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 CABP and ABSSSI due to designated susceptible bacteria, as described below.

TEFLARO®: Proven Effective in Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

CAUSED BY SUSCEPTIBLE BACTERIA

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

TEFLARO ABSSSI Study Designs1,2
Type of trial: Two identical randomized, multicenter, multinational, double-blind, noninferiority trials
Study population: 1396 adults with clinically documented complicated skin and skin structure infection
Comparative agents: TEFLARO — 600 mg administered IV over 1 hour every 12 hours for 5-14 days;
Vancomycin plus aztreonam — 1g vancomycin administered IV over 1 hour followed by 1g aztreonam administered IV over 1 hour every 12 hours for 5-14 days
Treatment duration: Treatment duration was 5 to 14 days. A switch to oral therapy was not allowed
TEFLARO Study Populations
Day 4 Population* The analysis evaluated patients with lesion size ≥75 cm2 and having one of the following infection types:
— Major abscess with ≥5 cm of surrounding erythema
— Wound infection
— Deep/extensive cellulitis
Test of Cure (TOC) Populations
MITT Modified Intent-to-treat All randomized subjects who received any amount of study drug.
CE Clinically Evaluable Patients in the MITT population who demonstrated sufficient adherence to the protocol. Sufficient adherence is defined as patients who met the minimal clinical disease criteria for cSSSI and all evaluability criteria, including subjects who received at least the pre-specified minimal amount of the intended dose and duration of study drug therapy, for which sufficient information regarding the cSSSI site is available to determine the subject's outcome, and for which there were no confounding factors that interfered with the assessment of that outcome.
ME Microbiologically Evaluable This population consists of a subset of subjects from the CE population who had at least one bacterial pathogen identified from a blood culture or culture of an adequate microbiological sample obtained from the cSSSI site at the baseline and who had susceptibility testing performed on at least one of the isolated baseline pathogens.

*To evaluate the treatment effect of ceftaroline, an analysis was conducted in 797 patients with ABSSSI (such as deep/extensive cellulitis or a wound infection [surgical or traumatic]) for whom the treatment effect of antibacterials may be supported by historical evidence. This analysis evaluated responder rates based on achieving both cessation of lesion spread and absence of fever on Trial Day 3.

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

absssi studydesign
News

TEFLARO is included in CMS*/Joint Commission Core Measures.

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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
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AWARE 2011 Surveillance Study

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INDICATIONS AND USAGE
  • 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.
  • TEFLARO is also 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.
  • 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.
IMPORTANT SAFETY INFORMATION
Contraindications
  • 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 antibacterials. Before therapy with TEFLARO is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or carbapenems should be made. If this product is to be given to a penicillin- or other beta-lactam-allergic patient, caution should be exercised because cross sensitivity among beta-lactam antibacterial agents has been clearly established.
  • If an allergic reaction to TEFLARO occurs, the drug should be discontinued. Serious acute hypersensitivity (anaphylactic) reactions require emergency treatment with epinephrine and other emergency measures that may include airway management, oxygen, intravenous fluids, antihistamines, corticosteroids, and vasopressors as clinically indicated.
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 events 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 events 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 events 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.

References:

  1. TEFLARO (ceftaroline fosamil) [prescribing information]. St Louis, MO: Forest Pharmaceuticals, Inc.
  2. Data on file. Forest Laboratories, Inc.