Novel formulation combines a granulocyte colony-stimulating factor (G-CSF) analog with an Fc fragment of human immunoglobulin G4 (IgG4)2
Supported by a complete innovator biopharmaceutical development program
Selected Safety Information
Serious Allergic Reactions
Serious allergic reactions, including anaphylaxis, can occur in patients receiving rhG-CSF products. Permanently discontinue ROLVEDON in patients who experience serious allergic reactions.
FcRn facilitates ROLVEDON transcytosis3
It has been shown in:
in vitro studies2:
To bind the neonatal Fc receptor (FcRn), which facilitates transcytosis
in vivo animal studies:
To facilitate uptake and retention of G‑CSF in the bone marrow
The clinical significance of these findings is unknown
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Schwartzberg LS, Bhat G, Peguero J, et al. Eflapegrastim, a long-acting granulocyte-colony stimulating factor for the management of chemotherapy-induced neutropenia: results of a phase III trial. Oncologist. 2020;25(8):e1233-e1241.
ROLVEDON [package insert]. Irvine, CA: Spectrum Pharmaceuticals, Inc.
Barrett J, et al. Eflapegrastim's enhancement of efficacy compared with pegfilgrastim in neutropenic rats supports potential for same-day dosing. Experimental Hematology 2020;92:51-61.
ROLVEDON is administered via a single subcutaneous dose