Class 4 Medicines Notification, Accord Healthcare Limited, UK, Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion, EL (23)A/30

Accord Healthcare Ltd, UK has informed the MHRA about an error with the Patient Information Leaflets (PILs) that have been packaged in the batches of these products mentioned in this notification.

MDR Number: MDR 105-08/23

Company name: Accord Healthcare Limited, UK

Product descriptions:

Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion

Brief description of problem:

Accord Healthcare Ltd, UK has informed the MHRA about an error with the Patient Information Leaflets (PILs) that have been packaged in the above batches of these products. The PIL does not include the most up to date safety information regarding the contraindication for Gilbert’s syndrome. The full information missing from the PILs is reproduced below.

Missing Information in PIL:

 

Advice to Healthcare Professionals:

There is no risk to product quality as a result of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when dispensing the product and where possible, provide an updated PIL. The updated PIL is available electronically and can be downloaded from the Accord website.

Healthcare professionals are advised to exercise caution when prescribing this product to UGT1A1 poor metabolisers, such as patients with Gilbert’s syndrome, due to an increased risk of severe adverse reactions. Consult the Summary of Product Characteristics for further advice.

Advice to Patients:

This issue is about missing information on the Patient Information Leaflets (PILs). The medicine itself is not affected and therefore patients do not need to take any action. Talk to your doctor, pharmacist or nurse before using Irinotecan Hydrochloride if you have Gilbert’s syndrome, an inherited condition that can cause elevated bilirubin levels and jaundice (yellow skin and eyes). Your cancer team can provide more information.

These products will have been prescribed and dispensed by the qualified healthcare professional(s) responsible for your care. If you have any concerns, please speak with your cancer team or your healthcare professional in the first instance.

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:

Accord Medical Information Department on 01271 385257, email- medinfo@accord-healthcare.com

For stock control enquiries please contact:

Accord- Customer Services Team on 0800 373573

To access the full alert: Class 4 Medicines Notification, Accord Healthcare Limited, UK, Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion, EL (23)A/30