Provincial Blood Coordinating Program

Guidelines for Respiratory Syncytial Virus Infection Prophylaxis (RSVP) G 2008-2009 Season

General Considerations
Respiratory Syncytial Virus (RSV) is the main cause of acute respiratory tract infection in infants. Infections occur predominantly in young infants and premature infants are particularly prone to more severe primary infections. Infant exposure to smoking in the home, siblings, family history of wheezing, day care settings and other crowded environments present additional risks for the young or premature infant. Preventive measures such as restricting visitors, careful hand washing and keeping young infants out of day-care settings may be best measures to follow. Palivizumab (Synagis) is a recombinant monoclonal antibody developed to prevent RSV infections. The product is available in 50mg and 100mg vial sizes and is distributed by Abbott Laboratories.

Indications for use of Palivizumab (Synagis)

The following summarizes guidelines for Respiratory Syncytial Virus Prophylaxis (RSVP) for Infants at Risk. The attending Pediatrician / Physician should review the Canadian Pediatric Society guidelines (http://www.cps.ca/english/statements/ID/ID03-03.htm) as well as the National Advisory Committee on Immunization Guidelines for Childhood Immunization Practices (http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/97pdf/acs-6.pdf ) and the Canadian Immunization Guide 2006, 7th Edition; (http://www.phac-aspc.gc.ca/publicat/cig-gci/pdf/cig-gci-2006_e.pdf ) if there are questions regarding whether patients are candidates for prophylaxis. The RSV season varies across Canada. Physicians should check with local infectious disease specialists or microbiologists to determine when the RSV season begins in their communities. (eg. The RSV season in the Labrador Grenfell regional health authority may begin earlier and/or end later than the season in the island portion of the province.) Synagis should be administered at least twenty-five (25) days prior to the start of the RSV season and continue once a month for five months until the end of the RSV season. All eligible infants will be offered and receive Synagis prophylaxis against RSV according to the following guidelines.

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Provincial Blood Coordinating Program

Guidelines for Respiratory Syncytial Virus Infection Prophylaxis (RSVP) G 2008-2009 Season

Guidelines
Synagis prophylaxis should be considered for children at highest risk of severe RSV infection including: 1. Infants born at 32 weeks and 0 days gestation or earlier who are 6months of age (with or without Broncho Pulmonary Dysplasia (BPD) at the beginning of the RSV season 2. Infants 24 months of age with Broncho Pulmonary Dysplasia (BPD) who require oxygen and/or medical therapy within the 6 months prior to the start of the RSV season. 3. Children <24 months of age with hemodynamically significant heart disease, cyanotic or acyanotic, requiring corrective surgery or receiving cardiac medication for hemodynamic consideration. The presence of hemodynamically significant CHD will be determined by a pediatric cardiologist. 4. Infants born between 32 and 35 weeks gestation who live in isolated or remote northern communities where hospital care is not readily accessible may be given special consideration for RSV prophylaxis. 5. Other children considered at high risk: a) For other children considered at high risk for contracting RSV but not falling within the preceding indications, the requesting physician will consult Dr. Jennifer ODea (consulting pediatrician for Synagis) to perform an assessment based on risk factors to determine eligibility to receive Synagis. A letter/risk assessment must be provided as medical justification for ordering Synagis, in addition to the Newfoundland and Labrador ordering requisition, to Abbott Laboratories Limited (Abbott). The consulting pediatrician, Dr. Jennifer ODea at the Janeway Child Health Centre, will be available for consult at (709) 777- 4520 or contact the RSV Nurse Coordinator at (709) 777-8473.

