These highlights do not include all the information needed to use TEFLARO safely and effectively. See full prescribing information for TEFLARO.
TEFLARO ® (ceftaroline fosamil) injection for intravenous (IV) use
Initial U.S. Approval: 2010
To reduce the development of drug-resistant bacteria and maintain the effectiveness of TEFLARO and other antibacterial drugs, Teflaro should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.
RECENT MAJOR CHANGES
Dosage and Administration (2.3) 10/2012
Dosage and Administration (2.3) 12/2013
INDICATIONS AND USAGE
Teflaro® is a cephalosporin antibacterial indicated for the treatment of the following infections caused by designated susceptible bacteria:
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Acute bacterial skin and skin structure infections (ABSSSI) (1.1)
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Community-acquired bacterial pneumonia (CABP) (1.2)
DOSAGE AND ADMINISTRATION
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600 mg every 12 hours by IV infusion administered over 1 hour in adults ≥ 18 years of age (2.1)
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Dosage adjustment in patients with renal impairment (2.2)
Estimated Creatinine Clearance#
(mL/min) |
Teflaro Dosage Regimen |
|
|
|
>50
|
No dosage adjustment necessary
|
|
>30 to ≤ 50
|
400 mg IV (over 1 hour) every 12 hours
|
|
≥ 15 to ≤ 30
|
300 mg IV (over 1 hour) every 12 hours
|
|
End-stage renal disease (ESRD), including hemodialysis
|
200 mg IV (over 1 hour) every 12 hours
|
DOSAGE FORMS AND STRENGTHS
600 mg or 400 mg of sterile Teflaro powder in single-use 20 mL vials. (3)
CONTRAINDICATIONS
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Known serious hypersensitivity to ceftaroline or other members of the cephalosporin class. (4)
WARNINGS AND PRECAUTIONS
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Serious hypersensitivity (anaphylactic) reactions have been reported with beta-lactam antibiotics, including ceftaroline. Exercise caution in patients with known hypersensitivity to beta-lactam antibiotics. (5.1)
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Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including Teflaro. eva luate if diarrhea occurs. (5.2)
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Direct Coombs' test seroconversion has been reported with Teflaro. If anemia develops during or after therapy, a diagnostic workup for drug-induced hemolytic anemia should be performed and consideration given to discontinuation of Teflaro. (5.3)
ADVERSE REACTIONS
The most common adverse reactions occurring in >2 % of patients are diarrhea, nausea, and rash. (6.3)
To report SUSPECTED ADVERSE REACTIONS, contact Forest Pharmaceuticals, Inc., at 1-800-678-1605 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Dosage adjustment is required in patients with moderate or severe renal impairment and in ESRD patients, including patients on hemodialysis. (2.2,12.3)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 12/2013
