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Disclaimer to the On-line Edition
This Manual has been designed for use in the NICU at London Health Sciences Centre (LHSC), London, Ontario, Canada, and represents clinical practice at this institution. The information contained within the Manual may not be applicable to other centres. If users of this Manual are not familiar with a drug, it is recommended that the official monograph be consulted before it is prescribed and administered. Any user of this information is advised that the contributors, Editor and LHSC are not responsible for any errors or omissions, and / or any consequences arising from the use of the information in this Manual.

Synagis
(Palivizumab)

Indication

  • SYNAGIS is indicated for the prevention of serious lower respiratory tract infection caused by the respiratory syncytial virus (RSV) in paediatric patients at high risk of RSV disease.

    In Canada, eligible patients include:

  • infants 32 weeks gestation and aged 6 months at the start of the RSV season
  • infants 2 years of age with BPD and who have required oxygen within the 6 months preceding the RSV season
  • in SW Ontario the RSV season generally extends from December to April
SYNAGIS is not effective for the treatment of established RSV disease nor does it prevent non-RSV respiratory illness or otitis media

Clinical Pharmacology

  • SYNAGIS is a humanized monoclonal antibody directed against a specific protein site on the respiratory syncytial virus
  • it is produced by recombinant DNA technology and is a composite of human (95%) and murine (5%) antibody sequences
  • the effective target concentration of SYNAGIS in studies was 40 mcg/mL; peak serum concentrations of 80 mcg/mL were achieved in children within 2 days after IM administration of 15 mg/kg
  • SYNAGIS administration does not appear to alter the response to any vaccines, and routine childhood immunization schedules do not need to be altered
  • the IMpact -Trial of RSV prophylaxis showed a 6.3% (8.1% vs 1.8%) decrease in RSV hospitalizations in premature infants without BPD who received SYNAGIS compared to infants who received a placebo

Side Effects

  • the frequency of various adverse effects (eg, rash, pain, wheeze, apnea, local site reactions) were no different between the SYNAGIS(R) and placebo groups in the IMpact -Trial
  • anaphylactoid reactions following the administration of SYNAGIS(R) have not been observed. However, as with the administration of other protein containing products, anaphylaxis or a severe allergic reaction is a possibility. If this occurs epinephrine administration is recommended.

Dose and Administration

  • 15 mg/kg IM monthly for 5 months during the RSV season
  • reconstitute by slowly adding 1 mL sterile water for injection to a 100 mg vial OR add 0.6 mL sterile water for injection to 50 mg vial; the final concentration in both cases is IDENTICAL, ie., 100 mg/mL
  • the vial should be gently swirled for 30 seconds to avoid foaming
  • DO NOT SHAKE THE VIAL
  • reconstitute SYNAGIS(R) should stand at room temperature for a minimum of 20 minutes until the solution clarifies
  • reconstituted SYNAGIS(R) should be used within 6 hours
  • store SYNAGIS(R) vials in the refrigerator. Do not freeze.
  • to minimize product wastage, try to arrange for 2 eligible patients to receive their injection within the 6 hour period after a vial of SYNAGIS(R) has been reconstituted

Supplied

  • 100 mg and 50 mg vial of lyophilized product

References

  1. IMpact-RSV Study Group: Palivizumab, a Humanized Respiratory Syncytial Virus Monoclonal Antibody, Reduces Hospitalization From Respiratory Syncytial Virus Infection in High-risk Infants. Pediatrics, 102(3);1998:531-537.
  2. Synagis (Palivizumab) Product Monograph. MedImmune, Inc, Gaithersburg, MD, June 19, 1998.

Updated: November 2002


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