Active Ingredient: Nirsevimab
Nirsevimab is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
Nirsevimab should be used in accordance with official recommendations.
For this indication, competent medicine agencies globally authorize below treatments:
For:
In case that patient age in months is ≤ 24
Intramuscular, 200 milligrams nirsevimab, one dose.
The recommended dose is a single dose of 200 mg. Nirsevimab should be administered ideally prior to the start of the second RSV season.
For individuals undergoing cardiac surgery with cardiopulmonary bypass, an additional dose may be administered as soon as the individual is stable after surgery to ensure adequate nirsevimab serum levels. If within 90 days after receiving the first dose of nirsevimab, the additional dose during the first RSV season should be 50 mg or 100 mg according to body weight, or 200 mg during the second RSV season. 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 during the first RSV season, or 100 mg during the second RSV season, to cover the remainder of the RSV season.
The safety and efficacy of nirsevimab in children aged 2 to 18 years have not been established. No data are available.
Nirsevimab is for intramuscular injection only.
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. If two injections are required, different injection sites should be used.
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