Rolvedon FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 28, 2022.
FDA Approved: Yes (First approved September 9, 2022)
Brand name: Rolvedon
Generic name: eflapegrastim-xnst
Dosage form: Injection
Previous Name: Rolontis
Company: Spectrum Pharmaceuticals, Inc.
Treatment for: Neutropenia Associated with Chemotherapy
Rolvedon (eflapegrastim-xnst) is a leukocyte growth factor used to reduce the incidence of infection due to chemotherapy-induced neutropenia.
- 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.
- Rolvedon is a novel formulation that combines a granulocyte colony-stimulating factor (G-CSF) analog with an Fc fragment of human immunoglobulin G4 (IgG4).
- Rolvedon works by binding to G-CSF receptors on myeloid progenitor cells and neutrophils, triggering signaling pathways that control cell differentiation, proliferation, migration and survival.
- Rolvedon is administered subcutaneously once per chemotherapy cycle, approximately 24 hours after cytotoxic chemotherapy.
- Warnings and precautions associated with Rolvedon include fatal splenic rupture, acute respiratory distress syndrome (ARDS), serious allergic reactions, sickle cell crisis in patients with sickle cell disorders, glomerulonephritis, leukocytosis, thrombocytopenia, myelodysplastic syndrome, and acute myeloid leukemia.
- Common adverse reactions include fatigue, nausea, diarrhea, bone pain, headache, pyrexia, anemia, rash, myalgia, arthralgia, and back pain.
Development timeline for Rolvedon
Further information
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