BEYFORTUS Solution for injection Ref.[50357] Active ingredients: Nirsevimab

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.

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.

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 5.1).

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.

Beyfortus 50 mg (50 mg/0.5 mL) pre-filled syringe with a purple plunger rod.

Beyfortus 100 mg (100 mg/1 mL) pre-filled syringe with a light blue plunger rod.

Refer to Figure 1 for pre-filled syringe components.

Figure 1. Luer lock 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.

There is no specific treatment for an overdose with nirsevimab. In the event of an overdose, the individual should be monitored for the occurrence of adverse reactions and provided with symptomatic treatment as appropriate.

15 months.

Beyfortus may be kept at room temperature (20°C-25°C) when protected from light for a maximum of 8 hours. After this time, the syringe must be discarded.

Store in a refrigerator (2°C-8°C).
Do not freeze.
Do not shake or expose to direct heat.

Keep the pre-filled syringe in the outer carton in order to protect from light.

For storage conditions of the medicinal product, see section 6.3.

Siliconised Luer lock Type I glass pre-filled syringe with a FluroTec-coated plunger stopper.

Each pre-filled syringe contains 0.5 mL or 1 mL solution.

Pack sizes:

• 1 or 5 pre-filled syringe(s) without needles.
• 1 pre-filled syringe packaged with two separate needles of different sizes.

Not all pack sizes may be marketed.

This medicinal product should be administered by a trained healthcare professional using aseptic techniques to ensure sterility.

Visually inspect the medicinal product for particulate matter and discolouration prior to administration. The medicinal product is a clear to opalescent, colourless to yellow solution. Do not inject if the liquid is cloudy, discoloured, or it contains large particles or foreign particulate matter.

Do not use if the pre-filled syringe has been dropped or damaged or the security seal on the carton has been broken.

Disposal

Each pre-filled syringe is for single-use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.