News » MHRA alert » Alert: Vyvgart 1000 mg solution for injection
December 20th 2024
Argenx BV has issued an alert for Vyvgart 1000 mg solution for injection (efgartigimod alfa).
Four batches contain an incorrect Patient Information Leaflet (PIL) which refers to two subcutaneous injection sites (abdomen and thigh) at Step 20 of the instructions.
The correct PIL only contains reference to one subcutaneous injection site (abdomen).
The affected batches are:
|
Batch No |
Expiry Date |
Pack Size |
First Distributed |
|
P99834CE |
Mar 2025 |
1 vial |
7 March 2024 |
|
P99834CJ |
Feb 2025 |
1 vial |
17 Jun 2024 |
|
P99834CK |
Feb 2025 |
1 vial |
Not yet distributed |
|
P99842CH |
Sep 2025 |
1 vial |
Not yet distributed |
Healthcare professionals should only administer the product via the abdomen. Patients should continue to take medicines from the affected batches and if they self-administer should be advised to administer via the abdomen.
Correct PILs are available online.
For medical information enquiries please contact ukmedinfo@argenx.com or +44 (0)20 4532 4016.
For stock control enquiries please contact rpi@argenx.com or +44 (0)7801 748936.
