Generic Name and Formulations:
Romiplostim (recombinant) 250mcg, 500mcg; per vial; lyophilized pwd for SC inj after reconstitution; contains sucrose and mannitol; preservative-free.

Company:
Amgen, Inc.
Indications for NPLATE:
Thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

Adult:
Give by SC inj. To reduce risk of bleeding: use lowest effective dose to achieve and maintain platelets ≥50x109/L. ≥18yrs: initially: 1mcg/kg weekly; may increase by 1mcg/kg if platelets <50x109/L; max: 10mcg/kg weekly. May reduce by 1mcg/kg if platelets >200x109/L for 2 consecutive weeks. Do not dose if platelets >400x109/L; resume Nplate at a dose reduced by 1mcg/kg when platelets fall to <200x109/L. Discontinue if platelets have not increased after 4 weeks at max dose.

Children:
<18yrs: not recommended.

Pharmacological Class:
Thrombopoietin receptor agonist.

Warnings/Precautions:
Not for normalization of platelet counts or to treat thrombocytopenia due to MDS or any cause of thrombocytopenia other than chronic ITP. Risk of bone marrow fibrosis with cytopenias. Worsened thrombocytopenia after discontinuation. Monitor CBCs, platelets, and peripheral blood smears before and weekly during dose adjustments then monthly after achieving stable dose; and weekly for 2 weeks after discontinuation of therapy. Monitor after initial response for formation of neutralizing antibodies. Risk of hematologic malignancies (esp. myelodysplastic syndrome). Renal or hepatic impairment. Elderly. Pregnancy (Cat.C). Nursing mothers.

Interactions:
May increase bleeding risk with anticoagulants or antiplatelet agents.

Adverse Reactions:
Arthralgia, dizziness, insomnia, myalgia, pain in extremity, abdominal pain, shoulder pain, dyspepsia, paresthesia, headaches; bone marrow reticulin deposition, worsening thrombocytopenia, risk of bleeding, thrombotic/thromboembolic complications, antibody formation.

REMS:
YES

How Supplied:
Single-use vial—1