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Provincial Blood Coordinating Program

Guidelines for Respiratory Syncytial Virus Infection Prophylaxis (RSVP) G 2008-2009 Season

Requests for Palivizumab (Synagis)

1. Complete an RSV prophylaxis Request form. The Regional Health Authority (RHA) requesting the initial dose must record the RHA name in Section I of the form. 2. Document the shipping address of the applicable RHA for the initial and subsequent doses. 3. All requests for Synagis should be faxed to Abbott Laboratories, using the Newfoundland and Labrador request form. NOTE: Abbott Laboratories is authorized to only ship product that meet the guidelines indicated above. 4. Upon initial request and approval each infant will receive a reference number for the season. 5. If the request is a subsequent request, the reference number (C#) assigned by Abbott upon initial request must be provided. 6. Requests for Synagis for children that do not meet the above criteria (ie OTHER) must be accompanied by the Medical Justification for Other Category form and an explanatory letter. 7. Synagis should be delivered to the hospital pharmacy due to the strict storage requirements. Refer to storage guidelines for Physicians Offices (page 5). Synagis should be administered to patients through same-day clinics when possible. 8. Synagis is generally administered as 5 doses per season as outlined in Table 1. The initial dose should be given between December 1 and December 23 and every 4 weeks to a maximum of 5 doses based on when infants are at most risk unless otherwise indicated by the duration of the RSV season. Table1. Guidance for number of doses depending on request date Request Date (if start date is) December January February March April Number of Doses to be given (Dose is 15 mg/kg as per package insert) Five Doses Four Doses Three Doses Two Doses One Dose

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Provincial Blood Coordinating Program

Guidelines for Respiratory Syncytial Virus Infection Prophylaxis (RSVP) G 2008-2009 Season

9. Pharmacies or offices with remaining inventory should still submit a request form to Abbott but reduce requested doses so remaining inventory may be used first to eliminate expiry of product. Due to storage requirements it is strongly recommended that Synagis be delivered and stored in hospital pharmacies rather than physician offices.

Administration of Synagis
1. The dose of Synagis is 15mg/kg of body weight, administered intramuscularly. The product is available in 50 mg and 100 mg vial sizes. 2. Synagis has a strict reconstitution process. If reconstituted inappropriately, the product will foam and the required dosage may not be withdrawn from the vial resulting in an inadequate dose for the patient and product wastage. Once reconstituted, allow the product to stand at room temperature for a minimum of 20 minutes until the solution clears. Information regarding reconstitution can be obtained from the Janeway by calling 709-7778473 or by visiting the following link: http://www.synagis.com/hcp/docs/SSP04%20072.pdf 3. Synagis does not contain preservatives and therefore should be administered within 6 hours of reconstitution. 4. A Registered Nurse (RN) or MD should administer Synagis according to the following: a) The first dose should be administered prior to the start of the RSV season. b) The first dose of Synagis should be administered approximately 2 weeks prior to discharge, if discharge is during the RSV season. c) Document the lot number, expiry date, site of administration and final disposition of the administered Synagis on the patients health record. d) Document outdated or destroyed product including the quantity, lot number and expiry date and report to the Newfoundland and Labrador Provincial Blood Coordinating Program using the Synagis Product Disposition Log. Fax completed log at the end of the RSV season or no later than June 30, to (709)729-4009. This information will be used to monitor inventory and utilization practices for the province.

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Provincial Blood Coordinating Program

Guidelines for Respiratory Syncytial Virus Infection Prophylaxis (RSVP) G 2008-2009 Season

Storage Guidelines for Physician Offices and Hospital Pharmacies

1. Appropriate storage of this product should follow cold chain maintenance protocols. 2. Store palivizumab in a refrigerator at +2o C to +8oC immediately upon receipt. 3. All refrigerators containing this product should have a maximum-minimum thermometer. 4. The temperature of the refrigerator should be checked at least once daily. 5. If a site is unable to maintain refrigerator temperatures between +2o C to +8oC, alternative appropriate storage should be arranged.

