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ADULT DATA

Achieving the right therapeutic dose

TEFLARO® dosing recommendations in pediatric patients 2 months to <18 years of age with ABSSSI or CABP*1

Recommended dosage of TEFLARO in pediatric patients 2 months to <18 years based on age and weight1
Age Range Dosage and Frequency Infusion Time Recommended Duration of Treatment†
2 months to <2 years 8 mg/kg every 8 hours    
≥2 years to <18 years (≤33 kg) 12 mg/kg every 8 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    
Recommended dosage of TEFLARO in pediatric patients 2 months to
<18 years is based on age
and weight1
Age Range
2 months to <2 years
Dosage and Frequency Infusion Time Recommended Duration of Treatment†
8 mg/kg every 8 hours 5 to 60 minutes 5 to 14 days
≥2 years to <18 years (≤33 kg)
Dosage and Frequency Infusion Time Recommended Duration of Treatment†
12 mg/kg every 8 hours 5 to 60 minutes 5 to 14 days
≥2 years to <18 years (>33 kg)
Dosage and Frequency Infusion Time Recommended Duration of Treatment†
400 mg every 8 hours or 600 mg every 12 hours 5 to 60 minutes 5 to 14 days

For patients with CrCl >50 mL/min/1.73 m2.

Duration of therapy guided by the severity and site of infection and the patient's clinical and bacteriological progress.1

There is insufficient information to recommend a dosage regimen for pediatric patients with CrCl ≤50 mL/min/1.73 m2.‡1

CrCl estimated using the Schwartz equation.

TEFLARO® dosing recommendations in pediatric patients less than 2 months of age with ABSSSI§1

Recommended dosage of TEFLARO in pediatric patients less than 2 months based on age and weight§1
Age Range Dosage and Frequency Infusion Time Recommended Duration of Treatment†
0§ to <2 months 6 mg/kg every 8 hours 30 to 60 minutes 5-14 days
Recommended dosage of TEFLARO in pediatric patients less than 2 months based on age and weight§1
Age Range
0§ to <2 months
Dosage and Frequency Infusion Time Recommended Duration of Treatment†
6 mg/kg every 8 hours 30 to 60 minutes 5-14 days

Duration of therapy guided by the severity and site of infection and the patient's clinical and bacteriological progress.1

Gestational age 34 weeks and older and postnatal age
12 days and older.

Flexible infusion time1

A 5 TO 60 MINUTE INFUSION ALLOWS INCREASED FLEXIBILITY OF INFUSION TIME1

STRAIGHTFORWARD ADMINISTRATION1

  • No drug-level monitoring required
  • No need to monitor CPK levels
  • No refrigeration required for TEFLARO vials
  • Can be used with the Baxter® Mini-Bag Plus™ System

Unreconstituted TEFLARO vials should be stored at room temperature, 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

Please see individual product label for storage instructions and product expiration date.

NO KNOWN DRUG-DRUG INTERACTIONS1

  • No clinical drug-drug interaction studies have been conducted with TEFLARO
  • There is a 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

CPK=creatine phosphokinase.

Standard preparation of solutions1
Step 1 Step 2

Aseptic technique must be followed in preparing the infusion solution. The contents of a TEFLARO vial should be constituted with 20 mL of one of the following:

  • Sterile Water for Injection, USP
  • 0.9% Sodium Chloride Injection, USP (normal saline)
  • 5% Dextrose Injection, USP
  • Lactated Ringer's Injection, USP
  • Constitution time is less than 2 minutes. Mix gently to constitute and check to see that the contents have dissolved completely

The constituted solution must be further diluted in a range between 50 mL* to 250 mL before intravenous infusion into patients. Use the same diluent used for constitution of the powder for this further dilution, unless sterile water for injection was used earlier. If sterile water for injection was used earlier, then appropriate infusion solutions include:

  • 0.9% Sodium Chloride Injection, USP (normal saline)
  • 5% Dextrose Injection, USP
  • 2.5% Dextrose Injection, USP, and 0.45% Sodium Chloride Injection, USP
  • Lactated Ringer's Injection, USP
Standard preparation of solutions1
Step 1

Aseptic technique must be followed in preparing the infusion solution. The contents of a TEFLARO vial should be constituted with 20 mL of one of the following:

  • Sterile Water for Injection, USP
  • 0.9% Sodium Chloride Injection, USP (normal saline)
  • 5% Dextrose Injection, USP
  • Lactated Ringer's Injection, USP
  • Constitution time is less than 2 minutes. Mix gently to constitute and check to see that the contents have dissolved completely
Step 2

The constituted solution must be further diluted in a range between 50 mL* to 250 mL before intravenous infusion into patients. Use the same diluent used for constitution of the powder for this further dilution, unless sterile water for injection was used earlier. If sterile water for injection was used earlier, then appropriate infusion solutions include:

