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Nirsevimab: Pediatric drug information

Nirsevimab: Pediatric drug information
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For additional information see "Nirsevimab: Drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Beyfortus
Brand Names: Canada
  • Beyfortus
Dosing: Neonatal
Respiratory syncytial virus, prevention

Respiratory syncytial virus (RSV), prevention: Note: Administer nirsevimab within 1 week of birth for neonates born shortly before or during the RSV season, ideally during the birth hospitalization (Ref).

Patient's first RSV season:

Preterm and term neonates:

Weight <5 kg: IM: 50 mg as a single dose.

Patients who undergo cardiopulmonary bypass after dose: IM: Administer a 50 mg dose as soon as patient is stable after surgery (regardless of time elapsed).

Weight ≥5 kg: IM: 100 mg as a single dose.

Patients who undergo cardiopulmonary bypass after dose: Administer an additional dose as follows as soon as patient is stable after surgery:

≤90 days since initial dose: IM: 100 mg as a single dose.

>90 days since initial dose: IM: 50 mg as a single dose.

Dosing: Pediatric
Respiratory syncytial virus, prevention

Respiratory syncytial virus (RSV), prevention: Note: Administer shortly before the RSV season begins; if not administered before start of season, may administer at any time during the season (Ref).

Patient's first RSV season: Note: While nirsevimab is FDA approved for all infants in their first RSV season, ACIP and AAP recommendations specify use in infants <8 months of age (Ref).

Infants:

Weight <5 kg: IM: 50 mg as a single dose.

Patients who undergo cardiopulmonary bypass after dose: IM: Administer a 50 mg dose as soon as patient is stable after surgery (regardless of time elapsed).

Weight ≥5 kg: IM: 100 mg as a single dose.

Patients who undergo cardiopulmonary bypass after dose: Administer an additional dose as follows as soon as patient is stable after surgery:

≤90 days since initial dose: IM: 100 mg as a single dose.

>90 days since initial dose: IM: 50 mg as a single dose.

Patient's second RSV season: Note: While nirsevimab is FDA approved for patients up to 24 months of age who remain at increased risk for severe disease during their second RSV season, ACIP and AAP recommend second-season dosing only for patients 8 to ≤19 months of age who are at increased risk for severe disease (Ref).

Infants and Children <24 months: IM: 200 mg as a single dose (Ref).

Patients who undergo cardiopulmonary bypass after dose: Administer an additional dose as follows as soon as patient is stable after surgery:

≤90 days since initial dose: IM: 200 mg as a single dose.

>90 days since initial dose: IM: 100 mg as a single dose.

Dosing: Kidney Impairment: Pediatric

No dosage adjustments are provided in the manufacturer's labeling; however, nirsevimab is not cleared in the kidney and change in kidney function is not expected to influence clearance, so dosage adjustment is likely not needed.

Dosing: Liver Impairment: Pediatric

No dosage adjustments are provided in the manufacturer's labeling; however, nirsevimab is not cleared in the liver and change in liver function is not expected to influence clearance, so dosage adjustment is likely not needed.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in neonates and infants.

<1%:

Dermatologic: Skin rash (0.9%) (table 1)

Nirsevimab: Adverse Reaction: Skin Rash

Drug (Nirsevimab)

Placebo

Population

Dose

Dosage Form

Indication

Number of Patients (Nirsevimab)

Number of Patients (Placebo)

0.9%

0.6%

Neonates and Infants

50 or 100 mg

IM

Prevention of respiratory syncytial virus

2,570

1,284

Local: Injection-site reaction (0.3%) (table 2)

Nirsevimab: Adverse Reaction: Injection-Site Reaction

Drug (Nirsevimab)

Placebo

Population

Dose

Dosage Form

Indication

Number of Patients (Nirsevimab)

Number of Patients (Placebo)

0.3%

0%

Neonates and Infants

50 or 100 mg

IM

Prevention of respiratory syncytial virus

2,570

1,284

Postmarketing: Hypersensitivity: Hypersensitivity reaction (including severe hypersensitivity reaction)

Contraindications

Serious hypersensitivity (eg, anaphylaxis) to nirsevimab or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Serious hypersensitivity reactions, including cyanosis, dyspnea, hypotonia, and/or urticaria, have been reported. Anaphylaxis has been reported with other human IgG1 monoclonal antibodies. If signs or symptoms of anaphylaxis or significant hypersensitivity reaction occur, administer appropriate medications (eg, epinephrine) and provide supportive care as required.

