How do I apply for RSV prophylaxis for my patients?
The referring physician/Nurse practitioner (NP) completes the Nova Scotia RSV Prophylaxis Request Form 2024-2025. The Provincial RSV Working Group reviews each year the results of monitoring for the RSV season and consider if revisions are necessary. Nova Scotia also contributes to the national body of evidence/knowledge/practice regarding RSV prophylaxis by sharing aggregate data.
Once the request is approved, who administers Nirsevimab?
For infants living in Halifax, prophylaxis will be administered through the centralized RSV Prevention Clinic at IWK. A RSV Prevention Clinic Referral Form must be sent from a family doctor, pediatrician, or nurse practitioner with the required referral information.
For infants outside Halifax prophylaxis is given in your family doctor/nurse practitioner, pediatrician’s office, or regional health centre.
Those requests that are for “other” children considered to be at high risk for complicated RSV should be faxed to the IWK Health RSV Prevention Program, along with the two appropriate letters providing medical justification for ordering the product.
The initial dose should be given in early December. The defined Nova Scotia RSV season typically has been January to May (ie the higher risk season when the annual RSV outbreak occurs). Nova Scotia epidemiology experts will continue to monitor this defined season.
Requests that require medical consultation ("cardiac indications" and "other" children considered at high risk for complicated RSV") will be faxed to the IWK Health RSV Prevention Program for review. The IWK Health RSV Prevention Program will refer these requests for consultation to the appropriate clinical specialists at the IWK Health and once approved will request dispensing of Nirsevimab .
Requests that require medical consultation ("cardiac indications" and "other" children considered at high risk for complicated RSV") will be faxed to the IWK Health RSV Prevention Program for review. The IWK Health RSV Prevention Program will refer these requests for consultation to the appropriate clinical specialists at the IWK Health and once approved will request dispensing of Nirsevimab .
How many doses of nirsevimab are given?
Administration of Beyfortus™(Nirsevimab):
Nirsevimab is administered as a one time, fixed dose of 50mg (infants < 5kg), or 100mg (infants ≥ 5 kg).
BEYFORTUS™ is provided as single dose pre-filled syringes for injection in (50 mg in 0.5 mL (100 mg/mL) or 100 mg in 1 mL (100 mg/mL). Please refer to the Product Monograph for BEYFORTUS™ (nirsevimab) for detailed administration instructions.
- Nirsevimab is dosed as a single fixed dose of 50 mg for infants weighing <5 kg and a single fixed dose of 100 mg for infants weighing ≥5 kg. Dosing in infants with a body weight between 1.0 and 1.6 kg is based on extrapolation. It is administered intramuscularly preferably in the anterolateral aspect of the thigh.
- Nirsevimab solution for injection
- The two pre-filled syringe sizes available are 50 mg and 100 mg.
- Do not dilute the product.
- c. Do not shake the vial.
- d. Nirsevimab does not contain a preservative and should be administered immediately upon preparation.
- Administration of Nirsevimab in the Neonatal Intensive Care Unit (NICU):
- In general, eligible hospitalized NICU patients would begin RSV prophylaxis just prior to their discharge into the community. Meticulous attention to infection prevention and control practices to prevent all respiratory and other infections is the most important means to interrupt transmission of infection for admitted patients.
- In all cases where Nirsevimab is administered, the lot number and final disposition of the product should be accurately documented. Nirsevimab that is expired or destroyed should have the quantity, lot number and expiry date recorded and reported to the IWK Health at (902) 470-2723. The Program will do a follow up at the end of season to collect information on inventory in the province.
- Nirsevimab does not interfere with response to vaccines in clinical trials.
Nirsevimab Storage
Store in the refrigerator at +2°C to +8°C immediately following receipt. Keep the pre-filled syringe in the outer carton in order to protect from light.
BEYFORTUS may be kept at room temperature (20°C - 25°C) for a maximum of 8 hours. After
removal from the refrigerator, BEYFORTUS must be used within 8 hours or discarded.
Personnel responsible for storage and handling of this publicly funded product must:
- have a maximum-minimum refrigerator thermometer in all refrigerators containing product.
- check and record refrigerator temperatures at least once a day (on office opening).
If a site is unable to maintain refrigerator temperatures between +2°C and +8°C alternative appropriate storage should be arranged before Nirsevimab is delivered.
Store on the middle shelves of the refrigerator.
Do not store Nirsevimab on the door shelves of the refrigerator, in vegetable bins or on the shelf below the freezer as temperatures in these areas will fluctuate.
* For more details on storage please refer to the cold chain maintenance document found in the Nova Scotia Immunization Manual online or contact the IWK Pharmacy Department at (902) 470-8165 for a copy of this document, or information.
Adverse Event Reporting
When an adverse event follows the administration of a passive immunizing agent (e.g. immune globulin) and/or diagnostic agent (e.g. tuberculin skin test), an AEFI form should not be completed. Instead, the event should be reported to Health Canada on Canada Vigilance Adverse Reaction Reporting Form. http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng.php
References
- Sanofi Pasteur Limited. (April 19, 2023) Product Monograph Beyfortus ™ (nirsevimab) solution for injection, 100 mg/mL, 50 mg single-use, pre-filled syringe, 100 mg single-use, pre-filled syringe intramuscular injections.
- Position statement: Preventing hospitalizations for respiratory syncytial virus Respiratory syncytial virus (RSV) vaccines: Canadian Immunization Guide - Canada.ca
- National Advisory Committee on Immunization (NACI) Statement on the prevention of respiratory syncytial virus (RSV) disease in infants (May 17, 2024) naci-statement-2024-05-17.pdf