BEYFORTUS 100 mg injectable solution in pre-filled syringe

Introduction

Package Leaflet: Information for the User

Beyfortus 50mg solution for injection in pre-filled syringe

Beyfortus 100mg solution for injection in pre-filled syringe

nirsevimab

This medicine is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects your child may experience. The last part of section 4 will tell you how to report side effects.

Read all of this leaflet carefully before giving this medicine to your child, because it contains important information for you and your child.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If your child experiences any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What is Beyfortus and what is it used for
2. What you need to know before Beyfortus is given to your child
3. How and when to give Beyfortus
4. Possible side effects
5. Storage of Beyfortus
6. Contents of the pack and further information

1. What is Beyfortus and what is it used for

What is Beyfortus

Beyfortus is a medicine given as an injection to protect babies and children under 2 years of age against the respiratory syncytial virus(RSV). RSV is a common respiratory virus that usually causes mild symptoms similar to those of the common cold. However, especially in babies, vulnerable children, and older adults, RSV can cause serious diseases, such as bronchiolitis (inflammation of the small airways in the lung) and pneumonia (infection of the lungs) that can lead to hospitalization or even death. The virus is usually more common during the winter.

Beyfortus contains the active substance nirsevimab, which is an antibody (a protein designed to bind to a specific target) that binds to the protein that RSV needs to infect the body. By binding to this protein, Beyfortus blocks its action, thereby preventing the virus from entering and infecting human cells.

What Beyfortus is used for

Beyfortus is a medicine used to protect your child against disease caused by RSV.

2. What you need to know before Beyfortus is given to your child

Your child should not use Beyfortus if they are allergic to nirsevimab or to any of the other ingredients of this medicine (listed in section 6).

Tell your child's doctor, pharmacist, or nurse if this applies to your child. If you are not sure, consult your child's doctor, pharmacist, or nurse before giving the medicine.

If your child shows signs of a severe allergic reaction,contact a doctor immediately.

Warnings and precautions

Consult your doctor or seek medical help immediately if you notice any signs of allergic reaction, such as:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue, or throat
• severe itching of the skin, with a red rash or raised bumps

Consult your healthcare professional before giving Beyfortus to your child if they have a low number of platelets in the blood (which help blood to clot), a bleeding disorder, or bruise easily, or if they are taking an anticoagulant (a medicine to prevent blood clots).

In certain chronic diseases, where too much protein is lost through the urine or intestine, for example, nephrotic syndrome and chronic liver diseases, the level of protection of Beyfortus may be reduced.

Beyfortus contains 0.1 mg of polysorbate 80 in each 50 mg dose (0.5 ml) and 0.2 mg in each 100 mg dose (1 ml). Polysorbates can cause allergic reactions. Tell your doctor if your child has any known allergy.

Children and adolescents

Do not give this medicine to children between 2 and 18 years of age because it has not been studied in this age group.

Other medicines and Beyfortus

No interactions have been observed between Beyfortus and other medicines. However, tell your doctor, pharmacist, or nurse if your child is taking, has recently taken, or might take any other medicine.

Beyfortus can be given at the same time as vaccines that are part of the national vaccination program.

3. How and when to give Beyfortus

Beyfortus should be given by a healthcare professional as an injection into the muscle. It is usually given in the outer part of the thigh.

The recommended dose is:

• 50 mg for children who weigh less than 5 kg and 100 mg for children who weigh 5 kg or more in their first RSV season.
• 200 mg for children who remain vulnerable to serious RSV disease in their second RSV season (given as 2 injections of 100 mg at separate sites).

Beyfortus should be given before the RSV season. The virus is usually more common during the winter (known as the RSV season). If your child is born during the winter, Beyfortus should be given after birth.

If your child is going to have heart surgery (cardiac surgery), they may be given an additional dose of Beyfortus after the surgery to ensure they have adequate protection for the rest of the RSV season.

If you have any other questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects may include:

Uncommon(may affect up to 1 in 100 children)

• rash
• reaction at the injection site (i.e., redness, swelling, and pain where the injection is given)
• fever

Frequency not known(cannot be estimated from the available data)

• allergic reactions

Reporting of side effects

If your child experiences any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Beyfortus

Your doctor, pharmacist, or nurse is responsible for storing this medicine and disposing of any unused product correctly. The following information is for healthcare professionals only.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Store in a refrigerator (between 2°C and 8°C). After removal from the refrigerator, Beyfortus should be protected from light and used within 8 hours or discarded.

Store the pre-filled syringe in the outer carton to protect it from light.

Do not freeze, shake, or expose to direct heat.

Disposal of unused medicine and all materials that have come into contact with it should be done according to local regulations.

6. Contents of the pack and further information

What Beyfortus contains

• The active substance is nirsevimab.

• One pre-filled syringe of 0.5 ml solution contains 50 mg of nirsevimab.
• One pre-filled syringe of 1 ml solution contains 100 mg of nirsevimab.

• The other ingredients are: L-histidine, L-histidine hydrochloride, L-arginine hydrochloride, sucrose, polysorbate 80 (E433), and water for injections.

Appearance and pack size of Beyfortus

Beyfortus is a colourless to yellowish solution for injection.

Beyfortus is available in:

• 1 or 5 pre-filled syringe(s) without needles.
• 1 pre-filled syringe packed with 2 separate needles of different sizes.

Not all pack sizes may be marketed.

Marketing authorisation holder

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

Manufacturer

AstraZeneca AB

Gärtunavägen

SE‑152 57 Södertälje

Sweden

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

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This information is intended only for healthcare professionals:

In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.

Inspect Beyfortus visually for particles and discoloration before administration. Beyfortus is a transparent to opalescent, colourless to yellowish solution. Do not inject Beyfortus if the liquid is cloudy, discoloured, or contains large or foreign particles.

Do not use it if the Beyfortus pre-filled syringe has been dropped or damaged or if the security seal of the packaging is broken.

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 due to the risk of damage to the sciatic nerve.