Inflectra (infliximab-dyyb)

INFLECTRA (infliximab-dyyb) is biosimilar* to REMICADE (infliximab) for the indications listed.

INFLECTRA™ is a tumor necrosis factor (TNF) blocker indicated for:

Crohn’s Disease (1.1):
• 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.
• reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease.

Pediatric Crohn’s Disease (1.2):
• 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.

Ulcerative Colitis (1.3):
• 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.

Rheumatoid Arthritis (1.4) 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.

Ankylosing Spondylitis (1.5):
• reducing signs and symptoms in patients with active disease.

Psoriatic Arthritis (1.6):
• reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function.

Plaque Psoriasis (1.7):
• 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.

For indications, dosing and other information, please refer to the prescribing information.

* Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product.

 

Inflectra (Infliximab-dyyb) ‐ Pfizer

Size:
100 mg per vial
NDC #:
00069-0809-01
Download:
PI