Teflaro
(Ceftaroline Fosamil)Dosage & Administration
The recommended dosage of Teflaro is 600 mg administered every 12 hours by intravenous (IV) infusion over 5 to 60 minutes 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.
In dication | Dosage | Frequency | Infusion Time | Recommended Duration of Treatment |
| Acute Bacterial Skin and Skin Structure Infections (ABSSSI) | 600 mg | Every 12 hours | 5 to 60 minutes | 5-14 days |
| Community-Acquired Bacterial Pneumonia (CABP) | 600 mg | Every 12 hours | 5 to 60 minutes | 5-7 days |
The recommended dosage of Teflaro in pediatric patients is based on the age and weight of the child. The duration of therapy should be guided by the severity, site of infection and the patient’s clinical and bacteriological progress.
Indication | Age Range | Dosage and Frequency | Infusion time | Recommended Duration of Treatment |
| Acute Bacterial Skin and Skin Structure Infections (ABSSSI) OR Community-Acquired Bacterial Pneumonia (CABP) | 2 months to < 2 years | 8 mg/kg every 8 hours | 5 to 60 minutes | 5-14 days |
> 2 years to < 18 years (< 33 kg) | 12 mg/kg every 8 hours | |||
> 2 years to < 18 years (> 33 kg) | 400 mg every 8 hours OR 600 mg every 12 hours |
Indication | Age Range | Dosage and Frequency | Infusion time | Recommended Duration of Treatment |
| Acute Bacterial Skin and Skin Structure Infections (ABSSSI) | 0* to < 2 months | 6 mg/kg every 8 hours | 30 to 60 minutes | 5-14 days |
*Gestational age 34 weeks and older and postnatal age 12 days and older.
Indication | Age Range | Dosage | Infusion Time | Duration |
| Acute Bacterial Skin and Skin Structure Infections (ABSSSI) | 18 years and older | 600 mg every 12 hours | 5 to 60 minutes | 5 to 14 days |
| ≥2 years to < 18 years (> 33 kg) | 400 mg every 8 hours OR 600 mg every 12 hours | 5 to 60 minutes | 5 to 14 days | |
| ≥2 years to < 18 years (≤ 33kg) | 12 mg/kg every 8 hours | 5 to 60 minutes | 5 to 14 days | |
| 2 months to < 2 years | 8 mg/kg every 8 hours | 5 to 60 minutes | 5 to 14 days | |
| 0* to < 2 months | 6 mg/kg every 8 hours | 30 to 60 minutes | 5 to 14 days |
*Gestational age 34 weeks and older and postnatal age 12 days and older
Indication | Age Range | Dosage | Infusion Time | Duration |
| Community Acquired Bacterial Pneumonia (CABP) | 18 years and older | 600 mg every 12 hours | 5 to 60 minutes | 5 to 7 days |
| ≥2 years to < 18 years (> 33 kg) | 400 mg every 8 hours OR 600 mg every 12 hours | 5 to 60 minutes | 5 to 14 days | |
| ≥2 years to < 18 years (≤ 33kg) | 12 mg/kg every 8 hours | 5 to 60 minutes | 5 to 14 days | |
| 2 months to < 2 years | 8 mg/kg every 8 hours | 5 to 60 minutes | 5 to 14 days |
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Teflaro Prescribing Information
Teflaro is a cephalosporin antibacterial indicated in adult and pediatric patients for the treatment of the following infection caused by designated susceptible bacteria:
- Acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) ()1.1Acute Bacterial Skin and Skin Structure Infections
Teflaro is indicated in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) 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[see Dosage and Administration (2.2) and Use in Specific Populations (8.4)]. - Community-acquired bacterial pneumonia (CABP) in adult and pediatric patients 2 months of age and older ()1.2Community-Acquired Bacterial Pneumonia
Teflaro is 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,andEscherichia coli.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Teflaro and other antibacterial drugs, Teflaro should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Teflaro and other antibacterial drugs, Teflaro should be used to treat or prevent infections 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.
The recommended dosage of Teflaro is 600 mg administered every 12 hours by intravenous (IV) infusion over 5 to 60 minutes 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.
