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.

Want news like this straight to your inbox?
Sign up for our bulletins

Have you registered with us yet?

Register now to enjoy more articles and free email bulletins

Register
Already registered?
Sign in

MIMS Product Slides

Product overviews prepared by the MIMS team, in a handy slide format.

Click here

Slides are initiated, funded & reviewed by the companies specified.

Register or Subscribe to MIMS

GPs can get MIMS print & online and GPonline for free when they register online – take 2 minutes, and make sure you get your free MIMS access! If you're not a GP, you can subscribe to MIMS for full access.

Register or subscribe

MIMS Dermatology

Read the latest issue online exclusively on MIMS Learning.

Read MIMS Dermatology

MIMS Adviser

Especially created for prescribing influencers.

Request free copy

Mobile apps

MIMS: access the full drug database and quick-reference tables on the go

MIMS Diagnosis and Management: concise information on signs and symptoms, investigations and diseases