Abstract
The pharmacology, pharmacokinetics, indications, clinical efficacy, adverse effects, drug interactions, and dosage and administration of eculizumab are reviewed. Eculizumab, a recombinant, humanized, monoclonal, immunoglobulin G antibody produced from murine myeloma cells, is the first agent to be approved for labeling by the Food and Drug Administration for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). Eculizumab works by inhibiting the complement cascade. It binds specifically to complement protein C5 and inhibits cleavage to C5a and C5b, resulting in the prevention of terminal complex formation and therefore cell lysis. In clinical studies, the effect of eculizumab on hemolysis was measured by a reduction in serum lactase dehydrogenase levels. The effect on hemolysis was evident after one week of treatment. The safety and efficacy of eculizumab were evaluated in a series of three trials. Results from the trials indicated that eculizumab reduces hemolysis and improves symptoms such as the number of paroxysms, dysphagia, and abdominal pain. The most frequent adverse reactions reported in the clinical trials included headache, nasopharyngitis, back pain, and nausea. The recommended i.v. dosing regimen is 600 mg we...Continue Reading
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