FDA Approves Promacta(R) (Eltrombopag), the First Oral Medication to Increase Platelet Production for People With Serious Bloo...(urrent treatment guidelines. .....),Health

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 > / = 50 x 10(9)/L.

Malignancies and Progression of Malignancies: Stimulation of the TPO receptor on the surface of hematopoietic cells may increase the risk for hematologic malignancies. PROMACTA is not indicated for the treatment of thrombocytopenia due to causes of thrombocytopenia (e.g, myelodysplasia or chemotherapy) other than chronic ITP.

Laboratory Monitoring:Complete Blood Counts (CBCs) - Monitor CBCs, including platelet counts and WBC differentials prior to initiation, throughout, and following discontinuation of PROMACTA therapy. Prior to the initiation of PROMACTA, examine the peripheral blood differential to establish the extent of red and white blood cell abnormalities. Obtain CBCs, including platelet counts and peripheral blood smears, weekly during the dose adjustment phase of therapy with PROMACTA and then monthly following establishment of a stable dose of PROMACTA. Obtain CBCs, including platelet counts, weekly for at least 4 weeks following discontin
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