Product Description

Formula & Concentration

RENFLEXIS (infliximab-abda) for Injection, for Intravenous Use

Manufacturer

Organon

Indications

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.
  • reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease.

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.

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.

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.

Ankylosing Spondylitis:

  • reducing signs and symptoms in patients with active disease.

Psoriatic Arthritis:

  • reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function.

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.

Product Options

Package Size

NDC #

Presentation

Intravenous Solution Reconstituted 100 mg

78206-0162-01

Single Dose Vial

Shelf Life and Storage

Store unopened RENFLEXIS vials in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF).

If needed, unopened RENFLEXIS vials may be stored at room temperatures up to a maximum of 30ºC (86°F) for a single period of up to 6 months but not exceeding the original expiration date. Once removed from the refrigerator, RENFLEXIS cannot be returned to the refrigerator.