es have occurred in patients with Crohn’s disease or ulcerative
colitis and most were in adolescent and young adult males.
1 INDICATIONS AND USAGE
1.1 Crohn’s Disease
RENFLEXIS is indicated for reducing signs and symptoms and inducing and maintainingclinical remission in adult patients with moderately to severely active Crohn’s disease whohave had an inadequate response to conventional therapy.
RENFLEXIS is indicated for reducing the number of draining enterocutaneous andrectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn’sdisease.
1.2 Pediatric Crohn’s Disease
RENFLEXIS is indicated for reducing signs and symptoms and inducing and maintainingclinical remission in pediatric patients 6 years of age and older with moderately to severelyactive 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 maintainingclinical remission and mucosal healing, and eliminating corticosteroid use in adult patientwith moderately to severely active ulcerative colitis who have had an inadequate response toconventional therapy.
1.4 Rheumatoid Arthritis
RENFLEXIS, in combination with methotrexate, is indicated for reducing signs andsymptoms, inhibiting the progression of structural damage, and improving physical functionin patients with moderately to severely active rheumatoid arthritis.
1.5 Ankylosing Spondylitis
RENFLEXIS is indicated for reducing signs and symptoms in patients with active ankylosingspondylitis.
1.6 Psoriatic Arthritis
RENFLEXIS is indicated for reducing signs and symptoms of active arthritis, inhibiting theprogression of structural damage, and improving physical function in patients with psoriaticarthritis.
1.7 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 andwhen other systemic therapies are medically less appropriate. RENFLEXIS should only beadministered to patients who will be closely monitored and have regular follow-up visits witha physician [see Boxed Warnings, Warnings and Precautions (5)].
2 DOSAGE AND ADMINISTRATION
2.1 Crohn’s Disease
The recommended dose of RENFLEXIS is 5 mg/kg given as an intravenous inductionregimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks
thereafter for the treatment of adults with moderately to severely active Crohn’s disease orfistulizing Crohn’s disease. For adult patients who respond and then lose their response,consideration may be given to treatment with 10 mg/kg. Patients who do not respond by Week 14 are unlikely to respond with continued dosing and consideration should be given to
discontinue RENFLEXIS in these patients.
2.2 Pediatric Crohn’s Disease
The recommended dose of RENFLEXIS for pediatric patients 6 years and older withmoderately to severely active Crohn’s disease is 5 mg/kg given as an intravenous inductionregimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks.
2.3 Ulcerative Colitis
The recommended dose of RENFLEXIS is 5 mg/kg given as an intravenous inductionregimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks
thereafter for the treatment of adult patien |
