Clesrovimab

Class
Antiviral agents
Subclass
Anti-prefusion RSV F protein monoclonal antibodies
Substance name
Clesrovimab, clesrovimab-cfor
Brand names
Enflonsia®
Common formulations
Solution for injection
Dosage and administration
Pediatric patients
Prevention of RSV infection • Lower respiratory tract disease, neonates and infants born during or entering their first RSV season
•
105 mg IM × 1 at birth if born during the RSV season, or before the start of the season if born outside the RSV season
Indications for use
Labeled indications
Children
•
Prevention of RSV infection (lower respiratory tract disease, neonates and infants born in patients undergoing or entering their first RSV season)
Safety risks
Contraindications
Hypersensitivity to clesrovimab or its components
Warnings and precautions
Drug hypersensitivity reaction
•
Maintain a high level of suspicion, as serious hypersensitivity reactions, including anaphylaxis, have been reported with other human immunoglobulin G1 monoclonal antibodies.
RSV test interference
•
Maintain a high level of suspicion, as clesrovimab may interfere with immunologically-based RSV diagnostic assays (rapid antigen tests). Obtain a reverse transcriptase PCR assay for confirmation when rapid antigen assay results are negative and clinical presentation is consistent with RSV infection.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required. Renal impairment is not expected to affect the pharmacokinetics of clesrovimab.
Renal replacement therapy
Any modality
•
Use acceptable. No dose adjustment required.
Hepatic impairment
Any severity
•
Use acceptable. No dose adjustment required. Hepatic impairment is not expected to affect the pharmacokinetics of clesrovimab.
Pregnancy and breastfeeding
Pregnancy
All trimesters
•
Not intended for use in females of childbearing potential.
Breastfeeding
Not intended for use in females of childbearing potential.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Common 1-10%
•
Injection site erythema, injection site swelling, skin rash
Unknown frequency
•
Anaphylaxis
Interactions
Drug(s)
Check Interactions
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