Pharmacy Services
Anagrelide (Agrylin) exposure increased in patients with hepatic impairment, contraindicated in severe hepatic impairment
February 10, 2005
Total drug exposure (AUC) increases 8-fold when anagrelide (Agrylin) is given to patients with moderate hepatic impairment, compared to patients with normal hepatic function. Dosage reduction and increased monitoring are recommended in moderate hepatic impairment. Although anagrelide has not been studied in patients with severe hepatic impairment, a greater increase in total drug exposure would be expected. Anagrelide is contraindicated in severe hepatic impairment.
The FDA has issued a MedWatch safety alert and Shire has updated the product labeling with this information. Additional information is available online at the following links:
- MedWatch Alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150600.htm - Letter to Healthcare Professionals:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm164135.htm - Revised Product Labeling:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20333s010lbl.pdf
Updated
February 10, 2005; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
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