Adults w/ moderately to severely active ulcerative colitis & Crohn's disease who have had an inadequate response w/, lost response to, or were intolerant to either conventional therapy or tumour necrosis factor-α (TNFα) antagonist.
Ulcerative colitis 300 mg IV infusion at 0, 2 & 6 wk, & then every 8 wk thereafter. May increase to 300 mg every 4 wk if there is decrease in response. Retreatment: Consider dosing at every 4 wk if therapy is interrupted & there is need to restart treatment. Discontinue if no evidence of therapeutic benefit is observed by wk 10. Crohn's disease 300 mg IV infusion at 0, 2 & 6 wk, & then every 8 wk thereafter. Continue therapy every 8 wk from wk 14 in responding patients. May increase to 300 mg every 4 wk if there is decrease in response. Retreatment: Consider dosing at every 4 wk if therapy is interrupted & there is need to restart treatment. Discontinue if no evidence of therapeutic benefit is observed by wk 14.
Observe patients for signs & symptoms of acute hypersensitivity reactions for approx 2 hr following completion of the 1st two infusions & approx 1 hr following completion for all subsequent infusions. Discontinue immediately if severe infusion-related reactions (IRR), anaphylactic, or other severe reactions occur. Consider pre-treatment (eg, w/ antihistamine, hydrocortisone &/or paracetamol) prior to the next infusion for patients w/ history of mild to moderate IRR. Increased risk of opportunistic infections or infections specifically in the gut. Do not initiate in patients w/ active, severe infections until the infections are controlled; consider w/holding treatment in patients who develop a severe infection while on chronic treatment. Controlled chronic severe infection or history of recurring severe infections. Screen for TB before starting treatment; start anti-TB treatment if latent TB is diagnosed. Discontinue until the infection has been resolved if TB is diagnosed during therapy. Monitor for any new onset or worsening of neurological signs & symptoms. Increased risk of malignancy in patients w/ ulcerative colitis & Crohn's disease; use w/ immunomodulatory medicinal products. Induction of remission in Crohn's disease may take up to 14 wk particularly in patients w/ severe active disease at baseline not previously treated w/ TNFα antagonists. Previous treatment w/ natalizumab or rituximab. Not recommended in concomitant use w/ biologic immunosuppressants. Live & oral vaccines. Minor influence on the ability to drive or operate machines. Adequate contraception is strongly recommended in women of childbearing potential & to continue its use for at least 18 wk after the last treatment. Pregnancy & lactation. Childn 0-17 yr.
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