Beyfortus 50 mg solution for injection in pre filled syringe

• 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 gets any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

Beyfortus is a medicine given as an injection to protect babies and children less than 2 years of age against respiratory syncytial virus (RSV). RSV is a common respiratory virus that usually causes mild symptoms comparable to the common cold. However, especially in babies, vulnerable children and older adults, RSV can cause severe illness, including bronchiolitis (inflammation of the small airways in the lung) and pneumonia (infection of the lungs) that may lead to hospitalisation or even death. The virus is usually more common during the winter.

Beyfortus contains the active ingredient nirsevimab which is an antibody (a protein designed to attach to a specific target) that attaches to a protein that RSV needs to infect the body. By attaching to this protein, Beyfortus blocks its action, thereby stopping the virus from entering and infecting human cells.

Beyfortus is a medicine to protect your child from getting RSV disease.

Tell your doctor or seek medical help immediately 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 low numbers of blood platelets (which help blood clotting), a bleeding problem or bruise easily or if they are taking an anticoagulant (a medicine to prevent blood clots).

In certain chronic health conditions, where too much protein is lost via the urine or the gut, for example nephrotic syndrome and chronic liver disease, the level of protection 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. Tell your doctor if your child has any known allergies.

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

Beyfortus is not known to interact with other medicines. However, tell your doctor, pharmacist or nurse if your child is taking, has recently taken or might take any other medicines.

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

If your child gets any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is nirsevimab.
  • One pre-filled syringe of 0.5 mL solution contains 50 mg nirsevimab.
  • One pre-filled syringe of 1 mL solution contains 100 mg nirsevimab.
• The other ingredients are L-histidine, L-histidine hydrochloride, L-arginine hydrochloride, sucrose, polysorbate 80 (E433), and water for injections.

Beyfortus is a colourless to yellow solution for injection.

Beyfortus is available as:

• 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.