Nirsevimab-alip
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alen Antony Pathil, M.D.[2]
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Overview
Nirsevimab-alip is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that is FDA approved for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease for neonates and infants born during or entering their first RSV season and children up to 24 years of age who are vulnerable to severe RSV disease in their second RSV season.. Common adverse reactions include rashes and injection site reactions..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
BEYFORTUS is a respiratory syncytial virus (RSV) F protein‑directed fusion inhibitor indicated for the prevention of RSV lower respiratory tract disease in neonates and children up to age 24 years during the RSV season.
The recommended dosage of BEYFORTUS for neonates and infants born during or entering their first RSV season, which is given intramuscularly: Less than 5 kg: 50 mg of IM injection 5 kg or greater: 100 mg of IM injection
The recommended dosage for children up to 24 months of age who remain at increased risk for severe RSV disease in their second RSV season is 200 mg administered as two doses (100 mg each).
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Nirsevimab-alip FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
BEYFORTUS is contraindicated in children who have any history of hypersensitivity reaction to nirsevimab-alip or to any of the excipients.
Warnings
1. Hypersensitivity Reactions Including Anaphylaxis some children may develop severe hypersensitivity reactions like urtricaria, dyspnea, cyanosis, or hypotonia following the administration. Since BEYFORTUS is a human immunoglobulin G1 (IgG1) monoclonal antibodies, it may even cause anaphylatic reaction. Appropriate treatment should be immediately given if the child develops any of the reaction.
2. Usage in children with bleeding and coagulation disorder. Since BEYFORTUS is administered intramuscularly, it should given with caution in the children with thrombocytopenia and other bleeding disorder.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Nirsevimab-alip Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Nirsevimab-alip Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Nirsevimab-alip Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Nirsevimab-alip in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Nirsevimab-alip in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Nirsevimab-alip during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Nirsevimab-alip in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Nirsevimab-alip in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Nirsevimab-alip in geriatric settings.
Gender
There is no FDA guidance on the use of Nirsevimab-alip with respect to specific gender populations.
Race
There is no FDA guidance on the use of Nirsevimab-alip with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Nirsevimab-alip in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Nirsevimab-alip in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Nirsevimab-alip in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Nirsevimab-alip in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Nirsevimab-alip Administration in the drug label.
Monitoring
There is limited information regarding Nirsevimab-alip Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Nirsevimab-alip and IV administrations.
Overdosage
There is limited information regarding Nirsevimab-alip overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Nirsevimab-alip Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Nirsevimab-alip Mechanism of Action in the drug label.
Structure
There is limited information regarding Nirsevimab-alip Structure in the drug label.
Pharmacodynamics
There is limited information regarding Nirsevimab-alip Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Nirsevimab-alip Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Nirsevimab-alip Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Nirsevimab-alip Clinical Studies in the drug label.
How Supplied
There is limited information regarding Nirsevimab-alip How Supplied in the drug label.
Storage
There is limited information regarding Nirsevimab-alip Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Nirsevimab-alip Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Nirsevimab-alip interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
BEYFORTUS
Look-Alike Drug Names
There is limited information regarding Nirsevimab-alip Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.