The prescribing information for Talzenna (talazoparib; Pfizer) has been updated to include recommendations for patients with severe renal impairment.

Talzenna, a poly (ADP-ribose) polymerase inhibitor, is indicated for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer. Patients with moderate or severe renal impairment have a higher exposure to Talzenna than patients with normal renal function and therefore require a dose reduction. 

Previously, dosing for patients with severe renal impairment (CrCl 15-29mL/min) had not been established, however based on new pharmacokinetic data, the updated labeling states that a dose of 0.5mg once daily is recommended for these patients. In addition, patients with severe renal impairment should be monitored for potential increased adverse reactions and the dose should be adjusted accordingly. Talzenna has not been studied in patients requiring hemodialysis.

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The product is available in 0.25mg and 1mg capsules. The 0.25mg capsule is available for dose reduction.

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