N PLATE 250 MCG 1 VIAL

* Nplate (Romiplostim) 250 mcg (micrograms) powder for solution for injection 1 vial. Subcutaneous use.

* Therapeutic 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 non-splenectomised patients where surgery is contra-indicated.

* Pharmacotherapeutic group:
Antihaemorrhagics, other systemic hemostatics, ATC code: B02BX04

* Mechanism of action:
Romiplostim is an Fc-peptide fusion protein (peptibody) that signals and activates intracellular transcriptional pathways via the TPO receptor (also known as cMpl) to increase platelet production. The peptibody molecule is comprised of a human immunoglobulin IgG1 Fc domain, with each single-chain subunit covalently linked at the C-terminus to a peptide chain containing 2 TPO receptor-binding domains.
Romiplostim has no amino acid sequence homology to endogenous TPO. In pre-clinical and clinical trials no anti-romiplostim antibodies cross reacted with endogenous TPO.

* Vial containing 250 micrograms of romiplostim. After reconstitution, a deliverable volume of 0.5 ml solution contains 250 micrograms of romiplostim (500 micrograms/ml).
Mannitol (E421), sucrose, l-histidine, hydrochloric acid (for pH adjustment) and polysorbate 20.

* Store in a refrigerator (2-8 degrees C). Do not freeze. Store in the original carton in order to protect from light.
After reconstitution: 24 hours when stored at 25 degrees C or in a refrigerator (2-8 degrees C) if kept in the original vial and protected from light.

* Read the package leaflet before use. Keep out of the reach and sight of children.

* Medicinal product subject to medical prescription (POM). List I. Prescription only.

* AMGEN Europe B.V., Minervum 7061, 4817 ZK Breda – The Netherlands.