BEYFORTUS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100 MG/ 1.0 ML [SIN17138P]

Product Info

BEYFORTUS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100 MG/ 1.0 ML

[SIN17138P]

Therapeutic indications

Beyfortus is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV season.

Beyfortus should be used in accordance with official recommendations.

Posology and method of administration

Posology

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 prior to commencement of the RSV season, or from birth for infants born during 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).

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 Beyfortus, 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.

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.

Instructions for administration

Beyfortus is available in a 50 mg and a 100 mg pre-filled syringe. Check the labels on the carton and pre-filled syringe to make sure you have selected the correct 50 mg or 100 mg presentation as required.

Refer to Figure 1 for pre-filled syringe components.

Step 1: Holding the Luer lock in one hand (avoid holding the plunger rod or syringe body), unscrew the syringe cap by twisting it counter clockwise with the other hand.

Step 2: Attach a Luer lock needle to the pre-filled syringe by gently twisting the needle clockwise onto the pre-filled syringe until slight resistance is felt.

Step 3: Hold the syringe body with one hand and carefully pull the needle cover straight off with the other hand. Do not hold the plunger rod while removing the needle cover or the rubber stopper may move. Do not touch the needle or let it touch any surface. Do not recap the needle or detach it from the syringe.

Step 4: Administer the entire contents of the pre-filled syringe as an intramuscular injection, 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.

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.