Class 4 Medicines Notification: Argenx BV, Vyvgart 1000 mg solution for injection, EL (24)A/63

Argenx BV have informed MHRA that the Patient Information Leaflet (PIL) in the affected packs incorrectly contains reference to two subcutaneous injection sites. Only subcutaneous injection to the abdomen is permitted.

DMRC Number: DMRC-34131563

Company name: Argenx BV

Product description: Vyvgart 1000 mg solution for injection, PLGB 47104/0005

SNOMED Code: 42703811000001101

Details of the affected batch: 

Active Pharmaceutical Ingredient: efgartigimod alfa

Brief description of problem:

Argenx BV have informed MHRA that the Patient Information Leaflet (PIL) in the affected packs incorrectly contains reference to two subcutaneous injection sites (abdomen and thigh) at Step 20 of the instructions. The correct PIL, approved as part of the GB marketing authorisation, only contains reference to one subcutaneous injection site (abdomen).

Advice to Healthcare Professionals:

Healthcare professionals should only administer the product via the abdomen. This is described in the approved PIL and can be accessed electronically at VYVGART 1000 mg solution for injection - Patient Information Leaflet (PIL) - (emc).

Any healthcare professionals providing the affected batches to patients for self-administration should advise patients to administer via the abdomen.

Advice to Patients:

Patients should continue to take medicines from these batches as prescribed by your healthcare professional. This does not affect the quality of the product. Any patient who has received self-administration training should administer the product via the abdomen. This is described in the approved (correct) PIL and can be accessed electronically at VYVGART 1000 mg solution for injection - Patient Information Leaflet (PIL) - (emc).

Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Company contacts for further information:

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.

To access the full recall: 

Class 4 Medicines Notification: Argenx BV, Vyvgart 1000 mg solution for injection, EL (24)A/63