Indications For Use: Palivizumab (Synagis®)

Children with BPD/CLD Palivizumab (Synagis®) 

Seasonal administration of palivizumab should be considered for children <24 months of age with bronchopulmonary dysplasia (BPD) / chronic lung disease (CLD) and who have required oxygen within 6 months preceding the RSV season (i.e. June 1st - November 2022), or other pulmonary disorders requiring oxygen therapy (e.g. hypoplastic lung).

Premature infants: Palivizumab (Synagis®) 

Seasonal administration of palivizumab should be considered for infants born at 30 weeks, 0 days or earlier gestation and who are <6 months of age at the beginning of the RSV season (i.e. must be born on or after June 1st, 2022).

Young children with Congenital Heart Disease (CHD): Palivizumab (Synagis®) 

Palivizumab will be considered for children 12 months of age or younger at the start of the RSV season diagnosed with “hemodynamically significant” congenital heart disease (CHD).

The presence of hemodynamically significant CHD will be determined by a pediatric cardiologist. The IWK Children’s Heart Centre will be consulted prior to distribution of palivizumab for these requests.

Hemodynamically significant is defined as:

• Children with left to right shunts who require medication 
• Children with congenital heart disease for whom surgery is pending 
• Children with ongoing cyanosis 

Palivizumab is not recommended for use in children with minor or hemodynamically non-significant congenital or acquired heart disease, including:

• Small patent arterial ducts 
• Small atrial septal defects 
• Small ventricular septal defects (not requiring medication use and/or with no significant LA or LV dilation on echo) 
• Those children with fully repaired congenital heart disease 

Patients given palivizumab for cardiac indications who subsequently undergo cardiopulmonary bypass, will be given a "post pump" dose if they have ongoing risk factors. Patients for whom the cardiac operation results in their no longer meeting criteria for palivizumab will not be given a post-pump dose. All patients started on a course of palivizumab will still complete the full course (5-6 doses) for that season, regardless of the type of repair they have.

The requesting physician and an Infectious Disease Specialist or Respirologist should supply a letter along with the Nova Scotia ordering requis

"Other" children considered to be at high risk for complicated RSV: Palivizumab (Synagis®) 

The requesting physician and an Infectious Disease Specialist or Respirologist should supply a letter along with Nova Scotia ordering requisition to AstraZeneca Canada Inc. (AstraZeneca) providing medical justification for ordering palivizumab. 

Eligible requests will be approved by an Infectious Disease physician at the IWK Health Centre.

If physicians are unsure whether a patient is eligible, the Pediatric Infectious Diseases physician on call at the IWK Health Centre is willing to provide a consult and can be contacted at (902) 470-8888 or a fax can be sent to their attention at (902) 470-7846. Examples of children who could be considered high risk are those with severe combined immunodeficiency syndrome or severe hypotonia preventing adequate clearance of respiratory secretions or those with severe chronic lung disease not due to prematurity. 

Requests for Palivizumab (Synagis®)

The referring physician completes the Nova Scotia RSV Prophylaxis Request Form 2022-2023. This form requires that the referring physician indicate that the parent/guardian was informed and consented to their child’s demographic information being shared with AstraZeneca Canada Inc. in Mississauga (AstraZeneca) for the purpose of ordering “product” (ie. palivizumab prophylaxis ), and that the health condition that puts the child at high risk for complicated RSV be indicated (check box). AstraZeneca shares the demographic information with IWK Health for the purposes of monitoring costs/utilization of palivizumab. The Provincial Palivizumab Working Group conducts this review yearly prior to establishing provincial prophylaxis guidelines. Nova Scotia also contributes to the national body of evidence/knowledge/practice regarding RSV prophylaxis by sharing aggregate data. Although direct identifiers are not shared, the Nova Scotia Personal Health Information Act requires consent for release of any personal health information, including demographics.

In all cases, to order palivizumab, the requesting physician should fax a fully completed Nova Scotia RSV Prophylaxis request form to AstraZeneca. The request form now includes an area to indicate if this is the first time product is requested (ie “initial” dose) or if it is a request for additional product (ie “subsequent” dose). For subsequent requests, the patient reference number assigned by AstraZeneca upon “initial” request must be provided. This will insure each infant/child has a unique reference number and only one file. As palivizumab is sold on a “non-returnable” and “non-refundable” basis, pharmacies or offices having inventory from last season should still submit a request form to AstraZeneca but reduce doses requested so remaining inventory may be used first to eliminate expiry of product. Those requests that are for “other” children considered to be at high risk for complicated RSV should be faxed to AstraZeneca along with the two appropriate letters providing medical justification for ordering the product.

Palivizumab funding will be limited to 5 doses per season as outlined in Table 1. 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 4 weeks to a maximum of 5 doses. The defined Nova Scotia RSV season typically in the past 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. Table 1 outlines the number of doses required dependent on the date of request for palivizumab.

Table 1: Guidance for number of doses depending on request date - (Dose is 15 mg/kg as per package insert)

Request Date	Number of Doses
November	Five Doses
December	Four Doses
January	Three Doses
February	Two Doses
March	One Dose

 

It is recommended that palivizumab be delivered to hospital pharmacy services due to strict storage requirements, and be administered to patients through same-day, centralized clinics wherever possible. Infants in Halifax (formerly the Halifax Regional Municipality) may receive palivizumab through the IWK RSV Prevention Clinic. Infants in Colchester County and the Municipality of East Hants may receive palivizumab through the Colchester East Hants Health Center (contact the Maternal/Child Unit at (902) 893-5544). Infants in the region of Cape Breton may receive palivizumab through a clinic at the Cape Breton Regional Hospital by contacting (902) 567-7844. Requests for indications that meet the provincial guidelines and do not require medical consultation will be immediately dispensed by AstraZeneca.