Disease-related concerns:

• Bleeding disorders: Use with caution in patients with a history of bleeding disorders (including thrombocytopenia); bleeding/hematoma may occur from IM administration.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Prefilled Syringe, Intramuscular [preservative free]:

Beyfortus: Nirsevimab-alip 100 mg/mL (1 mL); Nirsevimab-alip 50 mg/0.5 mL (0.5 mL) [contains polysorbate 80]

Generic Equivalent Available: US

No

Pricing: US

Solution Prefilled Syringe (Beyfortus Intramuscular)

50 mg/0.5 mL (per 0.5 mL): $667.36

100 mg/mL (per mL): $667.36

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Prefilled Syringe, Intramuscular:

Beyfortus: Nirsevimab-alip 100 mg/mL (1 mL); Nirsevimab-alip 50 mg/0.5 mL (0.5 mL) [contains polysorbate 80]

Administration: Pediatric

Note: Intended for administration by a health professional only.

Parenteral: IM: Solution should be clear to opalescent, colorless to yellow. Do not use prefilled syringe if it has been dropped or damaged or if the liquid is cloudy, discolored, or contains large particles or foreign particulate matter. Administer IM in the anterolateral aspect of the thigh (Ref); for patients ≥1 year of age, injection may also be performed in the deltoid muscle if the muscle mass is adequate (Ref). Two injections are required to make the total 200 mg dose; different injection sites should be used. Do not routinely inject in the gluteal muscle because of risk of damage to the sciatic nerve. Note: It is not recommended to split a single 100 mg manufacturer-filled syringe into two 50 mg doses, or to administer two 50 mg doses in place of a single 100 mg dose (Ref).

Administration deviations:

Infants ≥8 months and Children ≤19 months of age (second RSV season): If a patient who should have received 200 mg received only 100 mg (half dose), administer the remaining 100 mg dose as soon as possible, and no later than the end of the season (Ref).

Storage/Stability

Store intact vials between 2°C to 8°C (36°F to 46°F) in original carton to protect from light. May be kept at 20°C to 25°C (68°F to 77°F) for a maximum of 8 hours. After removal from the refrigerator, must be used within 8 hours or discarded. Do not freeze, shake, or expose to heat.

Medication Guide and/or Vaccine Information Statement (VIS)

In the United States, caregivers of patients receiving nirsevimab through the Vaccines for Children program must be provided the appropriate CDC-approved Immunization Information Statement (IIS) before nirsevimab administration. The AAP recommends that the IIS be provided to all families, either electronically or hard copy, to review at home or in-office (AAP 2023). The IIS is available at https://www.cdc.gov/vaccines/vpd/rsv/immunization-information-statement.html.

Use

Prevention of respiratory syncytial virus (RSV) lower respiratory tract disease during a patient's first RSV season (FDA approved in neonates and infants); prevention of RSV lower respiratory tract disease during a patient's second RSV season if they remain vulnerable to severe RSV disease (FDA approved in children <24 months of age).

ACIP and AAP recommend nirsevimab use beginning shortly before and during the RSV season (typically October through the end of March in most of the continental United States, but may be adjusted based on local epidemiology) in the following patients (Red Book [AAP 2024]; ACIP [Jones 2023]):

• All infants <8 months of age prior to or during their first RSV season

Note: Nirsevimab is not needed for most infants born at ≥34 weeks gestation whose mothers received RSVpreF (Abrysvo) vaccination during their pregnancy ≥14 days prior to birth. However, nirsevimab may be considered for infants born to vaccinated mothers when the potential incremental benefit of administration is warranted, based on the health care provider's clinical judgment. These situations might include, but are not limited to, the following (AAP 2024a; ACIP [Fleming-Dutra 2023]):

- Infants born to mothers who might not have mounted an adequate immune response to vaccination (eg, persons with immunocompromising conditions), or who have conditions associated with reduced transplacental antibody transfer (eg, persons living with HIV infection)

- Infants who might have experienced loss of maternal antibodies, such as those who have undergone cardiopulmonary bypass or extracorporeal membrane oxygenation

- Infants with substantially increased risk for severe RSV disease (eg, hemodynamically significant congenital heart disease, intensive care admission requiring oxygen at hospital discharge)

• Infants ≥8 months and children ≤19 months of age entering their second RSV season who are at an increased risk for severe RSV disease due to one of the following:

- Chronic lung disease of prematurity requiring medical support (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) any time during the 6-month period before the start of the RSV season

- Severe immunocompromise

- Cystic fibrosis with either manifestations of severe lung disease (eg, previous hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest imaging that persist when stable) or weight-for-length <10th percentile

- American Indian or Alaska Native

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program

Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Pregnancy Considerations

Nirsevimab is not approved for use in patients of reproductive potential.

