Prospect: information for the user

Beyfortus 50mg pre-filled injectable solution in syringe

Beyfortus 100mg pre-filled injectable solution in syringe

nirsevimab

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects your child may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospectus carefully before administering this medicine to your child, as it contains important information for you and your child.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• If your child experiences adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus. See section 4.

What is Beyfortus

Beyfortus is a medication administered as an injection to protect babies and children under 2 years old from therespiratory syncytial virus (RSV).RSV is a common respiratory virus that generally causes mild symptoms comparable to the common cold.However, especially in babies, vulnerable children, and older adults, RSV can cause severe diseases, such as bronchiolitis (inflammation of the small airways in the lung) and pneumonia (lung infection) that can lead to hospitalization or even death.The virus is usually more common during winter.

Beyfortus contains the active ingredient nirsevimab, which is a monoclonal 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.

How is Beyfortus used

Beyfortus is a medication used to protect your child from RSV disease.

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

Inform your child's doctor, pharmacist, or nurse if this applies to your child. If you are unsure, consult with your child's doctor, pharmacist, or nurse before administering the medication.

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

Warnings and precautions

Consult your doctor or seek immediate medical help if you observe any sign of allergic reaction , such as:

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

Consult with your healthcare professional before administering Beyfortus to your child if they have a low platelet count in the blood (which helps with blood clotting), a bleeding disorder, or if they are prone to easy bruising or are taking an anticoagulant (a medication to prevent blood clots).

In certain chronic diseases, where too many proteins are lost through the urine or intestines, for example, nephrotic syndrome and chronic liver disease, the level of protection provided by Beyfortus may be reduced.

Beyfortus contains 0.1 mg of polisorbate 80 in each 50 mg dose (0.5 ml) and 0.2 mg in each 100 mg dose (1 ml). Polisorbates may cause allergic reactions. Inform your doctor if your child has any known allergies.

Children and adolescents

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

Other medications and Beyfortus

No interactions with other medications have been observed. However, inform your doctor, pharmacist, or nurse if your child is taking, has taken recently, or may need to take any other medication.

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

Beyfortus must be administered by a healthcare professional as an injection into the muscle. Normally, it is administered 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 VRS season.
• 200 mg for children who remain vulnerable to severe disease by VRS in their second VRS season (administered as 2 injections of 100 mg in separate sites).

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

If your child is to undergo cardiac surgery, they may be administered an additional dose of Beyfortus after the surgery to ensure adequate protection for the remainder of the VRS season.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Adverse effects may include:

Rare(may affect up to 1 in 100 children)

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

Unknown Frequency(cannot be estimated from available data)

• allergic reactions

Reporting Adverse Effects

If your child experiences any type of adverse effect, consult your doctor,pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Your doctor, pharmacist, or nurse is responsible for storing this medication and properly disposing of any unused product. The following information is directed at healthcare professionals.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2°C and 8°C).After removing it from the refrigerator, Beyfortus must be protected from light and use within the next 8 hours or discard..

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

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

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

Beyfortus Composition

• The active ingredient is nirsevimab.

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

• The other components are: L-histidine, L-histidine chloride, L-arginine chloride, sucrose, polisorbate 80 (E433) and water for injection preparations.

Beyfortus Appearance and Packaging Contents

Beyfortus is a colourless to yellowish injectable solution.

Beyfortus is available in:

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

Not all packaging sizes may be marketed.

Marketing Authorization Holder

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

Manufacturer Responsible

AstraZeneca AB

Gärtunavägen

SE-152 57 Södertälje

Sweden

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet:

For detailed information about this medicine, please visit the website of the European Medicines Agency:http://www.ema.europa.eu.

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This information is intended for healthcare professionals only:

In order to improve the traceability of biological medicines, the name and batch number of the administered medicine must 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 turbid, discoloured or contains large particles or foreign particles.

Do not use Beyfortus if the pre-filled syringe has fallen or been damaged or if the safety seal on the packaging has been 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 as a routine injection site due to the risk of sciatic nerve damage.