Page 60 - mCSPC EN Booklet-Feb 2021 Web

Liver Function Test Abnormalities
(with abiraterone)

Abiraterone-associated • Drug-associated hepatoxicity with elevated AST/ALT and
Liver Toxicity total bilirubin
• Grade 3 or 4 hepatoxicity was observed in ~8% of patients in
STAMPEDE (newly diagnosed high-risk mCSPC)
Baseline Assessment • AST, ALT, and bilirubin

Monitoring • AST, ALT and bilirubin every 2 weeks, for first 3 months
of therapy

Treatment-emergent • If clinical symptoms or signs of hepatotoxicity
Hepatotoxicity – Measure AST, ALT, and bilirubin promptly
• If ALT or AST rises >5 x ULN or bilirubin rises >3 x ULN,
withhold treatment until LFTs normalize
– Following return of LFTs to baseline, re-treat at reduced
dose of 500 mg once daily
– For patients being re-treated, monitor liver enzymes
and bilirubin at least every 2 weeks for 3 months and
monthly thereafter
• Discontinue abiraterone if:
– Hepatoxicity recurs at reduced dose
– Patient develops severe hepatoxicity (ALT 20 x ULN)
anytime while on therapy (do not retreat)
– Patient develops concurrent elevation of ALT >3 x ULN
and total bilirubin >2 x ULN in absence of causes
responsible for the concurrent elevation

54 Practical Approaches to Managing mCNPC and mCSPC