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ABOUT CUBICIN
Get a useful overview ofCUBICIN along with the full Prescribing Information. Download the brochure |
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![]() ![]() ![]() Presentation & History Angela is a 47-year-old Hispanic female with a history of recurrent foot ulcers. She presents with an open wound on her left foot that developed 3 weeks ago. The patient reports pain in the area. Purulent discharge is present upon pressure to the affected area.
A wound culture of the site showed Gram-positive cocci. The presumptive diagnosis is MRSA complicated skin infection.
This profile is for educational purposes only and is not based on an actual patient. Actual diagnoses and treatments must be determined by attending physicians. Proven clinical success of CUBICIN 4 mg/kg once daily in complicated skin infections, including MRSA and MSSA1* ![]() CUBICIN once daily for complicated skin infections and bacteremia caused by S. aureus ![]() CLCR = creatinine clearance; CAPD = continuous ambulatory peritoneal dialysis.
References: 1. Arbeit RD, Maki D, Tally FP, Campanaro E, Eisenstein BI. The safety and efficacy of daptomycin for Clin Infect Dis. 2004;38:1673-1681. The treatment of complicated skin and skin structure infections. 2. Silverman JA, Perlmutter NG, Shapiro HM. Correlation of daptomycin bactericidal activity and membrane depolarization in Staphylococcus aureus. Antimicrob Agents Chemother. 2003;47:2538-2544. ![]() ![]() Presentation & History Roger is a 56-year-old African American male with renal impairment and a history of prior exposure to vancomycin. During a recent appointment, he was noted to have fever and chills, which led the clinic to transfer him to the hospital. Examination: temperature 101°F, pulse 110, BP 100/70, middle-aged male in no apparent distress
Lab analyses reveal a white blood cell count of 9,000 with 80% neutrophils and 5% bands. A chest x-ray is within normal limits. Gram-positive cocci were cultured in blood. The initial presumptive diagnosis is MRSA bacteremia (later confirmed by culture). Presumed source of infection is catheter; catheter pulled. This profile is for educational purposes only and is not based on an actual patient. Actual diagnoses and treatments must be determined by attending physicians. Proven clinical success of CUBICIN 6 mg/kg once daily in S. aureus bacteremia ![]()
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 gentamicin. 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. || Only patients with persisting/relapsing S. aureus infection, death, or clinical failure at the Test of Cure visit 6 weeks after the end of therapy were considered failures in this analysis, which differs from the definition of clinical failure in the overall study. ![]() Significantly less renal decline (P =.004)2¶ ![]() Dual-therapy was defined as treatment with vancomycin or a semisynthetic penicillin + 4 days of initial low-dose gentamicin. ¶ Decreased renal function defined as a creatinine clearance level <50 mL/min if baseline clearance was =50 mL/min or a decrease of =10 mL/min if baseline clearance was <50 mL/min. Dosing once every 48 hours for renally-impaired patients with complicated skin infections and S. aureus bacteremia ![]() CLCR = creatinine clearance; CAPD = continuous ambulatory peritoneal dialysis. #These dosing recommendations are based on pK data.
References: 1. Boucher H, Corey G, Filler S, Parsonnet J, Campion M, Fowler V. Appropriateness of two-week therapy for catheter-related (cath-rel) S. aureus bacteremia (SAB). Poster presented at: the 46th Annual ICAAC Meeting; September 27-30, 2006; San Francisco, Calif. Poster L-1204. 2. 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. ![]() ![]() ![]() Presentation & History George is a 63-year-old, overweight white male who is recovering on the cardiac care wing of a teaching hospital following femoral popliteal bypass surgery in the right leg. Past medical history includes poorly controlled diabetes, hypertension, and a 2-pack-a-day smoking habit for the past 35 years. It is significant that this hospital has noted an increased incidence of MRSA infections in postsurgical patients over the past 2 years. Examination: temperature 100.8°F, pulse 98, RR 16, BP 145/90, a middle-aged male in no acute distress
The patient has a white blood cell count of 12,000 with 85% neutrophils and 5% bands. His BUN/creatinine is 23/1.3. A wound culture of the surgical site showed Gram-positive cocci. The initial diagnosis is complicated skin infection at the surgical site with presumptive MRSA (later confirmed by culture). This profile is for educational purposes only and is not based on an actual patient. Actual diagnoses and treatments must be determined by attending physicians. Proven clinical success of CUBICIN 4 mg/kg once daily in complicated skin infections, including MRSA and MSSA1* ![]() CUBICIN once daily for complicated skin infections and bacteremia caused by S. aureus ![]() CLCR = creatinine clearance; CAPD = continuous ambulatory peritoneal dialysis.
