netFormulary South East London Joint Medicines Formulary NHS
Guy's and St Thomas' NHS Foundation Trust
Kings College Hospital NHS Foundation Trust
Lewisham and Greenwich NHS Trust
 
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 Formulary Chapter 1: Gastro-intestinal system - Full Chapter
Notes:

Where a formulary entry does not detail a medicine’s indications for use, the medicine can be assumed to be approved for all licensed indications.

Formulary approved "off-label" use is detailed separately.

 Details...
01.05.03  Expand sub section  Drugs affecting the immune response
Cytotoxic Drug Azathioprine tablets (gastroenterology indications - off-label)
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Formulary
Amber 3

Refer to SE London immunomodulatory shared care guidance for list of indications (link below at end of BNF section)

 
   
Cytotoxic Drug Mercaptopurine tabs (gastroenterology indications, including off-label use)
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Formulary
Amber 3

Refer to SE London immunomodulatory shared care guidance for list of indications (link below at end of BNF section)

 
   
Cytotoxic Drug Methotrexate tablets (gastroenterology indications, including off-label use)
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Formulary
Amber 3

Refer to SE London immunomodulatory shared care guidance for list of indications (link below at end of BNF section)

 
   
Sulfasalazine tabs, oral suspension
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Formulary
Amber 3

Acute management of ulcerative colitis only

Refer to SE London immunomodulatory shared care guidance (link below at end of BNF section)

 
   
Anti-MAP (mycobacterium avium paratuberculosis) therapy (clarithromycin, rifabutin and clofazimine)
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Formulary
Red

Specialist gastroenterology use only

Follow local guidelines for use at GSTT Patient Information Leaflet available on GTi (GSTT intranet)

Last line option for Crohn's disease patients who have not responded to/have been intolerant of or have a contraindication to treatment options and strategies for Crohn’s disease outlined within the SEL IBD Pathways (including immunosuppressants and biologics) and do not wish to have surgery.

Regimen:

  • Clarithromycin 250 mg each morning and 500 mg at night
  • Rifabutin 150 mg daily for 1 week, then 150 mg twice daily. If >50kg the dose may be increased to 450mg total daily dose
  • Clofazimine 100 mg daily (unlicensed product) The maximum treatment duration is 2 years
 
Link  SE London APC recommendation: Clofazimine in combination with clarithromycin and rifabutin as anti-MAP (Mycobacterium avium subspecies paratuberculosis) therapy for the treatment of Crohn’s disease in adults
   
Ciclosporin injection (ulcerative colitis - off-label)
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Formulary
Red

Approved off-label indication:

Severe acute ulcerative colitis refractory to corticosteroid treatment. Dose: 2 mg/kg over 24hours and dose adjusted according to blood-ciclosporin concentration and response

 
   
Tacrolimus (Adoport®) (IBD - off-label)
(Prescribe by brand)
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Formulary
Red

Approved off-label indication:

Refractory Crohn’s disease or ulcerative colitis, in patients who have failed or are contraindicated to all other conventional immunosuppressant and biological treatments.

 
   
Cytotoxic Drug Tioguanine tabs (IBD - off-label)
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Formulary
Red

Approved off-label indication:

3rd line oral immunosuppressive agent for maintaining remission in adult patients with Crohn’s disease and ulcerative colitis

  • For use in patients who are intolerant or unresponsive to both azathioprine and mercaptopurine
  • Hospital prescribing and supply only
  • Dose: 20 mg to 40 mg daily
 
Link  SE London APC recommendation: Tioguanine for the treatment of adults with inflammatory bowel disease
   
Tacrolimus ointment (perianal Crohn’s disease - off-label)
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Formulary

Approved off-label indication:

Ulcerating perianal Crohn’s disease and pyoderma gangrenosum as a last-line option if all other therapies and surgery have failed or are unsuitable

 
   
