ENFLONSIA Solution for injection Ref.[115723] Active ingredients: Clesrovimab

Source: FDA, National Drug Code (US)  Revision Year: 2025 

Product description

Clesrovimab-cfor is a respiratory syncytial virus F protein-directed fusion inhibitor. Clesrovimab-cfor is a fully human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody produced in recombinant Chinese hamster ovary (CHO) cells. The molecular weight is approximately 149 kDa.

ENFLONSIA (clesrovimab-cfor) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for intramuscular injection.

Each 0.7 mL contains 105 mg of clesrovimab-cfor, arginine hydrochloride (10.33 mg), histidine (0.55 mg), L-histidine monohydrochloride monohydrate (0.74 mg), polysorbate 80 (0.14 mg), sucrose (35 mg) and water for injection (USP). The pH is 6.0.

Dosage Forms and Strengths

Injection: 105 mg/0.7 mL clear to slightly opalescent, colorless to slightly yellow solution in a single-dose prefilled syringe.

How Supplied

ENFLONSIA injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution supplied as follows:

Carton containing one or ten single-dose prefilled type I glass syringe(s) with Luer Lock and plunger stopper. The prefilled syringe is not made with natural rubber latex.

Prefilled syringePack SizeNDC
105 mg/0.7 mL single-doseCarton of 10006-5073-01
105 mg/0.7 mL single-doseCarton of 100006-5073-02

Manufactured by: Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA

Drugs

Drug Countries
ENFLONSIA United States

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