Drug Action
Vedolizumab is a monoclonal antibody that binds specifically to the a4b7 integrin, which is expressed on gut homing T helper lymphocytes and causes a reduction in gastrointestinal inflammation.
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Drug reference
Vedolizumab is a monoclonal antibody that binds specifically to the a4b7 integrin, which is expressed on gut homing T helper lymphocytes and causes a reduction in gastrointestinal inflammation.
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Moderate to severe active ulcerative colitis in patients who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor alpha inhibitor (under expert supervision) ▶BY INTRAVENOUS INFUSION ▶Adult: Initially 300 mg, then 300 mg after 2 weeks, followed by 300 mg after 4 weeks, followed by 300 mg every 8 weeks, dose to be given over 30 minutes, if treatment is interrupted or response decreases, dosing frequency may be increased—consult product literature; review treatment if no response within 10 weeks of initial dose Moderate to severe active Crohn’s disease in patients who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor alpha inhibitor (under expert supervision) ▶BY INTRAVENOUS INFUSION ▶Adult: Initially 300 mg, then 300 mg after 2 weeks, followed by 300 mg after 4 weeks, followed by 300 mg every 8 weeks, dose to be given over 30 minutes, if no response is observed, an additional dose of 300 mg may be given 10 weeks after initial dose; if treatment is interrupted or response decreases, dosing frequency may be increased—consult product literature; review treatment if no response within 14 weeks of initial dose
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Severe active infection
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Controlled chronic severe infection. history of recurring severe infection. previous treatment with natalizumab (wait at least 12 weeks between natalizumab use and initiation of vedolizumab unless potential benefit outweighs risk). previous treatment with rituximab CAUTIONS, FURTHER INFORMATION ▶Risk of infection Patients must be screened for tuberculosis before starting treatment; if latent tuberculosis is diagnosed, appropriate treatment must be initiated prior to vedolizumab treatment; if tuberculosis is diagnosed during treatment, discontinue vedolizumab until infection is resolved. Patients should be brought up to date with current immunisation schedule before initiating treatment.
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NICE decisions ▶Vedolizumab for treating moderately to severely active Crohn’s disease after prior therapy (August 2015) NICE TA352 Vedolizumab (Entyvio ®) is recommended as an option for the treatment of moderate to severe active Crohn’s disease 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 cannot be tolerated or is contra-indicated, and . the manufacturer provides vedolizumab with the discount agreed in the patient access scheme. Vedolizumab should be given as a planned course of treatment until treatment fails, or surgery is needed, or until 12 months after starting treatment, whichever is the shorter. Treatment should be continued only if there is clear evidence of a response. Patients who continue treatment should be reassessed at least every 12 months to determine whether ongoing treatment is still clinically appropriate. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta352 ▶Vedolizumab for treating moderately to severely active ulcerative colitis (June 2015) NICE TA342 Vedolizumab (Entyvio ®) is recommended, within its marketing authorisation, as an option for treating moderately to severely active ulcerative colitis in adults only if the manufacturer provides vedolizumab with the discount agreed in the patient access scheme. Vedolizumab should be given until treatment fails, or surgery is needed. At 12 months after the start of treatment, patients should be reassessed to see whether treatment should continue. Treatment should be continued only if there is clear evidence of a response. Patients who continue treatment should be reassessed at least every 12 months to determine whether ongoing treatment is still clinically appropriate. www.nice.org.uk/guidance/ta342 Scottish Medicines Consortium (SMC) decisions SMC No. 1064/15 The Scottish Medicines Consortium has advised (July 2015) that vedolizumab (Entyvio ®) is accepted for restricted use within NHS Scotland for the treatment of adults with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to a tumour necrosis factor alpha inhibitor. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower. SMC No. 1045/15 The Scottish Medicines Consortium has advised (May 2015) that vedolizumab (Entyvio ®) is accepted for use within NHS Scotland for the treatment of adults 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 inhibitor. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.
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→Appendix 1: monoclonal antibodies
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▶Common or very common Arthralgia. constipation. cough. fatigue. fever. gastrointestinal discomfort. gastrointestinal disorders. headache. hypertension. increased risk of infection. muscle spasms. muscle weakness. nasal congestion. nausea. night sweats. oropharyngeal pain. pain. paraesthesia. skin reactions ▶Uncommon Chills. feeling cold ▶Frequency not known Hypersensitivity. infusion related reaction SIDE-EFFECTS, FURTHER INFORMATION Infusion-related and hypersensitivity reactions have been reported. Patients should be observed continuously during each infusion for signs and symptoms of acute hypersensitivity reactions; they should also be observed for 2 hours after the initial two infusions, and for 1 hour after subsequent infusions. Discontinue treatment if a severe infusion- related or other severe reaction occurs and initiate appropriate treatment (e.g. adrenaline and antihistamines); if a mild to moderate infusion-related reaction occurs, interrupt infusion or reduce infusion rate and initiate appropriate treatment (if reaction subsides the infusion may be continued)—consider pretreatment with an antihistamine, hydrocortisone, and/or paracetamol prior to subsequent infusions in patients who experience mild to moderate infusion-related reactions.
