RYZNEUTA Solution for injection Ref.[107384] Active ingredients: Efbemalenograstim alfa

Source: FDA, National Drug Code (US)  Revision Year: 2023 

Product description

Efbemalenograstim alfa-vuxw, a leukocyte growth factor, is a 413 amino acid recombinant fusion protein consisting of human G-CSF, a 16 amino-acid linker, and the Fc portion of human IgG2. In solution, efbemalenograstim alfa-vuxw forms covalently-linked dimers (disulfide bonds between Fc moieties), resulting in an immunoglobulin-like structure. The dimer is a water-soluble, glycosylated protein with a molecular weight of approximately 93.4 kilodaltons (kDa), of which 89.5 kDa is attributed to amino acids (protein sequence) and the remainder is from glycosylation. Efbemalenograstim alfa-vuxw is obtained from genetically-engineered strain of Chinese hamster ovary (CHO) cells grown in a serum-free medium.

RYZNEUTA (efbemalenograstim alfa-vuxw) injection is supplied in 1 mL prefilled single-dose syringes for manual subcutaneous injection. The prefilled syringe does not bear graduation marks and is designed to deliver the entire contents of the syringe (20 mg/mL). Each syringe contains 20 mg efbemalenograstim alfa-vuxw in a sterile, clear, colorless, preservative-free solution (pH 5.2) containing acetate (0.6 mg), EDTA (0.29 mg), polysorbate 20 (0.1 mg), sodium (0.23 mg), and sorbitol (50 mg) in Water for Injection, USP.

Dosage Forms and Strengths

Injection: 20 mg/mL clear, colorless, preservative-free solution in a single-dose prefilled syringe.

How Supplied

RYZNEUTA (efbemalenograstim alfa-vuxw) injection is a clear, colorless, preservative-free solution supplied in a prefilled single-dose syringe with a 27-gauge, 1/2-inch needle and an UltraSafe Passive Needle Guard, containing 20 mg of efbemalenograstim alfa-vuxw.

Caution: This product contains natural rubber latex which may cause allergic reactions. The needle cap of the prefilled syringe contains natural rubber; persons with latex allergies should not administer this product.

RYZNEUTA is provided in a dispensing pack containing one 20 mg/mL prefilled syringe (NDC 73491-627-01).

RYZNEUTA prefilled syringe does not bear graduation marks and is intended only to deliver the entire contents of the syringe (20 mg/mL) for direct administration to adult patients.

Drugs

Drug Countries
RYZNEUTA United States

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