Adverse Incident Reporting

Any suspected adverse incident should be reported to the Canadian Adverse Drug Reaction Monitoring Program at: Canadian Adverse Drug Reaction Monitoring Program (CADRMP) Marketed Health Products Directorate Health Canada Address Locator: 0701C Ottawa, Ontario, K1A 0K9 Tel: 613-957-0337 Fax: 613-957-0335 Toll free for consumers and health professionals: Tel: 866-234-2345 Fax: 866-678-6789 E-mail: cadrmp@hc-sc.gc.ca The AR Reporting Form and AR guidelines can be found on the Health Canada web site or in The Canadian compendium of Pharmaceutical and Specialties. The Newfoundland and Labrador Provincial Blood Coordinating Program will request a report from Health Canada on any adverse reactions within Canada during the previous RSV season and will review this information annually. Copies of the Newfoundland and Labrador request form and the full 2008/09 guidelines can be found at http://www.health.gov.nl.ca/health/bloodprogram/utilization.htm under Programs, Utilization Management, Synagis The NLPBCP will continue to monitor the use of Synagis and will provide feedback on the 2008/09 RSV season and processes for next year. If you have any comments, questions or suggestions, please contact Marilyn Collins at marilyncollins@gov.nl.ca

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Provincial Blood Coordinating Program

Guidelines for Respiratory Syncytial Virus Infection Prophylaxis (RSVP) G 2008-2009 Season

References:
1. Abbott Laboratories Limited (April 2006) Product insert Synagis (palivizumab) 50 mg and 100 mg Intramuscular Injections. American Academy of Pediatrics, 2006. 2. Canadian Agency for Drugs and Technologies in Health, Technology Report, Palivizumab Prophylaxis against Respiratory Syncytial Virus, HTA Issue 80, March 2007. 3. Canadian Immunization Guide, 2006, 7th ed. Public Health Agency of Canada, National Advisory Committee on Immunization http://www.phac-aspc.gc.ca/publicat/cig-gci/pdf/ciggci-2006_e.pdf 4. Carbonell-Estrany X, Figueras-Aloy J, Identifying Risk Factors for Severe Respiratory Syncytial Virus Among Infants Born After 33 through 35 Completed Weeks of Gestation, The Pediatrics Infectious Disease Journal, Volume 23, Number 11, November 2004. 5. Cooper AR, Yetman M, Hickey F, Moralejo D, The Prevention of RSV Bronchiolitis In High-Risk Infants in NL Palivizumab Prophylaxis Is it Worth It in All Healthy Premature Infants?,2005 6. Figueras-Aloy J, Carbonell-Estrany X, Quero J, Case-Control Study of the Risk Factors Linked to Respiratory Syncytial Virus Infection Requiring Hospitalization in Premature Infants Born at a Gestational Age of 33-35 Weeks in Spain, The Pediatric Infectious Disease Journal, Volume 23, Number 9, September 2004. 7. Horn Susan D, Smout Randell J, Effect of Prematurity on Respiratory Syncytial Virus Hospital Resource Use and Outcomes, The Journal of Pediatrics, November 2003. 8. Infectious Diseases and Immunization Committee, Canadian Paediatric Society (CPS), Use of palivizumab in children with congenital heart disease. Paediatrics & Child Health 2003; 8(10):632-633 Reference No. ID03-03

9. Law B, Langley J, et al, the Pediatric Investigators Collaborative Network on Infections in Canada Study of Predictors of Hospitalization for Respiratory Syncytial Virus Infection for Infants Born at 33 through 35 Completed Weeks of Gestation, The Pediatrics Infectious Disease Journal. Volume 23, Number 9, September 2004. 10. Medscape Review, Highlights of the American Academy of Pediatrics Annual Meeting, Update from the Red Book Committee, http://www.medscape.com/viewarticle/466495

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Provincial Blood Coordinating Program

Guidelines for Respiratory Syncytial Virus Infection Prophylaxis (RSVP) G 2008-2009 Season

11. Meissner C, Long SS and Committee on Infectious Diseases, and Committee on Fetus and Newborn, Revised Indications for the Use of Palivizumab and Respiratory Syncytial Virus Immune Globulin Intravenous for the Prevention of Respiratory Syncytial Virus Infections, Pediatrics, Vol 112, No.6 December 2003.
http://pediatrics.aappublications.org/cgi/reprint/112/6/1447

12. Recommendations for Care of Children in Special Circumstances: Other Infections Spread by the Respiratory Route, Section 2, American Academy of Pediatrics Red Book 2006: 146148. 13. Respiratory Syncytial Virus, Summaries of Infectious Diseases, Section 3, American Academy of Pediatrics Red Book 2006, p 560-566.

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