Nirsevimab-alip (Monograph)

Brand name: Beyfortus
Drug class: Monoclonal Antibodies

Medically reviewed by Drugs.com on Nov 17, 2023. Written by ASHP.

Introduction

Antiviral agent; recombinant humanized monoclonal antibody directed against the F surface of respiratory syncytial virus (RSV).

Uses for Nirsevimab-alip

Prevention of Lower Respiratory Tract Disease Caused by RSV

Prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

There are no data regarding substitution of nirsevimab for palivizumab once prophylaxis is initiated with palivizumab for the RSV season. Palivizumab should not be administered to infants who have already received nirsevimab in the same season. Nirsevimab may be administered prior to or during the second RSV season to children up to 24 months of age who remain vulnerable to severe RSV disease, and who received palivizumab in their first RSV season.

Recommended by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control (CDC) and the American Academy of Pediatrics (AAP) for all infants <8 months of age born during or entering their first RSV season, including those recommended by AAP to receive palivizumab. Also recommended in infants and children 8–19 months of age who are at increased risk of severe RSV disease and entering their second RSV season, including those recommended by AAP to receive palivizumab.

Children 8–19 months of age who are recommended to receive nirsevimab when entering their second RSV season because of increased risk of severe disease includes those with chronic lung disease of prematurity who required medical support (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) any time during the 6-month period before the start of the second RSV season; those who are severely immunocompromised; those with cystic fibrosis who have manifestations of severe lung disease (previous hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest imaging that persist when stable) or have weight-for-length that is <10th percentile; and American Indian and Alaska Native children (a new group for whom second-season nirsevimab prophylaxis is recommended in contrast to current palivizumab recommendations).

Related/similar drugs

Arexvy, Abrysvo, ribavirin, palivizumab, Beyfortus, Synagis, rsv vaccine, pref a-pref b, recombinant

Nirsevimab-alip Dosage and Administration

General

Dispensing and Administration Precautions

• Infants and children with thrombocytopenia or any coagulation disorder, or receiving anticoagulation therapy, should be given IM injections with caution.

• Must be administered by a healthcare provider.

• Check the labels on the nirsevimab-alip carton and prefilled syringe to ensure that the correct 50-mg or 100-mg dosage strength is being used.

Administration

IM Administration

Administer IM, preferably in anterolateral aspect of the thigh. Avoid gluteal muscle because of risk of damage to sciatic nerve.

Supplied as a clear to opalescent, colorless to yellow solution in a prefilled syringe containing 50 or 100 mg nirsevimab-alip. Do not use if solution is cloudy, discolored, or contains large particles or foreign particulate matter. Do not use if prefilled syringe has been dropped or damaged, security seal on carton has been broken, or expiration date has passed.

Administer entire contents of prefilled syringe.

If a dose of 200 mg is required, administer as two 100-mg injections at different injection sites.

May give concomitantly with childhood vaccines. When administered concomitantly with injectable vaccines, administer using separate syringes and different injection sites. Do not mix nirsevimab-alip with any vaccines or drugs in the same syringe or vial.

Dosage

Pediatric Patients

Prevention of RSV

Neonates and Infants in First RSV Season

IM

Neonates and infants weighing <5 kg: 50 mg.

Neonates and infants weighing ≥5 kg: 100 mg.

Administer dose starting from birth in those born during RSV season. For infants born outside of RSV season, administer dose prior to the start of RSV season, considering duration of protection provided by the drug.

Infants undergoing cardiopulmonary bypass should receive a supplemental dose after the procedure as soon as the infant is stable. If surgery is within 90 days after administration of the initial dose, base supplemental dose on body weight at time of supplemental dose (50 mg in patients <5 kg or 100 mg in patients ≥5 kg). If >90 days have elapsed since the initial dose, supplemental dose should be 50 mg regardless of body weight.

Children at Increased Risk for Severe RSV Disease Through Second RSV Season

IM

Children up to 24 months of age who remain at increased risk for severe RSV disease in their second RSV season: 200 mg administered as two 100-mg injections.