In dication | Dosage | Frequency | Infusion Time | Recommended Duration of Treatment |
| Acute Bacterial Skin and Skin Structure Infections (ABSSSI) | 600 mg | Every 12 hours | 5 to 60 minutes | 5-14 days |
| Community-Acquired Bacterial Pneumonia (CABP) | 600 mg | Every 12 hours | 5 to 60 minutes | 5-7 days |
The recommended dosage of Teflaro in pediatric patients is based on the age and weight of the child. The duration of therapy should be guided by the severity, site of infection and the patient’s clinical and bacteriological progress.
- For pediatric patients 2 months of age and older, Teflaro is administered every 8 hours by intravenous infusion over 5 to 60 minutes.
- Teflaro dosing regimen is dependent on the type of infection (ABSSSI, CABP). See dosing Table 2below.
Indication | Age Range | Dosage and Frequency | Infusion time | Recommended Duration of Treatment |
| Acute Bacterial Skin and Skin Structure Infections (ABSSSI) OR Community-Acquired Bacterial Pneumonia (CABP) | 2 months to < 2 years | 8 mg/kg every 8 hours | 5 to 60 minutes | 5-14 days |
> 2 years to < 18 years (< 33 kg) | 12 mg/kg every 8 hours | |||
> 2 years to < 18 years (> 33 kg) | 400 mg every 8 hours OR 600 mg every 12 hours |
- Teflaro is administered every 8 hours by intravenous infusion over 30 to 60 minutes for patients less than 2 months of age.
- Teflaro dosing regimen is only recommended for patients with ABSSSI. See dosing Table 3below.
- Concentrations of Teflaro in the cerebrospinal fluid have not been evaluated[see Use in Specific Populations (8.4)].
- There is no information for dosing Teflaro in infants less than 34 weeks gestational age and less than 12 days postnatal age.
Indication | Age Range | Dosage and Frequency | Infusion time | Recommended Duration of Treatment |
| Acute Bacterial Skin and Skin Structure Infections (ABSSSI) | 0* to < 2 months | 6 mg/kg every 8 hours | 30 to 60 minutes | 5-14 days |
*Gestational age 34 weeks and older and postnatal age 12 days and older.
Indication | Age Range | Dosage | Infusion Time | Duration |
| Acute Bacterial Skin and Skin Structure Infections (ABSSSI) | 18 years and older | 600 mg every 12 hours | 5 to 60 minutes | 5 to 14 days |
| ≥2 years to < 18 years (> 33 kg) | 400 mg every 8 hours OR 600 mg every 12 hours | 5 to 60 minutes | 5 to 14 days | |
| ≥2 years to < 18 years (≤ 33kg) | 12 mg/kg every 8 hours | 5 to 60 minutes | 5 to 14 days | |
| 2 months to < 2 years | 8 mg/kg every 8 hours | 5 to 60 minutes | 5 to 14 days | |
| 0* to < 2 months | 6 mg/kg every 8 hours | 30 to 60 minutes | 5 to 14 days |
*Gestational age 34 weeks and older and postnatal age 12 days and older
Indication | Age Range | Dosage | Infusion Time | Duration |
| Community Acquired Bacterial Pneumonia (CABP) | 18 years and older | 600 mg every 12 hours | 5 to 60 minutes | 5 to 7 days |
| ≥2 years to < 18 years (> 33 kg) | 400 mg every 8 hours OR 600 mg every 12 hours | 5 to 60 minutes | 5 to 14 days | |
| ≥2 years to < 18 years (≤ 33kg) | 12 mg/kg every 8 hours | 5 to 60 minutes | 5 to 14 days | |
| 2 months to < 2 years | 8 mg/kg every 8 hours | 5 to 60 minutes | 5 to 14 days |
- Dosage adjustment is required in adult patients with creatinine clearance (CrCl) < 50 mL/min and in End-stage Renal Disease (ESRD) including hemodialysis ()2.000000000000000e+003DosageAdjustmentsinPatients with Renal ImpairmentAdults:No dosage adjustment is required in adult patients with CrCL > 50 mL/min. The dose in adult patients should be adjusted when creatinine clearance (CrCL) is<50 mL/min as shown below (see Table 4).
