Tumor Necrosis Factor Alfa Antagonists for Pediatric Immune-Mediated Diseases

Marcia L. Buck, Pharm.D., FCCP

Pediatr Pharm. 2007;13(8):1-4. 

In This Article

Contraindications and Precautions

All three TNFα antagonists are contraindicated in patients with known hypersensitivity reactions to the drug or murine proteins. Patients on TNFα antagonists are at risk for serious infections, including sepsis, pneumonia, opportunistic and invasive fungal infections, and tuberculosis. Patients should be assessed for potential infections prior to initiating therapy, including documentation of a negative tuberculosis skin test. Continued monitoring is necessary, and families should be aware of the need to report signs of infection to medical personnel.[3,4,5,6,7,8]

A higher rate of malignancies has been reported in patients receiving TNFα antagonists. In open-label infliximab studies, the rate of lymphoma was 3 to 5-fold higher than expected in the general population.[6] In clinical trials with etanercept, the rate of lymphomas was 3-fold higher, and in adalimumab trials, the rate was 3.5-fold higher.[7,8] The risk for malignancy may be increased in patients receiving other immunosuppressive agents. Hepatosplenic T-cell lymphoma, a rare and usually fatal disease, has been reported in adolescents and adults with Crohn's disease being treated with infliximab and azathioprine or 6-mercaptopurine.[6] As described previously, an increased rate of solid tumors was observed in patients with Wegener granulomatosis who were receiving etanercept and cyclophosphamide, methotrexate, and corticosteroids.[7] In addition to these restrictions and warnings, the use of infliximab is contraindicated in patients with severe heart failure.[6] Etanercept and adalimumab should be used with caution in patients with heart failure.[7,8]

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