INFLIXIMAB-DYYB INJ,SOLN
Clinical Criteria Summary
Indications & Treatment Phase
- Maintenance treatment of adults with moderately to severely active Crohn’s disease following treatment with an infliximab product administered intravenously.
- Maintenance treatment of adults with moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously.
- Treatment phase is restricted to maintenance only; lacks indication for fistulizing CD.
Patient Population & Clinical Status
- Adults who experience a clinical response or improvement in moderate to severe, active CD or moderate to severe, active UC at Week 10 or thereafter following IV induction doses of infliximab/biosimilar at Weeks 0, 2, and 6.
- Patients who are clinically stable and receiving IV infliximab/biosimilar to maintain clinical remission.
- Patients unable to adhere with IV maintenance infusion schedules.
Switching & Administration Criteria
- For patients responding to maintenance therapy with an IV infliximab product, administer the first SC dose in place of the next scheduled IV infusion, then every 2 weeks thereafter.
- Dosage regimen for Week 10 and on: 120 mg subcutaneously once every 2 weeks.
Safety & Contraindication Considerations
- Not contraindicated in moderate or severe heart failure (unlike INFLECTRA at doses > 5 mg/kg).
- Warning to avoid use in patients with congestive heart failure; monitor closely and discontinue therapy if symptoms of CHF develop.