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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 any unexplained elevations should be monitored more frequently
No pharmacokinetic interactions with aztreonam, warfarin, simvastatin, or probenecid in clinical trials
The interaction between CUBICIN and tobramycin with a clinical dose of CUBICIN (4 mg/kg) is unknown. Caution is warranted when CUBICIN is coadministered with tobramycin
Anticoagulant activity in patients receiving CUBICIN and warfarin should be monitored for the first several days after initiating therapy with CUBICIN
Unlikely to inhibit or induce the metabolism of drugs metabolized by the CYP450 system.
Experience with coadministration of HMG-CoA reductase inhibitors and CUBICIN in patients is limited; therefore, consideration should be given to temporarily suspending use of HMG-CoA reductase inhibitors in patients receiving CUBICIN

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.

Demonstrated safety profile of CUBICIN for up to 42 days (limited safety data for more than 28 days)
Patients in landmark S. aureus bacteremia and endocarditis Phase 3 trial treated with CUBICIN 6 mg/kg once daily for up to 6 weeks

Learn more about the safety of CUBICIN in complicated skin infections

Learn more about the safety of CUBICIN in bacteremia

Indications and Important Safety Information

CUBICIN® (daptomycin for injection) is indicated for the following infections:
- Complicated skin and skin structure infections caused by susceptible isolates of the following Gram-positive microorganisms: S. aureus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subspecies equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only). Combination therapy may be clinically indicated if the documented or presumed pathogens include Gram-negative or anaerobic organisms
- S. aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates. Combination therapy may be clinically indicated if the documented or presumed pathogens include Gram-negative or anaerobic organisms
The efficacy of CUBICIN in patients with left-sided infective endocarditis due to S. aureus has not been demonstrated. The clinical trial of CUBICIN in patients with S. aureus bloodstream infections included limited data from patients with left-sided infective endocarditis; outcomes in these patients were poor. CUBICIN has not been studied in patients with prosthetic valve endocarditis or meningitis
Patients with persisting or relapsing S. aureus infection or poor clinical response should have repeat blood cultures. If a culture is positive for S. aureus, MIC susceptibility testing of the isolate should be performed using a standardized procedure, as well as diagnostic evaluation to rule out sequestered foci of infection. Appropriate surgical intervention (eg, debridement, removal of prosthetic devices, valve replacement surgery) and/or consideration of a change in antibiotic regimen may be required
CUBICIN is not indicated for the treatment of pneumonia
Clostridium difficile-associated diarrhea (CDAD) has been reported with the use of nearly antibacterial agents, including CUBICIN, and may range in severity from mild diarrhea to fatal colitis. CDAD has been reported to occur over 2 months post-antibiotic treatment. If CDAD is suspected, antibiotic treatment may need to be suspended
Patients receiving CUBICIN should be monitored for the development of muscle pain or weakness, particularly of the distal extremities. In patients who receive CUBICIN, creatine phosphokinase (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 demonstrate 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 (~5 x ULN), or in patients without reported symptoms who have marked elevations in CPK >2000 U/L (≥10 x ULN)
Most adverse events reported in CUBICIN clinical trials were mild to moderate in intensity. The most common CUBICIN adverse events were anemia, constipation, diarrhea, nausea, vomiting, injection-site reactions, and headache

Please refer to full Prescribing Information

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