Moderately to severely active ulcerative colitis or Crohn's disease in adults who have had an inadequate response w/, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-α antagonist. Moderately to severely active chronic pouchitis in adults who have undergone proctocolectomy & ileal pouch anal anastomosis for ulcerative colitis & have had an inadequate response w/ or lost response to antibiotic therapy.
300 mg IV infusion over 30 min at 0, 2, & 6 wk, & then every 8 wk thereafter. Ulcerative colitis & Crohn's disease Dosing at every 4 wk may be considered in case of decreased response or retreatment.
Observe all patients continuously during each infusion, then for approx 2 hr following completion of the 1st 2 infusions for signs & symptoms of acute hypersensitivity reactions, & for approx 1 hr following completion of all subsequent infusions. Immediately discontinue in case of severe infusion-related reaction, anaphylactic reaction, or other severe reaction. Closely monitor patients for infections before, during, & after treatment eg, TB screening before treatment initiation. Do not initiate in patients w/ active severe infections until infections are controlled. Caution in patients w/ controlled chronic severe infection or history of recurring severe infections. Increased risk of malignancy in patients w/ ulcerative colitis & Crohn's disease. Caution in patients previously treated w/ natalizumab or rituximab. Not recommended w/ biologic immunosuppressants. Live vaccines may be administered concurrently only if benefits clearly outweigh risks. Minor influence on ability to drive & use machines. Has not been studied in patients w/ renal or hepatic impairment. Women of childbearing potential should use adequate contraception & continue its use for at least 18 wk after last treatment. Avoid use during pregnancy unless benefits clearly outweigh risks. Consider benefits & risks for use during lactation. Safety & efficacy in childn ≤17 yr have not been established.
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