TEFLARO® Monotherapy: Efficacy Demonstrated at TOC

Test of Cure (TOC) Occurred 8 to 15 Days After the End of Therapy1

TEFLARO Demonstrated Efficacy at TOC* (CE) in Acute Bacterial Skin and Skin Structure Infections1
CANVAS 1
Treatment Difference -2.2%
(95% Cl: -6.6, 2.1)
TEFLARO
monotherapy
91.1%
(288/316)
Vancomycin
+ aztreonam
93.9%
(280/300)
CANVAS 2
Treatment Difference 0.1%
(95% Cl: -4.4, 4.5)
TEFLARO
monotherapy
92.2%
(271/294)
Vancomycin
+ aztreonam
92.1%
(269/292)

CI=confidence interval.   
Clinical cure rates, % (n/N)

Comparisons at TOC cannot be used to establish noninferiority.*

There are insufficient historical data to establish the magnitude of drug effect for antibacterial drugs compared with placebo at a TOC time point.

CANVAS=Ceftaroline vs Vancomycin in Skin and Skin Structure Infection. CANVAS 1=ABSSSI Trial 1, CANVAS 2=ABSSSI Trial 2.

Additional TOC Data from
CANVAS Trials:
90% (18/20) of TEFLARO patients
with baseline S. aureus bacteremia
demonstrated clinical success
at TOC1
Efficacy at TOC for ABSSSI caused by MRSA1
93.4%
(142/152)
TEFLARO
monotherapy
94.3%
(115/122)
Vancomycin
+ aztreonam

Pooled clinical cure rates in ME patients, % (n/N)

Comparisons at TOC cannot be used to establish noninferiority.*

Monotherapy efficacy proven at TOC against the most common pathogens in ABSSSI1
  Pooled clinical cure rates in ME patients, % (n/N)
Pathogen TEFLARO Vancomycin + aztreonam
Gram-positive    
MSSA 93.0 (212/228) 94.5 (225/238)
MRSA 93.4 (142/152) 94.3 (115/122)
S. pyogenes 100.0 (56/56) 96.6 (56/58)
S. agalactiae 95.5 (21/22) 100.0 (18/18)
Gram-negative    
E. coli 95.2 (20/21) 90.5 (19/21)
K. pneumoniae 94.4 (17/18) 92.9 (13/14)
K. oxytoca 83.3 (10/12) 100.0 (6/6)

Comparisons at TOC cannot be used to establish noninferiority.*

Monotherapy efficacy proven at TOC against the most common pathogens in ABSSSI1
Pooled clinical cure rates in ME patients, % (n/N)
TEFLARO Monotherapy Vancomycin + aztreonam
Pathogen
Gram-positive
MSSA
93.0 (212/228) 94.5 (225/238)
MRSA
93.4 (142/152) 94.3 (115/122)
S. pyogenes
100.0 (56/56) 96.6 (56/58)
S. agalactiae
95.5 (21/22) 100.0 (18/18)
Gram-negative
E. coli
95.2 (20/21) 90.5 (19/21)
K. pneumoniae
94.4 (17/18) 92.9 (13/14)
K. oxytoca
83.3 (10/12) 100.0 (6/6)

Comparisons at TOC cannot be used to establish noninferiority.*

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.

Next: Patient Case Studies

ABSSSI Patient Cases See Patient Case

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

Dosing

The 5-60 minute infusion allows increased flexibility of infusion time

SEE DOSING
INDICATIONS AND USAGE
  • TEFLARO® (ceftaroline fosamil) 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.
  • TEFLARO is also 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.

IMPORTANT SAFETY INFORMATION

Contraindications

Warnings and Precautions

Hypersensitivity Reactions

Clostridium difficile-Associated Diarrhea

Direct Coombs' Test Seroconversion

Development of Drug-Resistant Bacteria

Adverse Reactions in Adults

Adverse Reactions in Pediatrics

Drug Interactions

Use in Specific Populations

Please also see full Prescribing Information.

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IMPORTANT SAFETY INFORMATION

Contraindications

  • TEFLARO is contraindicated in patients with known serious hypersensitivity to ceftaroline or other members of the cephalosporin class. Anaphylaxis has 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 clinical 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

  • In adults, 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 adult Phase 3 trials.
  • In children, seroconversion from a negative to a positive direct Coombs' test result occurred in 42/234 (17.9%) of patients receiving TEFLARO and 3/93 (3.2%) of patients receiving comparator drugs in the three pooled pediatric 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 Adults

  • In the four pooled adult 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.
  • The most common adverse reactions occurring in >2% of patients receiving TEFLARO in the adult pooled Phase 3 clinical trials were diarrhea (5%) nausea (4%), and rash (3%).

Adverse Reactions in Pediatrics

  • In the three pooled pediatric clinical trials, serious adverse reactions occurred in 10/257 (4%) of patients receiving TEFLARO and 3/102 (3%) of patients receiving comparator drugs. Treatment discontinuation due to adverse reactions occurred in 10/257 (3.9%) of patients receiving TEFLARO and 2/102 (2%) of patients receiving comparator drugs with the most common adverse reaction leading to discontinuation being rash in 2/257 (0.8%) of patients treated with TEFLARO.
  • The most common adverse reactions occurring in ≥3% of patients receiving TEFLARO in the pooled pediatric clinical trials were diarrhea (8%), rash (7%), vomiting (5%), pyrexia (3%) and nausea (3%).

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

  • There have been no adequate and well-controlled studies with TEFLARO in pregnant or nursing women. TEFLARO should only be used if the potential benefit justifies the potential risk in these populations.
  • Safety and effectiveness in pediatric patients below the age of 2 months have not been established as no data are available.
  • 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 adult 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). There is insufficient information to recommend a dosage regimen for pediatric patients with CrCl <50 mL/min/1.73m2.
  • The pharmacokinetics of ceftaroline in patients with hepatic impairment have not been established.

Please also see full Prescribing Information.