Resources for ENFLONSIA^TM (clesrovimab-cfor)

• Do not administer ENFLONSIA to infants with a history of serious hypersensitivity reactions, including anaphylaxis, to any component of ENFLONSIA.
• Serious hypersensitivity reactions, including anaphylaxis, have been observed with other human immunoglobulin G1 (IgG1) monoclonal antibodies. If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, initiate appropriate medications and/or supportive therapy.
• ENFLONSIA may interfere with some immunologically-based RSV diagnostic assays (i.e., rapid antigen tests) as observed in laboratory studies. Confirmation using a reverse transcriptase polymerase chain reaction (RT-PCR) assay is recommended when rapid antigen assay results are negative and clinical observations are consistent with RSV infection.
• The most common adverse reactions were injection-site erythema (3.8%), injection-site swelling (2.7%), and rash (2.3%).

Dosage and Administration

• The recommended dose 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 5 months duration of protection by ENFLONSIA.
• For infants undergoing cardiac surgery with cardiopulmonary bypass during or entering their first RSV season, an additional 105 mg dose is recommended as soon as the infant is stable after surgery to ensure adequate clesrovimab-cfor serum levels.

Before administering ENFLONSIA, please read the accompanying Prescribing Information. The Patient Information also is available.