Version May 2024
The Centers for Disease Control and Prevention (CDC) issued a Health Alert Network Health Advisory in response to a limited supply of nirsevimab (Beyfortus). These interim recommendations apply to health care settings with limited nirsevimab availability during the 2023–2024 respiratory syncytial virus (RSV) season. Interim recommendations are subject to change as new evidence becomes available.
1. For infants weighing <5 kg, Advisory Committee on Immunization Practices (ACIP) recommendations are unchanged. For infants born before October 2023, administer a 50 mg dose of nirsevimab now. For infants born during October 2023 and throughout the RSV season, administer a 50 mg dose of nirsevimab in the first week of life.
2. For infants weighing ≥5 kg, prioritize using nirsevimab 100 mg doses in infants at highest risk of severe RSV disease:
a. Infants aged <6 months.
b. American Indian and Alaska Native infants aged <8 months.
c. Infants aged 6 to <8 months with conditions that place them at high risk of severe RSV disease: premature birth at <29 weeks’ gestation, chronic lung disease of prematurity, hemodynamically significant congenital heart disease, severe immunocompromise, severe cystic fibrosis (either manifestations of severe lung disease or weight-for-length <10th percentile), neuromuscular disease, or congenital pulmonary abnormalities that impair the ability to clear secretions.
3. In palivizumab-eligible pediatric patients aged 8 to 19 months, suspend using nirsevimab for the 2023–2024 RSV season. They should receive palivizumab per American Academy of Pediatrics (AAP) recommendations.
4. Continue offering nirsevimab to American Indian and Alaska Native pediatric patients aged 8 to 19 months who are not palivizumab-eligible and who live in remote regions, where transporting with severe RSV for escalation of medical care may be challenging, or in communities with known high rates of severe RSV among older infants and toddlers.
5. Follow AAP recommendations for palivizumab-eligible infants aged <8 months when the appropriate dose of nirsevimab is not available.
6. Avoid using two 50 mg doses for infants weighing ≥5 kg (50 mg doses should be reserved only for infants weighing <5 kg).
7. Encourage pregnant people to receive RSV recombinant vaccine (Abrysvo) during 32 weeks’ gestation through 36 weeks and 6 days’ gestation to prevent RSV-associated lower respiratory tract disease in infants.
8. Either RSV recombinant vaccine (Abrysvo) vaccination or nirsevimab immunization for infants is recommended to prevent RSV-associated lower respiratory tract disease in infants, but administration of both products is not needed for most infants.
Further information may be found at https://emergency.cdc.gov/han/2023/han00499.asp
(For additional information see "Nirsevimab: Pediatric drug information")
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). Due to limited supply for the 2023-2024 RSV season, the CDC recommends prioritizing patients at highest risk for severe RSV and recommends against using two 50 mg doses to obtain a 100 mg dose (Ref).
Patient's first RSV season: Note: While dose is FDA approved for all infants in their first RSV season, ACIP and AAP recommendations specify use of this dose 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 dose 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.
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.
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.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
<1%:
Dermatologic: Skin rash (0.9%) (table 1)
|
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%)
|
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 |
Serious hypersensitivity (eg, anaphylaxis) to nirsevimab or any component of the formulation.
Concerns related to adverse effects:
• Hypersensitivity reactions: Serious hypersensitivity reactions, including anaphylaxis, have been reported with other human immunoglobulin G1 (IgG1) monoclonal antibodies. If signs or symptoms of 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.
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]
No
Solution Prefilled Syringe (Beyfortus Intramuscular)
50 mg/0.5 mL (per 0.5 mL): $594.00
100 mg/mL (per mL): $594.00
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.
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. If 2 injections are required to make up the total dose (eg, 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.
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.
Respiratory syncytial virus, prophylaxis: Prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season and pediatric patients up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
None known.
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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Nirsevimab is not approved for use in patients of reproductive potential.
Nirsevimab is not approved for use in patients of reproductive potential.
Observe for severe hypersensitivity reactions; respiratory syncytial virus infection.
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.
Anti-infective considerations:
Parameters associated with efficacy: AUC: >12.8 days•mg/mL (Jorgenson 2023; Simões 2023; manufacturer's labeling).
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