Drug Information Sheet("Kusuri-no-Shiori")
Injection
Published: 05/2024
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.	
Brand name:Beyfortus 50mg solution for intramuscular injection in syringe
Active ingredient:Nirsevimab (genetical recombination)
Dosage form:injection (prefilled syringe)
Imprint or print on wrapping:		
Effects of this medicine
This medicine neutralizes RS virus by binding to the antigenic site of F protein, which is important in the invasion process of RS virus (Respiratory Syncytial Virus).
It is usually used to suppress or prevent the onset of lower respiratory tract disease caused by RS virus infection in neonates, infants, and young children.
1. Suppression of onset of lower respiratory tract disease in neonates, infants and young children at risk of the following serious RS virus infections:
〇In the early stage of first RS virus infection epidemic after birth
・Neonates and infants aged 12 months or younger born prematurely at 28 weeks of gestation or less
・Neonates and infants aged 6 months or younger born prematurely at 29 to 35 weeks of gestation
〇In the early stages of first and second RS virus infection epidemics after birth
・Newborns, infants and young children aged 24 months or younger treated for chronic lung disease within the last six months
・Newborns, infants and young children aged 24 months or younger with congenital heart disease with haemodynamic abnormalities
・Newborns, infants and young children aged 24 months or younger with immunodeficiency
・Newborns, infants and young children aged 24 months or younger with Down syndrome
2. Prevention of lower respiratory tract disease due to RS virus infection in all newborns and infants except 1. in the first RS virus infection epidemic period after birth	
The following patients may need to be careful when using this medicine.Be sure to tell your doctor and pharmacist.
・If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines or foods.
If you are currently at risk of bleeding risk such as thrombocytopenia or coagulopathy, or receiving anticoagulant therapy.
If you have acute infection or febrile illness.
・If you are pregnant or breastfeeding.
・If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)	
Dosing schedule (How to take this medicine)
・Your dosing schedule prescribed by your doctor is((            to be written by a healthcare professional))
・In general, inject intramuscularly once in the early stage of RS virus infection epidemic.
・The number of doses may vary between individuals.	
Precautions while taking this medicine
・Avoid excessive exercise on the day of injection and keep the injected site clean.
・Pay close attention to health condition after injection. If you experience abnormal reactions in the injection site or changes in physical condition as well as abnormal symptoms such as fever and convulsion, see your doctor immediately.
・If you will see other doctors or receive other vaccines, be sure to inform your doctor, pharmacist or nurse that you have been injected with this medicine.
	
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include injection site reaction (redness, swelling, pain), fever and rash. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
・itchy skin, itchy throat, respiratory distress [serious hypersensitivity including anaphylaxis]
・bruising, bleeding tendency (gum bleeding, nasal bleeding, etc.) [decreased platelets]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.	
Storage conditions and other information
・Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
・Discard the remainder. Do not store them. If you do not know how to discard, consult your pharmacy or medical institution about how to discard them. Do not give this medicine to anyone else.	
For healthcare professional use only      /    /

For further information, talk to your doctor or pharmacist.