cenflonsia clesrovimab prefilled syringe 150mg 0.7ml per single dose prefilled syringe

Description

Indication & Scope

Enflonsia contains clesrovimab, a monoclonal antibody for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in infants.

Mechanism: Neutralizes RSV by binding the prefusion F protein.
Drug class: Long-acting monoclonal antibody (anti-RSV).
Clinical use: Prevention of RSV-associated lower respiratory tract disease in infants.

Specification

Generic Name	Clesrovimab
Brand Name	Enflonsia®
Ingredient	Each prefilled syringe contains 105 mg of clesrovimab in 0.7 mL
Dosage Form	Prefilled Syringe
Package	One prefilled syringe (0.7 mL)
Conditions Treated	Prevention of respiratory syncytial virus (RSV)-associated lower respiratory tract disease in infants
Taboos	Hypersensitivity to clesrovimab or any component of the product
Place of origin	USA
Prescription type	Prescription Drug (Rx)
Storage Conditions	Store refrigerated at 2°C–8°C. Do not freeze. Keep in the original carton to protect from light. Do not shake.
Manufacturer	Merck Sharp & Dohme LLC (a subsidiary of Merck & Co., Inc., Rahway, NJ, USA)
Registration Authority	U.S. Food and Drug Administration (FDA)
Approval number	BLA 761420
Date of Revision	2025
Shelf Life	Refer to the expiration date on the carton and syringe (official shelf-life duration has not been separately specified in public labeling).

How to use ?

Recommended Dose: 105 mg administered as a single intramuscular (IM) injection.

Time: Administer once before or during the infant’s first RSV season.

Instructions for use: Administer by intramuscular injection using the prefilled syringe. Inspect the solution before use. Do not use if discolored, cloudy, or containing particulate matter. Do not shake.

Interaction: May interfere with rapid antigen detection RSV diagnostic assays.

Side effects: Injection-site erythema, injection-site swelling, rash.

Important Notice

This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indication, and regional regulatory requirements.

Packaging & Shipping

Packaging

Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.

Shipping Methods

Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.

Export Support

Certificate of Analysis

GMP Certificate

Commercial Invoice

Packing List & CPP

Cold Chain Logistics

Customs Documentation

Scientific and regulatory sources

1.WHO References

2.NMPA

3.FDA

4.EMA

FAQ

When will Enflonsia be available?

Merck plans to open ordering access for physicians and healthcare administrators in July 2025. Product shipments will be completed prior to the onset of the 2025–2026 RSV season.

Is Enflonsia approved by the FDA?

Yes. The FDA granted approval to ENFLONSia based on clinical data from two pivotal trials (Trial 004 and Trial 007). It is indicated to prevent RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season.

What is clesrovimab?

Clesrovimab-cfor for injection is a long-acting fully human monoclonal antibody sold under the brand name Enflonsia. It is indicated to prevent severe RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season. It delivers passive immunity by supplying preformed neutralizing antibodies that block RSV from infecting lung cells.

How is clesrovimab administered?

Clesrovimab-cfor is supplied as an injectable solution administered intramuscularly into the thigh by qualified medical personnel. A single dose is generally recommended. A second dose may be administered to infants undergoing cardiac surgery with cardiopulmonary bypass.