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CUBICIN Is in the 2010 IDSA Guidelines for MRSA cSSTI and Bacteremia1

Outpatient Parenteral Antimicrobial Therapy (OPAT): An Appropriate Option to Reduce Inpatient Treatment Costs

  • OPAT can provide an opportunity to facilitate patient discharge and ensure continued access to intravenous (IV) antibiotic treatment2,3
  • Hospital avoidance may represent an opportunity to avoid unnecessary admissions and complete patient treatment on an entirely outpatient basis2
  • Continued physician monitoring of the patient and patient care delivery are essential components of OPAT2
  • Market forces―healthcare reform―will further accelerate the shift of care from the inpatient to the outpatient setting4

Pathways to OPAT5

  • Initiate OPAT in patients with infections who do not require hospitalization
  • – OPAT may be initiated in the hospital emergency department2
  • OPAT may be administered in the hospital outpatient clinic, long-term care/skilled nursing facility, and physician's office, as well as in the home by a healthcare professional5
  • Hospital case managers can play a key role through review of the patient's total care needs and identifying those who may be discharged to OPAT3

A Single-Center Approach to Optimizing Outpatient Therapy

Costs per day of treating cellulitis: AIMS vs hospital care6

Single-center observational evaluation of a screening protocol (2005–2006)

AIMS=Acute Infections Management Service.
aPer visit day; bPer hospital day; cAIMS direct costs included but were not limited to drug acquisition costs, wound care supply costs, and costs to administer infusion

  • Estimated cost savings with the 472 AIMS visits (53 patients) related to cellulitis was $375,240
  • Only 3% of patients treated in the AIMS clinic required subsequent admission to the hospital

Study Description6,7

  • Single-center (UC Davis Medical Center, Sacramento, California) observational evaluation of a screening protocol (2005–2006)
  • Objectives of hospitalist-led OPAT clinic: Acute Infections Management Service
  • – Deliver low-cost, high-quality healthcare
  • – Enable hospital avoidance
  • – Ease patients' transition to the outpatient setting
  • – Better utilization of hospital resources
  • AIMS process and resources
  • – Staff includes clinic manager, infectious disease and hospitalist physicians, infectious disease
    pharmacist, and support staff (nurses, medical assistants)
  • – Assist in care transition from emergency department
  • • Discharge to home
  • • Admit to hospital
  • • Treat in AIMS clinic
  • – Facilitate discharge from the hospital

Outpatient Settings of Care2,8

Setting of Care Considerations When Administering Antimicrobial Therapy

  • Hospital inpatient
  • Availability of equipment, facilities, and medical staff for the administration and monitoring of therapy5
  • Hospital-based infusion center
  • Directly supervised therapy with the availability of medical staff and resources, if needed5
  • Requires patient transportation to the center5
  • Long-term care/skilled nursing facility
  • Provides medical resources for patients not capable of self care, who do not have satisfactory caregivers, have multiple medical problems, are undergoing rehabilitation, or are unlikely to be compliant9
  • Suitable for patients who require skilled therapy beyond infusion of antimicrobial agents9
  • Physician's office
  • Physician management and supervision of therapy5
  • Requires patient transportation to the office5
  • Home infusion by a healthcare professional
  • Allows patients who are difficult to transport (eg, limited mobility, bedridden) or do not have transportation to receive supervised therapy with skilled clinical assessments in their home2,5

General advantages and disadvantages of OPAT2,6,10,11


AdvantagesDisadvantages
Return to daily activities
(eg, work, school)
Decreased supervision
Less expensive than
hospital care
Patient noncompliance
Avoidance of nosocomial
infections
Interruption of therapy
High degree of patient
satisfaction: 96.5% preferred
OPAT to inpatient treatmenta
Increased out-of-pocket
expenses depending on the
patient's insurance coverage
Allows for treatment at home
by a healthcare provider
Misuse of the IV access device

aBased on 1998-2001 registry data from Scotland.



INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS

  • CUBICIN® (daptomycin for injection) is indicated for the following infections:

    Complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subspecies equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only).

    S. aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates.

LIMITATIONS OF USE

  • CUBICIN is not indicated for the treatment of left-sided infective endocarditis due to S. aureus. 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.
  • CUBICIN is not indicated for the treatment of pneumonia.

