HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to useRENFLEXIS safely and effectively. See full prescribing information for
RENFLEXIS.
RENFLEXIS(infliximab-abda)for injection, for intravenous use
Initial U.S. Approval: 2017
RENFLEXIS (infliximab-abda) is biosimilar* to REMICADE (infliximab). (1)
WARNING: SERIOUS INFECTIONS and MALIGNANCY
See full prescribing information for complete boxed warning.
Increased risk of serious infections leading to hospitalization ordeath, including tuberculosis (TB), bacterial sepsis, invasive fungalinfections (such as histoplasmosis) and infections due to otheropportunistic pathogens.
Discontinue RENFLEXIS if a patient develops a serious infection.
Perform test for latent TB; if positive, start treatment for TB prior tostarting RENFLEXIS. Monitor all patients for active TB duringtreatment, even if initial latent TB test is negative. (5.1)
Lymphoma and other malignancies, some fatal, have been reportedin children and adolescent patients treated with tumor necrosisfactor (TNF) blockers, including infliximab products.
Postmarketing cases of fatal hepatosplenic T-cell lymphoma(HSTCL) have been reported in patients treated with TNF blockersincluding infliximab products. Almost all had received azathioprineor 6- mercaptopurine concomitantly with a TNF-blocker at or priorto diagnosis. The majority of cases were reported in patients with
Crohn’s disease or ulcerative colitis, most of whom were adolescentor young adult males. (5.2)
RECENT MAJOR CHANGES
Warnings and Precautions: Malignancies (5.2) 3/2019
Warnings and Precautions: Cardiovascular and Cerebrovascular ReactionsDuring and After Infusion (5.8) 3/2019
INDICATIONS AND USAGE
RENFLEXIS is a tumor necrosis factor (TNF) blocker indicated for:
Crohn’s Disease :
reducing signs and symptoms and inducing and maintaining clinicalremission in adult patients with moderately to severely active diseasewho have had an inadequate response to conventional therapy. (1.1)
reducing the number of draining enterocutaneous and rectovaginalfistulas and maintaining fistula closure in adult patients with fistulizingdisease. (1.1)
Pediatric Crohn’s Disease:
reducing signs and symptoms and inducing and maintaining clinicalremission in pediatric patients with moderately to severely activedisease who have had an inadequate response to conventional therapy.
Ulcerative Colitis:
reducing signs and symptoms, inducing and maintaining clinicalremission and mucosal healing, and eliminating corticosteroid use inadult patients with moderately to severely active disease who have hadan inadequate response to conventional therapy. (1.3)
Rheumatoid Arthritis in combination with methotrexate:
reducing signs and symptoms, inhibiting the progression of structuraldamage, and improving physical function in patients with moderately toseverely active disease. (1.4)
Ankylosing Spondylitis:
reducing signs and symptoms in patients with active disease. (1.5)
Psoriatic Arthritis:
reducing signs and symptoms of active arthritis, inhibiting theprogression of structural damage, and improving physical function. (1.6)
Plaque Psoriasis:
treatment of adult patients with chronic severe (i.e., extensive and/ordisabling) plaque psoriasis who are candidates for systemic therapy andwhen other systemic therapies ar |
