FDA licensure of NEUMEGA to prevent severe chemotherapy-induced thrombocytopenia.
This paper discusses background information and the body of clinical data that has been accumulated to demonstrate the efficacy and safety of NEUMEGA (recombinant human interleukin 11) when used to prevent severe chemotherapy-induced thrombocytopenia and reduce the need for platelet transfusions in patients with nonmyeloid malignancies. NEUMEGA is recommended to be used at a dose of 50 microg/kg s.c. once daily starting the day after chemotherapy ends until a platelet count of 50,000 cells/microl is achieved after the expected nadir.
Kaye
J A
JA
Clinical Research/Hematology, Genetics Institute, Inc., Cambridge, Massachusetts, USA.
D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002986:Clinical Trials as Topic; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D017370:Interleukin-11 / Q000008:administration & dosage* / Q000009:adverse effects; D009369:Neoplasms / Q000188:drug therapy*; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D013921:Thrombocytopenia / Q000139:chemically induced* / Q000517:prevention & control*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
D000970:Antineoplastic Agents; D017370:Interleukin-11; D011994:Recombinant Proteins; C105308:oprelvekin