Crohn’s disease
30mg-40mg daily for 2-4 weeks, reducing by 5mg weekly thereafter according to patient response.
5mg twice daily, to be inserted into the rectum morning and night, after a bowel movement.
20mg daily for 2–4 weeks, continued if response good, to be used at bedtime.
3mg three times daily for up to 8 weeks, reduce dose for last two weeks of treatment.
9mg in the morning for 8 weeks, reduce dose for last two weeks of treatment. Granules should be placed on the tongue and swallowed whole with plenty of liquid.
1 metered application once daily via rectum for up to 8 weeks.
Prescribing Notes:
- Specialist advice should be sought if diagnosis is unclear.
- Treatment should not be stopped abruptly and should be tapered down over the last 2 weeks. A suggested regimen for the capsule formulation is to reduce to 3mg twice daily for one week, then 3mg once daily for one week. For the granule formulation, administration can be reduced to alternate days for the last two weeks of treatment.
- Due to the potential for erratic absorption from the gastrointestinal tract enteric coated tablets of prednisolone should be avoided.
- Budesonide oral capsules may be used for inducing remission in ileo-caecal Crohn’s disease and microscopic colitis but patients should be reviewed by a specialist before maintenance therapy is considered.
- For patients on long term oral steroids, the risk of osteoporosis should be considered
- Acute exacerbation of extensive disease requires systemic corticosteroids.
- The most cost effective choice of enema should be selected.
History Notes
15/12/2021
East Region Formulary content agreed.
2–2.5mg/kg daily.
2–2.5mg/kg daily.
1–1.5mg/kg daily.
Folic acid should be prescribed to reduce methotrexate toxicity.
10-25mg once weekly dose titrated according to response and toxicity.
10-25mg once weekly dose titrated according to response and toxicity.
10-25mg once weekly dose titrated according to response and toxicity.
10-25mg once weekly dose titrated according to response and toxicity.
10-25mg once weekly dose titrated according to response and toxicity.
10-25mg once weekly dose titrated according to response and toxicity.
10-25mg once weekly dose titrated according to response and toxicity.
10-25mg once weekly dose titrated according to response and toxicity.
5mg once a day, on the day following methotrexate therapy.
Prescribing Notes:
- Azathioprine and mercaptopurine are used on specialist advice in selected patients with steroid dependent inflammatory bowel disease as a steroid sparing agent. It is appropriate for a shared care arrangement to facilitate the seamless transfer of individual patient care from secondary care to general practice.
- Methotrexate should only be used under specialist supervision of a consultant gastroenterologist. It is appropriate for a shared care arrangement to facilitate the seamless transfer of individual patient care from secondary care to general practice.
- Mesalazine should not be used as maintenance therapy in patients with Crohn’s disease.
- New measures have been implemented to prompt healthcare professionals to record the day of the week for intake of methotrexate and to remind patients of the dosing schedule and the risks of overdose due to continued reports of inadvertent overdose. For further advice see MHRA Drug Safety Update September 2020.
History Notes
27/10/2022
Methotrexate prefilled syringes changed from generic to brand.
15/12/2021
East Region Formulary content agreed.
Adalimumab should be prescribed by brand name.
By subcutaneous injection, initially 80mg, then 40mg after 2 weeks; maintenance 40mg every 2 weeks, increased if necessary to 40mg once weekly, alternatively 80mg every 2 weeks, review treatment if no response within 12 weeks.
By subcutaneous injection, initially 80mg, then 40mg after 2 weeks; maintenance 40mg every 2 weeks, increased if necessary to 40mg once weekly, alternatively 80mg every 2 weeks, review treatment if no response within 12 weeks.
By subcutaneous injection, initially 80mg, then 40mg after 2 weeks; maintenance 40mg every 2 weeks, increased if necessary to 40mg once weekly, alternatively 80mg every 2 weeks, review treatment if no response withing 12 weeks.
By subcutaneous injection, initially 80mg, then 40mg after 2 weeks; maintenance 40mg every 2 weeks, increased if necessary to 40mg once weekly, alternatively 80mg every 2 weeks, review treatment if no response within 12 weeks.
By subcutaneous injection, initially 80mg, then 40mg after 2 weeks; maintenance 40mg every 2 weeks, increased if necessary to 40mg once weekly, alternatively 80mg every 2 weeks, review treatment if no response within 12 weeks.