Reference: 1. Arbeit RD, Maki D, Tally FP, Campanaro E, Eisenstein BI. The safety and efficacy of daptomycin for the treatment of complicated skin and skin structure infections. Clin Infect Dis. 2004;38:1673-1681. ![]() ![]() ![]() Presentation & History Helen is a 71-year-old obese, diabetic white female with a chief complaint of extreme pain near her right ankle over the past 2 weeks. She has noted an ulcer at the site, accompanied by radiating pain and swelling. She has covered the site with sterile bandages. Past medical history is significant for varicose vein surgery 3 years ago in the area of her right leg below the knee and above the ankle. Medications include hypoglycemics to manage her diabetes. With the onset of pain, she self-medicated with aspirin and daily leg elevation. Examination: temperature 100.6°F, pulse 92, RR 16, BP 110/68, obese female in no acute distress
Transcutaneous oxygen measurement confirms poor arterial flow to the right leg. The initial diagnosis is a stasis ulcer with infection presumptively due to MRSA. This patient was initially started on vancomycin; however, at 48 hours no improvement was seen upon visual inspection of the infection site. This profile is for educational purposes only and is not based on an actual patient. Actual diagnoses and treatments must be determined by attending physicians. Proven clinical success of CUBICIN 4 mg/kg once daily in complicated skin infections, including MRSA and MSSA1† ![]() CUBICIN once daily for complicated skin infections and bacteremia caused by S. aureus ![]() CLCR = creatinine clearance; CAPD = continuous ambulatory peritoneal dialysis.
Reference: 1. Arbeit RD, Maki D, Tally FP, Campanaro E, Eisenstein BI. The safety and efficacy of daptomycin for the treatment of complicated skin and skin structure infections. Clin Infect Dis. 2004;38:1673-1681. |
CUBICIN: MORE THAN 500,000* PATIENTS TREATED TO DATE
* Estimated number of patients treated based on sales through March 2008.
† The clinical relevance of in vitro data has not been established.
Outpatient Use
With a once daily, 30-minute infusion dosing regimen, CUBICIN is a good fit for outpatient MRSA/MSSA care in complicated skin infections and bacteremia. The MRSA Threat
With the high rate of MRSA Indications & Usage
CUBICIN is a once-a-day agent approved for the treatment of MRSA and MSSA in complicated skin infections and bacteremia, including right-sided endocarditis. |
![]() ![]() ![]() Presentation & History Angela is a 47-year-old Hispanic female with a history of recurrent foot ulcers. She presents with an open wound on her left foot that developed 3 weeks ago. The patient reports pain in the area. Purulent discharge is present upon pressure to the affected area.
A wound culture of the site showed Gram-positive cocci. The presumptive diagnosis is MRSA complicated skin infection.
This profile is for educational purposes only and is not based on an actual patient. Actual diagnoses and treatments must be determined by attending physicians. Proven clinical success of CUBICIN 4 mg/kg once daily in complicated skin infections, including MRSA and MSSA1* ![]() CUBICIN once daily for complicated skin infections and bacteremia caused by S. aureus ![]() CLCR = creatinine clearance; CAPD = continuous ambulatory peritoneal dialysis.
References: 1. Arbeit RD, Maki D, Tally FP, Campanaro E, Eisenstein BI. The safety and efficacy of daptomycin for Clin Infect Dis. 2004;38:1673-1681. The treatment of complicated skin and skin structure infections. 2. Silverman JA, Perlmutter NG, Shapiro HM. Correlation of daptomycin bactericidal activity and membrane depolarization in Staphylococcus aureus. Antimicrob Agents Chemother. 2003;47:2538-2544. ![]() ![]() Presentation & History Roger is a 56-year-old African American male with renal impairment and a history of prior exposure to vancomycin. During a recent appointment, he was noted to have fever and chills, which led the clinic to transfer him to the hospital. Examination: temperature 101°F, pulse 110, BP 100/70, middle-aged male in no apparent distress
Lab analyses reveal a white blood cell count of 9,000 with 80% neutrophils and 5% bands. A chest x-ray is within normal limits. Gram-positive cocci were cultured in blood. The initial presumptive diagnosis is MRSA bacteremia (later confirmed by culture). Presumed source of infection is catheter; catheter pulled. This profile is for educational purposes only and is not based on an actual patient. Actual diagnoses and treatments must be determined by attending physicians. Proven clinical success of CUBICIN 6 mg/kg once daily in S. aureus bacteremia ![]()
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 gentamicin. 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. || Only patients with persisting/relapsing S. aureus infection, death, or clinical failure at the Test of Cure visit 6 weeks after the end of therapy were considered failures in this analysis, which differs from the definition of clinical failure in the overall study. ![]() Significantly less renal decline (P =.004)2¶ ![]() Dual-therapy was defined as treatment with vancomycin or a semisynthetic penicillin + 4 days of initial low-dose gentamicin. ¶ Decreased renal function defined as a creatinine clearance level <50 mL/min if baseline clearance was =50 mL/min or a decrease of =10 mL/min if baseline clearance was <50 mL/min. Dosing once every 48 hours for renally-impaired patients with complicated skin infections and S. aureus bacteremia ![]() CLCR = creatinine clearance; CAPD = continuous ambulatory peritoneal dialysis. #These dosing recommendations are based on pK data.
