INFLECTRA (infliximab for Injection) Indications

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Indications have been granted on the basis of similarity between INFLECTRA® and the reference biologic drug REMICADE®.

INFLECTRA® (infliximab for injection) is indicated for:

  • use in combination with methotrexate for the reduction in signs and symptoms, inhibition of the progression of structural damage and improvement in physical function in adult patients with moderately to severely active rheumatoid arthritis.
  • the reduction of signs and symptoms and improvement in physical function in patients with active ankylosing spondylitis who have responded inadequately, or are intolerant to, conventional therapies.
  • reduction of signs and symptoms, induction and maintenance of clinical remission and mucosal healing and reduction of corticosteroid use in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to a corticosteroid and/or aminosalicylate. INFLECTRA® can be used alone or in combination with conventional therapy.
  • reduction of signs and symptoms and induction and maintenance of clinical remission in pediatric patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy (corticosteroid and/or aminosalicylate and/or immunosuppressant). The safety and efficacy of INFLECTRA® is not established in patients less than 9 years of age.
  • treatment of fistulising Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment.
  • reduction of signs and symptoms, induction and maintenance of clinical remission and mucosal healing, and reduction or elimination of corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy (i.e., aminosalicylate and/or corticosteroid and/or an immunosuppressant).
  • reduction of signs and symptoms, induction and maintenance of clinical remission, and induction of mucosal healing in pediatric patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy (i.e., aminosalicylate and/or corticosteroid and/or an immunosuppressant). The safety and efficacy of INFLECTRA® have not been established in patients less than 6 years of age.
  • reduction of signs and symptoms, induction of major clinical response, and inhibition of the progression of structural damage of active arthritis, and improvement in physical function in patients with psoriatic arthritis.
  • treatment of adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy. For patients with chronic moderate plaque psoriasis, INFLECTRA® should be used after phototherapy has been shown to be ineffective or inappropriate. When assessing the severity of psoriasis, the physician should consider the extent of involvement, location of lesions, response to previous treatments, and impact of disease on the patient’s quality of life.

INFLECTRA® should be used by physicians who have sufficient knowledge of rheumatoid arthritis and/or ankylosing spondylitis and/or Crohn’s disease and/or ulcerative colitis and/or psoriatic arthritis and/or plaque psoriasis and who have fully familiarized themselves with the efficacy/safety profile of INFLECTRA®.

Pediatrics

INFLECTRA® is indicated for reducing signs and symptoms and for inducing and maintaining clinical remission in pediatric patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. INFLECTRA® is also indicated for reducing signs and symptoms, inducing and maintaining clinical remission and inducing mucosal healing in pediatric patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy (i.e., aminosalicylate and/or corticosteroid and/or an immunosuppressant). In general, the adverse events in pediatric patients with Crohn’s disease or ulcerative colitis who received infliximab for injection were similar to those seen in adult patients with Crohn’s disease or ulcerative colitis respectively. It should be noted that in the Phase 3 trial (REACH) of pediatric patients with Crohn’s disease, all patients were required to be on a stable dose of either 6-mercaptopurine (6-MP), azathioprine (AZA), or methotrexate (MTX). (See INDICATIONS; WARNINGS AND PRECAUTIONS, Special Populations, Pediatrics; ADVERSE REACTIONS, Adverse Reactions in Pediatric Patients, Crohn’s Disease, Adverse Reactions in Pediatric Patients, Ulcerative Colitis; DOSAGE AND ADMINISTRATION; and CLINICAL TRIALS - REFERENCE BIOLOGIC DRUG).

The safety and efficacy of infliximab for injection has not been established in pediatric patients with Crohn’s disease <9 years of age or with ulcerative colitis <6 years of age. The safety and efficacy of infliximab for injection in pediatric patients with plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and in juvenile rheumatoid arthritis have not been established.

Geriatrics (≥ 65years of age)

Evidence from clinical studies suggests that the use in geriatric population is associated with no overall differences in safety and efficacy.

In rheumatoid arthritis clinical trials (ATTRACT) and plaque psoriasis trials, no overall differences were observed in the effectiveness or safety in 181 patients with rheumatoid arthritis and 75 patients with plaque psoriasis, aged 65 or older compared to younger patients although the incidence of serious adverse events in patients aged 65 or older was higher in both infliximab for injection and control groups compared to younger patients. In Crohn’s disease, ulcerative colitis, ankylosing spondylitis and psoriatic arthritis studies, there were insufficient numbers of patients aged 65 and over to determine whether they respond differently from patients aged 18 to 64. Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly (see ADVERSE REACTIONS, Infections).