Demonstrated Safety Profile of 6mg/kg Once Daily for S. aureus Bacteremia
- The most common CUBICIN adverse events in the S. aureus bacteremia and endocarditis Phase 3 clinical trial were anemia, diarrhea, vomiting, and constipation
*Patients assigned to receive vancomycin + 4 days of initial low-dose gentamicin or a semisynthetic penicillin + 4 days of initial low-dose gentamicin.
NOS=not otherwise specified.
Significantly lower incidence of decreased renal function*
Low rate of discontinuation due to CPK elevation
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- 2.5% of patients (3 of 120) treated with CUBICIN discontinued therapy due to CPK elevation4
*Decreased renal function defined as a creatinine clearance level <50 mL/min if baseline clearance was ≥50 mL/min or a decrease of ≥10 mL/min if baseline clearance was <50 mL/min.
†Patients assigned to receive vancomycin + 4 days of initial low-dose gentamicin or a semisynthetic penicillin + 4 days of initial low-dose gentamicin.
‡P=.03 vs dual-therapy comparators.
4
§P=.004 vs dual-therapy comparators.
4
||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.
Demonstrated safety profile of 6 mg/kg once daily in S. aureus bacteremia, including right-sided endocarditis
- Demonstrated safety profile of CUBICIN for up to 42 days (limited safety data for more than 28 days)
