What is the indication for Synagis (palivizumab) 100mg/mL?

Indication of SYNAGIS 100MG/ML

Synagis (palivizumab) 100mg/mL is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in high-risk pediatric populations. 1, 2

FDA-Approved Indication

The FDA-approved package insert states that Synagis is indicated for prevention of serious lower respiratory tract disease caused by RSV in children at high risk of RSV disease. 1, 2 The medication is administered intramuscularly at 15 mg/kg body weight monthly during RSV season. 1, 2

Specific High-Risk Populations Eligible for Prophylaxis

Premature Infants Without Chronic Lung Disease or Congenital Heart Disease

• Infants born before 29 weeks, 0 days' gestation who are younger than 12 months at the start of RSV season should receive palivizumab. 1, 3
• Infants born at 29 weeks, 0 days' gestation or later do not universally qualify for prophylaxis based on prematurity alone, unless they have other qualifying conditions. 1

Infants with Chronic Lung Disease (CLD) of Prematurity

• Infants less than 24 months with CLD requiring medical therapy (supplemental oxygen, bronchodilators, diuretics, or corticosteroids) within 6 months before RSV season should receive palivizumab. 3
• In the second year of life, prophylaxis is recommended only for infants who continue to require medical support (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) during the 6-month period before the start of the second RSV season. 1

Infants with Hemodynamically Significant Congenital Heart Disease (CHD)

• Children 12 months or younger with hemodynamically significant CHD may benefit from palivizumab prophylaxis. 1
• Specific qualifying conditions include: 1, 3
  • Acyanotic heart disease requiring medication to control congestive heart failure
  • Infants who will require cardiac surgical procedures
  • Moderate to severe pulmonary hypertension
  • Cyanotic heart defects (decisions made in consultation with pediatric cardiologist)

Populations That Should NOT Receive Palivizumab

• Infants with hemodynamically insignificant heart disease (secundum atrial septal defect, small VSD, mild pulmonic stenosis, uncomplicated aortic stenosis, mild coarctation, patent ductus arteriosus). 1, 3
• Infants with adequately corrected cardiac lesions unless they continue requiring medication for congestive heart failure. 3
• Infants with Down syndrome without qualifying heart disease, CLD, airway clearance issues, or prematurity (<29 weeks). 1
• Infants with cystic fibrosis unless clinical evidence of CLD and/or nutritional compromise exists in the first year of life. 1

Special Populations for Consideration

Immunocompromised Children

• Prophylaxis may be considered for children younger than 24 months who are profoundly immunocompromised during RSV season. 1, 4
• Children younger than 2 years who undergo cardiac transplantation during RSV season may be considered for prophylaxis. 1

Post-Cardiac Surgery Considerations

• An additional dose of palivizumab (15 mg/kg) should be administered after cardiopulmonary bypass surgery, as bypass decreases serum palivizumab concentrations by 58%. 1, 3
• The post-operative dose should be given as soon as the patient is medically stable. 3

Clinical Efficacy

• Palivizumab provides a 55% overall reduction in RSV-related hospitalizations in premature infants and those with chronic lung disease. 3, 4, 5
• In infants with hemodynamically significant CHD, palivizumab achieves a 45% reduction in RSV-related hospitalizations. 3, 4, 6
• Important limitation: Palivizumab has not been demonstrated to reduce mortality from RSV infection and does not significantly decrease recurrent wheezing after RSV infection. 1, 4

Administration Guidelines

• Dosing is 15 mg/kg intramuscularly every 28-30 days throughout RSV season, with a maximum of 5 doses for most eligible infants. 1, 3, 2
• The first dose should be given before RSV season starts, or as soon as possible if the season has already begun. 2
• If breakthrough RSV hospitalization occurs, monthly prophylaxis should be discontinued due to extremely low likelihood (<0.5%) of a second RSV hospitalization in the same season. 1
• Palivizumab does not interfere with routine childhood immunizations, which should proceed on schedule. 1, 3

Common Pitfalls to Avoid

• Failure to administer an additional dose after cardiac bypass surgery. 3
• Inappropriate use in infants with hemodynamically insignificant heart disease. 3
• Discontinuing prophylaxis prematurely before the end of RSV season. 3
• Neglecting general preventive measures (hand hygiene, avoiding crowds, eliminating tobacco smoke exposure) while relying solely on pharmacological prophylaxis. 3