treatment, can be treated beyond 2 years. Please refer to the product information for bevacizumab for the recommended overall duration of treatment of a maximum of 15 months including the periods in combination with chemotherapy and as maintenance; for maintenance treatment of platinum sensitive relapsed ovarian cancer, start no later than 8 weeks after completion of their final dose of the platinum‑containing regimen, continue until progression of the underlying disease or unacceptable toxicity; for gBRCA1/2-mutated high risk early breast cancer, treat for up to 1 year, or until disease recurrence, or unacceptable toxicity, whichever occurs first; for gBRCA1/2-mutated HER2-negative metastatic breast cancer, continue until progression of the underlying disease or unacceptable toxicity; for first-line maintenance treatment of gBRCA-mutated metastatic adenocarcinoma of the pancreas, it is recommended that treatment be continued until progression of the underlying disease or unacceptable toxicity; for BRCA1/2-mutated mCRPC, it is recommended that treatment be continued until progression of the underlying disease or unacceptable toxicity. Medical castration with luteinising hormone releasing hormone (LHRH) analogue should be continued during treatment in patients not surgically castrated; for mCRPC in combination with abiraterone and prednisone or prednisolone, it is recommended that treatment be continued until progression of the underlying disease or unacceptable toxicity. Treatment with a gonadotropin-releasing hormone (GnRH) analogue should be continued during treatment in all patients, or patients should have had prior bilateral orchiectomy. Please refer to the product information for abiraterone; swallow whole and do not chew, crush, dissolve or divide tablets. Lynparza tablets should not be substituted for Lynparza capsules on a milligram-to-milligram basis. Contraindications: Hypersensitivity to any of its ingredients, during breast-feeding and for one month after last dose. Precautions: Should not be used in patients with haematological toxicity, pregnancy. Women should not become pregnant while on Lynparza and at the beginning of treatment. Male patients and their female partners of childbearing potential should use reliable contraception during therapy and for 3 months after receiving the last dose of Lynparza. Risk of myelodysplastic syndrome/acute myeloid leukemia, pneumonitis, embryofoetal toxicity, venous thromboembolic events and hepatotoxicity. Cautious use in patients on statins, vaccines, immunosuppressant agents. May affect ability to drive or use machines. Interactions: Other anticancer medications; CYP3A inhibitors and inducers; substrates of CYP1A2, 2B6, 3A4; substrates of P-gp, BCRP, OATP1B1, OCT1, OCT2, OAT3, MATE1 and MATE2K; hormonal contraceptives. Undesirable effects: (Very Common≥10%) nausea, fatigue, anaemia, vomiting, diarrhoea, decreased appetite, headache, cough, dysgeusia, dyspnoea, neutropenia, dizziness, dyspepsia, leukopenia and thrombocytopenia. (Common ≥1 - <10%) lymphopenia, stomatitis, upper abdominal pain, rash, increased blood creatinine and transaminases increased. Full local prescribing information is available upon request.  API.HK.LT.0524​​

HK-11914 05/06/2025