ENFLONSIA 150 mg/mL
CLESROVIMAB · INJECTION, SOLUTION · Merck Sharp & Dohme LLC
ENFLONSIA is a injection, solution containing clesrovimab at 150 mg/mL, taken intramuscular. Manufactured by Merck Sharp & Dohme LLC.
Key Facts
- Brand Name
- ENFLONSIA
- Generic Name
- CLESROVIMAB
- NDC Code (Product)
0006-5073- Manufacturer
- Merck Sharp & Dohme LLC
- Strength
- 150 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Marketing Status
- Application #
- BLA761432
- Drug Class
- Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody [EPC]
- Marketing Start
- 06/09/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended dosage: 105 mg administered as a single intramuscular (IM) injection. ( 2.1 ) 2.1 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 [see Clinical Pharmacology (12.2) ]. 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. 2.2 Administration Instructions ENFLONSIA must be administered by a healthcare provider. Before injection, remove ENFLONSIA from the refrigerator and allow the prefilled syringe to come to room temperature for approximately 15 minutes. Parenteral dr…
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 Description (11) ]. ENFLONSIA is contraindicated in infants with a history of serious hypersensitivity reactions, including anaphylaxis, to any component of ENFLONSIA. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 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 [see Warnings and Precautions (5.2) ] .
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions were injection-site erythema (3.8%), injection-site swelling (2.7%) and rash (2.3%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ENFLONSIA was evaluated in 2,858 infants who received ENFLONSIA in Phase 2b/3 and Phase 3 clinical trials (Trial 004 and Trial 007). Neonates and Infants Entering Their First RSV Season (Trial 004) Trial 004 was a Phase 2b/3, randomized, double-blind placebo-controlled, multisite trial conducted in early and moderate preterm infants (≥29 to <35 weeks gestational age (GA)) and late preterm and full-term infants (≥35 weeks GA). Participants were randomized 2:1 and received a single 105 mg dose of ENFLONSIA (N=2,412, including 422 early and moderate preterm infants) or saline placebo (N=1,202, including …
Frequently Asked Questions
What is ENFLONSIA used for?
ENFLONSIA contains CLESROVIMAB. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.
Is ENFLONSIA a controlled substance?
ENFLONSIA is not classified as a controlled substance by the DEA.
What is the generic name for ENFLONSIA?
The generic name for ENFLONSIA is CLESROVIMAB. There are no other listed brand versions of CLESROVIMAB.
What is the NDC code for ENFLONSIA 150 mg/mL?
The NDC (National Drug Code) for ENFLONSIA 150 mg/mL is 0006-5073, listed by Merck Sharp & Dohme LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)