vedolizumab

Question 1

MOA

Answer 1

• immunosupressant anti-lymphocyte max
• binds specifically to a4b7 integral which is expressed in the gut and homes T helper cells and causes reduction in GI inflammation

Question 2

indications

Answer 2

under expert supervision: Crohn’s disease and UC

Question 3

cautions

Answer 3

• Controlled chronic severe infection
• History of recurring severe infection
• Previous treatment with rituximab
• Previous treatment with natalizumab (wait at least 12 weeks between use unless potential benefit outweighs risk)
• Risk of infection
  – Patients must be screened for TB before starting
  – If latent TB is diagnosed, appropriate treatment must be initiated prior to treatment
  – If TB diagnosed during treatment, discontinue until infection resolved

Question 4

pre-screening needed before initiation

Answer 4

○ Patients must be screened for TB before starting
○ If latent TB is diagnosed, appropriate treatment must be initiated prior to treatment
○ If TB diagnosed during treatment, discontinue until infection resolved

Question 5

interactions

Answer 5

• Live vaccines predicted to increase risk of generalised infection, possibly life threatening
• avoid!!
• e.g. cholera, dengue, influenza, MMR, rotavirus, typhoid, varicella-zoster, yellow fever, Bacillus Calmette-Gurein

Question 6

Conception and contraception

Answer 6

effective contraception required during and for at least 18 weeks after treatment

Question 7

monitoring requirements

Answer 7

• Monitor closely for infection before, during and after treatment - potential increased risk for opportunistic infection
• Monitor for new onset or worsening neurological signs and symptoms (withhold treatment if progressive multifocal leukoencephalopathy (PML) suspected)
• signs of PML include: Loss of coordination and weakness, loss of language, visual problems, headaches

Question 8

SE

Answer 8

• arthralgia
• constipation, GI discomfort, GI disorders
• headache, fatigue, fever
• increased risk of infection
• cough, nasal congestion
• hypertension
• muscle spasms, muscle weakness
• oropharyngeal pain, pain, paraesthesia
• skin reactions

Question 9

infusion related and hypersensitivity reactions have been reported

Answer 9

• pt need to be observed continuously during each infusion for signs and symptoms of acute hypersensitivity reactions
• observe pt 2 hours after initial to infusions, and for 1 hour after subsequent infusions
• discontinue if severe infusion related or other severe reaction occurs and initiate appropriate treatment (e.g. adrenaline and antihistamine)
• if mild to moderate infusion related reaction, interrupt infusion or reduce infusion rate and initiate appropriate treatment ; if reaction subsides infusion may be continued
• consider pretreatment with an antihistamine, HC, and/or paracetamol prior to subsequent infusions in pt with mild to moderate infusion related reactions