Moderate to severe active ulcerative colitis or Crohn's disease who have had an inadequate response w/, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-α (TNFα) antagonist.
300 mg IV infusion at wk 0, 2 & 6, & then every 8 wk thereafter, may be increased to every 4 wk. Re-treatment: Every 4 wk. Crohn's disease Continue therapy every 8 wk from wk 14 in responding patients.
Discontinue use if severe infusion-related, anaphylactic or other severe reactions occur or progressive multifocal leukoencephalopathy is confirmed; TB is diagnosed. Not to be initiated in active, severe infections. Monitor for new onset or worsening of neurological signs & symptoms. Controlled chronic or history of recurring severe infection. Increased risk of malignancy. Patients w/ severe active disease at baseline not previously treated w/ TNFα antagonists. Not recommended in patients previously treated w/ biologic immunosuppressants eg, natalizumab or rituximab. Concurrent use w/ live & oral vaccines. May affect ability to drive & use machines. Renal or hepatic impairment. Women of childbearing potential should use adequate contraception for 18 wk after treatment. Pregnancy & lactation. Childn 0-17 yr.
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