REMICADE 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.

Pediatric Ulcerative Colitis (1.4):

• 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.

Rheumatoid Arthritis (1.5) 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 (1.6):

• reducing signs and symptoms in patients with active disease.

Psoriatic Arthritis (1.7):

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

Plaque Psoriasis (1.8):

• 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.

REMICADE is administered by intravenous infusion over a period of not less than 2 hours.

Crohn's Disease (2.1)

• 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some adult patients who initially respond to treatment may benefit from increasing the dose to 10 mg/kg if they later lose their response.

Pediatric Crohn's Disease (2.2)

• 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.

Ulcerative Colitis (2.3)

• 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.

Pediatric Ulcerative Colitis (2.4)

• 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.

Rheumatoid Arthritis (2.5)

• In conjunction with methotrexate, 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some patients may benefit from increasing the dose up to 10 mg/kg or treating as often as every 4 weeks.

Ankylosing Spondylitis (2.6)

• 5 mg/kg at 0, 2 and 6 weeks, then every 6 weeks.

Psoriatic Arthritis (2.7) and Plaque Psoriasis (2.8)

• 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.

100 mg of lyophilized infliximab in a 20 mL vial for intravenous infusion. (3)
CONTRAINDICATIONS

• Serious infections – do not give REMICADE during an active infection. If an infection develops, monitor carefully and stop REMICADE if infection becomes serious. (5.1)
• Invasive fungal infections – for patients who develop a systemic illness on REMICADE, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic (5.1)
• Malignancies – the incidence of malignancies including lymphoma was greater in REMICADE treated patients than in controls. Due to the risk of HSTCL carefully assess the risk/benefit especially if the patient has Crohn's disease or ulcerative colitis, is male, and is receiving azathioprine or 6-mercaptopurine treatment. (5.2)
• Hepatitis B virus reactivation – test for HBV infection before starting REMICADE. Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop REMICADE and begin anti-viral therapy. (5.3)
• Hepatotoxicity – rare severe hepatic reactions, some fatal or necessitating liver transplantation. Stop REMICADE in cases of jaundice and/or marked liver enzyme elevations. (5.4)
• Heart failure – new onset or worsening symptoms may occur. (4, 5.5)
• Cytopenias – advise patients to seek immediate medical attention if signs and symptoms develop, and consider stopping REMICADE. (5.6)
• Hypersensitivity – serious infusion reactions including anaphylaxis or serum sickness-like reactions may occur. (5.7)
• Demyelinating disease – exacerbation or new onset may occur. (5.8)
• Lupus-like syndrome – stop REMICADE if syndrome develops. (5.13)
• Live vaccines or therapeutic infectious agents – should not be given with REMICADE. Bring pediatric patients up to date with all vaccinations prior to initiating REMICADE. At least a six month waiting period following birth is recommended before the administration of live vaccines to infants exposed in utero to infliximab (5.14)

Most common adverse reactions (>10%) – infections (e.g. upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

• Use with anakinra or abatacept– increased risk of serious infections (7.1)

• Pediatric Use –REMICADE has not been studied in children with Crohn's disease or ulcerative colitis <6 years of age. (8.4)