WARNINGS AND PRECAUTIONS

  • Anaphylaxis/hypersensitivity reactions have been reported with the use of antibacterial agents, including CUBICIN, and may be life-threatening. If an allergic reaction to CUBICIN occurs, discontinue the drug and institute appropriate therapy.
  • Myopathy, defined as muscle aching or muscle weakness in conjunction with increases in creatine phosphokinase (CPK) values to greater than 10 times the upper limit of normal (ULN), has been reported with the use of CUBICIN. Rhabdomyolysis, with or without acute renal failure, has been reported. Patients receiving CUBICIN should be monitored for the development of muscle pain or weakness, particularly of the distal extremities. In patients who receive CUBICIN, CPK levels should be monitored weekly, and more frequently in patients who received recent prior or concomitant therapy with an HMG-CoA reductase inhibitor or in whom elevations in CPK occur during treatment with CUBICIN. In patients with renal impairment, both renal function and CPK should be monitored more frequently than once weekly. In Phase 1 studies and Phase 2 clinical trials, CPK elevations appeared to be more frequent when CUBICIN was dosed more than once daily. Therefore, CUBICIN should not be dosed more frequently than once a day. CUBICIN should be discontinued in patients with unexplained signs and symptoms of myopathy in conjunction with CPK elevations to levels >1,000 U/L (~5× ULN), and in patients without reported symptoms who have marked elevations in CPK, with levels >2,000 U/L (≥10× ULN). In addition, consideration should be given to suspending agents associated with rhabdomyolysis, such as HMG-CoA reductase inhibitors, temporarily in patients receiving CUBICIN.
  • Eosinophilic pneumonia has been reported in patients receiving CUBICIN. In reported cases associated with CUBICIN, patients developed fever, dyspnea with hypoxic respiratory insufficiency, and diffuse pulmonary infiltrates. In general, patients developed eosinophilic pneumonia 2 to 4 weeks after starting CUBICIN and improved when CUBICIN was discontinued and steroid therapy was initiated. Recurrence of eosinophilic pneumonia upon re-exposure has been reported. Patients who develop these signs and symptoms while receiving CUBICIN should undergo prompt medical evaluation, and CUBICIN should be discontinued immediately. Treatment with systemic steroids is recommended.
  • Cases of peripheral neuropathy have been reported during the CUBICIN postmarketing experience. Therefore, physicians should be alert to signs and symptoms of peripheral neuropathy in patients receiving CUBICIN.
  • Clostridium difficile–associated diarrhea (CDAD) has been reported with the use of nearly all systemic antibacterial agents, including CUBICIN, and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents.
  • Patients with persisting or relapsing S. aureus bacteremia/endocarditis or poor clinical response should have repeat blood cultures. If a blood culture is positive for S. aureus, minimum inhibitory concentration (MIC) susceptibility testing of the isolate should be performed using a standardized procedure, and diagnostic evaluation of the patient should be performed to rule out sequestered foci of infection. Appropriate surgical intervention (e.g., debridement, removal of prosthetic devices, valve replacement surgery) and/or consideration of a change in antibacterial regimen may be required. Failure of treatment due to persisting or relapsing S. aureus bacteremia/endocarditis may be due to reduced daptomycin susceptibility (as evidenced by increasing MIC of the S. aureus isolate).
  • There are limited data available from the cSSSI clinical trials regarding the clinical efficacy of CUBICIN treatment in patients with creatinine clearance (CrCL) <50 mL/min; only 6% (31/534) patients treated with CUBICIN in the intent-to-treat (ITT) population had a baseline CrCL <50 mL/min. The clinical success rates in CUBICIN (4 mg/kg q24h)-treated patients with CrCL 50–70 mL/min and CrCL 30–<50 mL/min were 66% (25/38) and 47% (7/15), respectively. The clinical success rates in comparator-treated patients with CrCL 50–70 mL/min and CrCL 30–<50 mL/min were 63% (30/48) and 57% (20/35), respectively. In a subgroup analysis of the ITT population in the S. aureus bacteremia/endocarditis trial, clinical success rates in the CUBICIN-treated patients were lower in patients with baseline CrCL <50 mL/min.

ADVERSE REACTIONS

  • The most clinically significant adverse reactions observed with CUBICIN 4 mg/kg (cSSSI trials) and 6 mg/kg (S. aureus bacteremia/endocarditis trial) were abnormal liver function tests, elevated CPK, and dyspnea.

References

1. Liu C, Bayer A, Cosgrove SE, et al. Clinical practice guidelines by the Infectious Diseases Society of America for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children. Clin Infect Dis. 2011;52:e18-e55. 2. Williams DN, Rehm SJ, Tice AD, et al. Practice guidelines for community-based parenteral anti-infective therapy. Clin Infect Dis. 1997;25(4):787-801; 3. Heintz BH, Halilovic J, Christensen CL. Impact of a multidisciplinary team review of potential outpatient parenteral antimicrobial therapy prior to discharge from an academic medical center. Ann Pharmacother. 2011;45:1329-1337; 4. Thomson Reuters. Pinpoint and capture profitable outpatient business. November 2009; 5. Tice AD. An overview of outpatient parenteral antimicrobial therapy. In: Tice AD, ed. Handbook of Outpatient Parenteral Antimicrobial Therapy. Tarrytown, NY: CRG Publishing; 2006:9-21; 6. Nguyen HH. Hospitalist to home: outpatient parenteral antimicrobial therapy at an academic center. Clin Infect Dis. 2010;51(suppl 2):S220-S223; 7. Nguyen HH, Hoze MD. Hospital-based outpatient parenteral antimicrobial therapy (OPAT) at a university hospital. Poster presented at: 44th Annual Meeting of the Infectious Diseases Society of America; October 13, 2006; Toronto, Ontario, Canada. Poster 221; 8. Data on file. Cubist Pharmaceuticals, Inc.; 9. Tice AD, Rehm SJ, Dalovisio JR, et al. Practice guidelines for outpatient parenteral antimicrobial therapy. Clin Infect Dis. 2004;38:1651-1672; 10. Tice A. Outpatient parenteral antimicrobial therapy as an alternative to hospitalization. Int J Clin Pract Suppl. 1998;95:4-8; 11. Nathwani D, Tice A. Ambulatory antimicrobial use: the value of an outcomes registry. J Antimicrob Chemother. 2002;49(1):149-154.