|Manufacturer:||Cubist Pharmaceuticals, Inc.|
|Other Info:||Rx onlyCUBICIN is a registered trademark of Cubist Pharmaceuticals, Inc. All other trademarks are property of their respective owners.Manufactured for:Cubist Pharmaceuticals, Inc.Lexington, MA 02421 USAFor all medical inquiries call: (866) 793-2786August 2008 (1004-8)|
CUBICIN (daptomycin for injection) is indicated for the following infections (see also DOSAGE AND ADMINISTRATION and CLINICAL STUDIES):Complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp.
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.Staphylococcus 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 (see CLINICAL STUDIES). 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 (see PRECAUTIONS).CUBICIN is not indicated for the treatment of pneumonia.Appropriate specimens for microbiological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to daptomycin. Empiric therapy may be initiated while awaiting test results. Antimicrobial therapy should be adjusted as needed based upon test results.To reduce the development of drug-resistant bacteria and maintain the effectiveness of CUBICIN and other antibacterial drugs, CUBICIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Clostridium difficile–associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including CUBICIN, and may range in severity from mild diarrhea to fatal colitis.
Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C.
difficile produces toxins A and B, which contribute to the development of CDAD.
Hypertoxin-producing strains of C.
difficile cause increased morbidity and mortality, since these infections can be refractory to antimicrobial therapy and may require colectomy.
CDAD must be considered in all patients who present with diarrhea following antibiotic use.
Careful medical history is necessary because CDAD has been reported to occur over 2 months after the administration of antibacterial agents.If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C.
difficile may need to be discontinued.
Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C.difficile, and surgical evaluation should be instituted as clinically indicated.