Active Ingredient: Nirsevimab
Nirsevimab is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV season.
Nirsevimab should be used in accordance with official recommendations.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: In case that patient weight is ≤ 5 kg, intramuscular, 50 milligrams nirsevimab, one dose.
Regimen B: In case that patient weight is ≥ 5 kg, intramuscular, 100 milligrams nirsevimab, one dose.
The recommended dose is a single dose of 50 mg administered intramuscularly for infants with body weight <5 kg and a single dose of 100 mg administered intramuscularly for infants with body weight ≥5 kg.
Nirsevimab should be administered prior to commencement of the RSV season, or from birth for infants born during the RSV season.
For infants undergoing cardiac surgery with cardiopulmonary bypass, an additional dose may be administered as soon as the infant is stable after surgery to ensure adequate nirsevimab serum levels. If within 90 days after receiving the first dose of nirsevimab, the additional dose should be 50 mg or 100 mg according to body weight. If more than 90 days have elapsed since the first dose, the additional dose could be a single dose of 50 mg regardless of body weight, to cover the remainder of the RSV season.
There are no safety and efficacy data available on repeat dosing.
Dosing in infants with a body weight from 1.0 kg to <1.6 kg is based on extrapolation, no clinical data are available. Exposure in infants <1 kg is anticipated to yield higher exposures than in those weighing more. The benefits and risks of nirsevimab use in infants <1 kg should be carefully considered.
There are limited data available in extremely preterm infants (Gestational Age [GA] <29 weeks) less than 8 weeks of age. No clinical data available in infants with a postmenstrual age (gestational age at birth plus chronological age) of less than 32 weeks.
It is administered intramuscularly, preferably in the anterolateral aspect of the thigh. The gluteal muscle should not be used routinely as an injection site because of the risk of damage to the sciatic nerve.
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