for subcutaneous use Initial U.S. Approval: 2022
Rolvedon (eflapegrastim-xnst) is a leukocyte growth factor used 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. FDA-approved use: To decrease the incidence of infection in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia
Facts about eflapegrastim-xnst injection
Approval Date: 9/9/2022
Proprietary Name: Rolvedon
Active Ingredient(s): eflapegrastim-xnst
Dosage Form: Injection
DISEASE INDICATIONS-Breast Cancer, Lung Cancer
MANUFACTURER-Spectrum Pharmaceuticals, Inc.
MEDICINE APPROVED BY-Food and Drug Administration (FDA)
Summary of FDA-approved use on approval date: Click Here
(see Drugs@FDA for complete indication)
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Query For eflapegrastim-xnst injection
Approved accessible "eflapegrastim-xnst injection"
Eflapegrastim is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adults with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. Its efficacy has been shown to be non-inferior to pegfilgrastim. This medicine was approved by the US Food an Drug Administration on 9 September 2022.
Eflapegrastim, sold under the brand names Rolvedon among others, is a long-acting G-CSF analog developed by Hanmi Pharmaceutical and licensed to Spectrum Pharmaceuticals. Eflapegrastim is a leukocyte growth factor. It is used to reduce the risk of febrile neutropenia in people with non-myeloid malignancies receiving myelosuppressive anti-cancer agents. Eflapegrastim was approved for medical use in the United States in September 2022.
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ROLVEDON (eflapegrastim-xnst) injection, for subcutaneous use Initial U.S. Approval: 2022
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