Ketoconazole HRA for Cushing's syndrome: hepatoxicity risk

Ketoconazole HRA is a new treatment option for endogenous Cushing's syndrome. Monitoring of liver function is mandatory owing to the risk of hepatotoxicity.

Ketoconazole HRA is licensed for use in adults and adolescents over 12 years of age.
Ketoconazole HRA is licensed for use in adults and adolescents over 12 years of age.

Following the launch of Ketoconazole HRA, the manufacturer HRA Pharma has sent a letter to healthcare professionals highlighting the risk of hepatotoxicity and reiterating the monitoring requirements detailed in the SPC.

The letter reminds prescribers that to reduce the risk of severe hepatic injury, monitoring of LFTs is mandatory in all patients before treatment initiation and periodically thereafter.

Further information
Letter to healthcare professionals

Ketoconazole HRA is contraindicated in patients with acute or chronic liver disease and/or if pre-treatment liver enzyme levels are above two times the upper limit of normal (ULN).

Although hepatotoxicity is usually observed at treatment initiation and within the first six months of treatment, after this time monitoring of liver enzymes should be continued as clinically appropriate and on a weekly basis for a minimum of one month whenever the dose is increased. Treatment should be discontinued if liver enzyme levels rise to three times the ULN or if clinical symptoms of hepatitis develop.

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