BEYFORTUS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 50 MG/ 0.5 ML [SIN17137P]

Product Info

BEYFORTUS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 50 MG/ 0.5 ML

[SIN17137P]

Indication

Therapeutic indications

Beyfortus is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in

1. neonates and infants during their first RSV season.

2. Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season (see section Pharmacodynamic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Beyfortus should be used in accordance with official recommendations.

Dosing

Posology and method of administration

Posology

Infants during their first RSV season
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.

Beyfortus should be administered from birth for infants born during the RSV season. For others born outside the season Beyfortus should be administered ideally prior to the RSV season.

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 (see section Pharmacodynamic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Children who remain vulnerable to severe RSV disease through their second RSV season
The recommended dose is a single dose of 200 mg given as two intramuscular injections (2 x 100 mg). Beyfortus 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 Beyfortus, 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.

Method of administration

Beyfortus 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.

For instructions on special handling requirements, see section Special precautions for disposal and other handling – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Contraindications

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section list of excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.