  • 0.9% Sodium Chloride Injection, USP (normal saline)
  • 5% Dextrose Injection, USP
  • 2.5% Dextrose Injection, USP, and 0.45% Sodium Chloride Injection, USP
  • Lactated Ringer's Injection, USP

Only for the 50 mL infusion bags dilution:

  • Preparation of 600 mg of TEFLARO dose in 50 mL infusion bag (for adult patients): 1) Withdraw 20 mL of diluent from the infusion bag. 2) Proceed to inject entire content of the TEFLARO vial into the bag to provide a total volume of 50 mL. The resultant concentration is approximately 12 mg/mL.
  • Preparation of 400 mg of TEFLARO dose in 50 mL infusion bag (for adult patients or pediatric patients weighing >33 kg): 1) Withdraw 20 mL of diluent from the infusion bag. 2) Proceed to inject entire content of the TEFLARO vial into the bag to provide a total volume of 50 mL. The resultant concentration is approximately 8 mg/mL.
  • The amount of solution withdrawn from the constituted TEFLARO vial for pediatric patients weighing ≤33 kg for dilution in the infusion bag will vary according to the weight and age of the child. Preparation of TEFLARO does in the infusion bag (for pediatric patients weighing ≤33 kg): The infusion solution concentration for administration should not exceed 12 mg/mL ceftaroline fosamil.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit
  • The color of TEFLARO infusion solutions ranges from clear, light to dark yellow depending on the concentration and storage conditions
  • The resulting solution should be administered over 5 to 60 minutes
  • The constituted solution in the infusion bag should be used within 6 hours when stored at room temperature or within 24 hours when stored under refrigeration at 2° to 8°C (36° to 46°F)
  • The compatibility of TEFLARO with other drugs has not been established. TEFLARO should not be mixed with or physically added to solutions containing other drugs

USP=U.S. Pharmacopeial Convention.

For complete instructions on how to prepare TEFLARO for administration, please see full Prescribing Information.

Next: Safety Profile

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INDICATIONS AND USAGE

IMPORTANT SAFETY INFORMATION

Contraindications

Warnings and Precautions

Hypersensitivity Reactions

Clostridioides difficile-Associated Diarrhea

Neurological Adverse Reactions

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.

References:
  1. TEFLARO® (ceftaroline fosamil) [prescribing information]. Allergan USA, Inc.
  2. Elixhauser A, Owens P. Reasons for being admitted to the hospital through the emergency department, 2003. Healthcare Cost and Utilization Project Statistical Brief #2. February 2006. Agency for Healthcare Research and Quality, Rockville, MD. http://www.hcup-us.ahrq.gov/reports/statbriefs/sb2.pdf. Accessed February 7, 2020.
  3. FDA Guidance ABSSSI. Guidance for industry: acute bacterial skin and skin structure infections: developing drugs for treatment. October 2013. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm071185.pdf. Accessed February 7, 2020.
  4. Data on file. Allergan, Inc.
  5. Corey GR, Wilcox M, Talbot GH, et al. Integrated analysis of CANVAS 1 and 2: phase 3, multicenter, randomized, double-blind studies to evaluate the safety and efficacy of ceftaroline versus vancomycin plus aztreonam in complicated skin and skin-structure infection. Clin Infect Dis. 2010;51(6):641-650.
  6. Friedland HD, O'Neal T, Biek D, et al. CANVAS 1 and 2: analysis of clinical response at day 3 in two phase 3 trials of ceftaroline fosamil versus vancomycin plus aztreonam in treatment of acute bacterial skin and skin structure infections. Antimicrob Agents Chemother. 2015;56(5):2231-2236.
  7. Eckburg PB, Friedland HD, Llorens L, et al. Day 4 clinical response of ceftaroline fosamil versus ceftriaxone for community-acquired bacterial pneumonia. Infect Dis Clin Pract. 2012;20:254-260.
  8. File TM Jr, Low DE, Eckburg PB, et al. Integrated analysis of FOCUS 1 and FOCUS 2: randomized, double-blinded, multicenter phase 3 trials of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in patients with community-acquired pneumonia. Clin Infect Dis. 2010;51(12):1395-1405.

TEFLARO® and its design are registered trademarks of Allergan Sales, LLC, an AbbVie company.

© 2023 AbbVie. All rights reserved. US-TEF-230028 06/23

This site is intended for U.S. healthcare professionals only. If you are a patient, and have any questions, please discuss them with your doctor or healthcare professional. For additional information about TEFLARO, call AbbVie Medical Information at 1.800.678.1605.

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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.

Clostridioides difficile-Associated Diarrhea

  • Clostridioides 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.

Neurological Adverse Reactions

  • Neurological adverse reactions have been reported during postmarketing surveillance in patients treated with cephalosporins, including TEFLARO. These reactions include encephalopathy and seizures. 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.

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 or a prophylactic indication 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 of TEFLARO for the treatment of ABSSSI in pediatric patients less than 34 weeks gestational age and less than 12 days postnatal age have not been established. Safety and effectiveness for the treatment of CABP 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 ≤30mL/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.