Demonstrated safety profile of 4 mg/kg once daily for complicated skin infections caused by most Gram-positive pathogens
Most adverse events reported with CUBICIN in clinical studies were described as mild to moderate in intensity.
Incidence (%) of adverse events reported at ≥3% in 1092 patients in clinical trials for complicated skin infections
*Comparators included vancomycin (1 g IV q12h) and antistaphylococcal penicillins (ie, nafcillin, oxacillin, cloxacillin, flucloxacillin; 4-12 g/day IV in divided doses).
Patients receiving CUBICIN should be monitored for the development of muscle pain or weakness, particularly of the distal extremities. CPK levels should be monitored weekly, and more frequently in patients who received recent prior or concomitant therapy with an HMG-CoA reductase inhibitor. In patients with renal insufficiency, both renal function and CPK should be monitored more frequently. Patients who develop unexplained elevations in CPK while receiving CUBICIN should be monitored more frequently. CUBICIN should be discontinued in patients with unexplained signs and symptoms of myopathy in conjunction with CPK elevation >1000 U/L, or in patients without reported symptoms who have marked elevations in CPK (≥10 x ULN).
