Summary

• There is no clinical experience reported in patients with prostate cancer and severe renal impairment receiving AKEEGA. Caution is advised in these patients.¹
• No dose adjustment for AKEEGA is recommended in patients with mild to moderate renal impairment.¹ Please refer to local labeling for additional considerations.
• In MAGNITUDE, the phase 3 study evaluating the efficacy and safety of AKEEGA with prednisone compared to placebo/abiraterone acetate with prednisone (AAP) as first-line (L1) therapy in metastatic castration-resistant prostate cancer (mCRPC) for patients with certain homologous recombination repair (HRR) mutations, including BRCA1/2^2-5:
  • Renal and urinary treatment-emergent adverse events (TEAEs) leading to dose reduction were reported in the HRR+ cohort. Chronic kidney disease occurred in 1 patient (0.5%) in the niraparib/AAP group vs 0 patients in the placebo/AAP group at the first interim analysis after a median follow-up of 18.6 months. Renal impairment occurred in 1 patient (0.5%) in the niraparib/AAP group vs 0 patients in the placebo/AAP group.⁶

LITERATURE SEARCH

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) conducted on 17 July 2025 did not identify any relevant citations pertaining to this topic in patients with prostate cancer.