Palivizumab (Synagis®)

Alberta RSV Prevention Program

Indication | Pharmacology | Product Monograph | Availability/Stability | Administration | Side Effects | Dosage & Schedule | Considerations | Precautions | Routine Vaccinations | Adverse Reaction Reporting

Generic Name: Palivizumab
Trade Name: Synagis® - AstraZeneca Canada
Classification: Passive Immunizing agent

Shipping Process

• The Alberta RSV Prevention Program will arrange for delivery of palivizumab to designated points of care where cold chain practices can be implemented i.e. monitored refrigerator between 2° and 8° Celsius.
• Families will be directed to a point of care proximal to their place of residence.

Indication

For the prevention of serious respiratory tract disease due to respiratory syncytial virus (RSV) in infants and children at high risk of RSV disease.  Refer to Eligibility Criteria to identify patients at risk. Not indicated for treatment of RSV infection.

Pharmacology

Humanized monoclonal antibody (IgG 1K) produced by recombinant DNA technology; a composite of human (95%) and murine (5%) antibody sequences.  Inhibits RSV replication by neutralizing and inhibiting fusion of the RSV virus.  Significantly reduces the quantity of RSV in the lower respiratory tract. The target trough serum Palivizumab concentration for inhibition of RSV replication is 40mcg/ml which is provided by the 15mg/kg monthly dosing.

• Medicinal Ingredient- palivizumab
• Non-medicinal Ingredients- chloride, glycine and histidine

Availability/Stability

Supplied as solution for injection in a vial containing either 50 mg/0.5mL or 100 mg/1 mL. Follow cold chain practices for storage.

Administration

• The vial of SYNAGIS® solution for injection does not contain a preservative and should be administered immediately after drawing the dose into the syringe
• DO NOT DILUTE THE PRODUCT, DO NOT SHAKE THE VIAL
• Intramuscular (IM) injection.
• Preferred site of injection is the vastus lateralus aspect of the thigh.
• Injection volumes greater than 1.0 ml should be given as a divided dose.

Side Effects

• Palivizumab injections are generally well tolerated.
• Adverse effects reported in the Impact RSV Study in more than 1% of the patients receiving palivizumab included: upper respiratory infection, otitis media, fever, rhinitis, rash, pain at the injection site, hernia and elevated serum SGOT concentration.
• Adverse effects reported in the palivizumab group and the placebo group included: injection site reaction, apnea, vomiting and anemia.
• Acute hypersensitivity reactions and anaphylaxis have rarely been reported.

Dosage & Schedule

• 15mg/Kg of body weight.
• The recommended intervals between dosing for the Northern and Southern RSV Prevention Programs can be found in the table below
• The Alberta RSV Prevention Program will be using an abbreviated 4 dose regimen. Administration of a 5th dose will be assessed by Medical Directors on a case by case basis.

Considerations

Contraindications:

• Contraindicated in patients with known hypersensitivity to palivizumab or other humanized monoclonal antibodies.

Precautions

• As with any intramuscular injection, palivizumab should be given with caution to patients with thrombocytopenia or any coagulation disorder and those receiving anticoagulant therapy.
• A moderate to severe acute infection or febrile illness may warrant delaying the use of palivizumab, unless in the opinion of the physician, withholding palivizumab entails a greater risk. A mild upper respiratory infection is not usually reason to defer administration of palivizumab.
• An evidence-based practice guideline for strategies to reduce injection pain in children. Dr. Taddio’s full article.

Routine Vaccinations

• Palivizumab is not expected to interfere with the immune response to vaccines, as the monoclonal antibody is specific for RSV.
• For monitoring of adverse events, the preference is for a 48 hr interval between administration of palivizumab and routine vaccines.

Adverse Reaction Reporting

• Adverse reactions are noxious and unintended effects to health products.
• Reporting an adverse event contributes to improving the safety of drugs.
• All suspected adverse events must be reported to the Alberta RSV Prevention Program. (See contact information)