Monitoring Parameters

Observe for hypersensitivity reaction.

Mechanism of Action

Nirsevimab, a respiratory syncytial virus F protein-directed fusion inhibitor, is a human immunoglobulin G1 (IgG1) kappa monoclonal antibody with antirespiratory syncytial virus activity that provides passive immunization.

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Anti-infective considerations:

Parameters associated with efficacy: AUC: >12.8 days•mg/mL (Jorgenson 2023; Simões 2023; manufacturer's labeling).

  1. American Academy of Pediatrics (AAP). In: Kimberlin DW, Banerjee R, Barnett ED, Lynfield R, Sawyer MH, eds. Red Book: 2024-2027 Report of the Committee on Infectious Diseases. 33rd ed. American Academy of Pediatrics; 2024.
  2. American Academy of Pediatrics (AAP). Nirsevimab administration. https://www.aap.org/en/patient-care/respiratory-syncytial-virus-rsv-prevention/nirsevimab-administration/. Updated November 3, 2023. Accessed December 13, 2023.
  3. American Academy of Pediatrics (AAP). Nirsevimab administration visual guide. https://downloads.aap.org/AAP/PDF/Nirsevemab-Visual-Guide.pdf. Updated September 10, 2024a. Accessed September 26, 2024.
  4. American Academy of Pediatrics (AAP). Nirsevimab frequently asked questions. https://www.aap.org/en/patient-care/respiratory-syncytial-virus-rsv-prevention/nirsevimab-frequently-asked-questions/. Updated September 13, 2024b. Accessed September 26, 2024.
  5. Beyfortus (nirsevimab) [prescribing information]. Swiftwater, PA: Sanofi Pasteur Inc; August 2024.
  6. Beyfortus (nirsevimab) [prescribing information]. Swiftwater, PA: Sanofi Pasteur Inc; February 2024.
  7. Beyfortus (nirsevimab) [product monograph]. Mississauga, Ontario, Canada: AstraZeneca Canada Inc; April 2023.
  8. Fleming-Dutra KE, Jones JM, Roper LE, et al. Use of the Pfizer respiratory syncytial virus vaccine during pregnancy for the prevention of respiratory syncytial virus-associated lower respiratory tract disease in infants: recommendations of the Advisory Committee on Immunization Practices - United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72(41):1115-1122. doi:10.15585/mmwr.mm7241e1 [PubMed 37824423]
  9. Issa AN, Wodi AP, Moser CA, Cineas S. Advisory Committee on Immunization Practices recommended immunization schedule for children and adolescents aged 18 years or younger - United States, 2025. MMWR Morb Mortal Wkly Rep. 2025;74(2):26-29. doi:10.15585/mmwr.mm7402a2 [PubMed 39819853]
  10. Jones JM, Fleming-Dutra KE, Prill MM, et al. Use of nirsevimab for the prevention of respiratory syncytial virus disease among infants and young children: recommendations of the Advisory Committee on Immunization Practices - United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72(34):920-925. doi:10.15585/mmwr.mm7234a4 [PubMed 37616235]
  11. Jorgensen SCJ. Nirsevimab: review of pharmacology, antiviral activity and emerging clinical experience for respiratory syncytial virus infection in infants. J Antimicrob Chemother. 2023;78(5):1143-1149. doi:10.1093/jac/dkad076 [PubMed 36922390]
  12. Refer to manufacturer's labeling.
  13. Simões EAF, Madhi SA, Muller WJ, et al. Efficacy of nirsevimab against respiratory syncytial virus lower respiratory tract infections in preterm and term infants, and pharmacokinetic extrapolation to infants with congenital heart disease and chronic lung disease: a pooled analysis of randomised controlled trials. Lancet Child Adolesc Health. 2023;7(3):180-189. doi:10.1016/S2352-4642(22)00321-2 [PubMed 36634694]
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