Source: FDA, National Drug Code (US) Revision Year: 2023
Eflapegrastim-xnst is a granulocyte colony-stimulating factor (G‑CSF) produced by covalent coupling of a human G-CSF analog (18.6 kDa) and an Fc fragment of human immunoglobulin G4 (IgG4) (49.8 kDa), both derived from recombinant E. coli, via a single 3.4 kDa polyethylene glycol linker. The recombinant G-CSF domain in eflapegrastim-xnst is a variant of human G-CSF with two serine substitutions at positions 17 and 65, and no additional N-terminal methionine. Eflapegrastim-xnst has a molecular weight of approximately 72 kDa.
Rolvedon (eflapegrastim-xnst) injection is a sterile, preservative-free, clear, colorless solution supplied in a single-dose prefilled syringe for subcutaneous use. Each 0.6 mL single-dose prefilled syringe contains 13.2 mg of eflapegrastim-xnst, citric acid monohydrate (2.52 mg), mannitol (30 mg), polysorbate 80 (0.72 mg) and sodium chloride (5.26 mg) in Water for Injection. Sodium hydroxide may be used to adjust pH to 5.5 during manufacturing.
| Dosage Forms and Strengths |
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Injection: 13.2 mg/0.6 mL as a clear, colorless, preservative-free solution in a single-dose prefilled syringe. |
| How Supplied |
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Rolvedon (eflapegrastim-xnst) injection is a clear, colorless solution supplied in a single-dose prefilled syringe containing 13.2 mg of eflapegrastim-xnst in 0.6 mL solution, with 29-gauge ½ inch pre-attached (staked) needle with a needle guard. Rolvedon is provided in a dispensing pack containing one sterile 13.2 mg/0.6 mL prefilled syringe (NDC 76961‑101-01). Manufactured by: Spectrum Pharmaceuticals, Inc., 18200 Von Karman Avenue, Suite 700, Irvine, CA 92612 USA |
| Drug | Countries | |
|---|---|---|
| ROLVEDON | United States |
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