II. Indications

III. Contraindications

IV. Mechanism

V. Pharmacokinetics

  1. Half life of 5 mg/kg single dose: 10 days
  2. Metabolism by proteolysis

VI. Medications

  1. Infliximab (Remicade)
    1. Original prototype drug with release in 1998 for Crohn's Disease, with expanding indications since
  2. Multiple biosimilar agents ( Ixifi, Inflectra, Renflexis) are available
    1. Unknown efficacy of switching between agents

VII. Dosing

  1. See Monoclonal Antibody for preparation for use
  2. Background
    1. Unlike other modern TNF agents, Infliximab is by facility infusion (not for home use)
    2. Infuse over 2 hours
    3. Be prepared for Anaphylaxis during infusion and delayed reaction may occur
    4. Consider pretreatment with Antihistamines, Corticosteroids and Acetaminophen to reduce injection reactions
  3. Crohns Disease and Ulcerative Colitis (adults and age >= 6 years)
    1. Initial: 5 mg/kg IV at 0 weeks, 2 weeks and 6 weeks
    2. Maintenance: 5 mg/kg IV every 8 weeks
    3. Consider discontinuation if no response by 14 weeks
    4. Consider increasing dose to 10 mg/kg IV if response wanes with continued use
  4. Plaque Psoriasis
    1. Initial: 5 mg/kg IV at 0 weeks, 2 weeks and 6 weeks
    2. Maintenance: 5 mg/kg IV every 8 weeks
  5. Ankylosing Spondylitis
    1. Initial: 5 mg/kg IV at 0 weeks, 2 weeks and 6 weeks
    2. Maintenance: 5 mg/kg IV every 6 weeks
  6. Rheumatoid Arthritis or Juvenile Idiopathic Arthritis (off-label use for age >= 4 years)
    1. Initial: 3 mg/kg IV at 0 weeks, 2 weeks and 6 weeks
    2. Maintenance: 3 mg/kg IV every 8 weeks (6x/year)
    3. Dosing range is 3-10 mg/kg (typically higher doses than 3 mg are needed with longterm use)

VIII. Precautions

  1. See TNF Inhibitor
  2. TNF Inhibitors predispose to serious infections and malignancy
  3. Prepare for TNF Inhibitor use with infection screening (e.g. Tuberculosis) and Immunizations
    1. See Monoclonal Antibody

IX. Efficacy

  1. Among the most potent of TNF Inhibitors (consider in severe, fulminant disease)
  2. Crohns Disease
    1. Significant response to remission even with fistulas
    2. Relapse may occur after 3 months

X. Adverse Effects

  1. See Tumor Necrosis Factor Inhibitor
  2. Safety of repeated use unknown
  3. Reactions
    1. Anaphylaxis
    2. Serum Sickness
    3. Delayed reaction
      1. May occur 3 to 12 days after infusion
      2. Findings include myalgias, Arthralgias, feve, malaise, Pruritus, Urticaria, Angioedema, Lymphadenopathy
  4. Opportunistic Infection
    1. Associated with Granulomatous infection
      1. Tuberculosis
      2. Histoplasmosis
    2. Higher risk of infection than with Etanercept
      1. Wallis (2004) Clin Infect Dis 38:1261-5 [PubMed]
  5. Rare but serious complications
    1. Lymphoma
    2. Toxic optic Neuropathy (case reports)
    3. Cervical Cancer
    4. Hepatotoxicity
      1. Discontinue for Liver Function Test increases >5x normal

XI. Safety

  1. Considered safe in Lactation
  2. Pregnancy
    1. May use in pregnancy (any trimester) if indicated and benefit outweighs risk
    2. Exposure risk increases after 20 weeks (monitored by registry)

XII. Drug Interactions

XIII. Resources

XIV. References

  1. (2023) Biologics for Crohn's Disease, Presc Lett, #390826
  2. (2023) Drugs for Inflammatory Bowel Disease, Med Lett Drug Ther 65: 105-12
  3. Hamilton (2020) Tarascon Pocket Pharmacopoeia
  4. (1999) Med Lett Drugs Ther 41(1047): 19-20 [PubMed]
  5. Maini (2000) Lancet [PubMed]

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