II. Indications
- Moderate to severe refractory Crohn's Disease
- Ulcerative Colitis
- Refractory Rheumatoid Arthritis
- Added to Methotrexate or with other agents
- Ankylosing Spondylitis
- Plaque Psoriasis
- Psoriatic Arthritis
- Juvenile Idiopathic Arthritis
III. Contraindications
IV. Mechanism
- See Tumor Necrosis Factor Inhibitor
- Monoclonal Antibody against human Tumor Necrosis Factor alpha
V. Pharmacokinetics
- Half life of 5 mg/kg single dose: 10 days
- Metabolism by proteolysis
VI. Medications
- Infliximab (Remicade)
- Original prototype drug with release in 1998 for Crohn's Disease, with expanding indications since
- Multiple biosimilar agents ( Ixifi, Inflectra, Renflexis) are available
- Unknown efficacy of switching between agents
VII. Dosing
- See Monoclonal Antibody for preparation for use
- Background
- Unlike other modern TNF agents, Infliximab is by facility infusion (not for home use)
- Infuse over 2 hours
- Be prepared for Anaphylaxis during infusion and delayed reaction may occur
- Consider pretreatment with Antihistamines, Corticosteroids and Acetaminophen to reduce injection reactions
-
Crohns Disease and Ulcerative Colitis (adults and age >= 6 years)
- Initial: 5 mg/kg IV at 0 weeks, 2 weeks and 6 weeks
- Maintenance: 5 mg/kg IV every 8 weeks
- Consider discontinuation if no response by 14 weeks
- Consider increasing dose to 10 mg/kg IV if response wanes with continued use
- Plaque Psoriasis
- Initial: 5 mg/kg IV at 0 weeks, 2 weeks and 6 weeks
- Maintenance: 5 mg/kg IV every 8 weeks
-
Ankylosing Spondylitis
- Initial: 5 mg/kg IV at 0 weeks, 2 weeks and 6 weeks
- Maintenance: 5 mg/kg IV every 6 weeks
-
Rheumatoid Arthritis or Juvenile Idiopathic Arthritis (off-label use for age >= 4 years)
- Initial: 3 mg/kg IV at 0 weeks, 2 weeks and 6 weeks
- Maintenance: 3 mg/kg IV every 8 weeks (6x/year)
- Dosing range is 3-10 mg/kg (typically higher doses than 3 mg are needed with longterm use)
VIII. Precautions
- See TNF Inhibitor
- TNF Inhibitors predispose to serious infections and malignancy
- Prepare for TNF Inhibitor use with infection screening (e.g. Tuberculosis) and Immunizations
IX. Efficacy
- Among the most potent of TNF Inhibitors (consider in severe, fulminant disease)
-
Crohns Disease
- Significant response to remission even with fistulas
- Relapse may occur after 3 months
X. Adverse Effects
- See Tumor Necrosis Factor Inhibitor
- Safety of repeated use unknown
- Reactions
- Anaphylaxis
- Serum Sickness
- Delayed reaction
- May occur 3 to 12 days after infusion
- Findings include myalgias, Arthralgias, feve, malaise, Pruritus, Urticaria, Angioedema, Lymphadenopathy
- Opportunistic Infection
- Associated with Granulomatous infection
- Higher risk of infection than with Etanercept
- Rare but serious complications
- Lymphoma
- Toxic optic Neuropathy (case reports)
- Cervical Cancer
- Hepatotoxicity
- Discontinue for Liver Function Test increases >5x normal
XI. Safety
- Considered safe in Lactation
- Pregnancy
- May use in pregnancy (any trimester) if indicated and benefit outweighs risk
- Exposure risk increases after 20 weeks (monitored by registry)
XII. Drug Interactions
XIII. Resources
- Infliximab Powder for Injection Solutio (DailyMed)
XIV. References
- (2023) Biologics for Crohn's Disease, Presc Lett, #390826
- (2023) Drugs for Inflammatory Bowel Disease, Med Lett Drug Ther 65: 105-12
- Hamilton (2020) Tarascon Pocket Pharmacopoeia
- (1999) Med Lett Drugs Ther 41(1047): 19-20 [PubMed]
- Maini (2000) Lancet [PubMed]