• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Teflaro (ceftaroline fosamil)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Teflaro (ceftaroline fosamil)

  • Profile

Profile

Contact Information

Contact: Abbvie
Website: https://telfaro.com/

Currently Enrolling Trials

    Show More

    General Information

    Teflaro is specifically indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of applicable Gram-positive and Gram-negative microorganisms and for the treatment of community-acquired bacterial pneumonia caused by susceptible isolates of the applicable Gram-positive and Gram-negative microorganisms.

    Mechanism of Action

    Teflaro is a cephalosporin antibiotic with in vitro activity against Gram-positive and -negative bacteria. The bactericidal action of Ceftaroline is mediated through binding to essential penicillin-binding proteins (PBPs). Ceftaroline is bactericidal against S. aureus due to its affinity for PBP2a and against streptococcus pneumoniae due to its affinity for PBP2x.

    Side Effects

    Adverse events associated with the use of Teflaro may include, but are not limited to, the following:

    • Diarrhea
    • Nausea
    • Rash

    Dosing/Administration

    Teflaro is supplied as 600 mg or 400 mg of sterile powder for reconstitution into a solution designed for intravenous administration. The recommended dosage of Teflaro is 600 mg administered every 12 hours by intravenous (IV) infusion over one hour 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.

    Clinical Trial Results


    FDA approval of Teflaro was based on the following trials:

    Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

    Two identical randomized, multi-center, multinational, double-blind, noninferiority trials (trials One and Two) enrolled 1,396 adults with clinically documented complicated ABSSSI. The subjects received Teflaro (600 mg administered IV over one hour every 12 hours) or vancomycin plus aztreonam (1 g vancomycin administered IV over one hour followed by 1 g aztreonam administered IV over one hour every 12 hours). Treatment duration was five to 14 days. Trial One: at study day three in the Teflaro arm, 74 percent of the subjects were clinical responders, while 64.6 percent of subjects in the vancomycin plus aztreonam arm were clinical responders. Trial Two: at study day three in the Teflaro arm, 74 percent of the subjects were clinical responders, while 68.1 percent of subjects in the vancomycin plus aztreonam arm were clinical responders.

    Community-Acquired Bacterial Pneumonia (CABP)

    Two randomized, multi-center, multinational, double blind, noninferiority trials enrolled 1,231 adults. The trials were designed to compare Teflaro (600 mg administered IV over one hour every 12 hours) with ceftriaxone (1 g ceftriaxone administered IV over 30 minutes every 24 hours). In both treatment groups of Trial One, two doses of oral clarithromycin (500 mg every 12 hours) were administered as adjunctive therapy starting on study day one. No adjunctive macrolide therapy was used in CABP Trial Two. Treatment duration was five to seven days. The response rates at study day four (72-96 hours) were Trial One: Teflaro 69.6 percent responders and Ceftriaxone 58.3 percent responders, and Trial Two: Teflaro 69.0 percent responders and Ceftriaxone 61.4 percent responders.

    Additional Information

    For additional information regarding Teflaro or bacterial infections, please visit the Teflaro web page.

    Approval Date: 2010-11-01
    Company Name: Cerexa
    Back to Listings

    Upcoming Events

    • 16Feb

      Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

    • 21May

      WCG MAGI Clinical Research Conference – 2023 East

    Featured Products

    • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

      Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    Featured Stories

    • SurveywBlueBackground-360x240.png

      Sites Name Tech Acceptance as Essential Factor in Selection of Sponsors, Survey Finds

    • TrendsInsights2023-360x240.png

      WCG Clinical Research Trends and Insights for 2023, Part Two

    • TimeMoneyEffort-360x240.png

      Time is Money and So Is Effort, Budgeting Experts Say

    • TrendsInsights2023A-360x240.png

      WCG Clinical Research Trends and Insights for 2023, Part Three

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing