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Brand Name :
Enflonsia, clesrovimab-cfor
Synonyms :
Clesrovimab
Class :
RSV Agents
Brand Name :
Enflonsia, clesrovimab-cfor
Synonyms :
Clesrovimab
Class :
RSV Agents
Adult
It is not suggested for adults.
Dosage Forms & Strengths
Solution (IM injection)
105mg/0.7mL single-dose prefilled syringe
Respiratory Syncytial Virus Prevention
For neonates and infants:
Administer dose of 105 mg through intramuscular route in the form of single dose
Respiratory Syncytial Virus (RSV)Â
For neonates and infants:
Administer dose of 105 mg through intramuscular route in the form of single dose
Dosing Considerations
Only for neonates and infants born during RSV season:
Administer for one time from start of birth.
Only for infants born outside of RSV season:
Administer one time before start of their first RSV season and consider duration of protection given.
For only infants undergoing cardiac surgery with cardiopulmonary bypass:
Administer additional dose of 105 mg as early as infant is stable after surgery.
Geriatric
Refer to the adult dosing
Actions and Spectrum
It stops the fusion of the viral and cellular membranes and the entry of the virus by focusing on the extracellular domain of the RSV fusion protein.
The neutralizing monoclonal antibody for recombinant human immunoglobulin G1 kappa (IgG1Îş) has a YTE triple amino acid substitution in the Fc region.
It also improves binding to the neonatal Fc receptor and prolongs the serum half-life.
Adverse Reaction
Refer to the adult dosing
Black Box Warning
None
Contraindication / Caution:
Contraindications
History of serious hypersensitivity reactions
Cautions
RSV diagnostic test interference
Coadministration with routine childhood vaccines
Pregnancy / Lactation:
Pregnancy consideration:
No data is available regarding the administration of the drug during pregnancy.
Breastfeeding warnings:
No data is available regarding the excretion of drug in breast milk.
Pregnancy category:
Category A:Â well-controlled and satisfactory studies show no risk to the fetus in the first or later trimester.
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D:Â adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: No data is available for the drug under this category.
Pharmacology:
A conserved epitope in the prefusion conformation of the RSV F (fusion) protein is bound by the recombinant human monoclonal antibody clerovimab.
By blocking the virus’s ability to combine with and enter respiratory epithelial cells, this binding neutralizes RSV.
Clesrovimab has a high potency because it neutralizes antibodies effectively against the prefusion F protein.
Pharmacodynamics:
Studies shows a dose-dependent neutralization of RSV in vitro and in vivo.
While protective serum concentrations correlate with 90% to 95% lower RSV replication and severity of clinical symptoms.
The prolonged half-life of single-dose intramuscular or intravenous injection leads to sustained RSV-neutralizing titers.
An additional surrogate indicator is a decrease in nasopharyngeal RSV RNA levels following an infection challenge.
Pharmacokinetics:
Absorption:
It shows peak plasma concentration of 6.5 days.
Distribution:
It has volume of distribution of 830 ml in infant with 5 kg body weight.
Metabolism:
It is degraded into small peptides through catabolic pathways.
Excretion and elimination:
It has half-life of 44 days.
It shows daily clearance of 19.7 ml in infant with 5 kg body weight.
Administration:
The dose must be administered only by a healthcare provider.
Let the prefilled syringe get to room temperature for fifteen minutes after taking it out of the refrigerator.
Examine visually for discolouration and particle matter prior to delivery and discard immediately if any particulate matter or discoloration was noticed.
The prefilled syringe should not be used if it has been dropped or damaged, the carton’s security seal is broken, or the expiration date has passed.
inject the full contents of the prefilled syringe intramuscularly (IM) into the thigh’s anterolateral aspect.
Avoid injecting in the gluteal area or anywhere there might be a large blood vessel or nerve trunk.
Patient Information Leaflet
Generic Name: clesrovimab
Why do we use clesrovimab?
Clesrovimab is a monoclonal antibody indicated for the prevention and treatment of respiratory syncytial virus (RSV) infection.
It is lower respiratory tract disease observed in neonates and infants born during or starting their first season for RSV.
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