Infliximab

Infliximab is a chimeric monoclonal antibody that binds with high affinity to soluble and transmembrane forms of tumor necrosis factor-α (TNF-α) and inhibits binding of TNF-α to its receptors. It neutralizes biological activity of TNFα, including induction of pro-inflammatory cytokines (IL-1, IL-6), enhancement of leukocyte migration by increasing endothelial layer permeability, activation of neutrophil and eosinophil functional activity, and induction of acute phase reactants.

• Crohn's Disease (adults and pediatric)
• Ulcerative Colitis (adults and pediatric)
• Rheumatoid Arthritis (in combination with methotrexate)
• Ankylosing Spondylitis
• Psoriatic Arthritis
• Plaque Psoriasis

Adult Dose (IV Infusion):

• Crohn's Disease: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks; may increase to 10 mg/kg if loss of response
• Ulcerative Colitis: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks
• Rheumatoid Arthritis: 3 mg/kg (with methotrexate) at 0, 2 and 6 weeks, then every 8 weeks; may increase to 10 mg/kg or every 4 weeks
• Ankylosing Spondylitis: 5 mg/kg at 0, 2 and 6 weeks, then every 6 weeks
• Psoriatic Arthritis & Plaque Psoriasis: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks

Child Dose (IV Infusion):

• Crohn's Disease (6-17 years): 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks
• Ulcerative Colitis (6-17 years): 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks

Most Common (>10%):

• Infections (upper respiratory, sinusitis, pharyngitis)
• Infusion-related reactions
• Headache
• Abdominal pain

Others: Fever, chills, sweating, rash, pruritus

Precautions:

• Serious infections: Do not give during active infection; monitor and stop if infection becomes serious
• Invasive fungal infections: Consider empiric antifungal therapy for patients in endemic regions
• Malignancies: Incidence of malignancies including lymphoma was greater in infliximab treated patients
• Hepatitis B virus reactivation: Test for HBV before starting; monitor carriers during and after therapy
• Hepatotoxicity: Stop in cases of jaundice and/or marked liver enzyme elevations
• Heart failure: New onset or worsening symptoms may occur
• Cytopenias: Seek medical attention if signs develop; consider stopping infliximab
• Live vaccines or therapeutic infectious agents should not be given

Contraindications:

• Doses >5 mg/kg in moderate to severe heart failure (NYHA Class III or IV)
• TB or other severe infections (sepsis, abscesses, opportunistic infections)
• Previous severe hypersensitivity to Infliximab or inactive components or murine proteins

Drug Interactions:

• Use with anakinra or abatacept increases risk of serious infections
• Risk of clinical infections, including disseminated infections, with concurrent administration of live vaccines

Food Interactions: Consuming alcohol with Infliximab does not cause any harmful side effects.

Use in Pregnancy: Category B; it is not known whether Infliximab can cause fetal harm or affect reproduction capacity; animal studies have shown harmful effects; doctor will weigh benefits and risks.

Use in Lactation: It is not known whether Infliximab is excreted in human milk; due to potential for serious adverse reactions, women should not breastfeed; breastfeeding should be held until treatment is completed and drug is eliminated.

Pediatric Use: Crohn's Disease (6-17 years): 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks; Ulcerative Colitis (6-17 years): 5 mg/kg; not studied in children <6 years.

Renal Impairment: Limited information available; consult your doctor.

Hepatic Impairment: Limited information available; consult your doctor.

Overdose: No specific reactions known; provide symptomatic supportive treatment; seek immediate medical attention.