Cubicin.com

Mechanism of Action

The mechanism of action of CUBICIN is distinct from other antibiotics

Susceptibility

CUBICIN susceptibility in surveillance studies
CUBICIN is available on several susceptibility testing systems

*Bactericidal activity against Gram-positive pathogens.
† In general, exhibits bacteriostatic activity against enterococci and bactericidal activity against streptococci and staphylococci.5-7
‡ Bacteriostatic against enterococci and staphylococci. Bactericidal against most streptococci.
§ In general, bacteriostatic against aerobic and facultative Gram-positive and -negative pathogens, anaerobic microorganisms, and Mycobacterium abscessus, Mycobacterium chelonae, and Mycobacterium fortuitum in vitro.

References: 1. CUBICIN® [package insert]. Lexington, MA: Cubist Pharmaceuticals, Inc.; 2007. 2. Vancocin® HCl [package insert]. Deerfield, IL: Baxter International Inc.; 2003. 3. Zyvox® [package insert]. New York, NY: Pfizer Inc; 2007. 4. Tygacil® [package insert]. Madison, NJ; Wyeth; 2007. 5. Akins RL, Rybak MJ. Bactericidal activities of two daptomycin regimens against clinical strains of glycopeptide intermediate-resistant Staphylococcus aureus, vancomycin-resistant Enterococcus faecium, and methicillin-resistant Staphylococcus aureus isolates in an in vitro pharmacodynamic model with simulated endocardial vegetations. Antimicrob Agents Chemother. 2001;45:454-459. 6. Pankuch GA, Jacobs MR, Appelbaum PC. Bactericidal activity of daptomycin against Streptococcus pneumoniae compared with eight other antimicrobials. J Antimicrob Chemother. 2003;51:443-446. 7. Watanakunakorn C, Tisone JC. Effects of a vancomycin-rifampin combination on enterococci. Antimicrob Agents Chemother. 1982;22:915-916.

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

Home | Terms of Use | Privacy Policy | Site Map

Copyright ©2008 Cubist Pharmaceuticals, Inc., Lexington, MA, USA.
All rights reserved. CUBICIN is a registered trademark of Cubist Pharmaceuticals, Inc.
All other trademarks or registered trademarks are the property of their respective owners.