01.05.03  Expand sub section  Cytokine inhibitors
Adalimumab injection (IBD)
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Formulary
Red
High Cost Medicine
Approved as per NICE technology appraisal guidance  
Link  NICE TA187: Infliximab and adalimumab for the treatment of Crohn’s disease
Link  NICE TA329: Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy
   
Infliximab injection (IBD)
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Formulary
Red
High Cost Medicine

Approved as per NICE technology appraisal guidance

Biosimilar products available, to be prescribed by brand name. Contact pharmacy department for advice on brand for routine prescribing if unsure

 
Link  NICE TA163 Infliximab for acute exacerbations of ulcerative colitis
Link  NICE TA187: Infliximab and adalimumab for the treatment of Crohn’s disease
Link  NICE TA329: Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy
Link  SE London APC position statement: Biosimilar infliximab
   
Golimumab injection (ulcerative colitis)
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Formulary
Red
High Cost Medicine

Approved as per NICE technology appraisal guidance 

 
Link  NICE TA329: Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy
   
Infliximab injection (cancer immunotherapy related colitis - off-label)
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Formulary
Red
High Cost Medicine

Approved off-label indication:

Treatment of cancer immunotherapy (ipilimumab, nivolumab and pembrolizumab) related corticosteroid refractory colitis

  • The infliximab brand with the lowest acquisition cost should be used
  • Category B* form required
  • Restricted to use in in patients where conservative measures (e.g. loperamide, fluid replacement, withholding immunotherapy treatment) and high dose intravenous corticosteroids have failed
  • Approved for a maximum of 2 doses at 5mg/kg

Biosimilar products available. Use of best value product for infliximab to be implemented.  To be prescribed by brand name.

Contact pharmacy department for advice on brand for routine prescribing if unsure

 
   
Tofacitinib tabs (gastroenterology indications)
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Formulary
Red
High Cost Medicine

Approved as per NICE technology appraisal guidance

 
Link  MHRA Drug Safety Update May 19: 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
   
Ustekinumab injection (Crohn's disease)
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Formulary
Red
High Cost Medicine
Approved as per NICE technology appraisal guidance 
Link  NICE TA456: Ustekinumab for moderately to severely active Crohn’s disease after previous treatment
   
01.05.03  Expand sub section  Vedolizumab
Vedolizumab injection
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Formulary
Red
High Cost Medicine
 
Link  NICE TA342 Vedolizumab for treating moderately to severely active ulcerative colitis
Link  NICE TA352 Vedolizumab for treating moderately to severely active Crohn’s disease after prior therapy
   
 ....
Key
note Notes
Section Title Section Title (top level)
Section Title Section Title (sub level)
First Choice Item First Choice item
Non Formulary Item Non Formulary section
Restricted Drug
Restricted Drug
Unlicensed Drug
Unlicensed
Track Changes
Display tracking information
click to search medicines.org.uk
Link to adult BNF
click to search medicines.org.uk
Link to SPCs
SMC
Scottish Medicines Consortium
Cytotoxic Drug
Cytotoxic Drug
CD
Controlled Drug
High Cost Medicine
High Cost Medicine
Cancer Drugs Fund
Cancer Drugs Fund
NHSE
NHS England
Homecare
Homecare
CCG
CCG

Traffic Light Status Information

Status Description

Red

Specialist or hospital prescribing only. The responsibility for prescribing, monitoring, dose adjustment and review should remain with the specialist or hospital. In very exceptional circumstances a specialist may discuss individual patient need for a RED drug to be prescribed by a GP and the GP should consider informing the Medicines Management team before a decision is made to prescribe for individual patients.   

Amber 1

Treatment can be initiated in primary care after a recommendation from an appropriate specialist  

Amber 2

Specialist initiation followed by maintenance prescribing in primary care  

Amber 3

Specialist initiation with ongoing monitoring required. After dose stabilisation GPs can be requested to take over prescribing responsibilities using the approved APC shared care documentation  

Green

Specialist and non-specialist initiation  

Grey

Not recommended for prescribing  

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