Nirsevimab
Generic name
Nirsevimab
Brand name
ATC Code
J06BD08
- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
The pharmacokinetic properties of nirsevimab are based on data from individual studies and population pharmacokinetic analyses. The pharmacokinetics of nirsevimab were dose-proportional in children and adults following administration of clinically relevant intramuscular doses over a dose range of 25 mg to 300 mg.
| Parameter | Infant 5 kg |
| Tmax | 6 days (Range 1 - 28 days) |
| T1/2 (terminal) | 71 days |
| Vd (estimated): Vd (peripheral) | 261 mL |
| Vd(central) | 216 mL |
| Cl (estimated) |
3,42 mL/day |
The volume of distribution and clearance increase with increasing body weight
[SmPC Beyfortus]
dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
Available formulations
No information is present at this moment.
Dosages
| Prevention of lower respiratory tract disease due to RSV |
|---|
|
Renal impaiment in children > 3 months
No information available on dose adjustment in renal impairment.
The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Side effects in children
Uncommon: rash, injection site reaction, pyrexia
[SmPC Beyfortus]
The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications
No information available on specific contra indications in children.
The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here
Warnings & precautions in children
In children undergoing cardiac “bypass,” it is recommended that an additional dose be administered as soon as the child is stable after surgery to ensure adequate nirsevimab serum concentrations; if this occurs within 90 days of receiving the first dose, the additional dose should be 50 mg or 100 mg depending on the lich.weight; if more than 90 days have elapsed since the first dose, the additional dose may be 50 mg regardless of the lich.weight to cover the remainder of the RSV season.
In some immunocompromised children with protein-losing conditions, a high clearance of nirsevimab has been observed in clinical trials, and nirsevimab may not provide the same level of protection in those individuals.
[SmPC Beyfortus]
Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
IMMUNOGLOBULINS
This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.
| Immunoglobulins, normal human | ||
|---|---|---|
| J06BA02 | ||
| J06BA01 | ||
| Specific immunoglobulins | ||
|---|---|---|
| J06BB01 | ||
| J06BB04 | ||
| J06BB02 | ||
| J06BB03 | ||
| Antibacterial monoclonal antibodies | ||
|---|---|---|
| J06BC03 | ||
| IMMUNOGLOBULINS, NORMAL HUMAN | ||
|---|---|---|
| J06BA02 | ||
| J06BA01 | ||
| Antiviral monoclonal antibodies | ||
|---|---|---|
| J06BD07 | ||
| J06BD01 | ||
Reference
- Sanofi Winthrop Industrie, SmPC Beyfortus ® 50 mg Injektionslösung in einer Fertigspritze (EU/1/22/1689/001), 08/2024
Changes
Therapeutic Drug Monitoring
Overdose