Patients undergoing cardiopulmonary bypass should receive a supplemental dose after the procedure as soon as the patient is stable. If surgery is within 90 days after administration of the initial dose, supplemental dose should be 200 mg (administered as two 100-mg injections) regardless of body weight. If >90 days have elapsed since the initial dose, supplemental dose should be 100 mg regardless of body weight.

Cautions for Nirsevimab-alip

Contraindications

• History of serious hypersensitivity reactions to nirsevimab-alip or any ingredient in the formulation.

Warnings/Precautions

Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylaxis, reported following exposure to other human immunoglobulin G₁ monoclonal antibodies. If signs or symptoms of a clinically important hypersensitivity reaction or anaphylaxis occur, initiate appropriate treatment.

Coagulation Disorders

Infants and children with thrombocytopenia or any coagulation disorder, or receiving anticoagulation therapy, should be given IM injections with caution.

RSV Diagnostic Test Interference

Nirsevimab does not interfere with reverse transcriptase polymerase chain reaction (RT-PCR) or rapid antigen detection RSV diagnostic assays that employ commercially available antibodies targeting antigenic site I, II, or IV on the RSV F protein. For immunological assay results that are negative when clinical observations are consistent with RSV infection, confirmation using an RT-PCR-based assay is recommended.

Immunogenicity

Potential for immunogenicity. Anti-drug antibodies reported; however, effect on drug efficacy not known.

Specific Populations

Pregnancy

Not indicated for use in females of reproductive potential.

Lactation

Not indicated for use in females of reproductive potential.

Pediatric Use

Safety and efficacy not established in pediatric patients >24 months of age.

Common Adverse Effects

Adverse effects (reported in ≥0.3% of patients): Rash, injection site reactions.

Drug Interactions

Formal drug interaction studies not conducted.

Not predicted to be a substrate, inhibitor, or inducer of CYP enzymes or transporter systems.

Other Immunoglobulin Products

Nirsevimab-alip Pharmacokinetics

Absorption

Bioavailability

Estimated absolute bioavailability is 84%.

Onset

Following IM administration of nirsevimab in adults, RSV-neutralizing antibody levels in serum were approximately 4 times higher than baseline at 8 hours after dosing, and maximum levels were reached by day 6.

Duration

Duration of protection following a single dose of nirsevimab extends through 5 months.

Plasma Concentrations

The pharmacokinetics of nirsevimab are dose-proportional following IM administration of single doses ranging from 25–200 mg in pediatric subjects.

Peak concentrations are attained at a median of 6 days.

Special Populations

Following the recommended dose, serum nirsevimab 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.

Elimination

Metabolism

Degraded into small peptides by catabolic pathways.

Half-life

Approximately 71 days.

Special Populations

No clinically important differences in the pharmacokinetics of nirsevimab-alip 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 not expected to affect nirsevimab-alip pharmacokinetics.

Stability

Storage

Parenteral

Injection

2–8°C in original container; do not shake, freeze, or expose to heat.

May store at 20–25°C for up to 8 hours. Administer or discard within 8 hours of removal from refrigerator.

Actions

• Recombinant human IgG₁ kappa monoclonal antibody that provides passive immunity by targeting the prefusion conformation of the RSV F protein.

• Neutralizes RSV by inhibiting conformation changes in the F protein necessary for fusion of the viral and cellular membranes and viral entry.

• Active against both major strains of RSV (subgroups A and B).

• Long-acting due to a triple amino acid substitution (YTE) in the Fc region, which increases binding to neonatal Fc receptor, extending half-life.

• Mutations resulting in nirsevimab resistance reported rarely; limited data show possible cross-resistance to palivizumab.

Advice to Patients

• Advise the patient's caregiver that one dose of nirsevimab should be administered by a healthcare provider prior to or during the first RSV season by IM injection and that if the child remains at increased risk for RSV, they may receive a second dose in the second RSV season.

• Advise caregivers to inform clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.

• Inform caregivers of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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