Budesonide

• Budenofalk capsules containing gastro-resistant granules 3mg (£63.04 = 9mg daily)
• Entocort CR capsules containing modified-release gastro-resistant granules 3mg (£63.04 = 9mg once daily)
• Rectal foam enema, one metered application contains 2mg budesonide (£57.11 = 14 application canister)
• Orodispersible tablets sugar free 1mg, 500micrograms (£200.48 = 500micrograms twice daily) (£200.98 = 1mg twice daily) (see notes 2 & 3)
• Modified-release capsules 4mg

Indications and dose

• Induction of remission in mild or moderate ileocecal Crohn's disease:
  • Budenofalk: 9mg (three capsules) once daily or 3mg three times daily, for up to 8 weeks; reduce dose for the last 2 weeks of treatment
  • Entocort CR: 9mg (three capsules) once daily in the morning for up to 8 weeks; reduce dose for the last 2–4 weeks of treatment
• Active ulcerative colitis affecting the sigmoid colon and rectum:
  • Rectal foam enema: One metered application once daily for up to 8 weeks
• Induction of remission of eosinophilic oesophagitis in line with NICE TA708 (hospital only) (see note 2)
• Maintenance of remission in eosinophilic oesophagitis (see note 2):
  • Orodispersible tablets sugar free: 500micrograms twice daily, increased to 1mg twice daily for patients with long-term disease and/or extensive oesophageal inflammation in the acute phase. To be taken after food.
• Treatment of primary immunoglobulin A nephropathy (IgAN) in line with NICE TA937:
  • Modified-release capsules 4mg (hospital only)

Notes

1. Prescribe capsules by brand (to prevent confusion where multiple brands contain similar ingredients).
2. Eosinophilic oesophagitis:
   1. Treatment with budesonide orodispersible tablets sugar free should be initiated by a physician with experience in the diagnosis and treatment of eosinophilic oesophagitis (Summary of Product Characteristics).
   2. Induction of remission: prescribing to remain with specialists.
   3. Maintenance of remission: GPs may be asked to prescribe ongoing supplies. The specialist will continue to oversee the ongoing management of eosinophilic oesophagitis, including review of the need for ongoing treatment at least annually.
   4. If there are any changes in the severity of the patient's condition, concomitant medication, or if troublesome adverse reactions develop, the GP should seek advice from the specialist.
3. NICE TA708: Budesonide as an orodispersible tablet sugar free is recommended as an option for inducing remission of eosinophilic oesophagitis (June 2021).
4. NICE TA937: Targeted-release budesonide (Kinpeygo) is recommended as an option for treating primary immunoglobulin A nephropathy (IgAN) when there is a risk of rapid disease progression in adults with a urine protein-to-creatinine ratio of 1.5 g/g or more (December 2023), only if:
   1. it is an add-on to optimised standard care including the highest tolerated licensed dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), unless these are contraindicated and
   2. the company provides it according to the commercial arrangement.

Prednisolone

• Rectal solution 20mg/100ml (£29.95 = 7 enemas)
• Suppositories 5mg (£249.64 = 10 suppositories)

Budesonide prolonged release (Cortiment)

The routine commissioning of budesonide 9mg prolonged release multi-matrix tablets used for up to 8 weeks treatment is not accepted in Devon for induction of remission in adults with mild to moderate active ulcerative colitis where 5-aminosalicylic acid (5-ASA) treatment is not sufficient (see Commissioning Policy for more details). The policy indicates that in exceptional circumstances the Trust-Managed Individual Patient Treatments process can be used for this indication.

Corticosteroids in Inflammatory Bowel Disease (IBD)

1. Before starting steroids consider carefully if symptoms are due to active disease or other diagnosis e.g. co-existing irritable bowel syndrome. A raised CRP may help to confirm active disease.
2. Avoid ultra-short or low doses. For the majority of patients start at prednisolone 40mg and decrease over 8 weeks.
3. Steroids have no role in maintenance therapy.
4. At one year, approximately 50% of patients with ulcerative colitis will be steroid dependent or steroid refractory.

Decision to start immunomodulator therapy for patients with ulcerative colitis will be made by gastroenterologist, typically if:

• More than one course of steroids in any 2 year period
• Following any severe attack requiring IV steroids