Beyfortus (nirsevimab-alip)
Antiviral Monoclonal Antibodies Intramuscular Syringe (Ml)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Nirsevimab-alip, a recombinant humanized monoclonal antibody directed against the fusion (F) surface of respiratory syncytial virus (RSV), is an antiviral agent.
Nirsevimab-alip is a recombinant human IgG1 kappa monoclonal antibody that provides passive immunity to respiratory syncytial virus (RSV) by targeting the prefusion conformation of the RSV fusion (F) protein. Nirsevimab binds to a conserved epitope in antigenic site O on the prefusion protein. Nirsevimab neutralizes RSV by inhibiting conformation changes in the F protein necessary for fusion of the viral and cellular membranes and viral entry.
The drug is active against both subgroups A and B, the 2 major strains of RSV. Nirsevimab-alip is long-acting due to a triple amino acid substitution (YTE) in the Fc region, which increases binding to the neonatal Fc receptor and thereby extends serum half-life. Mutations resulting in nirsevimab resistance have been reported rarely.
Phenotypic testing of novel substitutions is ongoing. Limited data indicate that variants resistant to nirsevimab could have cross-resistance to palivizumab.
The pharmacokinetics of nirsevimab-alip are dose-proportional following IM administration of single doses ranging from 25 mg (0.5 times the lowest approved recommended dosage) to 200 mg in pediatric subjects. The estimated absolute bioavailability of nirsevimab-alip is 84%, and the median time to peak concentrations is 6 days. Following IM administration of nirsevimab-alip in adults, RSV-neutralizing antibody levels in serum were approximately 4 times higher than baseline at 8 hours after nirsevimab-alip dosing, and maximum levels were reached by day 6.
Based on clinical data, the duration of protection offered by a single dose of nirsevimab-alip extends through 5 months. Nirsevimab is degraded into small peptides by catabolic pathways. The drug has a terminal elimination half-life of approximately 71 days.
Following the recommended dose, nirsevimab serum exposures were similar in neonates and infants born during or entering their first RSV season, in neonates and infants born at <35 weeks gestational age (including <29 weeks gestational age) in their first RSV season, and in pediatric subjects <=24 months of age with chronic pulmonary or cardiovascular disease in their first and second RSV season. No clinically important differences in the pharmacokinetics of nirsevimab have been observed based on race or vulnerability to severe RSV disease (i.e., chronic pulmonary or cardiovascular disease, gestational age <29 weeks, immunocompromised states). Renal or hepatic impairment is not expected to affect nirsevimab pharmacokinetics.
USES: Nirsevimab is used by infants and certain young children to prevent serious lung infections (such as pneumonia) that are caused the respiratory syncytial virus (RSV). Nirsevimab belongs to a class of drugs known as monoclonal antibodies. It works by preventing the growth of the virus.
Generic name: nirsevimab-alip
Pronunciation: (nir-SEV-i-mab)
Drug class: Antiviral Monoclonal Antibodies
Therapeutic class: Biologicals
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Beyfortus
Indications
The following indications are listed for Beyfortus:
- Respiratory Syncytial Virus Pneumonia Prevention
Also known as: Respiratory Syncytial Virus Pneumonia Prophylaxis, Rsv Pneumonia Prophylaxis.
Dosing
No dosing information is available for this tab.
Nirsevimab-alip is administered by IM injection, preferably in the anterolateral aspect of the thigh. IM administration into the gluteal muscle should be avoided because of the risk of damage to the sciatic nerve.
Nirsevimab-alip is supplied as a clear to opalescent, colorless to yellow solution in a prefilled syringe containing 50 or 100 mg. Do not use the drug if the solution is cloudy, discolored, or contains large particles or foreign particulate matter. In addition, do not use the prefilled syringe if it has been dropped or damaged, the security seal on the carton has been broken, or the expiration date has passed. Do not shake the prefilled syringe.
Administer the entire contents of the prefilled syringe. If a dose of 200 mg is required, administer as two 100-mg injections at different injection sites.
Store nirsevimab-alip prefilled syringes between 2-8degreesC in their original container; do not freeze or expose to heat. Syringes may be stored at room temperature (20-25degreesC) for up to 8 hours. Administer or discard within 8 hours of removing the prefilled syringe from refrigeration.
Nirsevimab can be given concomitantly with childhood vaccines. When administered concomitantly with injectable vaccines, administer using separate syringes and different injection sites. Do not mix nirsevimab with any vaccines or drugs in the same syringe or vial.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
Formal studies have not been conducted to evaluate potential interactions between nirsevimab-alip and other drugs. Based on a mechanistic understanding of monoclonal antibodies, nirsevimab is not predicted to be a substrate, inhibitor, or inducer of cytochrome P-450 (CYP) enzymes or transporter systems.
There are no contraindication interactions for this drug.
Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
Igg Antibodies And Derivatives/Efgartigimod-Alfa
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Efgartigimod-alfa binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)
CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of efgartigimod-alfa states that efgartigimod-alfa should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, efgartigimod-alfa should be discontinued.(3)
DISCUSSION: Clinical drug interaction studies with efgartigimod-alfa have not been performed. Efgartigimod-alfa may decrease concentrations of compounds that bind to the human FcRn.(3)
Igg Antibodies And Derivatives/Nipocalimab-Aahu
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Nipocalimab-aahu binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)
CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of nipocalimab-aahu states that nipocalimab-aahu should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, nipocalimab-aahu should be discontinued.(3)
DISCUSSION: Clinical drug interaction studies with nipocalimab-aahu have not been performed. Nipocalimab-aahu may decrease concentrations of compounds that bind to the human FcRn.(3)
Moderate Interaction: Assess the risk to the patient and take action as needed.
Igg Antibodies And Derivatives/Rozanolixizumab-Noli
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Rozanolixizumab-noli binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)
CLINICAL EFFECTS: The effectiveness of medications that bind to FcRn may be decreased.(3)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of rozanolixizumab-noli states that concurrent use with medications that bind to the human neonatal Fc receptor (FcRn) should be closely monitored for reduced effectiveness of these medications. If long-term use of such medications is essential for the patient, consider discontinuing rozanolixizumab-noli and use alternative therapies.(3)
DISCUSSION: Clinical drug interaction studies with rozanolixizumab-noli have not been performed. Rozanolixizumab-noli may decrease concentrations of compounds that bind to the human FcRn.(3)
Contraindications
*History of serious hypersensitivity reactions to nirsevimab-alip or any ingredient in the formulation.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
- No disease contraindications
Adverse reactions
Adverse effects occurring in >=0.3% of patients receiving nirsevimab-alip in clinical studies include rash and injection site reactions.
Less Frequent
- Anaphylaxis
More Frequent
- Injection site sequelae
- Skin rash
Less Frequent
- Hypersensitivity drug reaction
Precautions
No enhanced messaging available.
Safety and efficacy of nirsevimab-alip have not been established in pediatric patients >24 months of age.
Nirsevimab-alip is not indicated for use in females of reproductive potential.
Nirsevimab-alip is not indicated for use in females of reproductive potential.
No enhanced messaging available.
ICD codes
| Code | Type | Description |
|---|---|---|
| Respiratory syncytial virus pneumonia prevention | ||
| Z23 | ICD10CM | Encounter for immunization |
| Z29.11 | ICD10CM | Encounter for prophylactic immunotherapy for respiratory syncytial virus (RSv) |
| Z29.89 | ICD10CM | Encounter for other specified prophylactic measures |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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