Synagis®

Synagis®

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 Ontario, eligible patients include:
  • Infants born prematurely at less than or equal to 32 weeks completed gestation and aged less than or equal to 6 months at the start of or during the local RSV season
  • Infants 33 – 35 completed weeks gestation and aged less than or equal to 6 months at the start of or during the local RSV season, who do not live in remote communities and have a Risk Assessment Tool Score of 49 -100
  • Infants 33 – 35 completed weeks gestation and aged less than or equal to 6 months at the start of or during the local RSV season who live in remote communities
  • Children less than 24 months of age with Trisomy 21
  • Children less than 24 months of age with bronchopulmonary dysplasia/chronic lung disease (BPD/CLD) and who have required oxygen and/or medical therapy specifically for chronic lung disease within the 6 months preceding the RSV season
  • Children less than 12 months of age with hemodynamically significant cyanotic or acyanotic congenital heart disease (CHD): requiring corrective surgery or are on cardiac medication for congestive heart failure or diagnosed with moderate to severe pulmonary hypertension
  • In SW Ontario the RSV season generally extends from November 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
• 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® and placebo groups in the IMpact -Trial
• Anaphylactoid reactions following the administration of Synagis® 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 consecutive doses during the RSV season
• Do not dilute the product
• Do not shake the vial
• store Synagis® vials in the refrigerator. Do not freeze
• To minimize product wastage, try to arrange for 2 eligible patients to receive their injections on the same day

Supplied As

• 100 mg and 50 mg vials of solution for injection
• Both vials contain a solution for injection with a concentration of 100 mg/mL
• Synagis® solution for injection does not require reconstitution