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2005 Safety Alert: Agrylin (anagrelide hydrochloride)

Feb 9, 2005 | www.fda.gov

Dear Healthcare Professional:

As part of our ongoing efforts to provide updated information to physicians, Shire would like to inform you of recent changes to the prescribing information for Agrylin (anagrelide hydrochloride), a medication approved for use in the US for the treatment of thrombocythemia secondary to myeloproliferative disorders to reduce platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombohemorrhagic events.

Pharmacokinetic studies have revealed an 8-fold increase in total exposure (AUC) to anagrelide hydrochloride in patients with moderate hepatic impairment. Although use of anagrelide hydrochloride has not been studied in patients with severe hepatic impairment, based upon the results from these pharmacokinetic studies, changes have been made to the Agrylin Prescribing Information. These changes include the addition of a Contraindications section to contraindicate the use of Agrylin (anagrelide hydrochloride) in patients with severe hepatic impairment. The Warnings section (which previously contained information regarding hepatically impaired patients) and the Clinical Pharmacology section have been updated to include this new information. The updated Warnings section also notes the need for dosage reduction in patients with moderate hepatic impairment and the necessity of monitoring these patients carefully for cardiovascular effects.

Additionally, new information is provided in the Clinical Pharmacology and Drug Interactions sections regarding use in renally impaired patients, and patients concomitantly taking aspirin, as well as information regarding the effect of food.

Please refer to the enclosed Prescribing Information to review the above-outlined changes. Should you have any questions or require additional information, please contact Shire's Medical Information Group at 1-800-828-2088.

Sincerely.

Dr. Jeffrey Freid
Senior US Pharmacovigilance Director
Shire Development Inc.


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