Table 4: Dosage of Teflaro in Adult Patients with Renal Impairment Estimated CrCla(mL/min)Recommended Dosage Regimen for Teflaro> 50 No dosage adjustment necessary > 30 to ≤ 50 400 mg IV (over 5 to 60 minutes) every 12 hours ≥ 15 to ≤ 30 300 mg IV (over 5 to 60 minutes) every 12 hours End-stage renal disease,
including hemodialysisb200 mg IV (over 5 to 60 minutes) every 12 hoursc aCreatinine clearance (CrCl) estimated using the Cockcroft-Gault formula.
bEnd-stage renal disease is defined as CrCl < 15 mL/min.
cTeflaro is hemodialyzable; thus Teflaro should be administered after hemodialysis on hemodialysis days.
Pediatrics:No dosage adjustment is required in pediatric patients with CrCL > 50 mL/min/1.73 m2, estimated using the Schwartz equation. There is insufficient information to recommend a dosage regimen for pediatric patients with CrCL < 50 mL/min/1.73 m2. - There is insufficient information to recommend a dosage regimen for pediatric patients with CrCL < 50 mL/min/1.73 m2 ()2.000000000000000e+003DosageAdjustmentsinPatients with Renal ImpairmentAdults:No dosage adjustment is required in adult patients with CrCL > 50 mL/min. The dose in adult patients should be adjusted when creatinine clearance (CrCL) is<50 mL/min as shown below (see Table 4).
Table 4: Dosage of Teflaro in Adult Patients with Renal Impairment Estimated CrCla(mL/min)Recommended Dosage Regimen for Teflaro> 50 No dosage adjustment necessary > 30 to ≤ 50 400 mg IV (over 5 to 60 minutes) every 12 hours ≥ 15 to ≤ 30 300 mg IV (over 5 to 60 minutes) every 12 hours End-stage renal disease,
including hemodialysisb200 mg IV (over 5 to 60 minutes) every 12 hoursc aCreatinine clearance (CrCl) estimated using the Cockcroft-Gault formula.
bEnd-stage renal disease is defined as CrCl < 15 mL/min.
cTeflaro is hemodialyzable; thus Teflaro should be administered after hemodialysis on hemodialysis days.
Pediatrics:No dosage adjustment is required in pediatric patients with CrCL > 50 mL/min/1.73 m2, estimated using the Schwartz equation. There is insufficient information to recommend a dosage regimen for pediatric patients with CrCL < 50 mL/min/1.73 m2.
For Injection: Teflaro is supplied as 600 mg or 400 mg of pale yellowish-white to light yellow sterile ceftaroline fosamil (equivalent to 668 mg and 446 mg, respectively, of ceftaroline fosamil monoacetate monohydrate) powder in single-dose, 20 mL clear glass vials. The powder is constituted and further diluted for intravenous injection.
There are no adequate studies with Teflaro in pregnant women that informed any drug associated risks. The background risk of major birth defects and miscarriage for the indicated population is unknown. The background risk of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies within the general population.
In developmental toxicity studies conducted in animals, no malformations or other adverse developmental effects were observed in offspring of rats exposed to Teflaro at up to 4 times the maximum recommended human dose (MRHD) during the period of organogenesis through lactation. In rabbits exposed to Teflaro during organogenesis at levels approximately equal to the MRHD, no drug-induced fetal malformations were observed despite maternal toxicity.
Developmental toxicity studies performed with ceftaroline fosamil in rats at IV doses up to 300 mg/kg demonstrated no maternal toxicity and no effects on the fetus. A separate toxicokinetic study showed that ceftaroline exposure in rats (based on AUC) at this dose level was approximately 4 times the exposure in humans given 600 mg every 12 hours. There were no drug-induced malformations in the offspring of rabbits given IV doses of 25, 50, and 100 mg/kg, despite maternal toxicity. Signs of maternal toxicity appeared secondary to the sensitivity of the rabbit gastrointestinal system to broad-spectrum antibacterials and included changes in fecal output in all groups and dose-related reductions in body weight gain and food consumption at > 50 mg/kg; these were associated with an increase in spontaneous abortion at 50 and 100 mg/kg. The highest dose was also associated with maternal moribundity and mortality. An increased incidence of a common rabbit skeletal variation, angulated hyoid alae, was also observed at the maternally toxic doses of 50 and 100 mg/kg. A separate toxicokinetic study showed that ceftaroline exposure in rabbits (based on AUC) was approximately 0.4 times the exposure in humans given 600 mg every 12 hours at 25 mg/kg and 0.7 times the human exposure at 50 mg/kg.
