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 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 administration of PROMACTA and, during therapy with PROMACTA, regularly monitor patients for signs and symptoms of cataracts.
About GlaxoSmithKline
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GlaxoSmithKline at www.gsk.com.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company's Annual Report on Form 20-F for 2007.
References:
1. US Food and Drug Administration. The Orphan Drug act (as amended). Accessed November 18, 2008. http://www.fda.gov/orphan/oda.htm
2. George, JN. Management of patients with refractory immune thrombocytopenic purpura. J Thromb. Haemost. 2006;4(8):1664-72.
3. National Heart, Lung, and Blood Institute. Diseases and Conditions Index. http://www.nhlbi.nih.gov/health/dci/Diseases/Itp/ITP_WhatIs.html. Accessed October 22, 2008.
4. Feudjo-Tepie M, Robinson N, Bennett D. Prevalence estimates of adult chronic idiopathic thrombocytopenic purpura (ITP). J Thromb Haemost. 2008; 6(4): 711 - 712.
SOURCE GlaxoSmithKline
/CONTACT: UK Media enquiries: Philip Thomson, Claire Brough, Alice Hunt or Gwenan White, 020 8047 5502; US Media enquiries: Nancy Pekarek, +1-919-483-2839, Mary Anne Rhyne, +1-919-483-2839, Sarah Alspach, +1-215-751-7709, or Ken Inchausti, +1-215-751-4294; European Analyst/Investor enquiries: David Mawdsley, 020 8047 5564, Sally Ferguson, 020 8047 5543, or Gary Davies, 020 8047 5503; US Analyst/ Investor enquiries: Tom Curry, +1-215-751-5419, all of GlaxoSmithKline
/Web site: http://www.gsk.com
/Web site: http://www.PROMACTACARES.com
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(END) Dow Jones Newswires
November 20, 2008 17:59 ET (22:59 GMT)

Publié le 20 novembre 2008 Copyright © 2008 Dowjones