Form: Sterile solution for intramuscular injection (50 mg/0.5 mL and 100 mg/1 mL)
Manufacturer: AstraZeneca Canada Inc.
Indications and Clinical Use
Indication: Prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk of RSV disease.
High-Risk Groups:
Infants with bronchopulmonary dysplasia (BPD)
Infants with a history of prematurity (≤ 35 weeks gestational age)
Children with hemodynamically significant congenital heart disease (CHD)
Pediatrics: Safety and effectiveness not established for children older than 24 months at the start of dosing.
Dosage and Administration
Recommended Dose: 15 mg/kg of body weight, administered intramuscularly every 28 to 30 days during the RSV season.
Administration:
Preferably in the anterolateral aspect of the thigh.
Avoid gluteal muscle due to the risk of sciatic nerve damage.
Do not mix with any medications or diluents.
Single-use vial; discard any unused contents.
If a child misses an injection, schedule another injection as soon as possible.
Contraindications
Known hypersensitivity to palivizumab or any of its excipients.
Known hypersensitivity to other humanized monoclonal antibodies.
Warnings and Precautions
Severe Allergic Reactions: Risk of anaphylaxis and other acute hypersensitivity reactions; epinephrine should be available.
Thrombocytopenia and Coagulation Disorders: Administer with caution.
Special Populations:
Not indicated for use in pregnant or breastfeeding women.
No data for geriatric use.
Adverse Reactions
Common: Injection site reactions (pain, erythema, swelling), rash, fever.
Serious: Anaphylaxis, severe hypersensitivity reactions.
Clinical Trial Findings: Most adverse reactions were mild to moderate. No significant difference in adverse events between SYNAGIS and placebo groups.
Drug Interactions
Vaccine Interactions: SYNAGIS does not interfere with the immune response to other vaccines, including live viral vaccines.
Diagnostic Interference: May interfere with immune-based RSV diagnostic tests, leading to potential false-negative results.
Storage and Stability
Storage: Store at 2°C to 8°C. Do not freeze. Use immediately after drawing the dose into the syringe.
Disposal: Single-use vial; discard any unused product.
Clinical Trials and Efficacy
Study MI-CP018: Demonstrated a 55% reduction in RSV hospitalizations in high-risk infants and children.
Study MI-CP048: Showed a 45% reduction in RSV hospitalizations among children with hemodynamically significant CHD.
