About Palivizumab (Synagis ®)

Updated November 2022

Palivizumab or Synagis® is a humanized monoclonal antibody produced by recombinant technology that is used to prevent respiratory syncytial virus (RSV) infection. It is administered intramuscularly as five monthly doses of 15 mg/kg during the RSV season.

In October of 2003, the Nova Scotia Provincial Blood Coordinating Program (NSPBCP) began monitoring requests for palivizumab in Nova Scotia. A letter from the NSPBCP was distributed to all Nova Scotia pediatricians in February 2004, detailing RSV infection prophylaxis recommendations for the remainder of the 2003/04 season. These recommendations were based on guidelines for palivizumab use from the Canadian Pediatric Society and the National Advisory Committee on Immunization (NACI). When NACI guidelines were extended to include the use of palivizumab for infants < 24 months with “hemodynamically significant” congenital heart disease, a review process was established by the NSPBCP in collaboration with the IWK Children’s Heart Centre to ensure appropriate use for infants with cardiac indications (CHD).

The NSPBCP convened a working group of medical specialists in April 2004 to review RSV prophylaxis cost and utilization data for Nova Scotia, to develop a Provincial RSV Infection Prophylaxis consensus guidelines for the upcoming RSV season. This was to assist the NSPBCP in designing a utilization management program for RSV immunoprophylaxis products. IWK Health will now continue the utilization management program initiated by the NSPBCP.

For the 2016-2017 season the Nova Scotia Palivizumab guidelines were changed by the IWK Utilization Management Program (IWKUMP) to align with recommendations from the Canadian Pediatric Society, in which palivizumab was considered  for infants < 30 weeks gestation, rather than for premature infants 30 to 32 weeks gestational age.  Of note, the American Academy of Pediatrics recommends the use of palivizumab for premature infants less than 29 weeks gestation.

There is a  change in eligibility    for palivizumab in NS for children with heart disease for the 2022-2023 guidelines compared to 2021-2022. Following the National Advisory Committee on Immunization statement of June 2022, https://www.canada.ca/en/public-health/services/publications/vaccines-immunization/palivizumab-respiratory-syncitial-virus-infection-infants.htm, young children with “hemodynamically significant” congenital heart disease (CHD) are eligible in the first year of life (≤ 12 months of age or younger) at the start of the RSV season. Previously children in the second year of life were eligible in NS. .

Documents for the 2022-23 season are to be distributed to stakeholders in November of 2022 and contain the indications for use of palivizumab (SYNAGIS®) in Nova Scotia for the recommended season. The RSV season has been noted to be different during the COVID-19 pandemic, with many areas seeing an earlier and more widespread local outbreak. RSV has arrived earlier in Nova Scotia as well, so the program will begin in the coming weeks (November) rather than waiting until December 6, the previously determined date The initial dose should be given in November  and every four weeks, to a maximum of five doses. This defined season is based on when infants are deemed to be most at risk for contracting the disease in Nova Scotia  as a result of RSV surveillance in the province. Nova Scotia epidemiology experts will continue to monitor this defined season.

Utilization Management Program

• Utilization Management Program Components
• Provincial Working Group Members

Provincial Guidelines

• Indications For Use
• Requests for Palivizumab
• Administration of Palivizumab
• Storage Guidelines for Physician Offices and Hospital Pharmacies
• Adverse Incident Reporting
• References

Cold Chain Maintenance

NS RSV Prophylaxis Request Form

Letter to Physicians