Indications for NPLATE:
Thrombocytopenia in adults with immune thrombocytopenia (ITP) and in pediatric patients ≥1yr old with ITP for at least 6 months, who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. To increase survival in adults and pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome [HS-ARS]).
Limitations of Use:
Not for treating thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than 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. Should not be used in an attempt to normalize platelet counts.
Adults and Children:
ITP: <1yr: not established. Use lowest effective dose to achieve and maintain platelets ≥50×109/L to reduce risk of bleeding. ≥1yr: initially 1mcg/kg weekly by SC inj; may increase by 1mcg/kg if platelets <50×109/L; max: 10mcg/kg weekly. May reduce by 1mcg/kg if platelets >200×109/L for 2 consecutive weeks. Do not dose if platelets >400×109/L; resume Nplate at a dose reduced by 1mcg/kg when platelets fall to <200×109/L. Discontinue if platelets have not increased after 4 weeks at max dose. HS-ARS: 10mcg/kg once by SC inj as soon as possible after exposure to radiation levels >2Gy, regardless of whether a CBC can be obtained.
Risk of progression from MDS to acute myelogenous leukemia. Thrombotic/thromboembolic complications (eg, portal vein thrombosis in chronic liver disease). For ITP: monitor CBCs with platelets weekly during dose adjustments, then monthly after achieving stable dose; and weekly for at least 2 weeks after discontinuation of therapy. Loss of response: monitor for formation of neutralizing antibodies. Elderly. 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, collagen fibrosis. In children: contusion, upper RTI, oropharyngeal pain.
To enroll pregnant patients in Amgen's Pregnancy Surveillance program, call (800) 772-6436.
Generic Drug Availability: