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.
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
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
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
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%).
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
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.