Can Beyfortus (nirsevimab) be administered after pediatric open heart surgery on cardiopulmonary bypass (CPB)?

Administration of Beyfortus After Pediatric Open Heart Surgery on Cardiopulmonary Bypass

Beyfortus (nirsevimab) should be administered as an additional dose after pediatric open heart surgery with cardiopulmonary bypass, with the dosage determined by timing of surgery and previous administration. 1

Dosing Recommendations After Cardiac Surgery with CPB

The FDA-approved labeling for Beyfortus provides specific guidance for children undergoing cardiac surgery with cardiopulmonary bypass:

• First RSV season patients:

  • If surgery occurs within 90 days after receiving Beyfortus, administer an additional dose based on current body weight (50 mg if <5 kg, 100 mg if ≥5 kg) 1
  • If surgery occurs more than 90 days after receiving Beyfortus, administer an additional 50 mg dose regardless of body weight 1

• Second RSV season patients:

  • If surgery occurs within 90 days after receiving Beyfortus, administer an additional 200 mg dose regardless of body weight 1
  • If surgery occurs more than 90 days after receiving Beyfortus, administer an additional 100 mg dose regardless of body weight 1

Administration Timing

• The additional dose should be administered as soon as the child is stable after surgery to ensure adequate nirsevimab-alip serum levels 1
• This timing recommendation accounts for potential alterations in drug pharmacokinetics following cardiopulmonary bypass 1

Administration Method

• Administer Beyfortus as an intramuscular (IM) injection 1
• Inspect the solution visually for particulate matter and discoloration prior to administration 1
• Do not mix Beyfortus with any vaccines or medications in the same syringe or vial 1

Special Considerations for Post-Cardiac Surgery Patients

• Pediatric patients after cardiac surgery often have hemodynamic instability and altered immune function that may increase their vulnerability to severe RSV disease 2
• Cardiopulmonary bypass can induce a systemic inflammatory response and transient immune suppression 3
• This immune modulation may potentially affect the efficacy of passive immunization, making the additional dose particularly important 3

Monitoring After Administration

• Monitor for signs of allergic reaction, as Beyfortus is contraindicated in persons with history of severe allergic reaction to previous doses or components 4
• When administering Beyfortus to children with increased risk for bleeding (which may include those on anticoagulation after cardiac surgery), follow general best practice guidelines for immunization 5, 4

Reporting Adverse Events

• Adverse reactions should be reported to FDA MedWatch, as FDA has classified nirsevimab as a drug 2, 4
• If co-administered with vaccines, adverse events should be reported to the Vaccine Adverse Event Reporting System (VAERS) 2

By following these specific guidelines, healthcare providers can ensure appropriate RSV protection for pediatric patients undergoing cardiac surgery with cardiopulmonary bypass while maintaining optimal serum levels of nirsevimab.