Class 4 Medicines Defect Information: Takeda UK Limited, Entyvio 108mg solution for injection in pre-filled syringe, EL(24)A/55

Takeda UK Limited has informed the MHRA that there is an error in the Patient Information Leaflet for specified batches of Entyvio 108mg pre-filled syringes.

DMRC/MDR Number: DMRC-33832314

Company name: Takeda Pharma A/S trading as Takeda UK Limited

Product description: Entyvio 108mg solution for injection in pre-filled syringe, PLGB 15475/0073 SNOMED Code 38289511000001101

Details of the affected batch: 

Brief description of problem:

Takeda UK Limited has informed the MHRA that there is an error in the Patient Information Leaflet (PIL) for the above specified batches of Entyvio 108mg pre-filled syringes. The errors are as follows:

• Text relating to a patient alert card being given to the patient by the healthcare professional at the time of prescribing should have been deleted.
• Missing information: In section 4, under the heading ‘common side effects’ the adverse reaction ‘infection of the large intestine due to Clostridium difficile bacteria’ is missing.
• Miscategorised information: In section 4, under common side effects: In addition to the listed side effects, the following should be included:
  • pneumonia (should be listed as common, but appears under very rare)
  • shingles (herpes zoster) (should be listed as common, but appears under uncommon)
  • blurred vision (loss of sharpness of eyesight) (should be listed as uncommon but appears under very rare)

This error affects the printed leaflet, supplied within the carton for the pre-filled syringe. The online version of the Patient Information Leaflet (PIL) is correct.

Advice to Healthcare Professionals:

Healthcare professionals should advise the patient of the possibility of these adverse reactions and refer patients to the electronic version of the Patient Information Leaflet (PIL).

Patients should also be told that there is no patient alert card with this medicine.

Advice to Patients:

Patients should continue to take medicines from these batches as prescribed by your healthcare professional.

The online version of the Patient Information Leaflet (PIL) is correct.

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 Email medinfoemea@takeda.com or telephone 03333 000 181

For stock control enquiries please Email ukie.supplychain@takeda.com

To access the full recall: Class 4 Medicines Defect Information: Takeda UK Limited, Entyvio 108mg solution for injection in pre-filled syringe, EL(24)A/55