1.1 Coeliac Disease
Local Gluten Free Formulary available at Gluten Free Services - NHS Dumfries and Galloway
1.2 Diverticulitis Disease and Diverticulitis
1.3 Inflammatory Bowel Disease
NICE NG129: Crohn’s disease: management
NICE NG130: Ulcerative colitis: management
Crohn’s Disease
Acute Exacerbation of Crohn’s Disease
- Prednisolone tablets ✓ First Choice
- Methylprednisolone IV – hospital only
- Budesonide (Budenofalk® E/C Capsules, E/C Granules, Entocort® Modified Release Tablets)
Budesonide can be used for patients with one or more of distal ileal, ileocaecal or right sided disease who are unsuitable or have contraindications to a conventional corticosteroid.
Budesonide may be less effective than prednisolone but may be better tolerated.
Within acute, methylprednisolone IV Injection with a dose of 30mg twice a day – is considered safer and more convenient than hydrocortisone injections four times a day.
Add on Treatment / Maintenance of Remission – Drugs Affecting the Immune Response
- Azathioprine tablets ✓ First Choice– unlicensed indication ✓ Specialist Initiation Only
- Mercaptopurine Tablets – unlicensed indication ✓ Specialist Initiation Only – use branded Hanixol
- Methotrexate (specialist initiation only)
All of the above can be used as steroid sparing agents to induce remission.
Thiopurine Blood monitoring:
FBC, U&E’s, LFT’s and CRP at weeks 2, 4, 8 and 12 and if satisfactory then move to 3 monthly bloods.
Ulcerative Colitis
Treatment of Acute Mild-Moderate Ulcerative Colitis - the severity and extent of the disease should be considered when choosing the route of administration.
Ulcerative Proctitis
- Mesalazine 1g Suppositories (Salofalk®) ✓ First Choice
- Budesonide 2mg foam enema
- Budesonide 4mg suppository
If not managed on rectal preparation add mesalazine 3mg MR Granules (Salofalk)
Rectosigmoid
- Mesalazine 1g Foam Enema (Salofalk®) ✓ First Choice
- Budenofalk 2mg foam enema
If not managed on rectal preparation add mesalazine 3mg MR Granules (Salofalk®)
Disease above the Rectosigmoid
- Mesalazine 2g Liquid enema (Salofalk®) ✓ First Choice
- Budesonide 2mg foam enema
- Mesalazine 3mg MR Granules (Salofalk®) ✓ First Choice
Pancolitis
- Octasa 800mg tablets ✓ First Choice
Severe Exacerbation
- Prednisolone tablets ✓ First Choice
- Budesonide (Cortiment®) 9mg prolonged release tablets - Restricted for use in patients with UC who present with active left-sided disease and/or proctosigmoiditis who are not suitable for oral prednisolone, as an alternative to budesonide rectal formulations or off-label oral budesonide
Salofalk® is the preferred brand when a patient is being initiated on Mesalazine. If Salofalk® is not suitable, Octasa® is an alternative brand that could be considered. Consideration should be given to reviewing and switching patients prescribed Asacol MR to equivalent dose of Octasa® MR.
Please consider bone protection for patients with repeated or prolonged treatment with corticosteroids.
For repeated courses of steroids (eg more than 2 in a year) please seek specialist advice regarding escalating treatment.
Other Corticosteroids
- Budesonide (Jorveza) 1mg orodispersible tablets – ✓ Specialist Initiation Only for the treatment of eosinophilic oesophagitis in adults (older than 18 years of age) who have been unsuccessfully treated with proton pump inhibitors..
This is 6 week treatment course which can be extended to max 12 weeks on review. Consider requirement for blood glucose monitoring.
Immunosuppressants
** Adalimumab – ✓ Specialist Use Only, prescribe by brand **
Amgevita® SC - preferred biosimilar
Crohn’s disease:
For the treatment of severe, active Crohn’s disease in adults whose disease has not responded to conventional therapy (including immunosuppressive and/or corticosteroid treatments) or who are intolerant of or have contraindications to such therapies, in line with NICE MTA 187.
Ulcerative colitis :
Use in the treatment of moderately to severely active ulcerative colitis in adults is restricted to those patients whose disease has responded inadequately to conventional therapy, including corticosteroids, Mercaptopurine and Azathioprine, or who cannot tolerate, or have medical contraindications for such therapies.
** Infliximab - ✓ Specialist Use Only, prescribe by brand **
Remsima® IV/SC– preferred biosimilar.
Crohn’s disease:
Infliximab is formulary for the treatment of severe active Crohn’s disease in adults whose disease has not responded to conventional therapy (including immunosuppressive and/or corticosteroid treatments) or who are intolerant of or have contraindications to conventional therapy, in line with NICE MTA 186.
Ulcerative colitis:
Treatment of moderately to severely active ulcerative colitis in adults is restricted to those patient whose disease has responded inadequately to conventional therapy, including corticosteroids, mercaptopurine and azathioprine, or who cannot tolerate, or have medical contraindications for such therapies.
** Ustekinumab - ✓ Specialist Use Only, prescribe by brand **
Wezenla® SC▼ - preferred biosimilar
Crohn’s disease:
The treatment of adults with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or where intolerant to either conventional therapy or a TNF alpha antagonist or have medical contraindication to such therapies.
Ulcerative colitis:
For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.
** Upadacitinib Tablets (Rinvoq®) – ✓ Specialist Use Only **
Crohn’s disease:
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 biologic agent, or for whom such therapies are not advisable.
Ulcerative colitis:
For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.
** Filgotinib Tablets (Jyseleca®) – ✓ Specialist Use Only **
Ulcerative colitis:
for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.
** Tofacitinib Tablets (Xeljanz®) – ✓ Specialist Use Only **
Ulcerative colitis:
For the treatment of adults with moderately to severely active ulcerative colitis is restricted to specialist use in patients who have had an inadequate response, lost response, or were intolerant to either conventional therapy and a biologic agent.
** Mirikizumab IV/SC (Omvoh®) – ✓ Specialist Use Only **
Ulcerative colitis:
For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.
** Risankizumab IV/SC (Skyrizi®) – ✓ Specialist Use Only **
Crohn’s disease:
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.
Ulcerative colitis:
For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy. (Business Case not yet through ADTC)
** Vedolizumab IV/SC (Entyvio®) – ✓ Specialist Use Only **
Crohn’s disease:
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.
Ulcerative colitis:
For the treatment of adult patients with moderately to severely active ulcerative colitis 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.
Blood monitoring for biologics FBC, U&E’s, LFT’s and CRP monthly for 3 months and if satisfactory then move to 3 monthly bloods.
1.4 Irritable bowel syndrome
NICE CG61: IBS in adults diagnosis and management
Antispasmodics
-
Hyoscine Butylbromide Tablets ✓ First Choice
-
Mebeverine 135mg Tablets
-
Peppermint oil capsules (Reserved for symptoms of bloating). Prescribe as Mintec®
Mebeverine/Fybogel combination is non formulary – it is more cost effective to prescribe as individual components.
Laxatives – Guanylate Cyclase c receptor agonists
Linaclotide – ✓ Specialist Initiation Only for IBS with constipation as predominant feature