Nplate

Product manufactured by Amgen Inc

Application Nr Approved Date Route Status External Links
BLA125268 None Subcutaneous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Nplate Is Indicated For The Treatment Of Thrombocytopenia In: • Adult Patients With Immune Thrombocytopenia (Itp) Who Have Had An Insufficient Response To Corticosteroids, Immunoglobulins, Or Splenectomy. • Pediatric Patients 1 Year Of Age And Older With Itp For At Least 6 Months Who Have Had An Insufficient Response To Corticosteroids, Immunoglobulins, Or Splenectomy. Limitations Of U Se: • Nplate Is Not Indicated For The Treatment Of Thrombocytopenia Due To Myelodysplastic Syndrome (Mds) Or Any Cause Of Thrombocytopenia Other Than Itp [See Warnings And Precautions ( 5.1 )]. • Nplate Should Be Used Only In Patients With Itp Whose Degree Of Thrombocytopenia And Clinical Condition Increases The Risk For Bleeding . • Nplate Should Not Be Used In An Attempt To Normalize Platelet Counts [See Warnings And Precautions ( 5.2 )]. Nplate Is A Thrombopoietin Receptor Agonist Indicated For The Treatment Of Thrombocytopenia In: Adult Patients With Immune Thrombocytopenia (Itp) Who Have Had An Insufficient Response To Corticosteroids, Immunoglobulins, Or Splenectomy. Pediatric Patients 1 Year Of Age And Older With Itp For At Least 6 Months Who Have Had An Insufficient Response To Corticosteroids, Immunoglobulins, Or Splenectomy. Limitations Of Use: Nplate Is Not Indicated For The Treatment Of Thrombocytopenia Due To Myelodysplastic Syndrome (Mds) Or Any Cause Of Thrombocytopenia Other Than Itp. Nplate Should Be Used Only In Patients With Itp Whose Degree Of Thrombocytopenia And Clinical Condition Increases The Risk For Bleeding. Nplate Should Not Be Used In An Attempt To Normalize Platelet Counts. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Romiplostim

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