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Adverse event reporting can be found at the bottom of the page
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For TALZENNA® (talazoparib) Prescribing Information click here.
Example
TALZENNA® ADMINISTRATION GUIDELINES
The recommended dose is 0.5mg talazoparib in combination with 160mg enzalutamide once daily.1
Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.1
Please refer to the enzalutamide Summary of Product Characteristics (SmPC) for recommended dosing information and dose adjustment guidance due to adverse events related to enzalutamide.
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DOSE MODIFICATION
TALZENNA® offers flexible dosing options for patients who require dose modification.1
To manage adverse reactions, consider interruption of treatment with or without dose reduction based on severity and clinical presentation.1
Treatment with TALZENNA® should be discontinued if more than three dose reductions are required.1
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No dose adjustment for mild or moderate hepatic impairment. TALZENNA® in combination with enzalutamide is not recommended for use in patients with severe hepatic impairment (Child-Pugh classification C) due to lack of data.1
For Patients with Mild Renal Impairment: (60 mL/min ≤ CrCL< 90 mL/min), no dose adjustment is necessary.1
For Patients with Moderate Renal Impairment: (30 mL/min ≤ CrCL < 60 mL/min), the recommended dose of TALZENNA® is 0.35 mg once daily in combination with enzalutamide orally once daily.1
For Patients with Severe Renal Impairment: (15 mL/min ≤ CrCL < 30 mL/min), the recommended dose of TALZENNA® is 0.25 mg once daily in combination with enzalutamide orally once daily.1
No data in patients with CrCL < 15 mL/min or patients requiring haemodialysis.1
The effect of coadministration of P-gp inhibitors on talazoparib exposure when talazoparib is given in combination with enzalutamide has not been studied. If coadministration of P-gp inhibitors cannot be avoided, when TALZENNA® is given with enzalutamide, the patient should be monitored for potential increased adverse reactions.1
No TALZENNA® dose adjustments are required when co-administered with rifampin. However, the effect of other P-gp inducers has not been studied and may decrease TALZENNA® exposure if co-administered.1
Coadministration of BCRP inhibitors may increase talazoparib exposure. If coadministration cannot be avoided, monitor patients for potential increased adverse reactions.1
The following dose modifications for TALZENNA® may help manage adverse reactions.1
Example
Figure adapted from TALZENNA® Summary of Product Characteristics for United Kingdom.1
The TALAPRO-2 study protocol allowed for the use of supportive care growth factors and/or transfusions to help manage anaemia or other cytopenia-related adverse reactions.2
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Abbreviations:
P-gp - P-glycoprotein, BCRP - Breast Cancer Resistance Protein, CrCL - Creatinine Clearance
1. TALZENNA® (talazoparib) Summary of Product Characteristics for United Kingdom available on www.medicines.org.uk
2. Agarwal N, Azad AA, Carles J, et al. Talazoparib plus enzalutamide in men with first-line metastatic castration-resistant prostate cancer (TALAPRO-2): a randomised, placebo-controlled, phase 3 trial. Lancet 2023;1-13. [Accessed: May 2025].
PP-TXT-GBR-0038 June 2025
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Adverse events should also be reported to Pfizer Medical Information on 01304 616161
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PP-UNP-GBR-13971. December 2025