HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use TEFLARO safely and effectively. See full prescribing information for TEFLARO. TEFLARO - ® (ceftaroline fosamil) for ...
These highlights do not include all the information needed to use TEFLARO safely and effectively. See full prescribing information for TEFLARO.
TEFLARO ® (ceftaroline fosamil) for injection, for intravenous use
Initial U.S. Approval: 2010
RECENT MAJOR CHANGES
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Indications and Usage (1.1, 1.2) |
5/2016 |
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Dosage and Administration (2.2, 2.3) |
5/2016 |
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Warnings and Precautions (5.3) |
5/2016 |
INDICATIONS AND USAGE
Teflaro® is a cephalosporin antibacterial indicated in adult and pediatric patients 2 months of age and older 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)
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 (1.3).
DOSAGE AND ADMINISTRATION
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Adult patients > 18 years of age: 600 mg every 12 hours by IV infusion administered over 5 to 60 min (2.1)
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Pediatric patients from 2 years to < 18 years of age weighing ≤ 33 kg: 12 mg/kg every 8 hours by IV infusion administered over 5 to 60 min. Pediatric patients from 2 years to < 18 years of age weighing > 33 kg: 400 mg every 8 hours or 600 mg every 12 hours by IV infusion administered over 5 to 60 min. (2.2)
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Pediatric patients from 2 months to < 2 years of age: 8 mg/kg every 8 hours by IV infusion administered over 5 to 60 min (2.2)
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Dosage adjustment is required in adult patients with creatinine clearance (CrCl) < 50 mL/min and in End-stage Renal Disease (ESRD) including hemodialysis (2.3)
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There is insufficient information to recommend a dosage regimen for pediatric patients with CrCL < 50 mL/min/1.73 m2 (2.3)
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|
Estimated Creatinine Clearance#
(mL/min) |
Teflaro Dosage Regimen in Adults |
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> 50 |
No dosage adjustment necessary |
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> 30 to ≤ 50 |
400 mg IV (over 5 to 60 minutes) every 12 hours |
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≥ 15 to ≤ 30 |
300 mg IV (over 5 to 60 minutes ) every 12 hours |
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End-stage renal disease (ESRD), including hemodialysis |
200 mg IV (over 5-60 minutes) every 12 hours |
DOSAGE FORMS AND STRENGTHS
For Injection: 600 mg or 400 mg of sterile ceftaroline fosamil powder in single-dose 20 mL vials. The powder is constituted and further diluted for intravenous injection. (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 antibacterial drugs, including Teflaro. If a hypersensitivity reaction occurs, discontinue Teflaro. (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 adult patients and ≥3% of pediatric patients are diarrhea, nausea, and rash. Additional adverse reactions that occurred in ≥3% of pediatric patients include vomiting and pyrexia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Forest Laboratories, LLC, at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 5/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
Table of Contents
1. INDICATIONS AND USAGE
1.1 Acute Bacterial Skin and Skin Structure Infections Teflaro is indicated in adult and pediatric patients 2 months of age and older for the treatment of acute ...
1.1 Acute Bacterial Skin and Skin Structure Infections
Teflaro is indicated in adult and pediatric patients 2 months of age and older for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca.
1.2 Community-Acquired Bacterial Pneumonia
Teflaro is indicated in adult and pediatric patients 2 months of age and older for the treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms:
Streptococcus pneumoniae (including cases with concurrent bacteremia),
Staphylococcus aureus (methicillin-susceptible isolates only),
Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and
Escherichia coli.
1.3 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Teflaro and other antibacterial drugs, Teflaro should be used to treat only ABSSSI or CABP that are proven or strongly suspected to be caused by susceptible bacteria. Appropriate specimens for microbiological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to ceftaroline. 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.
2. DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage in Adult Patients The recommended dosage of Teflaro is 600 mg administered every 12 hours by intravenous (IV) infusion over 5 to 60 minutes ...
2.1 Recommended Dosage in Adult Patients
The recommended dosage of Teflaro is 600 mg administered every 12 hours by intravenous (IV) infusion over 5 to 60 minutes in patients ≥ 18 years of age. The duration of therapy should be guided by the severity and site of infection and the patient's clinical and bacteriological progress.
The recommended dosage and administration by infection is described in Table 1.
2.2 Recommended Dosage in Pediatric Patients
The recommended dosage of Teflaro in pediatric patients is based on the age and weight of the child. Teflaro is administered every 8 hours by intravenous infusion over 5 to 60 minutes. The duration of therapy should be guided by the severity, site of infection and the patient's clinical and bacteriological progress.
The recommended dosage and administration by infection is described in Table 2.
2.3 Dosage Adjustments in Patients with Renal Impairment
Adults: No dosage adjustment is required in adult patients with CrCL > 50 mL/min. The dose in adult patients should be adjusted when creatinine clearance (CrCL) is ≤ 50 mL/min as shown below (see Table 3).
2.4 Preparation of Teflaro for Administration
Constitution of Teflaro Powder for Injection
Aseptic technique must be followed in preparing the infusion solution. The contents of Teflaro vial should be constituted with 20 mL Sterile Water for Injection, USP; or 0.9% of sodium chloride injection (normal saline); or 5% of dextrose injection; or lactated ringer's injection. Constitution time is less than 2 minutes. Mix gently to constitute and check to see that the contents have dissolved completely. The preparation of Teflaro solutions is summarized in Table 4.
Dilution of the Constituted Solution of Teflaro
The constituted solution must be further diluted in a range between 50 mL to 250 mL before intravenous infusion into patients. Use the same diluent used for constitution of the powder for this further dilution, unless sterile water for injection was used earlier. If sterile water for injection was used earlier, then appropriate infusion solutions include: 0.9% Sodium Chloride Injection, USP (normal saline); 5% Dextrose Injection, USP; 2.5% Dextrose Injection, USP, and 0.45% Sodium Chloride Injection, USP; or Lactated Ringer's Injection, USP.
Dilution of the Constituted Solution of Teflaro in the 50 mL Infusion Bags Only
Preparation of 600 mg of Teflaro dose in 50 mL infusion bag (for adult patients): Withdraw 20 mL of diluent from the infusion bag. Proceed to inject entire content of the Teflaro vial into the bag to provide a total volume of 50 mL. The resultant concentration is approximately 12 mg/mL.
Preparation of 400 mg of Teflaro dose in 50 mL infusion bag (for adult patients or pediatric patients weighing > 33 kg): Withdraw 20 mL of diluent from the infusion bag. Proceed to inject entire content of the Teflaro vial into the bag to provide a total volume of 50 mL. The resultant concentration is approximately 8 mg/mL.
Preparation of Teflaro dose in the infusion bag (for pediatric patients weighing ≤ 33 kg):The amount of solution withdrawn from the constituted Teflaro vial for pediatric patients weighing ≤ 33 kg for dilution in the infusion bag will vary according to the weight and age of the child. The infusion solution concentration for administration should not exceed 12 mg/ml ceftaroline fosamil.
The color of Teflaro infusion solutions ranges from clear, light to dark yellow depending on the concen
