Molecule
Clesrovimab is a respiratory syncytial virus anti-F protein monoclonal antibody 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. MedsAcross supplies Clesrovimab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
ENFLONSIA ™ 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. ENFLONSIA is a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor indicated for the prevention of RSV lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season.
Source: US FDA prescribing information
ENFLONSIA is a monoclonal antibody with anti-RSV activity.
Source: US FDA prescribing information
Recommended dosage: 105 mg administered as a single intramuscular (IM) injection. Recommended Dosage The recommended dose for neonates and infants born during or entering their first RSV season is 105 mg administered as a single intramuscular (IM) injection. For neonates and infants born during the RSV season, administer ENFLONSIA once 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. Infants Undergoing Cardiac Surgery with Cardiopulmonary Bypass For infants undergoing cardiac surgery with cardiopulmonary bypass during or entering their first RSV season, an additional 105 mg dose administered as an IM injection is recommended as soon as the infant is stable after surgery to ensure adequate clesrovimab-cfor serum levels.
Source: US FDA prescribing information
ENFLONSIA is contraindicated in infants with a history of serious hypersensitivity reactions, including anaphylaxis, to any component of ENFLONSIA.
Source: US FDA prescribing information
Hypersensitivity Including Anaphylaxis: Serious hypersensitivity reactions, including anaphylaxis, have been observed with other human immunoglobulin G1 (IgG1) monoclonal antibodies. Initiate appropriate medications and/or supportive care if such reactions occur.
Source: US FDA prescribing information
Most common adverse reactions were injection-site erythema (4.5%), injection-site swelling (3.2%) and rash (2.3%).
Source: US FDA prescribing information
Interference with Rapid Antigen Detection RSV Diagnostic Assays Clesrovimab-cfor may interfere with some immunologically-based RSV diagnostic assays (i.e., rapid antigen tests) as observed in laboratory studies. Confirmation using an RT-PCR assay is recommended when rapid antigen RSV diagnostic assay results are negative and clinical observations are consistent with RSV infection. Clesrovimab-cfor does not interfere with RT-PCR diagnostic assays.
Source: US FDA prescribing information
Store prefilled syringes under refrigeration at 36°F to 46°F (2°C to 8°C). ENFLONSIA may be kept at room temperature between 68°F to 77°F (20°C to 25°C) for a maximum of 48 hours. After removal from the refrigerator, ENFLONSIA must be used within 48 hours or discarded. Do not freeze. Keep the prefilled syringe in the original carton to protect from light until time of use. Do not shake.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Clesrovimab, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Enflonsia 105 mg/0.7 mL injectionIntramuscular Cold chain | Merck Sharp & Dohme | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Clesrovimab and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Clesrovimab, including Enflonsia.
Yes. The US FDA first approved Clesrovimab on 9 June 2025, according to Drugs@FDA.
Yes. Clesrovimab has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Clesrovimab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Clesrovimab is classified under ATC code J06BD10 (Clesrovimab).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.