Vyvgart 1,000 mg solution for injection (efgartigimod alfa): requirement to visually inspect vials from certain batches due to risk of contamination.

Summary 

• Following a report concerning an isolated quality defect, it cannot be excluded that some vials from batch P99872C (batch numbers P99872CA, P99872CB and P99872CE) of Vyvgart 1 000 mg solution for injection may show visible signs of contamination (foreign material suspended in the liquid and/or attached to the inside of the vial).
• Visually inspect vials of Vyvgart 1 000 mg solution for injection before use, as per the instructions provided in the package leafet leaflet (‘Important instructions for use’).

Measures and instructions / recommendations for healthcare professionals:

• Prior to administration, always check the appearance of the medicine in the pre-filled syringe/vial. The medicine should look clear to light yellow in colour. A little cloudiness is normal.
• Do not use if the medicine is discoloured or contains particles.
• Remind patients and caregivers to visually inspect each vial, as per the guidance in the package leaflet, and not to use any product with signs of contamination.