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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

cies 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 discontinuation of PROMACTA. Liver tests: Monitor serum liver tests (ALT, AST, total and fractionated bilirubin) prior to initiation of PROMACTA, every 2 weeks during the dose adjustment phase, and monthly following establishment of a stable dose. If abnormal levels are detected, repeat the tests within 3 to 5 days. If the abnormalities are confirmed, monitor serum liver tests weekly until the abnormality(ies) resolve, stabilize, or return to baseline levels. Discontinue PROMACTA for the development of clinically important liver test abnormalities.

Cataracts: In the controlled clinical studies, cataracts developed or worsened in five patients (5%) who received 50 mg PROMACTA daily and two placebo-group patients (3%). In the extension study, cataracts developed or worsened in 4% of patients who underwent ocular examination prior to therapy with PROMACTA. Cataracts were observed in toxicology studies of eltrombopag in rodents. Perform a baseline ocular examination prior to administrati
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SOURCE GlaxoSmithKline
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