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U.S. Department of Health and Human Services

Safety

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Agrylin (anagrelide hydrochloride)

Audience: Hematology/Oncology and other healthcare professionals

Shire and FDA notified healthcare professionals about changes to the CONTRAINDICATIONS and WARNINGS sections of the prescribing information for Agrylin (anagrelide hydrochloride), a medication approved 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. Use of anagrelide hydrochloride has not been studied in patients with severe hepatic impairment. Labeling changes include the contraindication to the use of Agrylin in patients with severe hepatic impairment. The WARNINGS section describes the need for dosage reduction in patients with moderate hepatic impairment and the necessity of monitoring these patients carefully for cardiovascular effects.

[January 2005 - Letter - Shire Development Inc.]
[December 2004 - Label - Shire Development Inc.]