What are the indications for Respiratory Syncytial Virus (RSV) prophylaxis with palivizumab (palivizumab)?

Indications for RSV Prophylaxis with Palivizumab

Palivizumab prophylaxis is indicated for a select group of high-risk infants and young children, primarily those born before 29 weeks gestation, those with chronic lung disease requiring recent medical therapy, and those with hemodynamically significant congenital heart disease. 1, 2

Primary Indications

• Premature infants born at less than or equal to 35 weeks gestational age who are 6 months of age or younger at the beginning of RSV season 2

  • More specifically, prophylaxis is strongly recommended for infants born before 29 weeks, 0 days' gestation who are younger than 12 months at the start of RSV season 3, 1
  • For infants born between 29-35 weeks gestation, the recommendations have become more restrictive in recent guidelines 3, 4

• Children with bronchopulmonary dysplasia (BPD)/chronic lung disease (CLD) who required medical treatment within the previous 6 months and are 24 months of age or younger at the beginning of RSV season 2, 3

  • Medical therapy may include supplemental oxygen, bronchodilator, diuretic, or corticosteroid therapy 3

• Children with hemodynamically significant congenital heart disease (CHD) who are 24 months of age or younger at the beginning of RSV season 2, 3

  • This includes infants with acyanotic heart disease who are receiving medication to control congestive heart failure and will require cardiac surgical procedures 3, 1

Additional Considerations for Prophylaxis

• Children with neuromuscular disorders or congenital abnormalities of the airways that impair the ability to clear secretions from the upper airways may be considered for prophylaxis in the first year of life 3, 1

• Continued use in the second year of life may be considered for children with CLD who continue to require medical therapy (oxygen, bronchodilator, diuretic or corticosteroid therapy) 3

• Children who undergo cardiac bypass should receive an additional dose of palivizumab after the procedure due to a significant decrease in serum concentration 1, 2

Dosing and Administration

• The recommended dose is 15 mg/kg body weight administered monthly by intramuscular injection 2, 1
• Maximum of 5 monthly doses during the RSV season 3, 1
• First dose should be administered prior to the start of RSV season 2
• In the northern hemisphere, RSV season typically runs from November through April, but may vary by region 2, 4

Important Limitations

• Palivizumab is not effective for treatment of established RSV disease and is not approved for this indication 3, 2
• Prophylaxis is not recommended for primary asthma prevention or to reduce subsequent episodes of wheezing 3, 1
• If a child receiving monthly palivizumab prophylaxis experiences a breakthrough RSV hospitalization, monthly prophylaxis should be discontinued due to the extremely low likelihood of a second RSV hospitalization in the same season (<0.5%) 3

Efficacy and Evidence

• Palivizumab reduces RSV-related hospitalizations by approximately 55% in premature infants and those with CLD 4, 5
• The reduction in hospitalization is approximately 45% in infants with hemodynamically significant CHD 4
• Despite reducing hospitalizations, palivizumab has not been demonstrated to reduce mortality from RSV infection 4, 6

Cost Considerations

• The high cost of palivizumab prophylaxis is associated with minimal health benefit, making it a low-value intervention for many patient groups 3
• This has led to increasingly restrictive guidelines focusing on the highest-risk populations 3

Additional Preventive Measures

• Limit exposure to contagious settings (e.g., child care centers) 3, 1
• Emphasize hand hygiene in all settings 3, 1
• Encourage breastfeeding 3
• Avoid crowds and tobacco smoke exposure 3, 1

Common Pitfalls

• Failure to administer an additional dose after cardiac bypass surgery 1
• Continuing prophylaxis after a breakthrough RSV hospitalization 3
• Using palivizumab for treatment of established RSV disease 3, 2
• Prescribing for patients outside the recommended indications, which is not cost-effective 3