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The following is a summary of “Safety and Pharmacokinetics of Nirsevimab in Immunocompromised Children,” published in the September 2024 issue of Pediatrics by Domachowske et al.
Children who are immunocompromised face a higher risk of severe respiratory syncytial virus (RSV) and lower respiratory tract infection (LRTI), which can lead to prolonged hospitalization and increased mortality.
Researchers conducted a prospective study to evaluate the safety and pharmacokinetics of nirsevimab in children who are immunocompromised aged 24 months and younger.
They administered a single intramuscular injection of nirsevimab (50 mg if less than 5 kg; 100 mg if 5 kg or more during the first RSV season; 200 mg during the second season) and evaluated safety, antidrug antibodies and pharmacokinetics up to day 361.
The results showed that among 100 participants with at least 1 immunocompromising condition, 6 children experienced 8 treatment-related AEs (none serious), 3 deaths occurred but were unrelated to treatment, 11 children developed antidrug antibodies, with minimal effects on pharmacokinetics and no apparent safety impact. Nirsevimab serum concentrations on day 151 effectively prevented medical attacks in healthy infants with RSV-LRTI, 14 children exhibited increased nirsevimab clearance. No protocol-defined medically attended RSV-LRTIs occurred through day 151.
They concluded that nirsevimab was well tolerated among children who are immunocompromised 24 months and younger, with supportive serum concentrations for efficacy.
