About Palivizumab (Synagis®)
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.
There isone change in eligibility for prophylaxis in NS for children with premature birth. Previously eligibility was limited to infants of 30 weeks gestational age (GA), days and younger. This year children up to 32 weeks 0 days GA are eligible.
A new anti-RSV monoclonal antibody was recently approved in Canada called Nirsevimab. It is given in one injection at the beginning of the season as its protection last for up to six months. It is not known if Nirsevimab will be available in NS for 2023-2024. The NS Provincial Palivizumab Working Group will be monitoring the availability and update if the drug becomes available.
Documents for the 2023-24 season are to be distributed to stakeholders in November of 2023 and contain the indications for use of palivizumab (SYNAGIS®) in Nova Scotia for the recommended season. Usually, doses of palivizumab are offered between December and April, to coincide with the annual RSV outbreak. During the COVID-19 pandemic the RSV season has been less predictable. The IWK Health Utilization Monitoring Program is monitoring RSV activity in the province in case the start date for the RSV prophylaxis should change. In the meantime, the plan is for prophylaxis to begin in December 2023. Health-care providers will be updated if there are any changes to the timing of the program.