Consumer medicine information

1. Why is my child being given BEYFORTUS?

BEYFORTUS contains the active ingredient nirsevimab. BEYFORTUS is a medicine used to protect your baby from getting respiratory syncytial virus (RSV) disease during their first RSV season. It may also be given to children less than 2 years of age who are at risk of severe RSV disease in their second RSV season.
For more information, see Section 1. Why is my child being given BEYFORTUS? in the full CMI.

2. What should I know before my child is given BEYFORTUS?

Do not use if you have ever had an allergic reaction to nirsevimab or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before my child is given BEYFORTUS? in the full CMI.

3. What if my child is taking other medicines?

Some medicines may interfere with BEYFORTUS and affect how it works.
For more information, see Section 3. What if my child is taking other medicines? in the full CMI.

4. How is BEYFORTUS given?

• BEYFORTUS is given by a healthcare professional as an injection in the muscle, usually in the outer part of the thigh.

• BEYFORTUS should be given before the RSV season, or as soon as possible after birth for children born during the RSV season.

• The recommended dose is dependent on weight, if it's for the first or second RSV season and also if your child is having a heart operation.

5. What should I know after my child is given BEYFORTUS?

6. Are there any side effects?

The most common side effects include redness, swelling or pain at the injection site, rash or fever.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Nirsevimab.

2 Qualitative and Quantitative Composition

Beyfortus 50 mg solution for injection in prefilled syringe. Each pre-filled syringe contains 50 mg of nirsevimab in 0.5 mL (100 mg/mL).
Beyfortus 100 mg solution for injection in prefilled syringe. Each pre-filled syringe contains 100 mg of nirsevimab in 1 mL (100 mg/mL).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection.
Clear to opalescent, colourless to yellow, pH 6.0 solution in a prefilled syringe.

4 Clinical Particulars

4.9 Overdose

There is very limited experience of overdose with nirsevimab.
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.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Nirsevimab is a monoclonal antibody, as such genotoxicity studies have not been conducted. As a large protein molecule, nirsevimab is not expected to interact directly with DNA or other chromosomal material.
Carcinogenicity. No carcinogenicity studies have been conducted because nirsevimab binds a viral-specific target that is not expressed in nonclinical models or in humans.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

General structure. Nirsevimab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. The Fc region of nirsevimab has been engineered with a triple amino acid substitution (YTE) to extend serum half-life.
CAS number. 1989556-22-0.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine (Schedule 4).

Summary Table of Changes

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