eflapegrastim-xnst

FDA Drug Profile — Rolvedon

Drug Details

Generic Name
eflapegrastim-xnst
Brand Names
Rolvedon
Application Number
BLA761148
Sponsor
Assertio Specialty Pharmaceuticals, LLC
NDC Codes
2
Dosage Forms
INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients
EFLAPEGRASTIM

Indications and Usage

1 INDICATIONS AND USAGE Rolvedon is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. Limitations of Use Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. Rolvedon is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. ( 1 ) Limitations of Use Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. ( 1 )