News Release

Launch of Nplate in Taiwan

October 31, 2013

Taipei, Taiwan, October 31, 2013 --- Kyowa Hakko Kirin Taiwan Co., Ltd., (General Manager: Yu, Kuo Jung; "Kyowa Hakko Kirin Taiwan") announced today that Nplate injection has launched since October 21, 2013 (nonproprietary name: Romiplostim; referred to below as "Nplate") in Taiwan.

Nplate, a genetically recombinant protein, stimulates platelet production via stimulation of the thrombopoietin receptors. In domestic and overseas clinical trials on patients with chronic Idiopathic Thrombocytopenic Purpura (ITP) it demonstrated effectiveness for sustained platelet production and patient tolerance.

Chronic ITP is normally treated with pharmaceuticals that improve blood platelet count by suppressing platelet destruction, but Nplate serves to improve platelet counts by stimulating platelet production. With the launch of Nplate in Taiwan, Kyowa Hakko Kirin Taiwan hopes to assist patients and medical professionals by providing a new treatment option for chronic ITP.

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Product summary for Nplate
Brand name Nplate injection
Nonproprietary name Romiplostim
Indications Nplate is indicated for adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) splenectomised patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).
Nplate may be considered as second line treatment for adult ITP non-splenectomised patients where surgery is contra-indicated.
Limitations of Use:
• 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.
Dosage and administration Treatment should remain under the supervision of a physician who is experienced in the treatment of haematological diseases. Use the lowest dose of Nplate to achieve and maintain a platelet count ≥ 50×109/L as necessary to reduce the risk for bleeding. The prescribed Nplate dose may consist of a very small volume (eg, 0.15 mL). Administer Nplate only with a syringe that contains 0.01 mL graduations.
Package 1 vial/box

The information on this website regarding Nplate is not intended for audience outside of, or to imply indication not approved in Taiwan. Nplate is a registered trademark of Amgen Inc.

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