References: 1. Boucher H, Corey G, Filler S, Parsonnet J, Campion M, Fowler V. Appropriateness of two-week therapy for catheter-related (cath-rel) S. aureus bacteremia (SAB). Poster presented at: the 46th Annual ICAAC Meeting; September 27-30, 2006; San Francisco, Calif. Poster L-1204. 2. 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. ![]() ![]() ![]() Presentation & History George is a 63-year-old, overweight white male who is recovering on the cardiac care wing of a teaching hospital following femoral popliteal bypass surgery in the right leg. Past medical history includes poorly controlled diabetes, hypertension, and a 2-pack-a-day smoking habit for the past 35 years. It is significant that this hospital has noted an increased incidence of MRSA infections in postsurgical patients over the past 2 years. Examination: temperature 100.8°F, pulse 98, RR 16, BP 145/90, a middle-aged male in no acute distress
The patient has a white blood cell count of 12,000 with 85% neutrophils and 5% bands. His BUN/creatinine is 23/1.3. A wound culture of the surgical site showed Gram-positive cocci. The initial diagnosis is complicated skin infection at the surgical site with presumptive MRSA (later confirmed by culture). This profile is for educational purposes only and is not based on an actual patient. Actual diagnoses and treatments must be determined by attending physicians. Proven clinical success of CUBICIN 4 mg/kg once daily in complicated skin infections, including MRSA and MSSA1* ![]() CUBICIN once daily for complicated skin infections and bacteremia caused by S. aureus ![]() CLCR = creatinine clearance; CAPD = continuous ambulatory peritoneal dialysis.
Reference: 1. Arbeit RD, Maki D, Tally FP, Campanaro E, Eisenstein BI. The safety and efficacy of daptomycin for the treatment of complicated skin and skin structure infections. Clin Infect Dis. 2004;38:1673-1681. ![]() ![]() ![]() Presentation & History Helen is a 71-year-old obese, diabetic white female with a chief complaint of extreme pain near her right ankle over the past 2 weeks. She has noted an ulcer at the site, accompanied by radiating pain and swelling. She has covered the site with sterile bandages. Past medical history is significant for varicose vein surgery 3 years ago in the area of her right leg below the knee and above the ankle. Medications include hypoglycemics to manage her diabetes. With the onset of pain, she self-medicated with aspirin and daily leg elevation. Examination: temperature 100.6°F, pulse 92, RR 16, BP 110/68, obese female in no acute distress
Transcutaneous oxygen measurement confirms poor arterial flow to the right leg. The initial diagnosis is a stasis ulcer with infection presumptively due to MRSA. This patient was initially started on vancomycin; however, at 48 hours no improvement was seen upon visual inspection of the infection site. This profile is for educational purposes only and is not based on an actual patient. Actual diagnoses and treatments must be determined by attending physicians. Proven clinical success of CUBICIN 4 mg/kg once daily in complicated skin infections, including MRSA and MSSA1† ![]() CUBICIN once daily for complicated skin infections and bacteremia caused by S. aureus ![]() CLCR = creatinine clearance; CAPD = continuous ambulatory peritoneal dialysis.
Reference: 1. Arbeit RD, Maki D, Tally FP, Campanaro E, Eisenstein BI. The safety and efficacy of daptomycin for the treatment of complicated skin and skin structure infections. Clin Infect Dis. 2004;38:1673-1681.
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 all 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 (~5X ULN), or in patients without reported symptoms who have marked elevations in CPK >2000 U/L (≥10X 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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