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Initial U.S. Approval: 2010
Teflaro is a sterile, semi-synthetic, broad-spectrum, prodrug antibacterial of cephalosporin class of beta-lactams (-lactams).
Teflaro vials contain either 600 mg or 400 mg of anhydrous ceftaroline fosamil. The powder for injection is formulated from ceftaroline fosamil monoacetate monohydrate, a pale yellowish-white to light yellow sterile powder. All references to ceftaroline activity are expressed in terms of the prodrug, ceftaroline fosamil. The powder is constituted for IV injection [see Dosage and Administration].
Each vial of Teflaro contains ceftaroline fosamil and L-arginine, which results in a constituted solution at pH 4.8 to 6.5.
Ceftaroline fosamil is the water-soluble prodrug of the bioactive ceftaroline.
Mechanism of Action
Ceftaroline is an antibacterial drug.
Mode of Action
Ceftaroline is a cephalosporin with in vitro activity against Gram-positive and -negative bacteria. The bactericidal action of ceftaroline is mediated through binding to essential penicillin-binding proteins (PBPs). Ceftaroline is bactericidal against S. aureus due to its affinity for PBP2a and against Streptococcus pneumoniae due to its affinity for PBP2x.
Mechanisms of Resistance
Ceftaroline is not active against Gram-negative bacteria producing extended spectrum beta-lactamases (ESBLs) from the TEM, SHV or CTX-M families, serine carbapenemases (such as KPC), class B metallo-beta-lactamases, or class C (AmpC cephalosporinases).
Although cross-resistance may occur, some isolates resistant to other cephalosporins may be susceptible to ceftaroline.
Interaction with Other Antimicrobials
In vitro studies have not demonstrated any antagonism between ceftaroline or other commonly used antibacterial agents (e.g., vancomycin, linezolid, daptomycin, levofloxacin, azithromycin, amikacin, aztreonam, tigecycline, and meropenem).
Ceftaroline has been shown to be active against most of the following bacteria, both in vitro and in clinical infections [see Indications and Usage].
Staphylococcus aureus (including methicillin-susceptible and -resistant isolates)
Community-Acquired Bacterial Pneumonia (CABP)
Staphylococcus aureus (methicillin-susceptible isolates only)
The following in vitro data are available, but their clinical significance is unknown. Ceftaroline exhibits in vitro MICs of 1 mcg/mL or less against most (= 90%) isolates of the following bacteria; however, the safety and effectiveness of Teflaro in treating clinical infections due to these bacteria have not been established in adequate and well-controlled clinical trials.
Susceptibility Test Methods
When available, the clinical microbiology laboratory should provide the results of in vitro susceptibility test results for antimicrobial drugs used in local hospitals and practice areas to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting an antibacterial drug product for treatment.
INDICATIONS AND USAGE
Teflaro™ (ceftaroline fosamil) is indicated for the treatment of patients with the following infections caused by susceptible isolates of the designated microorganisms.
Acute Bacterial Skin and Skin Structure Infections
Teflaro is indicated 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.
Community-Acquired Bacterial Pneumonia
Teflaro is indicated 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.
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
Known serious hypersensitivity to ceftaroline or other members
of the cephalosporin class.
WARNINGS AND PRECAUTIONS
Serious hypersensitivity (anaphylactic) reactions have been reported with beta-lactam antibiotics, including ceftaroline. Exercise caution in patients with known hypersensitivity to beta-lactam antibiotics.
Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including Teflaro. Evaluate if diarrhea occurs.
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.
USE IN SPECIFIC POPULATIONS
Dosage adjustment is required in patients with moderate or severe renal impairment and in ESRD patients, including patients on hemodialysis.
The most common adverse reactions occurring in >2 % of patients
are diarrhea, nausea, and rash.
To report SUSPECTED ADVERSE REACTIONS, contact Forest Pharmaceuticals, Inc., at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DOSAGE AND ADMINISTRATION
The recommended dosage of Teflaro is 600 mg administered every 12 hours by intravenous (IV) infusion over 1 hour 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
Patients with Renal Impairment
Preparation of Solutions
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. The preparation of Teflaro solutions is summarized in Table 3.
Constitution time is less than 2 minutes. Mix gently to constitute and check to see that the contents have dissolved completely. Parenteral drug products should be inspected visually for particulate matter prior to administration.
The color of Teflaro infusion solutions ranges from clear, light to dark yellow depending on the concentration and storage conditions. When stored as recommended, the product potency is not affected.
Studies have shown that the constituted solution in the infusion bag should be used within 6 hours when stored at room temperature or within 24 hours when stored under refrigeration at 2 to 8º C (36 to 46º F).
The compatibility of Teflaro with other drugs has not been established. Teflaro should not be mixed with or physically added to solutions containing other drugs.
HOW SUPPLIED/STORAGE AND HANDLING
Teflaro (ceftaroline fosamil) for injection is supplied in single-use, clear glass vials containing:
600 mg - individual vial (NDC 0456-0600-01) and carton containing 10 vials (NDC 0456-0600-10)
400 mg - individual vial (NDC 0456-0400-01) and carton containing 10 vials (NDC 0456-0400-10)
Teflaro vials should be stored refrigerated at 2 to 8° C (36 to 46° F). Unrefrigerated, unreconstituted Teflaro can be stored at temperatures not exceeding 25°C (77°F) for no more than 7 days.
Package Insert data:
Teflaro (ceftaroline fosamil) for injection
Forest Pharmaceuticals, Inc.
Subsidiary of Forest Laboratories, Inc.
St. Louis, MO 63045, USA
Facta Farmaceutici S.p.A.
Nucleo Industriale S. Atto–S. Nicolò a Tordino
64020 Teramo, Italy
Teflaro is a trademark of Forest Laboratories, Inc.
©2010 Forest Laboratories, Inc. All rights reserved.
Principal Display Panel – 400 mg Vial
Rx only NDC 0456-0400-01
(ceftaroline fosamil) for injection
FOR INTRAVENOUS INFUSION ONLY.
Reconstitute this vial with 20 mL of Sterile Water to obtain a concentration of 20 mg/mL. Further dilute the entire contents before infusing. See package insert tor instructions on reconstitution, dilution, and dosage.
Single use vial - Discard after use
EF95USCFR400 Rev. 10/2010