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 reference number
DMRC-34131563
Company name
Argenx BV
Vyvgart 1000 mg solution for injection, PLGB 47104/0005
SNOMED Code
42703811000001101
| 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 |
Active Pharmaceutical Ingredient: efgartigimod alfa
Brief description of the 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 for 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 for 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.
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.
Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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