By subcutaneous injection, initially 80mg, then 40mg after 2 weeks; maintenance 40mg every 2 weeks, increased if necessary to 40mg once weekly, alternatively 80mg every 2 weeks, review treatment if no response within 12 weeks.
By subcutaneous injection, initially 80mg, then 40mg after 2 weeks; maintenance 40mg every 2 weeks, increased if necessary to 40mg once weekly, alternatively 80mg every 2 weeks, review treatment if no response within 12 weeks.
By subcutaneous injection, initially 80mg, then 40mg after 2 weeks; maintenance 40mg every 2 weeks, increased if necessary to 40mg once weekly, alternatively 80mg every 2 weeks, review treatment if no response within 12 weeks.
By subcutaneous injection, initially 80mg, then 40mg after 2 weeks; maintenance 40mg every 2 weeks, increased if necessary to 40mg once weekly, alternatively 80mg every 2 weeks, review treatment if no response within 12 weeks.
By subcutaneous injection, initially 80mg, then 40mg after 2 weeks; maintenance 40mg every 2 weeks, increased if necessary to 40mg once weekly, alternatively 80mg every 2 weeks, review treatment if no response within 12 weeks.
Infliximab should be prescribed by brand name.
Initially 5mg/kg, then (by intravenous infusion) 5mg/kg after 2 weeks; (by subcutaneous injection) maintenance 120mg every 2 weeks, subcutaneous maintenance dosing to be started 4 weeks after the second of the initial intravenous infusions if a response has been seen. Discontinue if no response within 6 weeks of the initial infusion (after 2 doses).
Initially 5mg/kg, then (by intravenous infusion) 5mg/kg after 2 weeks; (by subcutaneous injection) maintenance 120mg every 2 weeks, subcutaneous maintenance dosing to be started 4 weeks after the second of the initial intravenous infusions if a response has been seen. Discontinue if no response within 6 weeks of the initial infusion (after 2 doses).
Ustekinumab should be prescribed by brand name
Consult product literature.
Consult product literature.
Consult product literature.
Consult product literature.
Consult product literature.
Consult product literature.
Consult product literature.
Consult product literature.
Consult product literature.
Consult product literature.
Consult product literature.
Consult product literature.
Consult product literature.
Consult product literature.
Consult product literature.
Prescribing Notes:
- Adalimumab and infliximab are approved for Specialist use only in severe active Crohn’s disease or active fistulising Crohn’s disease.
- Each Health Board will have a preferred brand of adalimumab, infliximab and ustekinumab– check to ensure the preferred one is chosen.
- All biological medicines, including biosimilars, should be prescribed by brand name.
- They should only be used in patients who have not responded to conventional therapy or who are intolerant of or have contraindications to conventional therapy.
- Ustekinumab is approved for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist or have medical contraindications to such therapies.
- Upadacitinib is approved for the treatment of adult patients with moderately to severely active Crohn's disease (CD) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biological agent, or for whom such therapies are not advisable.
- Refer to local board prescribing guidelines and MHRA guidance on Janus Kinase (JAK) Inhibitors.
- Risankizumab is approved for the treatment of patients 16 years and older with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy, or if such therapies are not advisable.
- Risankizumab may be utilised in preference to upadacitinib in older patients.
- Vedolizumab is approved for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to a TNFα antagonist.
- Further information for patients, regarding condition and treatments can be found at Crohn’s & Colitis UK.
- In NHS Fife, refer to IBD: use of Biological Agents and Small molecules in adult patients
History Notes
06/02/2025
Addition of new amgevita formulations, ERWG Jan 24.
22/10/2024
Ustekinumab formulations added. ERFC Oct 2024.
06/06/2024
Addition of Risankizumab, ERFC DEC 23
16/11/2023
Addition of Upadactinib SMC2575, Ustekinumab SMC1250/17 and Vedolizumab SMC1064/15 and SMC2277, ERFC August 2023.
31/08/2023
Removed 'Remsima 120mg/1ml solution for injection pre-filled syringes' as product discontinued.
Prednisolone oral solution and soluble tablets are restricted to use in patients who are unable to swallow tablets.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
Prescribing Notes:
- Specialist advice should be sought for acute exacerbations and if diagnosis is unclear. Children presenting with a possible flare of inflammatory bowel disease should be discussed with the GI team.
- Nutritional intervention (exclusive enteral nutrition (EEN)) may be required and is the preferred alternative in Crohn’s disease with steroids reserved for those unable to take or unresponsive to EEN.
