Journal of aerosol medicine and pulmonary drug delivery
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J Aerosol Med Pulm Drug Deliv · Aug 2011
Pharmacokinetics and tolerability of BAY41-6551 in subjects with chronic kidney disease.
Abstract Background: BAY41-6551, a drug-device combination in development for adjunctive treatment of Gram-negative pneumonia in mechanically ventilated patients, consists of amikacin formulated for inhalation coupled with the Pulmonary Drug Delivery System (PDDS) Clinical aerosol delivery platform. This study evaluated safety, tolerability, and pharmacokinetics (PK) of BAY41-6551 in subjects with chronic kidney disease (CKD). ⋯ Single doses of BAY41-6551 were well tolerated in subjects with CKD. HD effectively removed amikacin from serum in subjects with ESRD, and the timing relative to BAY41-6551 administration was an important determinant of systemic amikacin exposure. Nevertheless, standard precautionary measures for intravenous amikacin should apply for patients receiving BAY41-6551, and dose adjustments and/or dialysis should be considered for subjects with severe renal impairment.
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J Aerosol Med Pulm Drug Deliv · Aug 2011
Clinical TrialPharmacokinetics and tolerability of amikacin administered as BAY41-6551 aerosol in mechanically ventilated patients with gram-negative pneumonia and acute renal failure.
BAY41-6551, a drug-device combination in development for adjunctive treatment of Gram-negative pneumonia in intubated and mechanically ventilated patients, consists of amikacin formulated for inhalation coupled with the Pulmonary Drug Delivery System (PDDS) Clinical aerosol delivery platform. Given the predominantly renal clearance of aminoglycosides, understanding systemic amikacin exposure and safety during administration of BAY41-6551 to patients with acute renal failure (ARF) is clinically important. ⋯ CVVHDF appears to provide adequate clearance of systemically absorbed amikacin in mechanically ventilated patients with ARF, suggesting that dose adjustments for BAY41-6551 are probably not necessary for this patient population. Nonetheless, the standard precautionary measures for critically ill patients receiving i.v. amikacin should be followed for patients with ARF who are treated with BAY41-6551.