ASH News Daily - Saturday, December 10, 2011 - (Page C-16)

Trim: 10” Live: 9” C UNTS Evidence. Experience. Efficacy.1-6 Nplate® is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Nplate® is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than chronic ITP. Nplate® should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. Nplate® should not be used in an attempt to normalize platelet counts. Trim: 14” Live: 13” WHAT IN CHRONIC ITP Live rep support. Clinical data. Patient resources. Visit www.NplateHCP.com/Avisit IMPORTANT SAFETY INFORMATION ■ In Nplate® clinical trials of patients with myelodysplastic syndromes (MDS) and severe thrombocytopenia, progression from MDS to acute myelogenous leukemia (AML) has been observed. Nplate® is not indicated for the treatment of thrombocytopenia due to MDS or any cause of thrombocytopenia other than chronic ITP. ■ Additional serious adverse reactions associated with Nplate® are Thrombotic/Thromboembolic Complications, Bone Marrow Reticulin Formation and Risk for Bone Marrow Fibrosis, Worsened Thrombocytopenia after Cessation of Nplate®, and Lack or Loss of Response to Nplate®. ■ Monitor CBC’s, including platelet counts and peripheral blood smears, prior to initiation, throughout, and following discontinuation of Nplate® therapy. ■ Nplate® is available only through a restricted distribution program called Nplate® NEXUS (Network of Experts Understanding and Supporting Nplate® and Patients) Program. ■ In the placebo-controlled studies, headache was the most commonly reported adverse drug reaction. Please see Brief Summary of Prescribing Information on adjacent page. References: 1. Nplate® (romiplostim) prescribing information, Amgen. 2. Kuter DJ, Bussel JB, Lyons RM, et al. Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial. Lancet. 2008;371:395-403. 3. Kuter DJ, Rummel M, Boccia R, et al. Romiplostim or standard of care in patients with immune thrombocytopenia. N Engl J Med. 2010;363:1889-1899. Online Supplementary Appendix. http://www.nejm.org. Accessed March 10, 2011. 4. Bussel JB, Kuter DJ, Pullarkat V, Lyons RM, Guo M, Nichol JL. Safety and efficacy of long-term treatment with romiplostim in thrombocytopenic patients with chronic ITP. Blood. 2009;113:2161-2171. 5. Kuter DJ, Bussel JB, Newland A, et al. Long-term efficacy and safety of romiplostim treatment of adult patients with chronic immune thrombocytopenia (ITP): final report from an open-label extension study. Blood. 2010;116:Abstract 68. Presented at 52nd American Society of Hematology Annual Meeting and Exposition; Orlando, FL; December 4-7, 2010. 6. Data on file, Amgen. © 2011 Amgen Inc. All rights reserved. 60619-R1-V1 08/11 1AMUS037_ASHNewsDaily_D01_TabP4C.indd 1 8/16/11 9:18 AM 

Table of Contents for the Digital Edition of ASH News Daily - Saturday, December 10, 2011

ASH News Daily - Saturday, December 10, 2011

https://www.nxtbookmedia.com