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1.5 Chronic bowel disorders

1.5 CHRONIC BOWEL DISORDERS

1.5 Chronic Bowel Disorders

   1.5.1 Aminosalicylates

         These drugs for chronic bowel disorders are recommended for initiation only on specialist advice.

         Mesalazine 
         Mesalazine is an aminosalicylate that is used routinely to induce and maintain remission in chronic inflammatory bowel 
         disease -ulcerative colitis (UC) and Crohn’s disease.  Mesalazine is commonly given as a modified release  (MR) preparation to
         target delivery of the drug to the diseased area of the bowel to provide topical anti-inflammatory therapy.
         Available formulations have differences in licensed indications, tablet strengths, pharmaceutical, pharmacological and
         pharmacokinetic properties. As the delivery characteristics of the different mesalazine preparations may vary: mesalazine 
         preparations must be prescribed by brand name. 

         Octasa® is the first line choice across the ELMMB healthcare economy, and where possible 800mg strength tablets should 
         be prescribed and supplied. Patients currently taking generic mesalazine or Asacol® can be switched to Octasa®. Switching to 
         Octasa® in patients currently taking other brands of mesalazine can be considered, but response needs to be monitored
         as brands are not directly interchangeable. 
 
 
         AMBER     Octasa®  MR e/c 400mg & 800mg tablets (Mesalazine)  - (specify brand when prescribing)    
         In circumstances when a switch to Octasa® is not clinically appropriate, Asacol® or Mezavant® may be continued.
 
         New patients are not to be initiated on Asacol® or Mezavant®.
         AMBER      Asacol® MR 400mg e/c tablets (Mesalazine) - (specify brand when prescribing)  
         AMBER      Mezavant®  XL 1200mg tablets (once daily) (Mesalazine) - (specify brand when prescribing)
 
         Pentasa® is available for administration via large bore enteral feeding tubes or in swallowing difficulty.  
         The 500mg tablet will dissolve in water, leaving small beads (0.7mm-1mm diameter) that can be swallowed or administered 
         whole(beads must not be crushed).
 
         AMBER     Pentasa®  e/c 500mg tablets (Mesalazine) -  (specify brand when prescribing) 
 
         Rectal mesalazine preparations
         Asacol® foam enemas are licensed for mild to moderate acute exacerbations of ulcerative colitis affecting the distal colon, and
         Asacol® suppositories are also licensed for maintenance of remission of distal ulcerative colitis.
         AMBER     Asacol®  foam enema 1gram/metered application (Mesalazine)  - (specify brand when prescribing)
         AMBER     Salofalk®  suppositories 500mg, 1g (Mesalazine)  
 
         Pentasa® liquid enemas are licensed for the treatment of ulcerative colitis affecting the distal colon and rectum
         AMBER     Pentasa®  liquid retention enema 1gram/100mL (Mesalazine) - (specify brand when prescribing)    
 
         Ipocol® is not a recommended brand of mesalazine for new patients as it is not interchangeable with Asacol® due to 
         differences in its site of delivery, even though it is the same strength of mesalazine.
         AMBER     Balsalazide capsules 750mg
         AMBER     Sulfasalazine tablets 500mg (not recommended for new patients)
 
         Pouchitis         
         VSL#3 Sachets (but no other probiotics) 
         For specialist gastroenterology use only, where Pouchitis has been diagnosed and all other standard pharmacological 
         treatments have been tried. 
         RED           VSL#3 Sachets (specialist gastroenterology use only) [unlicensed]
 
         Alicaforsen Rectal Solution [unlicensed]
         Specialist use only in specific patients,
         RED           Alicaforsen rectal solution 4mg/mL


   1.5.2 Corticosteroids

         Treatment of acute attacks of ulcerative colitis and Crohn's disease:
         GREEN       Prednisolone 
                             tablets 5mg
                             suppositories 5mg
         GREEN       Hydrocortisone 10% rectal foam (Colifoam®)
         2nd line option
         GREEN       Budesonide foam enemas (Budenofalk®)
 
         Budesonide oral capsules 
         (as an option as per NICE clinical guideline for Crohn's disease, if  conventional corticoseteroid is not  tolerated) 
         RED            Budesonide multimatrix MMX 9mg prolonged release tablets (Cortiment®)
 
         Given that the Budenofalk brand of budesonide offers more flexible dosing than alternative products and is more cost 
         effective Consultants support using only the Budenofalk brand of budesonide.  All other brands are considered non- 
         formulary.
         AMBER       Budenofalk capsules 3mg


   1.5.3 Drugs affecting the immune response

         Ciclosporin is occasionally used in the management of severe inflammatory bowel disease (unlicensed). It requires regular
         monitoring and should only be prescribed under the direction of a specialist. Azathioprine is used in the maintenance of      
         remission of acute ulcerative colitis and Chron's disease, and also requires regular monitoring (unlicensed).
 
