Clesrovimab
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From MedlinePlus, U.S. National Library of Medicine
Specialty pharmacy: therapy management checklist, storage and cold chain, dosing calendar, Medicare Part D coverage.
Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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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 drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
ENFLONSIA is a clear to slightly opalescent, colorless to slightly yellow solution. This product should not be used if particulate matter or discoloration is found. Do not use if the prefilled syringe has been dropped or damaged, the security seal on the carton has been broken, or the expiration date has passed. Refer to Figure 1 for prefilled syringe components.
Figure 1: Prefilled Syringe Components Step 1: Hold the syringe barrel in one hand and unscrew the tip cap by twisting it counter-clockwise with the other hand. Do not remove the Luer Lock adaptor and the finger flange extender. Step 2: Attach a sterile Luer Lock needle by twisting in a clockwise direction until the needle fits securely on the syringe.
Due to the viscosity of the product, use a 22- to 25-gauge needle. Step 3: Inject the entire contents of the ENFLONSIA prefilled syringe intramuscularly in the anterolateral aspect of the thigh. ENFLONSIA should not be injected in the gluteal area or areas where there may be a major nerve trunk and/or blood vessel. Step 4: Discard syringe into a sharps container.
Co-administration with Childhood Vaccines and Immunoglobulin Products ENFLONSIA can be given concomitantly with childhood vaccines [see Clinical Pharmacology ] . When ENFLONSIA is administered concomitantly with injectable vaccines, it should be given using a separate syringe and at a different injection site. Do not mix ENFLONSIA with any vaccines or medications in the same syringe or vial.
There is no information regarding co-administration of ENFLONSIA with other immunoglobulin products. There are no data regarding substitution of ENFLONSIA for palivizumab once prophylaxis treatment is initiated with palivizumab for the RSV season. Prefilled Syringe
Drug interactions
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- Clesrovimab
Label text (2 paragraphs)
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) ] .
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 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for clesrovimab. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy ENFLONSIA is not indicated for use in females of reproductive potential.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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