DIFICID® is the first bactericidal therapy in more than 25 years that targets C. difficile1

DIFICID has primary activity against species of clostridia, including C. difficile in vitro1

  • Bactericidal against C. difficile in vitro1
  • Minimal inhibitory concentration (MIC90) = 0.25 μg/mL2,3
    • MIC range: 0.03-0.25 μg/mL1
  • Inhibits bacterial RNA polymerase1
  • Demonstrates no cross-resistance with other classes of antibacterial drugs in vitro1
  • Demonstrates a post-antibiotic effect versus C. difficile of 6-10 hours in vitro1

 

DIFICID ACTS LOCALLY IN THE
GASTROINTESTINAL TRACT1

 

DIFICID<sup>®</sup> ACTS LOCALLY IN THE GASTROINTESTINAL TRACT

 

DIFICID is mainly confined to the GI tract1

  • Acts locally in the gastrointestinal tract against C. difficile
  • Plasma concentrations were minimal, in the ng/mL range (ranging from 2-179 ng/mL within the Tmax window [1-5 hours])
  • Fecal concentrations in samples collected within 24 hrs of the last dose ranged from 639-2710 μg/g

 

Important Safety Information

  • DIFICID is contraindicated in patients with hypersensitivity to fidaxomicin
  • DIFICID should not be used for systemic infections
  • Acute hypersensitivity reactions (angioedema, dyspnea, pruritus, and rash) have been reported. In the event of a severe reaction, discontinue DIFICID.
  • Only use DIFICID for infection proven or strongly suspected to be caused by C. difficile.
    Prescribing DIFICID in the absence of a proven or strongly suspected C. difficile infection is unlikely to provide benefit to the patient and increases the risk of the development of drug- resistant bacteria.
  • The most common adverse reactions reported in clinical trials are nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia (2%), and neutropenia (2%)

 

Indications and Usage

  • DIFICID is a macrolide antibacterial drug indicated in adults ≥18 years of age for treatment of Clostridium difficile-associated diarrhea
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of DIFICID and other antibacterial drugs, DIFICID should be used only to treat infections that are proven or strongly suspected to be caused by Clostridium difficile

 

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