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

Adverse Effects

The most common adverse effects associated with infliximab administration are infusion-related reactions (in up to 20% of patients), upper respiratory infection (32%), nausea (21%), headache (18%), sinusitis (14%), coughing, pharyngitis, abdominal pain, and diarrhea (all 1012%).[3,6] In patients receiving etanercept, the most common adverse effects have included infections (35-64%), injection site reactions (37%), headache (17-24%), rhinitis (12-16%), and nausea (9-15%). Response rates were similar in the pediatric patients studied to date. In the 69 children studied by the manufacturer, 19% of patients reported headache or abdominal pain, 13% experienced vomiting, and 9% had nausea.[4,7] Common adverse reactions to adalimumab include upper respiratory tract infection (17%), injection site pain, headache, and rash (12% each), and sinusitis (11%).[5,8]

While most patients tolerate the milder adverse effects to TNFα antagonists without needing to stop therapy, more serious reactions may require discontinuation. Severe blood dyscrasias (leukopenia, neutropenia, thrombocytopenia, and pancytopenia) have been reported in adults and children receiving TNFα antagonists. Hepatotoxicity, including acute liver failure, has also been linked to these therapies. Patients and family members should know to seek medical attention for bleeding, severe bruising, pallor, or unexplained fever. Rare neurologic adverse effects, including optic neuritis, seizures, multiple sclerosis, and central nervous system demyelinating disorders have also been reported. Hypersensitivity reactions have been reported in 1-2% of patients, ranging in severity from mild to severe reactions requiring hospitalization. Autoimmune reactions, including a lupus-like syndrome, have also been reported.[3,4,5,6,7,8]


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