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Please note that infliximab levels will vary widely between infusions. For this reason, analysis of drug levels should use a trough level, obtained just prior to a scheduled infusion. Please obtain a trough level sample for further analysis.

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Therapeutic drug monitoring is most useful when trough drug level results are combined with anti-drug antibody titres. Repeat testing for anti-drug antibodies is recommended. As this data has not been provided, the interpretation that follows will assume that anti-drug antibodies are not present. Note that this may or may not be accurate and the presence of anti-drug antibodies might significantly alter test advice given.

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Inflectra® Treatment Decision Aid

Prescribing Information for Great Britain: Inflectra® Summary of Product Characteristics

Prescribing Information for Northern Ireland: Inflectra® Summary of Product Characteristics

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Intended Use of the Inflectra® Treatment Decision Aid

The Inflectra® Treatment Decision Aid is a web-based tool to provide guidance to healthcare professionals (HCPs) in the interpretation of infliximab therapeutic drug monitoring and anti-drug antibody test results in inflammatory bowel disease, for Inflectra® patients aged 16 years and older. HCPs must utilise their own clinical knowledge and judgement when using the tool to assess the disease activity of their patients, and when deciding whether to make adjustments to their treatment plan.

The tool provides simple, traffic light style guidance on a suggested treatment course, along with the associated supportive evidence, following the submission of anonymised patient information.

No patient information is stored.

Science Behind the Inflectra® Treatment Decision Aid

The guidance suggested is informed by current research on Inflectra® optimisation and uses the database of 955 patients from the PANTS study1. It was developed in partnership with Dr Tariq Ahmad (Royal Devon and Exeter Hospital, UK) and Dr Tim Raine (Addenbrookes Hospital, UK).

Legal Manufacturer

Pfizer Inc, 100 Route 206 North, Peapack, NJ 07977, United States

Authorised Representative

Pfizer Healthcare Ireland, 9, Riverwalk, National Digital Park, Citywest Business Campus,Dublin 24. D24NT20 Ireland

Inflectra® Treatment Decision Aid Version 1.0.0

Developed and funded by Pfizer

PP-IFA-GBR-0531 Date of Preparation: October 2021

Adverse Event Reporting

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google Play or the Apple App Store. Adverse events relating to Pfizer products should also be reported to Pfizer Medical Information on 01304 616161