Ceftaroline fosamil did not affect the postnatal development or reproductive performance of the offspring of rats given IV doses up to 450 mg/kg/day. Results from a toxicokinetic study conducted in pregnant rats with doses up to 300 mg/kg suggest that exposure was ≥ 4 times the exposure in humans given 600 mg every 12 hours.
Teflaro is contraindicated in patients with known serious hypersensitivity to ceftaroline or other members of the cephalosporin class. Anaphylaxis has been reported with ceftaroline.
- Serious hypersensitivity (anaphylactic) reactions have been reported with beta-lactam antibacterial drugs, including Teflaro. If a hypersensitivity reaction occurs, discontinue Teflaro. ()5.1Hypersensitivity Reactions
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving 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.
- Clostridioidesdifficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including Teflaro. Evaluate if diarrhea occurs. ()5.2Clostridioidesdifficile-AssociatedDiarrheaClostridioidesdifficile-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.
Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of
C. difficile.C. difficileproduces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains ofC. difficilecause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. 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. difficileshould be discontinued, if possible. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment ofC. difficile, and surgical evaluation should be instituted as clinically indicated[see Adverse Reactions (6.1)]. - Neurological adverse reactions have been reported in patients treated with cephalosporins, including Teflaro. If neurological adverse reactions occur, consider discontinuing Teflaro or making appropriate dosage adjustments in patients with renal impairment. (,2.000000000000000e+003DosageAdjustmentsinPatients with Renal ImpairmentAdults:No dosage adjustment is required in adult patients with CrCL > 50 mL/min. The dose in adult patients should be adjusted when creatinine clearance (CrCL) is<50 mL/min as shown below (see Table 4).
Table 4: Dosage of Teflaro in Adult Patients with Renal Impairment Estimated CrCla(mL/min)Recommended Dosage Regimen for Teflaro> 50 No dosage adjustment necessary > 30 to ≤ 50 400 mg IV (over 5 to 60 minutes) every 12 hours ≥ 15 to ≤ 30 300 mg IV (over 5 to 60 minutes) every 12 hours End-stage renal disease,
including hemodialysisb200 mg IV (over 5 to 60 minutes) every 12 hoursc aCreatinine clearance (CrCl) estimated using the Cockcroft-Gault formula.
bEnd-stage renal disease is defined as CrCl < 15 mL/min.
cTeflaro is hemodialyzable; thus Teflaro should be administered after hemodialysis on hemodialysis days.
Pediatrics:No dosage adjustment is required in pediatric patients with CrCL > 50 mL/min/1.73 m2, estimated using the Schwartz equation. There is insufficient information to recommend a dosage regimen for pediatric patients with CrCL < 50 mL/min/1.73 m2.)5.3Neurological Adverse ReactionsNeurological adverse reactions have been reported during postmarketing surveillance in patients treated with cephalosporins, including Teflaro. These reactions include encephalopathy and seizures
[see Adverse Reactions (6.2)]. Most cases occurred in patients with renal impairment who did not receive appropriate dosage adjustment. The neurological adverse reactions were reversible and resolved after discontinuation of Teflaro or after hemodialysis. If neurological adverse reactions associated with Teflaro therapy occur, consider discontinuing Teflaro or making appropriate dosage adjustments in patients with renal impairment[see Dosage and Administration (2.3)]. - 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. ()5.4Direct Coombs’Test Seroconversion
Seroconversion from a negative to a positive direct Coombs’ test result occurred in 120/1114 (10.8%) of adult patients receiving Teflaro and 49/1116 (4.4%) of patients receiving comparator drugs in the four pooled adult Phase 3 trials.
In the pooled adult Phase 3 CABP trials, 51/520 (9.8%) of Teflaro-treated patients compared to 24/534 (4.5%) of ceftriaxone-treated patients seroconverted from a negative to a positive direct Coombs’ test result. No adverse reactions representing hemolytic anemia were reported in any treatment group.
Seroconversion from a negative to a positive direct Coombs’ test result occurred in 42/234 (17.9%) of children 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. Diagnostic studies including a direct Coombs’ test, should be performed. If drug-induced hemolytic anemia is suspected, discontinuation of Teflaro should be considered and supportive care should be administered to the patient (i.e. transfusion) if clinically indicated.