Generic Name and Formulations:
Romiplostim (recombinant) 250mcg, 500mcg; per vial; lyophilized pwd for SC inj after reconstitution; contains sucrose and mannitol; preservative-free.
Indications for NPLATE:
Treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) and in children ≥1yr old with ITP for at least 6 months, who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Adults and Children:
<1yr: not established. Give by SC inj. To reduce risk of bleeding: use lowest effective dose to achieve and maintain platelets ≥50x109/L. ≥1yr: 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.
Not for normalization of platelet counts or to treat thrombocytopenia due to MDS or any cause of thrombocytopenia other than chronic ITP. Use only if the degree of thrombocytopenia and clinical condition increases the risk for bleeding. Risk of progression from MDS to acute myelogenous leukemia. Worsened thrombocytopenia and bleeding risk may develop after discontinuation. Monitor CBCs with platelets weekly during dose adjustments then monthly after achieving stable dose; and weekly for at least 2wks after discontinuation of therapy. Monitor after initial response for formation of neutralizing antibodies. Pregnancy. Nursing mothers: not recommended.
Thrombopoietin receptor agonist.
Arthralgia, dizziness, insomnia, myalgia, pain in extremity, abdominal pain, shoulder pain, dyspepsia, paresthesia, headaches; bone marrow reticulin formation, thrombotic/thromboembolic complications (eg, portal vein thrombosis in chronic liver disease), possible antibody formation. In children: contusion, upper RTI, oropharyngeal pain.
To enroll pregnant patients in Amgen's Pregnancy Surveillance program, call (800) 772-6436.
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