This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.
Rx
BEYFORTUS
50 mg, Roztwór do wstrzykiwań w ampułko-strzykawce
INN: Nirsevimabum
Data updated: 2026-04-13
Available in:
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Form
Roztwór do wstrzykiwań w ampułko-strzykawce
Dosage
50 mg
Route
domięśniowa
Storage
Storage and Handling Store refrigerated between 36°F to 46°F (2°C to 8°C). BEYFORTUS may be kept at room temperature 68°F to 77°F (20°C to 25°C) for a maximum of 8 hours. After removal from the refrigerator, BEYFORTUS must be used within 8 hours or discarded. Store BEYFORTUS in original carton to protect from light until time of use. Do not freeze. Do not shake. Do not expose to heat.
User Reviews
Reviews reflect personal experiences and are not medical advice. Always consult your doctor.
About This Product
Manufacturer
Sanofi Winthrop Industrie (Szwecja)
Composition
Nirsevimabum 50 mg
ATC Code
J06BD08
Source
URPL
11 DESCRIPTION Nirsevimab-alip, a respiratory syncytial virus F protein-directed fusion inhibitor, is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. The molecular weight is approximately 146.3 kDa. BEYFORTUS (nirsevimab-alip) injection is a sterile, preservative-free, clear to opalescent, colorless to yellow solution for intramuscular injection. It is supplied in a single-dose siliconized Luer lock Type I glass pre-filled syringe with a FluroTec coated plunger stopper. Each 0.5 mL contains 50 mg nirsevimab-alip, arginine hydrochloride (8 mg), histidine (1.1 mg), L-histidine hydrochloride monohydrate (1.6 mg), polysorbate 80 (0.1 mg), sucrose (21 mg), and water for injection (USP). The pH is 6.0. Each 1 mL contains 100 mg nirsevimab-alip, arginine hydrochloride (17 mg), histidine (2.2 mg), L-histidine hydrochloride monohydrate (3.3 mg), polysorbate 80 (0.2 mg), sucrose (41 mg), and water for injection (USP). The pH is 6.0.
⚠️ Warnings
This medicinal product should be administered by a trained healthcare professional using aseptic techniques to ensure sterility.
Visually inspect the medicinal product for particulate matter and discolouration prior to administration. The medicinal product is a clear to opalescent, colourless to yellow solution. Do not inject if the liquid is cloudy, discoloured, or it contains large particles or foreign particulate matter.
Do not use if the pre‑filled syringe has been dropped or damaged or the security seal on the carton has been broken.
Instructions for administration
Beyfortus is available in a 50 mg and a 100 mg pre-filled syringe. Check the labels on the carton and pre‑filled syringe to make sure you have selected the correct 50 mg or 100 mg presentation as required.
Beyfortus 50 mg (50 mg/0.5 mL) pre‑filled syringe with a purple plunger rod.
Beyfortus 100 mg (100 mg/1 mL) pre‑filled syringe with a light blue plunger rod.
Refer to Figure 1 for pre‑filled syringe components.
Figure 1:
Luer lock syringe components
Step 1
: Holding the Luer lock in one hand (avoid holding the plunger rod or syringe body), unscrew the syringe cap by twisting it counter clockwise with the other hand.
Step 2
: Attach a Luer lock needle to the pre‑filled syringe by gently twisting the needle clockwise onto the pre‑filled syringe until slight resistance is felt.
Step 3
: Hold the syringe body with one hand and carefully pull the needle cover straight off with the other hand. Do not hold the plunger rod while removing the needle cover or the rubber stopper may move. Do not touch the needle or let it touch any surface. Do not recap the needle or detach it from the syringe.
Step 4
: 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 because of the risk of damage to the sciatic nerve.
Step 5
: Dispose of the used syringe immediately, together with the needle, in a sharps disposal container or in accordance with local requirements.
If two injections are required, repeat steps 1-5 in a different injection site.
Disposal
Each pre‑filled syringe is for single‑use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.