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Manufacturer advises effective contraception required during and for at least 18 weeks after treatment.
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Manufacturer advises use only if potential benefit outweighs risk.
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Manufacturer advises avoid—present in milk in animal studies.
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▶Manufacturer advises monitor closely for infection before, during and after treatment—potential increased risk of opportunistic infection. ▶Manufacturer advises monitor for new onset or worsening neurological signs and symptoms (withhold treatment if progressive multifocal leukoencephalopathy (PML) is suspected).
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For intravenous infusion (Entyvio ®), give intermittently in Sodium chloride 0.9%; allow vial to reach room temperature then reconstitute with 4.8 mL of water for injection (using a syringe with a 21–25 gauge needle); gently swirl vial for at least 15 seconds, do not shake vigorously or invert; allow to stand for up to 20 minutes (gently swirl vial if needed), leave for an additional 10 minutes if not dissolved; gently invert vial three times, withdraw 5 mL of reconstituted solution (using a syringe with a 21–25 gauge needle), and add to 250 mL of infusion fluid; gently mix and give over 30 minutes.
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There can be variation in the licensing of different medicines containing the same drug. Powder for solution for infusion ▶Entyvio (Takeda UK Ltd) Vedolizumab 300 mg Entyvio 300mg powder for concentrate for solution for infusion vials | 1 vial P £2,050.00 (Hospital only) 1.4 Irritable bowel syndrome Irritable bowel syndrome Description of condition Irritable bowel syndrome (IBS) is a common, chronic, relapsing, and often life-long condition, mainly affecting people aged between 20 and 30 years. It is more common in women. Symptoms include abdominal pain or discomfort, disordered defaecation (either diarrhoea, or constipation with straining, urgency, and incomplete evacuation), passage of mucus, and bloating. Symptoms are usually relieved by defaecation. Obtaining an accurate clinical diagnosis of IBS prior to treatment is crucial. Aims of treatment The treatment of IBS is focused on symptom control, in order to improve quality of life. Non-drug treatment g Diet and lifestyle changes are important for effective self-management of IBS. Patients should be encouraged to increase physical activity, and advised to eat regularly, without missing meals or leaving long gaps between meals. Dietary advice should also include, limiting fresh fruit consumption to no more than 3 portions per day. The fibre intake of patients with IBS should be reviewed. If an increase in dietary fibre is required, soluble fibre such as ispaghula husk p. 58, or foods high in soluble fibre such as oats, are recommended. Intake of insoluble fibre (e.g. bran) and ‘resistant starch’ should be reduced or discouraged as they Gastro-intestinal system may exacerbate symptoms. Fluid intake (mostly water) should be increased to at least 8 cups each day and the intake of caffeine, alcohol and fizzy drinks reduced. The artificial sweetener sorbitol should be avoided in patients with diarrhoea. Where probiotics are being used, continue for at least 4 weeks while monitoring the effect. If a patient’s symptoms persist following lifestyle and dietary advice, single food avoidance and exclusion diets may be an option under the supervision of a dietitian or medical specialist. h Drug treatment g The choice of drug treatment depends on the nature and severity of the symptoms. Many drug treatment options for IBS are available over-the-counter. Antispasmodic drugs (such as alverine citrate p. 93, mebeverine hydrochloride p. 93 and peppermint oil p. 52) can be taken in addition to dietary and lifestyle changes. A laxative (excluding lactulose p. 60 as it may cause bloating) can be used to treat constipation. Patients who have not responded to laxatives from the different classes and who have had constipation for at least 12 months, can be treated with linaclotide p. 52. Loperamide hydrochloride p. 71 is the first-line choice of anti-motility drug for relief of diarrhoea. Patients with IBS should be advised how on to adjust their dose of laxative or anti-motility drug according to stool consistency, with the aim of achieving a soft, well-formed stool. h See Constipation p. 57, for information on other drugs used for chronic constipation. g A low-dose tricyclic antidepressant, such as amitriptyline hydrochloride p. 390 [unlicensed indication], can be used for abdominal pain or discomfort as a second- line option in patients who have not responded to antispasmodics, anti-motility drugs, or laxatives. A selective serotonin reuptake inhibitor may be considered in those who do not respond to a tricyclic antidepressant [unlicensed indication]. Psychological intervention can be offered to patients who have no relief of IBS symptoms after 12 months of drug treatment. h Useful Resources Irritable bowel syndrome in adults: diagnosis and management. Clinical guideline 61. February 2015 www.nice.org.uk/guidance/cg61 ANTISPASMODICS
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Patients should be provided with a patient alert card.
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Initially 300 mg, then 300 mg after 2 weeks,
First-line fragment. Read the complete Indications and Dose section above.
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Initially 300 mg, then 300 mg after 2 weeks,
First-line fragment. Read the complete Indications and Dose section above.
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