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Adverse event reporting can be found at the bottom of the page
The content of this website has been produced in line with the Talzenna®▼ Summary of Product Characteristics for Great Britain and Northern Ireland. Talzenna® (talazoparib) Prescribing Information for Great Britain and Northern Ireland click here. Adverse event reporting information can be found at the bottom of the page.
Myelosuppression consisting of anaemia, leukopenia/ neutropenia and/or thrombocytopenia have been reported in patients treated with TALZENNA® (see section 4.8 of the TALZENNA® SmPC).1
TALZENNA® should not be started until patients have recovered from haematological toxicity caused by previous therapy (≤Grade 1).1
Precautions should be taken to routinely monitor haematology parameters and signs and symptoms associated with anaemia, leukopenia/neutropenia and/or thrombocytopenia in patients receiving TALZENNA®. If such events occur, dose modifications (reduction or interruption) are recommended (see section 4.2 of the TALZENNA® SmPC or Monitoring and managing patients section on page 28). Supportive care with or without blood and/or platelet transfusions and/or administration of colony stimulating factors may be used as appropriate.1
MDS/AML has been reported in patients who received PARP inhibitors, including TALZENNA®. Overall, MDS/AML has been reported in <1% of patients with solid tumours treated with TALZENNA® in clinical studies (see section 4.8 of the TALZENNA® SmPC). Potential contributing factors for the development of MDS/AML include previous platinum-containing chemotherapy, other DNA-damaging agents or radiotherapy.1
Full blood count should be obtained at baseline and monitored monthly for signs of haematological toxicity during treatment. If MDS/AML is confirmed, TALZENNA® should be discontinued.1
TALZENNA® was clastogenic in an in vitro chromosomal aberration assay in human peripheral blood lymphocytes and in an in vivo bone marrow micronucleus assay in rats but not mutagenic in Ames assay (see section 5.3 of the TALZENNA® SmPC), and may cause foetal harm when administered to a pregnant woman.1
Pregnant women should be advised of the potential risk to the foetus (see section 4.6 of the TALZENNA® SmPC). Women of childbearing potential should not become pregnant while receiving TALZENNA® and should not be pregnant at the beginning of treatment. A pregnancy test should be performed on all women of childbearing potential prior to treatment.1
A highly effective method of contraception is required for female patients during treatment with TALZENNA®, and for at least 7 months after completing therapy. Since the use of hormonal contraception is not recommended in patients with breast cancer, two non-hormonal and complementary contraception methods should be used (see section 4.6 of the TALZENNA® SmPC).1
Male patients with female partners of reproductive potential or pregnant partners should be advised to use effective contraception (even after vasectomy), during treatment with TALZENNA® and for ≥4 months after the final dose.1
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SmPC.1
Breast feeding
It is unknown whether TALZENNA® is excreted in human breast milk. A risk to breast-fed children cannot be excluded and therefore breast feeding is not recommended during treatment with TALZENNA® and for at least 1 month after the final dose.1
Please refer to the TALZENNA® SmPC for full safety profile information and guidance on the management of treatment-related adverse events.
AML, acute myeloid leukaemia; BCRP, breast cancer resistance protein; BRCA, breast cancer susceptibility gene; mCRPC, metastatic castration-resistant prostate cancer; MDS, myelodysplastic syndrome; P-gp, P-glycoprotein
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search
for MHRA Yellow Card in Google Play or Apple App Store
Adverse events should also be reported to Pfizer Medical Information on 01304 616161
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PP-UNP-GBR-7812. January 2024