These highlights do not include all the information needed to use CUBICIN ® safely and effectively. See full prescribing information for CUBICIN.
CUBICIN ® (daptomycin for injection) for Intravenous Use
Initial U.S. Approval: 2003
To reduce the development of drug-resistant bacteria and maintain the effectiveness of CUBICIN and other antibacterial drugs, CUBICIN should be used to treat infections that are proven or strongly suspected to be caused by bacteria. (1)RECENT MAJOR CHANGES
|
Warnings and Precautions (5.5) |
11/2014 |
INDICATIONS AND USAGE
CUBICIN is a lipopeptide antibacterial indicated for the treatment of:
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Complicated skin and skin structure infections (cSSSI) (1.1)
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Staphylococcus aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis (1.2)
CUBICIN is not indicated for the treatment of pneumonia. (1.3)
DOSAGE AND ADMINISTRATION
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Recommended dosage regimen for adult patients (2.2, 2.3, 2.4):
Creatinine Clearance
(CLCR) |
Dosage Regimen |
cSSSI
For 7 to 14 days |
S. aureus Bacteremia
For 2 to 6 weeks |
|
|
|
≥30 mL/min |
4 mg/kg once every 24 hours |
6 mg/kg once every 24 hours |
|
<30 mL/min, including hemodialysis and CAPD |
4 mg/kg once every 48 hours* |
6 mg/kg once every 48 hours* |
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Administered intravenously in 0.9% sodium chloride, either by injection over a 2-minute period or by infusion over a 30-minute period. (2.1, 2.5)
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Do not use in conjunction with ReadyMED® elastomeric infusion pumps. (2.7)
DOSAGE FORMS AND STRENGTHS
500 mg lyophilized powder for reconstitution in a single-use vial (3)
CONTRAINDICATIONS
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Known hypersensitivity to daptomycin (4)
WARNINGS AND PRECAUTIONS
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Anaphylaxis/hypersensitivity reactions (including life-threatening): Discontinue CUBICIN and treat signs/symptoms. (5.1)
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Myopathy and rhabdomyolysis: Monitor CPK levels and follow muscle pain or weakness; if elevated CPK or myopathy occurs, consider discontinuation of CUBICIN. (5.2)
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Eosinophilic pneumonia: Discontinue CUBICIN and consider treatment with systemic steroids. (5.3)
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Peripheral neuropathy: Monitor for neuropathy and consider discontinuation. (5.4)
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Potential nervous system and/or muscular system effects in pediatric patients younger than 12 months: Avoid use of CUBICIN in this age group. (5.5)
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Clostridium difficile–associated diarrhea: eva luate patients if diarrhea occurs. (5.6)
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Persisting or relapsing S. aureus bacteremia/endocarditis: Perform susceptibility testing and rule out sequestered foci of infection. (5.7)
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Decreased efficacy was observed in patients with moderate baseline renal impairment. (5.8)
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. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Cubist Pharmaceuticals, Inc., at 1-877-282-4786 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 11/2014
