INFLIXIMAB-DYYB INJ,SOLN
Clinical Criteria Summary
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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.
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Indication & Disease Severity
- Moderate to severe active Crohn’s disease (CD) or moderate to severe active ulcerative colitis (UC)
Prescriber & Monitoring Requirements
- Prescribed and monitored by a VA / VA Community Care gastroenterologist/hepatologist or locally designated expert in inflammatory bowel disease
Baseline Diagnostic Criteria
- Disease confirmed by endoscopy or imaging at baseline
Clinical Response & Maintenance Requirements (One of the following must be met)
- Achieved clinical response after Week 10 following three intravenous (IV) induction doses of infliximab/biosimilar at Weeks 0, 2 and 6
- Clinically stable and receiving IV infliximab/biosimilar to maintain clinical remission
Alternative Administration Justification
- Unable to accommodate or comply with maintenance therapy intravenous infusion schedule (e.g., difficult intravenous access, travel limitations, work requirements, lack of sick leave)
Clinical Response Definitions
- UC clinical response: Decrease from baseline of ≥ 2 points and at least 30% on the modified Mayo score (range 0–9), including subscores for stool frequency, rectal bleeding, and endoscopic findings
- CD clinical response: Decrease from baseline in the Crohn’s Disease Activity Index (CDAI) of ≥ 100 points