When is Respiratory Syncytial Virus (RSV) prophylaxis indicated?

RSV Prophylaxis Indications

Palivizumab (Synagis) prophylaxis is indicated for prevention of serious RSV lower respiratory tract disease in high-risk infants and young children, specifically those born prematurely (<29 weeks gestation and <12 months old), those with chronic lung disease requiring ongoing medical therapy, and those with hemodynamically significant congenital heart disease—all under specific age and clinical criteria during RSV season. 1, 2

Primary Indications by Risk Category

Prematurity 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 prophylaxis 1
• Infants born at 29 weeks, 0 days' gestation or later do NOT universally qualify for prophylaxis based on prematurity alone 1
• The FDA label approves use for infants ≤35 weeks gestational age who are ≤6 months old at RSV season start, but current AAP guidelines are more restrictive 2

Important caveat: Older guidelines (2006) recommended prophylaxis for infants 32-35 weeks gestation with multiple risk factors (childcare attendance, school-aged siblings, environmental pollutants, airway abnormalities, neuromuscular disease), but the 2014 updated guidance narrowed indications significantly 1

Chronic Lung Disease of Prematurity

• Infants and children <12 months old with chronic lung disease (defined as requiring >21% oxygen for ≥28 days from birth) should receive prophylaxis 1
• Infants <24 months old who continue to require medical support (supplemental oxygen, diuretic therapy, or chronic corticosteroid therapy) within 6 months before RSV season start qualify for prophylaxis 1
• In the second year of life (12-24 months), prophylaxis is ONLY recommended if the child continues requiring medical support (oxygen, diuretics, or corticosteroids) during the 6-month period before the second RSV season 1
• If medical support is discontinued, prophylaxis should NOT be given in the second year 1

Hemodynamically Significant Congenital Heart Disease

• Children ≤12 months old with hemodynamically significant CHD may benefit from prophylaxis 1
• Specific high-benefit groups include:
  • Infants with acyanotic heart disease receiving medication for congestive heart failure who will require cardiac surgery 1
  • Infants with moderate to severe pulmonary hypertension 1
  • Infants with cyanotic heart defects (decisions made in consultation with pediatric cardiology) 1

Who should NOT receive prophylaxis:

• Infants with hemodynamically insignificant heart disease (secundum atrial septal defect, small ventricular septal defect, mild pulmonic stenosis, uncomplicated aortic stenosis, mild coarctation, patent ductus arteriosus) 1

Special Populations Where Prophylaxis MAY Be Considered

• Profoundly immunocompromised children <24 months during RSV season (though efficacy data are lacking) 1
• Children <2 years undergoing cardiac transplantation during RSV season 1
• Infants with cystic fibrosis with clinical evidence of chronic lung disease AND/OR nutritional compromise in the first year of life (NOT routine) 1
• Patients with SCID or suspected SCID should receive prophylaxis during RSV season 3

Populations Where Prophylaxis Is NOT Recommended

• Down syndrome alone does not warrant prophylaxis unless qualifying heart disease, chronic lung disease, airway clearance issues, or prematurity (<29 weeks) is present 1
• Cystic fibrosis patients should NOT routinely receive prophylaxis 1
• Neuromuscular disease, pulmonary abnormality, or immune compromise have insufficient data for routine prophylaxis recommendations 1

Dosing and Administration Algorithm

Standard Dosing Protocol

• 15 mg/kg intramuscularly every 30 days throughout RSV season 1, 2
• Maximum of 5 monthly doses for most infants in continental United States 1
• Initiate in November, continue through March (5 doses provides >24 weeks protection) 1
• If initiated in October, give fifth and final dose in February 1

Special Dosing Situations

• Post-cardiopulmonary bypass: Administer additional 15 mg/kg dose as soon as medically stable after bypass (even if <1 month from previous dose), as bypass decreases serum palivizumab by 58% 1, 2
• Infants born during RSV season: Fewer than 5 doses will be needed 1
• Breakthrough RSV hospitalization: DISCONTINUE prophylaxis after any breakthrough RSV hospitalization (extremely low likelihood of second hospitalization in same season, <0.5%) 1

Critical Pitfalls to Avoid

• Do NOT use palivizumab for treatment of established RSV infection—it has NO therapeutic benefit and is only approved for prevention 3, 2
• Do NOT continue prophylaxis in second year of life unless child has chronic lung disease requiring ongoing medical support 1
• Do NOT give prophylaxis to prevent recurrent wheezing—no evidence supports cost-effectiveness for this indication 1
• Do NOT use for nosocomial RSV prevention in NICU or hospital settings 1
• Do NOT withhold routine childhood immunizations—palivizumab does not interfere with standard vaccines 4

Geographic Considerations

• Florida variations: Northwest Florida follows typical November onset; north central and southwest Florida have earlier onset (late September-early October) requiring adjusted timing 1
• Alaska Native children: Timing should be determined by locally generated seasonal data 1