Infliximab Contraindications
Infliximab is contraindicated in patients with moderate to severe heart failure (NYHA Class III/IV), history of severe hypersensitivity reactions to infliximab, active infections including tuberculosis, and in those with known hypersensitivity to murine proteins or other components of the product. 1
Absolute Contraindications
Moderate to severe heart failure (NYHA Class III/IV): Infliximab at doses >5 mg/kg should not be administered to these patients due to increased risk of death and hospitalization from worsening heart failure 1
Previous severe hypersensitivity reactions to infliximab: Patients who have experienced anaphylactic shock or other severe infusion reactions should not receive the drug again 1, 2
Active infections: Infliximab should not be started in patients with active infections, including tuberculosis, and should be discontinued if serious infections develop 3, 4
Hypersensitivity to murine proteins: Due to the chimeric nature of infliximab (part mouse, part human antibody), patients with known hypersensitivity to murine proteins should not receive the drug 1
Relative Contraindications and Special Precautions
Latent tuberculosis: Patients should be screened and treated for latent TB before initiating infliximab therapy 3, 4
History of malignancy: Caution should be exercised in patients with a history of malignancy 3
Demyelinating disorders: Patients developing neurological symptoms suggestive of demyelinating disease should discontinue therapy 3, 5
Hepatic impairment: Rare cases of severe hepatitis and acute liver failure have been reported with infliximab 3
Increased risk of skin cancer: Patients with prior extensive phototherapy (>200 PUVA and/or >350 UVB treatments) should use infliximab with caution 3
Pregnancy and breastfeeding: While no increased risks have been observed, caution is currently advised 5
High-Risk Patient Groups Requiring Special Monitoring
Patients at risk for tuberculosis exposure: Consider alternative TNF inhibitors other than infliximab due to higher risk of TB reactivation 3, 4
Patients with history of recurrent infections: Infliximab may increase risk of infections approximately twofold 3
Patients receiving concomitant immunosuppressants: Particularly adolescents and young adults with Crohn's disease receiving azathioprine or 6-mercaptopurine, due to rare reports of hepatosplenic T-cell lymphoma 3
Patients with immune-related hepatitis: Infliximab is contraindicated in immune-related hepatitis 3
Pre-Treatment Screening Requirements
Tuberculosis screening: PPD (purified protein derivative) test is required before starting therapy 3
Hepatitis serology: To rule out active viral hepatitis 3
Complete blood count and liver function tests: To establish baseline values 3
Heart failure assessment: Particularly in patients with cardiac risk factors 1
Common Pitfalls and Considerations
Antibody formation: Development of antibodies to infliximab can increase risk of infusion reactions and reduce efficacy 6
Delayed hypersensitivity reactions: Can occur 3-12 days after infusion, presenting as serum sickness-like illness with myalgias, arthralgias, fever, and rash 7
Reactivation of opportunistic infections: Besides tuberculosis, histoplasmosis, coccidioidomycosis, and other fungal infections may occur 3
Development of autoantibodies: Anti-nuclear antibody or anti-ds-DNA may develop, though clinical lupus-like syndrome is rare 6
By carefully screening patients for these contraindications and monitoring high-risk individuals, the safety profile of infliximab can be optimized while maintaining its therapeutic benefits in appropriate patients.