Requests that require medical consultation ("cardiac indications" and "other" children considered at high risk for complicated  RSV") will be faxed to the IWK Health Centre Utilization Monitoring Program (IWKUMP) by AstraZeneca. The IWKUMP will refer these requests for consultation to the appropriate clinical specialists at IWK Health and once approved will request dispensing of palivizumab by AstraZeneca.

Administration of Palivizumab: Palivizumab (Synagis®)

 

SYNAGIS® is provided as a solution for injection in single dose vials (50mg per 0.5ml and 100mg per 1ml). (A lyophilized formulation is no longer available).

Please refer to the Product Monograph for SYNAGIS® (palivizumab) for administration instructions.

1. The dose of palivizumab is 15mg/kg, administered intramuscularly preferably in the anterolateral aspect of the thigh.
2. Synagis solution for injection
   1. The two vial sizes available are 50mg/0.5 ml and 100 mg/1ml
   2. Do not dilute the product.
   3. Do not shake the vial
   4. Palivizumab does not contain a preservative and should be administered immediately after drawing the dose into the syringe.
3. Administration of palivizumab 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 the transmission of infection for admitted patients.

4. In all cases where palivizumab is administered, the lot number and final disposition of the product should be accurately documented. Palivizumab that is outdated or destroyed should have the quantity, lot number and expiry date recorded and reported to 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.
5. Palivizumab does not interfere with response to vaccines.

Storage Guidelines for Physician Offices and Hospital Pharmacies: Palivizumab (Synagis®)

 

All sites where this publicly funded product is handled must: 

• Have a maximum-minimum refrigerator thermometer in all refrigerators containing product. 
• Check refrigerator temperatures at least once a day (on office opening). 

Individuals and institutions handling this publicly funded product are required to comply with the guidelines presented in this section. If a site is unable to maintain refrigerator temperatures between +2°C and +8°C alternative appropriate storage should be arranged. 

Store palivizumab in the refrigerator at +2°C to +8°C immediately following receipt. 

Do not store palivizumab on the door shelves of the refrigerator, in vegetable bins or on the shelf below the freezer as temperatures in these areas will fluctuate. Store on the middle shelves of the refrigerator. 

*For more details on storage please refer to the cold chain maintenance document found in the Nova Scotia Immunization Manual or contact the IWK Pharmacy Department at 470-8165 for a copy of this document, or information.

Adverse Incident Reporting: Palivizumab (Synagis®)

 

If a patient experiences an adverse event following immunization, please complete the appropriate Adverse Events Following Immunization (AEFI) Form. All forms and questions should be directed to your nearest public health office.

The AEFI Reporting Form and the Guide to Completion and Submission of AEFI Reports can be found on the Health Canada website. 

For more information please contact:

Dept. of Health and Wellness
Barrington Tower, 4th Floor
1894 Barrington Street
P.O. Box 488
Halifax, NS  B3J 2A8
Phone: 902-424-6567
Fax: 902-424-0550

Web Site: Government of Nova Scotia, Communicable Disease Prevention and Control

The IWK Health will request a report from Health Canada on any adverse reactions within Canada during the previous RSV season and review this information with the palivizumab working group annually

References

• AstraZeneca Canada Inc. (July 9, 2021). Product Monograph Synagis® (palivizumab) solution for injection 50 mg/0.5ml and 100 mg/ml Intramuscular Injections. 
  https://www.astrazeneca.ca/content/dam/az-ca/downloads/productinformation/synagis-product-monograph-en.pdf
• Committee on Infectious Diseases American Academy of Pediatrics. Red Book: 2018-2021 Report of the Committee on Infectious Diseases. Itasca, IL; 2018. URL (528 https://online.statref.com/Document.aspx?FxId=76&SessionID=2A3953ELWGUKXWRS#H&1&ChaptersTab&UHOsAWxnX1ooAz3HP2xxIw!!&&76). Accessed October 02, 2018.
• Canadian Communicable Disease Report, Statement of the recommended use of monoclonal anti-RSV antibody, 15 September 2003, Volume 29, ACS-7,8. 
• Position statement: Preventing hospitalizations for respiratory syncytial virus infection. Robinson Joan L, Le Saux Nicole; Canadian Paediatric Society, Infectious Diseases and Immunization Committee. Paediatr Child Health 2015; 20(6):321-26
• Canadian Pediatric Society Position Statement. Use of palivizumab in children with congenital heart disease. Paediatrics & Child Health 2009; Vol 14 No 8. 
• Feltes TF, Cabalka AK, Meissner HC et al. Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease. J Pediatr 2003; 143:532-40. 
• Ryan VR, Langley JM, Dodds L, Andreou P. Estimating Respiratory Syncytial Virus –associated hospitalization in the first year of life among infants born at 32 – 35 weeks gestation. Pediatr Infect Dis J 2016;35:851-855 doi: 10.1097/INF.0000000000001186

 

More on Palivizumab: 

About Palivizumab (Synagis®)

Utilization Management Program: Palivizumab (Synagis®)

Utilization Management Program Components: Palivizumab (Synagis®)

Provincial Working Group Members

Cold Chain Maintenance