Immunosuppressants - GI
Drug Safety Update
May 2025: Thiopurines and intrahepatic cholestasis of pregnancy
April 2023: Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality
September 2020: Methotrexate once-weekly for autoimmune diseases: new measures to reduce risk of fatal overdose due to inadvertent daily instead of weekly dosing
January 2015: Ustekinumab (Stelara): risk of exfoliative dermatitis
April 2014: There is an increased risk of tuberculosis, or reactivation of latent tuberculosis, during treatment with tumour necrosis factor alpha (TNF-alpha) inhibitors. TNF-alpha inhibitors are contraindicated in patients with active tuberculosis or other severe infections.
NICE Guidance (also see drug-specific NICE links below)
NG129: Crohn’s disease: management, May 2019
NG130: Ulcerative colitis: management, May 2019
Local Guidance
See here for local Inflammatory Bowel Disease (Adults) HCD pathway
Infliximab is approved for the treatment of ulcerative colitis/Crohn's disease when prescribed according to NICE TAs (see links attached to drugs below). It is also approved for the management of diarrhoea or colitis related to immune checkpoint inhibitor (ICPI) therapy (unlicensed indication).
The JAK inhibitors upadacitinib, tofacitinib and filgotinib are all approved for the treatment of ulcerative colitis and upadacitinib for treating moderately to severely active Crohn’s disease in adults in accordance with NICE TAs (see NICE links attached to drugs). They are for specialist use only.
Risankizumab is approved for previously treated moderately to severely active Crohn's disease in people 16 years and over in accordance with NICE TA 888, and for treating moderately to severely active ulcerative colitis in accordance with NICE TA 998.
Mirikizumab is approved for treating moderately to severely active ulcerative colitis in accordance with NICE TA 925, and for previously treated moderately to severely active Crohn's disease in accordance with NICE TA1080
Etrasimod is approved for treating moderately to severely active ulcerative colitis in people aged 16 and over in accordance with NICE TA 956.
Mercaptopurine/Methotrexate/ciclosporin/azathioprine for inflammatory bowel disease (IBD) should be initiated by a specialist and used according to NICE guidelines and local shared care guidelines. Mercaptopurine for IBD, methotrexate for severe Crohn's disease and ciclosporin for severe acute UC refractory to corticosteroid treatment are all unlicensed uses.
Also refer to the Kent and Medway position statement for prescribing oral methotrexate
Not licensed for use in severe ulcerative colitis and Crohn's disease
| Pack |
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| 25 tablet |
Note: when used to treat active rheumatoid arthritis, severe Crohn's disease and severe psoriasis the dose is a WEEKLY dose. To avoid error it is recommended that:
- the patient is carefully advised of the dose, the frequency and the reasons for taking methotrexate and any other co-prescribed medication e.g. folic acid
- only one strength of methotrexate tablet is prescribed and dispensed (usually 2.5mg)
- the prescription and the dispensing label clearly show the dose and the frequency of administration
- the patient is warned to report immediately the onset of any feature of blood disorders, liver toxicity and respiratory effects
- See drug safety update Sept 2020 for further adviceKMICB - Methotrexate (shared care guidance)
There is currently no commissioned mechanism for cytotoxic waste disposal in Medway. As such, GP practices providing services to patients living within Medway will not be expected to undertake shared care for cytotoxic injectables such as subcutaneous methotrexate and these medicines will remain hospital-only (RED) in this locality.
| Pack |
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| 100 tablet |
| 24 tablet |
| 28 tablet |
| Pack |
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| 35 ml |
| Pack |
|---|
| 1 pre-filled disposable injection |
| Pack |
|---|
| 1 pre-filled disposable injection |
| Pack |
|---|
| 1 pre-filled disposable injection |
| Pack |
|---|
| 1 pre-filled disposable injection |
| Pack |
|---|
| 1 pre-filled disposable injection |
| Pack |
|---|
| 1 pre-filled disposable injection |
| Pack |
|---|
| 1 pre-filled disposable injection |
| Pack |
|---|
| 1 pre-filled disposable injection |
| Pack |
|---|
| 1 pre-filled disposable injection |
| Pack |
|---|
| 1 pre-filled disposable injection |
| Pack |
|---|
| 2 pre-filled disposable injection |
| Pack |
|---|
| 2 pre-filled disposable injection |
| Pack |
|---|
| 2 pre-filled disposable injection |
| Pack |
|---|
| 2 pre-filled disposable injection |
| Pack |
|---|
| 2 pre-filled disposable injection |
| Pack |
|---|
| 1 pre-filled disposable injection |
| Pack |
|---|
| 2 pre-filled disposable injection |
| Pack |
|---|
| 2 pre-filled disposable injection |
| Pack |
|---|
| 1 pre-filled disposable injection |
| Pack |
|---|
| 1 vial |
| Pack |
|---|
| 1 vial |
| Pack |
|---|
| 1 vial |
| Pack |
|---|
| 2 pre-filled disposable injection |
| Pack |
|---|
| 2 pre-filled disposable injection |
| Pack |
|---|
| 2 pre-filled disposable injection |
| Pack |
|---|
| 1 vial |
| Pack |
|---|
| 7 capsule (1 x (4 caps + 3 caps)) |
| Pack |
|---|
| 4 capsule |
| Pack |
|---|
| 3 capsule |
| Pack |
|---|
| 28 capsule |
| Pack |
|---|
| 1 vial |
| Pack |
|---|
| 1 pre-filled disposable injection |
| Pack |
|---|
| 1 pre-filled disposable injection |
| Pack |
|---|
| 1 vial |
| Pack |
|---|
| 1 pre-filled disposable injection |
| 2 pre-filled disposable injection |
| Pack |
|---|
| 1 vial |
| Pack |
|---|
| 1 pre-filled disposable injection |
- On Formulary Preferred
- On Formulary Second Line
- On Formulary Third Line
- Specialist Initiation
- Secondary Care Only
- Not Approved for Formulary