Cubicin.com

Skip navigation

for serious Staphylococcus aureus infections

CUBICIN® (daptomycin for injection)
Vancocin® HCl (Vancomycin Injection, USP)
Zyvox® (linezolid injection/tablets/oral suspension)
Tygacil® (tigecycline for injection)

Indications

VREF = vancomycin-resistant Enterococcus faecium

Safety

AEs = adverse events; CBCs = complete blood counts
* Highlighted text represents new information added to package inserts in March 2007.
† C.difficile warning was not added to Vancocin package insert as of August 2007.

CIAI = complicated intra-abdominal infections; CPK = creatine phosphokinase; HMG-CoA = 3-hydroxy-3-methyl-glutaryl-Coenzyme A; SSRIs = selective serotonin reuptake inhibitors
* CUBICIN should be discontinued in patients with unexplained signs and symptoms of myopathy in conjunction with CPK elevation >1000 U/L (~5X ULN), or in patients without reported symptoms who have marked elevations in CPK >2000 U/L (310X ULN).

Administration, Dosing, and Monitoring in Adults

cSSSIs = complicated skin and skin structure infections; LRTIs = lower respiratory tract infections; CAP = community-acquired pneumonia; VREF = vancomycin-resistant E. faecium; CPK = creatine phosphokinase; CBCs = complete blood counts.
* In patients with creatinine clearance <30 mL/min, including those undergoing hemodialysis or continuous ambulatory peritoneal dialysis, 4 mg/kg q48h for cSSSI and 6 mg/kg q48h for S. aureus bacteremia, including right-sided endocarditis.
† Dosage adjustment must be made in patients with impaired renal function.
‡ Dosage adjustment necessary in patients with severe hepatic impairment (Child Pugh C).

Microbiology

*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.

Susceptibility

MSSA = methicillin-susceptible Staphylococcus aureus; MRSA = methicillin-resistant S. aureus; X = active both in vitro and in clinical infections; In vitro only = active in vitro, but clinical significance is unknown
* Including avium, casseliflavus, and gallinarum.

Acquisition Cost*

*Cost per day calculated using wholesale acquisition cost as listed in Thomson Micromedex Red Book™ ReadyPrice® System (March 2007 release) and assuming a 70-kg patient dosed according to the applicable package insert.
† WAC = wholesale acquisition cost, the list price to wholesalers without regard to prompt payment terms, discounts, rebates, or chargebacks.
‡ Assumes no product wastage. Less frequent dosing needed for patients with renal impairment. In patients with creatinine clearance <30 mL/min, CUBICIN should be dosed at 4 mg/kg q48h or 6 mg/kg q48h.
§ Vancomycin cost is approximated using a weighted average WAC of all generic formulations weighted by sales volume per IMS (Q105). Recommended vancomycin dosing for patients with creatinine clearance <30 mL/min varies based on several clinical variables referenced in the Vancocin package insert.
|| 100 mg loading dose followed by 50 mg BID. Cost of loading dose averaged over assumed average 10 day course of therapy.

Download the above information as a PDF
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.