- Acute exacerbation of extensive disease often requires systemic corticosteroids.
- Patients receiving prolonged courses of steroids should be given a steroid card.
- Systemic corticosteroid treatment should not be stopped abruptly and should be tapered down slowly as directed by the GI specialist.
- Due to the potential for erratic absorption from the gastrointestinal tract enteric coated tablets of prednisolone should be avoided.
- Budesonide oral capsules may be used for inducing remission in ileo-caecal Crohn’s disease and microscopic colitis, but patients should be reviewed by a specialist before maintenance therapy is considered.
- For patients on long term oral steroids, the risk of osteoporosis should be considered.
- Combinations of antibiotics may be used as adjunctive treatment or as the initial treatment of an exacerbation. Course lengths can be prolonged.
History Notes
28/11/2024
Updating 'Prednisolone 5mg soluble tablets' to sugar free preparation - ERFC Dec 2024.
30/08/2023
East Region Formulary content agreed - ERFC 09/08/2023.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
Folic acid should be prescribed to reduce methotrexate toxicity.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
Folic acid oral solution should only be used when patients cannot tolerate or use solid formulations.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
Prescribing Notes:
- Azathioprine and mercaptopurine are used on specialist advice in selected patients with steroid dependent inflammatory bowel disease as a steroid sparing agent. These medicines are appropriate for shared care, refer to local board policies.
- New measures have been implemented to prompt healthcare professionals to record the day of the week for intake of methotrexate and to remind patients of the dosing schedule and the risks of overdose due to continued reports of inadvertent overdose. For further advice see MHRA Drug Safety Update September 2020.
- Initial choice of medicine is based on individual clinical factors.
- For further information on the treatment of Crohn’s disease see NICE guideline NG129 Crohn’s disease management.
- For oral methotrexate, only 2.5mg tablet strength or 10mg/5mL suspension strength should be prescribed / dispensed.
- Folic acid 5mg should be prescribed for patients taking methotrexate. It should be taken the day after the methotrexate dose.
- Bone marrow suppression is generally dose related and reversible. If the patient develops malaise, fever, bruising, bleeding, rash or a sore throat, check the white cell count and discuss with the hospital team.
- Specialist advice should be sought if patients receiving immunosuppressants come into contact with infectious diseases such as chicken pox, if immunity status is unknown.
- Severely immunosuppressed patients should not receive live vaccines. Live vaccines should be postponed until at least 6 months after stopping immunosuppressive drugs.
- Do not crush or half azathioprine, mercaptopurine or methotrexate tablets.
- Patients who fail to respond to azathioprine may be prescribed methotrexate by subcutaneous injection, each week for 16 weeks (or longer), on the advice of a consultant gastroenterologist. If the patient responds to and tolerates parenteral therapy, then they may be switched to oral methotrexate, which is appropriate for a shared care arrangement to facilitate the seamless transfer of individual patient care from secondary care to general practice.
History Notes
30/08/2023
East Region Formulary content agreed - ERFC 09/08/2023.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
As per specialist.
As per specialist.
As per specialist.
As per specialist.
As per specialist.
As per specialist.
As per specialist.
As per specialist.
As per specialist.
Consult product literature.
Consult product literature
Prescribing Notes:
- Adalimumab, infliximab and ustekinumab are approved for Specialist use only in severe active Crohn’s disease or active fistulising Crohn’s disease.
- They should only be used in patients who have not responded to conventional therapy or who are intolerant of or have contraindications to conventional therapy except for those with perianal fistulising disease.
- If more than one treatment option is suitable then the least expensive should be chosen (taking into account administration costs, dosage and price per dose).
- Each Health Board will have a preferred brand of adalimumab, infliximab and ustekinumab – check to ensure the preferred one is chosen.
- All biological medicines, including biosimilars, should be prescribed by brand name.
- Ustekinumab is approved for the treatment of patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist or have medical contraindications to such therapies.
- Risankizumab is approved for the treatment of patients 16 years and older with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy, or if such therapies are not advisable.
History Notes
06/02/2025
Addition of new amgevita formulations, ERWG Jan 24.
22/10/2024
Addition of Ustekinumab formulations, ERFC Oct 2024.
09/07/2024
Risankizumab SMC 2534. ERWG July 24.
30/08/2023
East Region Formulary content agreed - ERFC 09/08/2023.