GovWire

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DMRC reference number

DMRC-33832314

Company name

Takeda Pharma A/S trading as Takeda UK Limited

Entyvio 108mg solution for injection in pre-filled syringe, PLGB 15475/0073

SNOMED Code

38289511000001101

Active Pharmaceutical Ingredient:vedolizumab

Brief description of the 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 for 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 for 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 theMHRA Yellow Card scheme.

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

Recipients of this Medicines Notifications 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

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

Download document

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