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National Drug Formulary

ENFLONSIA™ SOLUTION FOR INJECTION 105MG/0.7ML IN PRE-FILLED SYRINGE [SIN17467P]

Active ingredients: CLESROVIMAB

View product's general information
Last updated on 9 October 2026

Product Info

ENFLONSIA™ SOLUTION FOR INJECTION 105MG/0.7ML IN PRE-FILLED SYRINGE

[SIN17467P]

Product information

Active Ingredient and Strength

CLESROVIMAB - 105 MG/0.7 ML

Dosage Form

INJECTION, SOLUTION

Manufacturer and Country

PATHEON MANUFACTURING SERVICES LLC - UNITED STATES

Registration Number

SIN17467P

Licence Holder

MSD PHARMA (SINGAPORE) PTE. LTD.

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

J06BD10

Prescription-only Medicines with Exemptions for Supply without Prescription

NA

Indication

1. INDICATIONS AND USAGE

ENFLONSIA (clesrovimab) is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season.

Dosing

2. DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage
Neonates and Infants: First RSV Season
The recommended dose is 105 mg administered as a 0.7 mL single intramuscular (IM) injection.

For neonates and infants born during the RSV season, administer ENFLONSIA starting from birth. For infants born outside the RSV season, administer ENFLONSIA once prior to the start of their first RSV season considering the duration of protection provided by ENFLONSIA [see Clinical Pharmacology (11.3) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

Dosing in infants with a body weight <1.1 kg is based on extrapolation; no clinical data are available. The exposure in neonates <1.1 kg is expected to be higher than in patients with a higher body weight. The benefit and risk of the use of clesrovimab in neonates <1.1 kg should be carefully considered.

Infants Undergoing Cardiac Surgery with Cardiopulmonary Bypass
For infants undergoing cardiac surgery with cardiopulmonary bypass during the first RSV season, an additional 105 mg dose is recommended as soon as the infant is stable after surgery to ensure adequate clesrovimab serum levels.

Co-administration with Childhood Vaccines and Immunoglobulin Products
ENFLONSIA can be given concomitantly with childhood vaccines [see Clinical Pharmacology (11.5) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. When ENFLONSIA is administered concomitantly with injectable vaccines, it should be given using a separate syringe and at a different injection site. Do not mix ENFLONSIA with any vaccines or medications in the same syringe or vial.

There are no data regarding substitution of ENFLONSIA for palivizumab once prophylaxis treatment is initiated with palivizumab for the RSV season.

2.2 Renal Impairment
ENFLONSIA use has not been studied in patients with renal impairment.

2.3 Hepatic Impairment
ENFLONSIA use has not been studied in patients with hepatic impairment.

Contraindications

4. CONTRAINDICATIONS

ENFLONSIA is contraindicated in infants with a history of serious hypersensitivity reactions, including anaphylaxis, to any component of ENFLONSIA [see Warnings and Precautions (5.1) and Pharmaceutical Particulars (15.2) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].