         Maintenance and symptomatic treatment of ulcerative colitis and Crohn's disease:
         AMBER      Azathioprine tablets 25mg, 50mg (unlicensed for use in IBD) 
         AMBER      Ciclosporin capsules 10mg, 25mg, 50mg, 100mg (Neoral®) – (unlicensed for use in IBD) 
                            (specify brand when prescribing)
         RED            Ciclosporin 50mg/ml  concentrate for iv infusion– (unlicensed for use in IBD)
 
         Cytokine modulators
         NICE guidance for Ulcerative Colitis updated Feb 2015 (TA329) 
         Infliximab ( Remicade®, Inflectra® or Remsima®), adalimumab (Humira®) and golimumab (Simponi®) are recommended
         as possible treatments for adults with moderate to severe ulcerative colitis if conventional therapy hasn’t worked or isn’t 
         suitable. 
         Infliximab is also recommended as a possible treatment for children or young people aged 6–17 years with severe ulcerative 
         colitis, if conventional therapy hasn’t worked or isn’t suitable.
 
         Infliximab is a treatment option for acute exacerbation of severely active ulcerative colitis where the patient meets the NICE  
         criteria to start a biologic (TA163)
         RED          Infliximab ( Remicade®,Inflectra®,Remsima®.) Prescribe by brand 
         RED          Adalimumab   (Amgevita (1st line choice in new patients, Humira®,)                                     NHS England Commissioned
         RED          Golimumab (Simponi®)
 
         NICE guidance for treating moderately to severely active ulcerative colitis (TAG342
         Vedolizumab is recommended as a possible treatment for adults with moderate to severe ulcerative colitis
         RED         Vedolizumab  (Entyvio®)  
                         Concentrate for intravenous infusion 300mg vial
 
         NICE guidance for treating moderately to severely active ulcerative colitis (TA547)

         Tofacitinib is recommended, within its marketing authorisation, as an option for treating moderately to severely active 

         ulcerative colitis in adults when conventional therapy or a biological agent cannot be tolerated or the disease has responded
         inadequately or lost response to treatment.
         RED       Tofacitinib (Xeljanz®) tablets                                                                                    CCG Commissioned - Bluetec form required
 
         NICE guidance for treating moderately to severely active ulcerative colitis (TA633)
         Ustekinumab is recommended as an option for treating moderately to severely active ulcerative colitis in adults when
         conventional therapy or a biological agent cannot be tolerated, or the disease has responded inadequately or lost response
         to treatment, only if:
            °   a tumour necrosis factor-alpha inhibitor has failed (that is the disease has responded inadequately or has lost response
                 to treatment) or
            °   a tumour necrosis factor-alpha inhibitor canot be tolerated or is not suitable, and   
            °   the company provides ustekinumab at the same price  or lower than that agreed with the Commercials Medicines UNIT
 
         RED         Ustekinumab (Stelara®)                                                                                        CCG Commissioned - Bluetec form required
 
         NICE guidance for treating for moderately to severely active Crohn's disease after prior therapy (TA352)
         RED        Vedolizumab (Entyvio®)  
                        Concentrate for intravenous infusion 300mg vial
 
         NICE guidance for treating for moderately to severely active Crohn's disease after previous therapy (NICE TA456)
         RED        Ustekinumab (Stelara®)                                                                                                                            CCG Commissioned
                        Solution for injection, solution for injection pre-filled syringes 45mg/0.5ml 

                        Solution for injection pre-filled syringes 90mg/1ml

         NICE guidance for Crohn's disease (TAG187)   
 
               >     Adalimumab, within its licensed indications, is recommended as a treatment option for adults with severe active non-
                      fistulising Crohn's disease as induction treatment followed by maintenance treatment. Maintenance treatment with
                      adalimumab should continue until treatment failure (which includes the need for surgery), or until 12 months after the
                      start of treatment, whichever is the shorter. The patient's disease should then be reassessed. Maintenance should only 
                      then be continued if there is clear evidence of ongoing disease, as determined by clinical symptoms and investigation,
                      including endoscopy if necessary. People whose disease relapses after maintenace treatment is stopped should have 
                      the option to resume treatment for a further 12 months. They should then be reassessed to determine whether
                      ongoing treatment is still clinically appropriate.  
 
               >     Infliximab is a treatment option for severe Crohn's disease when there is clear evidence of primary intolerance to
                      adalimumab, or if Crohn's disease is fistulising, or if the patient is either a child or adolescent.    
 
         Please see the full guidance for further information.
         RED           Adalimumab pre-filled pen/syringe 40mg  (Amgevita (1st line choice in new patients, Humira®,)
         RED           Infliximab vial for infusion 100mg


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