North East and North Cumbria
ICS Formulary
 
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1 Gastro-intestinal system
01-05-03 Drugs affecting the immune response

Azathioprine
Formulary
Link  MHRA: Thiopurines and intrahepatic cholestasis of pregnancy
Link  NENC Shared Care Protocol - Azathioprine and mercaptopurine within adult services (non-transplant indications)

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Ciclosporin
Formulary
  • Capsules: 10mg, 25mg, 50mg, 100mg
  • Oral solution: 100mg/ml
    • Must be prescribed by brand name
    • Brands include Capimune, Capsorin, Deximune, Neoral, Vanquoral 
  • 50mg/1ml continuous infusion Red
Link  NENC Shared Care Protocol - Ciclosporin (oral) for patients within adult services (non-transplant indications)

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Etrasimod Velsipity®
Formulary
  • 2mg tablet
  • Approved for treating moderately to severely active ulcerative colitis in people aged 16 and over in line with NICE
Link  NICE TA956: Etrasimod for treating moderately to severely active ulcerative colitis in people aged 16 and over

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Filgotinib Jyseleca®
Formulary
  • 100mg and 200mg tablets
  • Approved for the treatment of moderate to severe active ulcerative colitis in line with NICE
Link  MHRA Drug Safety Update April 2023: Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality
Link  NICE TA792: Filgotinib for treating moderately to severely active ulcerative colitis

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Guselkumab Tremfya®
Formulary
  • 100mg/1mL pre-filled pen, 200 mg/2mL pre-filled pen, 200mg concentrate for solution for infusion 
  • Approved for the treatment of moderately to severely active ulcerative colitis in line with NICE
  • Approved for the treatment of previously treated moderately to severely active Crohn's disease in line with NICE

 
Link  NICE TA1094: Guselkumab for treating moderately to severely active ulcerative colitis
Link  NICE TA1095: Guselkumab for previously treated moderately to severely active Crohn’s disease

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Mercaptopurine
Formulary
Link  MHRA: Thiopurines and intrahepatic cholestasis of pregnancy
Link  NENC Shared Care Protocol - Azathioprine and mercaptopurine within adult services (non-transplant indications)

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Tofacitinib Xeljanz®
Formulary
  • 5mg and 10mg tablets.
  • Approved for the treatment of moderate to severe active ulcerative colitis in line with NICE
Link  MHRA Drug Safety Alert Oct 2021: Tofacitinib (Xeljanz▼): new measures to minimise risk of major adverse cardiovascular events and malignancies
Link  MHRA Drug Safety Alert March 2020: Tofacitinib (Xeljanz▼): new measures to minimise risk of venous thromboembolism and of serious and fatal infections
Link  MHRA Drug Safety Update (April 2023): Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality
Link  MHRA Drug Safety Update May 2019: Tofacitinib (Xeljanz▼): restriction of 10 mg twice-daily dose in patients at high risk of pulmonary embolism while safety review is ongoing
Link  NICE TA547: Tofacitinib for moderately to severely active ulcerative colitis

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Upadacitinib Rinvoq®
Formulary
  • 15 and 30mg tablets
  • Approved for the treatment of moderate to severe active ulcerative colitis in line with NICE
  • Approved for previously treated moderately to severely active Crohn's disease in line with NICE
Link  MHRA Drug Safety Update April 2023: Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality
Link  NICE TA856: Upadacitinib for treating moderately to severely active ulcerative colitis
Link  NICE TA905: Upadacitinib for previously treated moderately to severely active Crohn’s disease

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Methotrexate
Formulary
  • See section 8.1.3
  • NOTE: Subcutaneous injection for chronic inflammatory conditions in Tees SICBL Red

 
Link  County Durham and Darlington Shared Care Guideline: Methotrexate
Link  MHRA Drug Safety Update (August 2023): Methotrexate: advise patients to take precautions in the sun to avoid photosensitivity reactions
Link  MHRA Drug Safety Update (Sept 2020): Methotrexate once weekly for autoimmune diseases: new measures to reduce risk of fatal overdose due to inadvertent daily instead of weekly dosing

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Vedolizumab
Formulary
  • Only approved for use in accordance with NICE guidance. 
Link  NICE TA352: Vedolizumab for treating moderately to severely active Crohn’s disease after prior therapy
Link  NICE TA342: Vedolizumab for treating moderately to severely active ulcerative colitis
Link  NICE TA826: Vedolizumab for treating chronic refractory pouchitis after surgery for ulcerative colitis (terminated appraisal)

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