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CUBICIN: An empiric choice for S. aureus bacteremia, including right-sided endocarditis

First approval for S. aureus bacteremia, including right-sided endocarditis, in more than 20 years, based on results from the only prospective, randomized, and controlled registration trial of S. aureus bacteremia and endocarditis ever undertaken
CUBICIN monotherapy vs dual-therapy comparators (MRSA: vancomycin + 4 days of initial low-dose gentamicin; MSSA: semisynthetic penicillin + 4 days of initial low-dose gentamicin)

Proven clinical success of CUBICIN 6 mg/kg once daily in a landmark S. aureus bacteremia trial

CI=confidence interval.

*Patients in the comparator treatment arm were to receive vancomycin + 4 days of initial low-dose gentamicin or a semisynthetic penicillin + 4 days of initial low-dose gentamicin. (95% CI for the difference in success rates [CUBICIN – comparator]; intent-to-treat population.)

† Patients in the MRSA subgroup of the comparator treatment arm were to receive vancomycin + 4 days of initial low-dose gentamicin; however, 1 patient received a semisynthetic penicillin instead of vancomycin + 4 days of initial low-dose gentamicin. Four patients received vancomycin alone. (97.5% CI for the difference in success rates [CUBICIN – comparator; adjusted for multiplicity]; intent-to-treat population.)

‡ Patients in the MSSA subgroup of the comparator treatment arm were to receive a semisynthetic penicillin + 4 days of initial low-dose gentamicin; however, 10 patients received vancomycin instead of a semisynthetic penicillin + 4 days of initial low-dose gentamycin. Three patients received semisynthetic penicillin alone. (97.5% CI for the difference in success rates (CUBICIN – comparator; adjusted for multiplicity]; intent-to-treat population.)

§ The MRSA subgroup was prespecified in the protocol.

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.

Reference: 1. Fowler VG Jr, Boucher HW, Corey GR, et al. Daptomycin versus standard therapy for bacteremia and endocarditis caused by Staphylococcus aureus. N Engl J Med. 2006;355:653-665.

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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