SUMMARY

• No dosage adjustment for AKEEGA is necessary in patients with mild hepatic impairment. Do not use AKEEGA in patients with moderate to severe hepatic impairment. Please refer to local labeling for additional considerations.¹
• In MAGNITUDE, the phase 3 study evaluating the efficacy and safety of AKEEGA with prednisone as first-line (L1) therapy in metastatic castration-resistant prostate cancer (mCRPC) for patients with certain homologous recombination repair (HRR) mutations, including BRCA1/2, patients with active or symptomatic viral hepatitis or chronic liver disease (as evidenced by ascites, encephalopathy, or bleeding disorders secondary to hepatic dysfunction) were excluded.^2,3

Clinical Data

There are no data available on the administration of AKEEGA in patients with moderate to severe hepatic impairment.¹

MAGNITUDE Study

Chi et al (2023)^3-5 and Efstathiou et al (2023)⁶ reported the efficacy and safety of AKEEGA with prednisone in patients with mCRPC with HRR mutations including BRCA1/2. Patients with active or symptomatic viral hepatitis or chronic liver disease (as evidenced by ascites, encephalopathy, or bleeding disorders secondary to hepatic dysfunction) were excluded from the study.²

Efficacy and safety analyses were not specifically reported for patients with hepatic impairment in the MAGNITUDE study.

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 11 March 2025. Summarized in this response are relevant data limited to the phase 3 MAGNITUDE study in patients with mCRPC.