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Eculizumab is the first drug approved for the treatment of complement-mediated diseases, and current dosage schedules result in large interindividual drug concentrations. This review provides insight into the pharmacokinetic and pharmacodynamic properties of eculizumab, both for reported on-label (paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, generalized myasthenia gravis) and off-label (hematopoietic stem cell transplantation-associated thrombotic microangiopathy) indications. Furthermore, we discuss the potential of therapeutic drug monitoring to individualize treatment and reduce costs.

In addition to supplemental dosing during pregnancy, if there is a concern for TMA recurrence, the risks and benefits of therapy must include the context of potential drug transmission to the newborn through the breast milk. [...]in patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), eculizumab serum concentrations measured in the newborn as eculizumab concentrations measured in breast milk have been reported [3, 4]. [...]lower eculizumab exposure may be expected in preterm infants compared with infants born at term. Furthermore, placental factors, for example ischemic lesions as seen in a subset of patients with PNH or aHUS, could influence IgG transfer. [...]timing of eculizumab administration in relation to the birth probably has a notable influence on detectable eculizumab concentrations in the newborn.