Updated Guidance for Nirsevimab 100 mg

Commissioner Lambrew letterhead

To: Maine Immunization Program Providers

From: Maine Immunization Program

Subject: Updated Guidance for Nirsevimab 100 mg

Date: January 17, 2024

 

On January 5, 2024, CDC issued a COCA Now article recommending that health care providers return to the original recommendations on use of nirsevimab in young children and recommending that infants and children recommended to receive nirsevimab be immunized as quickly as possible. Do not save doses for later in the RSV season.

The Maine Immunization Program wanted to provide additional guidance for nirsevimab (Beyfortus) 100 mg. Given the recent increase of nirsevimab 100 mg doses received, ordering is now available for all Vaccine for Children (VFC) providers with no limit to minimum/maximum quantity. Please only order what will be needed for the remainder of the RSV season (end of March, 4-6 weeks of anticipated inventory). 

As previously stated, nirsevimab 50 mg doses will continue to be prioritized to birthing hospitals throughout Maine.

Summary of Recommendations: Nirsevimab (Beyfortus)

  • ACIP recommends 1 dose of nirsevimab to all infants aged <8 months born during or entering their first RSV season (50 mg for infants weighing <5 kg [<11 lb] in the first week of life.
  • 100 mg for infants weighing ≥5 kg [≥11 lb])
Beyfortus
  • 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.

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.

Administration Fee for One Dose of Nirsevimab (Two 100 mg Injections):

For Vaccines for Children (VFC) program vaccines, providers are permitted to only bill per vaccine - only one administration fee can be charged for one dose. For example - with one 200 mg dose, even if administered as two 100 mg injections given at the same time, it is considered one dose and should only be billed as one administration fee, not to exceed the state fee cap of $21.58.

Documenting Nirsevimab in ImmPact:

ImmPact will not have the capability to forecast for nirsevimab, due to the complexity of the ACIP recommended schedule. 

Providers should use the 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. 

Entering Nirsevimab Dose into Immpact:

Please see the following instructions on how to enter nirsevimab into ImmPact. These instructions include both manual and HL7 entry. 

If you have any questions, please contact the Maine Immunization Program at (207) 287-3746 or email ImmunizeME.DHHS@maine.gov.  

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