Nirsevimab will be administered much like vaccines. It should be administered through Intramuscular (IM) injection only and can be administered concomitantly with vaccines.
Routine Dosing
A single dose should be administered to all infants <8 months of age born during or entering their first RSV season (typically starting October 1 through March 31 in most of the continental US). For most babies whose mothers received RSVpreF at 32-36 weeks of pregnancy where at least 14 days have elapsed between vaccine administration and birth, nirsevimab will not be indicated. Please see the Nirsevimab Administration Visual Guide to help determine if and what dose is needed.
In addition to mother’s vaccination status, eligibility is determined by age at the time of administration. Infants born during the RSV season should receive nirsevimab within 1 week of birth. This can be given either in the hospital before discharge or at the doctor’s office after discharge. Those with a prolonged hospital stay should get it shortly before or promptly after discharge. In tropical climates and Alaska where the RSV season may be different than the rest of the US, clinicians should consult state, local or territorial guidance on timing.
Dosing by Weight/Age
A single dose should be administered to
- Infants weighing <5 kg: 50 mg dose (purple plunger rod)
- Infants weighing ≥5 kg: 100 mg dose (light blue plunger rod)
- Children receiving nirsevimab in their second RSV season should receive a single dose of 200 mg, administered through 2 separate 100 mg IM injections.
Dosing During Product Shortage
Recommendations for using 50 mg doses remain unchanged. All infants <8 months of age who are <5 kg on the day of administration should receive a 50 mg dose of nirsevimab.
The supply of 100 mg doses is anticipated to be limited during the 23-24 RSV season. CDC has made the following interim recommendations:
- For infants weighing ≥5 kg, prioritize using 100 mg nirsevimab doses in infants at highest risk of severe RSV disease:
- Young infants aged <6 months.
- American Indian and Alaska Native infants aged <8 months.
- 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 less than 10th percentile), neuromuscular disease or congenital pulmonary abnormalities that impair the ability to clear secretions.
- In palivizumab-eligible children aged 8–19 months, suspend using nirsevimab for the 2023–2024 RSV season. These children should receive palivizumab per AAP recommendations.
- Continue offering nirsevimab to American Indian and Alaska Native children aged 8–19 months who are not palivizumab-eligible and who live in remote regions, where transporting children 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.
- Follow AAP recommendations for palivizumab-eligible infants aged <8 months when the appropriate dose of nirsevimab is not available.
- Avoid using two 50mg doses for infants weighing ≥5 kilograms (≥11 pounds), because 50mg doses should be reserved only for infants weighing <5 kilograms (<11 pounds), for example those born during the season who will be at increased risk for severe RSV illness because of their young age. Furthermore, providers should be aware that some insurers may not cover the cost of two 50mg doses for an individual infant.
- Providers should encourage pregnant people to receive RSVpreF vaccine (Abrysvo, Pfizer) during 32 weeks’ gestation through 36 weeks and 6 days’ gestation to prevent RSV-associated lower respiratory tract disease in infants. Only the Pfizer RSVpreF vaccine (Abrysvo) is approved and recommended for use in pregnant people. The GSK RSVpreF3 vaccine (Arexvy) should not be used in pregnant people.
- Either RSVpreF 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.
The CDC Health Alert Network update can be found HERE.
Nirsevimab and Palivizumab
- If nirsevimab is administered, palivizumab should not be administered later that season.
- If palivizumab was administered initially for the season and <5 doses were administered, the infant should receive 1 dose of nirsevimab as soon as it is available, regardless of the time since the last palivizumab dose. No further palivizumab should be administered.
- If palivizumab was administered in season 1 and the child is eligible for RSV prophylaxis in season 2, the child should receive nirsevimab in season 2, if available. If nirsevimab is not available, palivizumab should be administered as previously recommended.
Immunization Information Statement
It recommended that an Immunization Information Statement be provided to families or caregivers when an infant or toddler receives nirsevimab. Consider offering this resource electronically, to review in-office, and/or to take home.
Reporting Adverse Events
Adverse events when giving nirsevimab alone should be reported to the FDA’s MedWatch Adverse Event Reporting Program.
If an adverse event occurs while co-administering nirsevimab with a vaccine, it should be reported to the Vaccine Adverse Event Reporting System.
Additional Information
In the rare event of vaccine wastage (eg, family changed mind at last moment, syringe is dropped or damaged before administration, etc), it is recommended that you contact the Sanofi Customer Service at 800-VACCINE or via vaccineshoppe.com to discuss. Sanofi does not have a formal wastage policy in place for nirsevimab.
Last Updated
11/03/2023
Source
American Academy of Pediatrics