1 INDICATIONS AND USAGE
RENFLEXIS is a tumor necrosis factor (TNF) blocker indicated for:
Crohn's Disease:
reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. (1.1)
reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease. (1.1)
Pediatric Crohn's Disease:
reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy. (1.2)
Ulcerative Colitis:
reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. (1.3)
Pediatric Ulcerative Colitis:
reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy. (1.4)
Rheumatoid Arthritis in combination with methotrexate:
reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active disease. (1.5)
Ankylosing Spondylitis:
reducing signs and symptoms in patients with active disease. (1.6)
Psoriatic Arthritis:
reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function. (1.7)
Plaque Psoriasis:
treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. (1.8)
1.1 Crohn's Disease
RENFLEXIS is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy.
RENFLEXIS is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn's disease.
1.2 Pediatric Crohn's Disease
RENFLEXIS is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy.
1.3 Ulcerative Colitis
RENFLEXIS is indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.
1.4 Pediatric Ulcerative Colitis
RENFLEXIS is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.
1.5 Rheumatoid Arthritis
RENFLEXIS, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis.
1.6 Ankylosing Spondylitis
RENFLEXIS is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.
1.7 Psoriatic Arthritis
RENFLEXIS is indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis.
1.8 Plaque Psoriasis
RENFLEXIS is indicated for the treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. RENFLEXIS should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Boxed Warnings, Warnings and Precautions (5)].