|
To: Maine Immunization Program Providers
From: Maine Immunization Program
Subject: RSV – Nirsevimab (Beyfortus) Now Available for Order
Date: October 4, 2023
The Maine Immunization Program is pleased to announce that Nirsevimab (Beyfortus) for infants is now available for ordering in ImmPact. Nirsevimab was approved by the U.S. Food and Drug Administration (FDA) on July 17, 2023. Nirsevimab is a long-acting monoclonal antibody product intended for use in newborns and infants to protect against respiratory syncytial virus (RSV) disease. RSV is recommended for two populations.
Summary of Recommendations:
- ACIP recommends 1 dose of Nirsevimab for all infants aged <8 months born during or entering their first RSV season (50 mg for infants weighing <5 kg [<11 lb] and 100 mg for infants weighing ≥5 kg [≥11 lb]) in their first week of life.
- ACIP recommends 1 dose of Nirsevimab (200 mg, administered as two 100 mg injections given at the same time at different injection sites) for infants and children aged 8 through 19 months who are at increased risk for severe RSV disease and entering their second RSV season.
- The following children aged 8 through 19 months are recommended to get a dose shortly before or during their second RSV season:
- American Indian/Alaska Native children
- Children with chronic lung disease of prematurity who require medical support during the six months before the start of their second RSV season
- Children with severe immunocompromise
- Children with severe cystic fibrosis
Children ages 8 months and older who are not at increased risk of severe RSV disease should not receive Nirsevimab.
Storage and Handling of Nirsevimab:
The pre-filled syringes should be stored refrigerated between 36°F to 46°F (2°C to 8°C) and may be kept at room temperature 68°F to 77°F (20°C to 25°C) for a maximum of 8 hours. They should be stored in the original carton to protect from light until time of use. Do not freeze or expose to heat.
After removal from the refrigerator, they must be used within 8 hours or discarded. Do not use Nirsevimab beyond the expiration date printed on the label.
Coadministration with Routine Childhood Vaccines:
Nirsevimab can be administered without regard to timing of routine childhood vaccines. This includes simultaneous administration (i.e., same clinic day) with vaccine products. No interval between Nirsevimab and live vaccines (such as MMR and Varicella) is necessary.
Documenting Nirsevimab in ImmPact:
ImmPact will not have the capability to forecast for Nirsevimab, due to the complexity of the ACIP recommended schedule.
Providers will be responsible to use resources available to determine when the patient is due for any upcoming doses. Providers will still be required to document each dose into ImmPact within 5 business days of being administered.
If you have any questions, please contact the Maine Immunization Program at (207) 287-3746 or email ImmunizeME.DHHS@maine.gov.
Resources:
|
