LYNPARZA (olaparib)

LynparzaTM (olaparib) is a first‐in‐class PARP inhibitor (PARPi) that allows women with BRCA mutated (BRCAm) platinum‐sensitive relapsed high-grade serous ovarian cancer to extend progression‐free survival (PFS).1-3

Prescribing Information

Warnings and Precautions

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients listed in SmPC.
  • Breast-feeding during treatment and 1 month after the last dose.

Special warnings and precautions for use:

Haematological toxicity has been reported in patients treated with Lynparza. Patients should not start treatment with Lynparza until they have recovered from haematological toxicity caused by previous anticancer therapy.4

  • Baseline testing, followed by monthly monitoring, of complete blood counts is recommended for the first 12 months of treatment and periodically after this time to monitor for clinically significant changes in any parameter during treatment.
  • If a patient develops severe haematological toxicity or blood transfusion dependence, treatment with Lynparza should be interrupted and appropriate haematological testing should be initiated. If the blood parameters remain clinically abnormal after 4 weeks of Lynparza dose interruption, bone marrow analysis and/or blood cytogenetic analysis are recommended.4

Myelodysplastic syndrome/Acute Myeloid Leukaemia (MDS/AML) have been reported in a small number of patients who received Lynparza alone or in combination with other anticancer drugs; the majority of cases have been fatal.4

  • If MDS and/or AML are confirmed while on treatment with Lynparza, it is recommended that the patient be treated appropriately. If additional anticancer therapy is recommended, Lynparza should be discontinued and not given in combination with other anticancer therapy.4

Pneumonitis has been reported in a small number of patients receiving Lynparza, and some reports have been fatal.4

  • If patients present with new or worsening respiratory symptoms such as dyspnoea, cough and fever, or a radiological abnormality occurs, Lynparza treatment should be interrupted and prompt investigation initiated. If pneumonitis is confirmed, Lynparza treatment should be discontinued and the patient treated appropriately.4

Based on its mechanism of action (PARP inhibition), Lynparza could cause foetal harm when administered to a pregnant woman.4

Lynparza should not be used during pregnancy and in women of childbearing potential not using reliable contraception during therapy and for 1 month after receiving the last dose of Lynparza (see section 4.6 of Summary of Product Characteristics).4

Lynparza co-administration with strong CYP3A inducers or inhibitors should be avoided.4 If co-administration with a strong or moderate CYP3A inhibitor must occur, the dose of Lynparza must be reduced. Co-administration with CYP3A inducers may substantially reduce Lynparza efficacy. It is also not recommended to consume grapefruit juice while on olaparib therapy. P-gp inhibitors may increase exposure to olaparib.4

For full dosing and safety information, please click here to see the Summary of Product Characteristics.4