Crohn disease, Ulcerative colitis, Rheumatoid arthritis. Ankylosing spondylitis

Antirheumatic, Disease Modifying; Gastrointestinal Agent, Miscellaneous; Immunosuppressant Agent; Monoclonal Antibody; Tumor Necrosis Factor (TNF) Blocking Agent

Onset of action:
Crohn disease: 1 to 2 weeks; Rheumatoid arthritis: 3 to 7 days; Psoriasis: 8 to 10 weeks.
Duration of action:
Crohn disease: 8 to 48 weeks; Rheumatoid arthritis: 6 to 12 weeks.
Distribution:
Within the vascular compartment; Vd: 3 to 6 L
Half-life elimination:
7 to 12 days

Previous severe hypersensitivity (eg, anaphylaxis, hypotension, serum sickness) to infliximab, murine proteins, or any component of the formulation; doses >5 mg/kg in patients with moderate or severe heart failure (NYHA class III/IV).

Infliximab crosses the placenta.
An increased risk of major birth defects has not been observed following infliximab exposure during pregnancy.
Based on available data, tumor necrosis factor alpha (TNFα)-blocking agents are considered to have low to moderate risk when used in pregnancy.

Infliximab is present in breast milk.
Adverse events were not observed in breastfed infants in the studies.
TNFα blocking agents, including infliximab, are considered compatible with breastfeeding.

>10%:
Gastrointestinal: Abdominal pain (12% to 26%), nausea (21%)
Hematologic & oncologic: Anemia (≤11%)
Hepatic: Increased serum alanine aminotransferase
Immunologic: Antibody development (10% to 52%), increased ANA titer (~50%)
Infection: Abscess (≤15%), infection (27% to 74%), serious infection (3% to 60%)
Nervous system: Headache (18%)
Respiratory: Cough (12%), pharyngitis (8% to 12%), sinusitis (14%), upper respiratory tract infection (12% to 32%)
Miscellaneous: Infusion related reaction (≤20%; severe infusion related reaction: <1%)

Ankylosing spondylitis: IV:
5 mg/kg at 0, 2, and 6 weeks, followed by 5 mg/kg every 6 weeks thereafter.
Crohn disease, moderate to severe, induction and maintenance of remission:IV:
5 mg/kg at 0, 2, and 6 weeks, followed by 5 mg/kg every 8 weeks thereafter; dose may be increased to 10 mg/kg every 8 weeks in patients who respond but then lose their response. If no response by week 14, consider discontinuing therapy.
Plaque psoriasis: IV:
5 mg/kg at 0, 2, and 6 weeks, followed by 5 mg/kg every 8 weeks thereafter. Note: Some patients may require 10 mg/kg and/or dosing as frequently as every 4 weeks during the maintenance phase.Psoriatic arthritis (with or without methotrexate): IV:
5 mg/kg at 0, 2, and 6 weeks, followed by 5 mg/kg every 8 weeks thereafter.Pustular psoriasis (off-label use): IV:
5 mg/kg at week 0, 2, and 6, followed by 5 mg/kg every 8 weeks for up to 46 weeks.Rheumatoid arthritis:IV:
3 mg/kg at 0, 2, and 6 weeks, followed by a maintenance regimen of 3 mg/kg every 8 weeks thereafter; for patients who have incomplete responses, consider adjusting the dose up to 10 mg/kg every 8 weeks or treating as often as every 4 weeks, although consider the risk of serious infections is increased at higher doses or with more frequent administration.Sarcoidosis, refractory (adjunctive agent) (off-label use):
Initial: IV: 3 to 5 mg/kg at weeks 0, 2, and 6.
Maintenance: IV: 3 to 5 mg/kg every 4 to 8 weeks thereafter.Ulcerative colitis: IV:
5 mg/kg at 0, 2, and 6 weeks, followed by 5 mg/kg every 8 weeks thereafter.

Dosage adjustment with heart failure:
Mild heart failure (NYHA class I/II): No dosage adjustment necessary; use with caution and monitor closely for worsening of heart failure.
Moderate to severe (NYHA class III or IV): ≤5 mg/kg.

There are no dosage adjustments provided in the manufacturer’s labeling.

There are no dosage adjustments provided in the manufacturer’s labeling.