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Eisai Inc. Supports Acting Surgeon General's Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism
Date:9/15/2008

for extended treatment of symptomatic VTE, due to an increased risk of bleeding associated with the dosage of FRAGMIN(R) recommended for these indications.

FRAGMIN(R) Injection is not intended for intramuscular administration.

FRAGMIN(R) cannot be used interchangeably (unit for unit) with unfractionated heparin or other low-molecular-weight heparins.

FRAGMIN(R), like other anticoagulants, should be used with extreme caution in patients who have an increased risk of hemorrhage; bleeding can occur at any site during therapy. An unexpected drop in hematocrit or blood pressure should lead to a search for a bleeding site.

FRAGMIN(R) should be used with extreme caution in patients with history of heparin-induced thrombocytopenia.

In FRAGMIN(R) clinical trials supporting non-cancer indications, platelet counts of <100,000/mm3 and <50,000/mm3 occurred in <1% and <1%, respectively.

In a clinical trial of patients with cancer and acute symptomatic VTE treated for up to 6 months in the FRAGMIN(R) treatment arm, platelet counts of <100,000/mm3 occurred in 13.6% of patients, including 6.5% who also had platelet counts less than 50,000/mm3. In the same clinical trial, thrombocytopenia was reported as an adverse event in 10.9% of patients in the FRAGMIN(R) arm and 8.1% of patients in the oral anticoagulant arm. FRAGMIN(R) dose was decreased or interrupted in patients whose platelet counts fell below 100,000/mm3.

Thrombocytopenia of any degree should be monitored closely. Heparin- induced thrombocytopenia can occur with administration of FRAGMIN(R). The incidence of this complication is unknown at present. In clinical practice, rare cases of thrombocytopenia with thrombosis have also been observed.

FRAGMIN(R) should be used in caution in patients with bleeding diathesis, thrombocytopenia or platelet defects; severe liver or kidney insufficiency, hypertensive or diabetic retinopathy, and recent gastrointestinal bleeding.

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