Important Safety Information: TEFLARO is contraindicated in patients with known serious hypersensitivity to ceftaroline or other members of the cephalosporin class. Anaphylaxis and anaphylactoid reactions have been reported with ceftaroline. Important Safety Information continued below.

Teflaro is indicated for the treatment of ABSSSI and CABP due to designated susceptible bacteria, as described below.

TEFLARO®: Proven Effective in Community-Acquired Bacterial Pneumonia (CABP)

Caused by Susceptible Bacteria

CABP Study Design with Patient

These hypothetical case studies present examples of types of patients who may benefit from TEFLARO.

TEFLARO CABP Study Designs1,2
Type of trial: Two randomized, multicenter, multinational, double-blind, noninferiority trials
Study population: 1231 adults with a diagnosis of CABP
Comparative agents: TEFLARO — 600 mg administered IV over 1 hour every 12 hours for 5-7 days; Ceftriaxone — 1g ceftriaxone administered IV over 30 minutes every 24 hours for 5-7 days
Adjunctive therapy: CABP Trial 1, two doses on Day 1 of oral clarithromycin 500 mg every 12 hours; CABP Trial 2, no adjunctive macrolide therapy
TEFLARO Study Populations
Day 4 Population (mITT)* A microbiological intent-to-treat population (mITT population) containing only subjects with a confirmed bacterial pathogen at baseline.
Test of Cure (TOC) Populations
MITT Modified Intent-to-treat All randomized subjects who received any amount of study drug.
MITTE Modified Intent-to-treat Efficacy All subjects in the MITT population who were in PORT Risk Class III or IV at baseline.
CE Clinically Evaluable All subjects in the MITTE population who demonstrated sufficient adherence to the protocol. Sufficient adherence is defined as patients who met the minimal disease criteria for CABP and for whom sufficient information regarding the CABP was available to determine the patient's outcome.
ME Microbiologically Evaluable All subjects in the CE population who had at least one typical bacterial pathogen identified at baseline from an appropriate microbiological specimen (eg, blood, sputum, or pleural fluid).

*To evaluate the treatment effect of ceftaroline, an analysis was conducted in CABP patients for whom the treatment effect of antibacterials may be supported by historical evidence. This analysis endpoint required subjects to meet sign and symptom criteria at Day 4 of therapy: a responder had to both (a) be in stable condition according to consensus treatment guidelines, and (b) show improvement from baseline on at least one symptom of cough, dyspnea, pleuritic chest pain, or sputum production, while not worsening on any of these four symptoms.

The protocol-specific analysis included clinical cure rates at the TOC (8 to 15 days after the end of therapy) in the coprimary MITTE and CE populations and clinical cure rates at TOC by pathogen in the ME population.

cabp studydesign

*TEFLARO is indicated for ABSSSI due to MRSA. It is not indicated for CABP due to MRSA. MSSA=Methicillin-susceptible Staphylococcus aureus. MRSA=Methicillin-resistant Staphylococcus aureus. *There are insufficient historical data to establish the magnitude of drug effect for antibacterial drugs compared with placebo at a TOC time point. Etest® is a registered trademark of BioMérieux §MSSA=Methicillin-susceptible Staphylococcus aureus. Clinical efficacy of TEFLARO in treating CABP due to MRSA has not been studied.

CABP Patient Case Studies
  • Jacob, 68-year-old male
  • Virginia, 78-year-old female
  • Brian, 44-year-old male

Not actual patients

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ABSSSI Patient Case Studies
  • Abscess With Cellulitis
  • Infected Wound
  • Deep and Extensive Cellulitis

Not actual patients

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Billing and Coding

Permanent J-code for TEFLARO effective January 1, 2012.

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Clinical Efficacy
Clinical Efficacy
Clinical Efficacy
See Regional In Vitro Susceptibility Information for MSSA

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AWARE 2013 Surveillance Study

View Regional and National Susceptibility Data.

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  • 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.
  • TEFLARO is also 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.
  • TEFLARO is contraindicated in patients with known serious hypersensitivity to ceftaroline or other members of the cephalosporin class. Anaphylaxis and anaphylactoid reactions have been reported with ceftaroline.
Warnings and Precautions
Hypersensitivity Reactions
  • Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported with beta-lactam antibacterial drugs. Before therapy with TEFLARO is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or carbapenems should be made. Maintain cllinical supervision if this product is to be given to a penicillin- or other beta-lactam-allergic patient, because cross sensitivity among beta-lactam antibacterial agents has been clearly established.
  • If an allergic reaction to TEFLARO occurs, discontinue TEFLARO and institute appropriate treatment and supportive measures.
Clostridium difficile-Associated Diarrhea
  • Clostridium difficile-Associated Diarrhea (CDAD) has been reported for nearly all systemic antibacterial agents, including TEFLARO, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, antibacterials not directed against C. difficile should be discontinued, if possible.
Direct Coombs' Test Seroconversion
  • Seroconversion from a negative to a positive direct Coombs’ test result occurred in 120/1114 (10.8%) of patients receiving TEFLARO and 49/1116 (4.4%) of patients receiving comparator drugs in the four pooled Phase 3 trials. No adverse reactions representing hemolytic anemia were reported in any treatment group. If anemia develops during or after treatment with TEFLARO, drug-induced hemolytic anemia should be considered. If drug-induced hemolytic anemia is suspected, discontinuation of TEFLARO should be considered and supportive care should be administered to the patient if clinically indicated.
Development of Drug-Resistant Bacteria
  • Prescribing TEFLARO in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Adverse Reactions
  • In the four pooled Phase 3 clinical trials, serious adverse reactions occurred in 98/1300 (7.5%) of patients receiving TEFLARO and 100/1297 (7.7%) of patients receiving comparator drugs. Treatment discontinuation due to adverse reactions occurred in 35/1300 (2.7%) of patients receiving TEFLARO and 48/1297 (3.7%) of patients receiving comparator drugs with the most common adverse reactions leading to discontinuation being hypersensitivity for both treatment groups at a rate of 0.3% in the TEFLARO group and 0.5% in the comparator group.
  • No adverse reactions occurred in greater than 5% of patients receiving TEFLARO. The most common adverse reactions occurring in >2% of patients receiving TEFLARO in the pooled Phase 3 clinical trials were diarrhea, nausea, and rash.
Drug Interactions
  • No clinical drug-drug interaction studies have been conducted with TEFLARO. There is minimal potential for drug-drug interactions between TEFLARO and CYP450 substrates, inhibitors, or inducers; drugs known to undergo active renal secretion; and drugs that may alter renal blood flow.
Use in Specific Populations
  • TEFLARO has not been studied in pregnant women. Therefore, TEFLARO should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.
  • It is not known whether ceftaroline is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TEFLARO is administered to a nursing woman.
  • Safety and effectiveness in pediatric patients have not been established.
  • Because elderly patients, those ≥65 years of age, are more likely to have decreased renal function and ceftaroline is excreted primarily by the kidney, care should be taken in dose selection in this age group and it may be useful to monitor renal function. Dosage adjustment for elderly patients should therefore be based on renal function.
  • Dosage adjustment is required in patients with moderate (CrCl >30 to ≤50 mL/min) or severe (CrCl ≥15 to ≤30 mL/min) renal impairment and in patients with end-stage renal disease (CrCl <15 mL/min).
  • The pharmacokinetics of ceftaroline in patients with hepatic impairment have not been established.

  1. TEFLARO® (ceftaroline fosamil) [prescribing information]. Cincinnati, OH: Forest Pharmaceuticals, LLC.; 2015.
  2. Data on file. Forest Laboratories, LLC.