Beyfortus 100 mg solution for injection in pre-filled syringe

Patient Information Leaflet

Introduction

Patient Information Leaflet

Beyfortus 50mg solution for injection in a pre-filled syringe

Beyfortus 100mg solution for injection in a pre-filled syringe

nirsevimab

This medicinal product is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any side effects that your child may experience. Information on how to report side effects is provided at the end of section 4.

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

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

Leaflet Contents

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

1. What Beyfortus is and what it is used for

What Beyfortus is

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

Beyfortus contains the active substance nirsevimab, which is an antibody (a protein designed to bind to a specific target) that attaches 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 your child is given Beyfortus

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).

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

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

Warnings and precautions

Speak to your doctor or seek immediate medical help if you notice any signs of an 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

Talk to your healthcare professional before your child is given Beyfortus if they have a low platelet count (which helps blood to clot), a blood clotting disorder, bruise easily, or are taking an anticoagulant (a medicine to prevent blood clots).

In certain chronic conditions where too much protein is lost through urine or the intestines—for example, nephrotic syndrome and chronic liver diseases—the protective effect of Beyfortus may be reduced.

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

Children and adolescents

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

Other medicines and Beyfortus

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

Beyfortus may be administered at the same time as vaccines included in the national vaccination program.

3. How and when Beyfortus is administered

Beyfortus must be administered by a healthcare professional as an intramuscular injection. It is usually given in the outer part of the thigh.

The recommended dose is:

• 50 mg for infants weighing less than 5 kg and 100 mg for infants weighing 5 kg or more during their first RSV season.
• 200 mg for children who remain vulnerable to severe RSV disease during their second RSV season (administered as two 100 mg injections at separate sites).

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

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse 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 adverse effects

If your child experiences any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 for the correct disposal of any unused product. The following information is intended for healthcare professionals.

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

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

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

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

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

Disposal of unused medicine and of all materials that have come into contact with it must be carried out in accordance with local regulations.

6. Contents of the pack and other information

Composition of Beyfortus

• The active substance is nirsevimab.

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

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

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

What Beyfortus looks like and contents of the pack

Beyfortus is an injectable solution, colourless to yellow.

Beyfortus is available in:

• 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.

Marketing Authorisation Holder

Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

Manufacturer

AstraZeneca AB
Gärtunavägen
SE‑152 57 Södertälje
Sweden

For more information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

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

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 should be clearly recorded.

Visually inspect Beyfortus for particles and discoloration prior to administration. Beyfortus is a solution that ranges from clear to opalescent, colorless to yellow. Do not inject Beyfortus if the liquid is cloudy, discolored, or contains large or foreign particles.

Do not use if the prefilled syringe of Beyfortus has been dropped or damaged, or if the safety seal on the packaging has been broken.

Administer the entire contents of the prefilled syringe as an intramuscular injection, preferably into the anterolateral aspect of the thigh. The gluteal muscle should not be routinely used as an injection site due to the risk of sciatic nerve injury.