Cyproterone

Danger

H351 (100%): Suspected of causing cancer [Warning Carcinogenicity]

P203, P280, P318, P405, and P501 (click each P-code to see the statement)

The GHS information provided by 1 company from 1 notification to the ECHA C&L Inventory.

Cyproterone has been associated with serum enzyme elevations during therapy in 10% to 14% of patients, but these elevations are usually transient and mild and often resolve even without dose modification. More importantly, cyproterone has been associated with many instances of clinically apparent liver injury with jaundice. The time to onset has ranged from a few months to as long as a year, but typically arises within 3 to 6 months of starting treatment. The liver injury is almost always hepatocellular with moderate to marked elevations in serum aminotransferase levels and minimal increases in alkaline phosphatase. Mixed and more cholestatic injury occurs occasionally and may have a more favorable prognosis. Importantly, the hepatocellular injury associated with cyproterone use is often severe and the mortality rate of patients presenting with jaundice is at least 10% (these patients frequently being elderly men with advanced prostate cancer and not qualifying for emergency liver transplantation). Immunoallergic features (fever, rash, eosinophilia) are uncommon, as are autoantibodies. Some patients, however, appear to respond to corticosteroid therapy and rare instances of autoimmune-hepatitis like injury have been attributed to cyproterone. Improvement is usually seen within 1 to 2 weeks of stopping cyproterone and resolution within 1 to 3 months. Nevertheless, many examples of progressive liver injury leading to death from hepatic failure despite prompt discontinuation of therapy have been reported. In rare cases, recovery has been incomplete and patients have had residual evidence of chronic liver disease or cirrhosis.

G03HA01

G - Genito urinary system and sex hormones

QG - Genito urinary system and sex hormones