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GSK Reports PROMACTA(R) (eltrombopag) Significantly Increased Platelet Counts and Reduced Bleeding in Long-Term Study of Patients With Chronic ITP
Date:12/6/2008

After PROMACTA Cessation: Discontinuation of PROMACTA may result in thrombocytopenia of greater severity than was present prior to therapy with PROMACTA. This worsened thrombocytopenia may increase the patient's risk of bleeding, particularly if PROMACTA is discontinued while the patient is on anticoagulants or antiplatelet agents. In the controlled clinical studies, transient decreases in platelet counts to levels lower than baseline were observed following discontinuation of treatment in 10% and 6% of the PROMACTA and placebo groups, respectively. Serious hemorrhagic events requiring the use of supportive ITP medications occurred in 3 severely thrombocytopenic patients within one month following the discontinuation of PROMACTA; none were reported among the placebo group. Following discontinuation of PROMACTA, obtain weekly CBCs, including platelet counts for at least 4 weeks and consider alternative treatments for worsening thrombocytopenia, according to current treatment guidelines.

Thrombotic/Thromboembolic Complications: Thrombotic/thromboembolic complications may result from excessive increases in platelet counts. Excessive doses of PROMACTA or medication errors that result in excessive doses of PROMACTA may increase platelet counts to a level that produces thrombotic/thromboembolic complications. In the controlled clinical studies, one thrombotic/thromboembolic complication was reported within the group that received PROMACTA and none within the placebo group. Seven patients experienced thrombotic/thromboembolic complications in the extension study. Use caution when administering PROMACTA to patients with known risk factors for thromboembolism. To minimize the risk for thrombotic/thromboembolic complications, do not use PROMACTA in an attempt to normalize platelet counts. Follow the dose adjustment guidelines to achieve and maintain a platelet count of greater than or equal to 50,000/microliters.

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SOURCE GlaxoSmithKline
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