DIFICID®

(fidaxomicin) tablets, for oral use

Safety 

Adverse reactions

Adverse reaction rates for DIFICID were similar to vancomycin in two Phase 3, randomized, double-blind, noninferiority trials

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%).

Adverse reactions with an incidence ≥2% in the DIFICID pivotal trials


DIFICID
(n=564) 
n (%)

Vancomycin
(n=583) 
n (%) 

Blood and lymphatic system disorders
Anemia 14 (2%) 12 (2%)
Neutropenia 14 (2%) 6 (1%)
Gastrointestinal disorders
Nausea 62 (11%) 66 (11%)
Vomiting 41 (7%) 37 (6%)
Abdominal pain 33 (6%) 23 (4%)
Gastrointestinal hemorrhage 20 (4%) 12 (2%)

Discontinuation rates

Among patients receiving DIFICID, 33 (5.9%) withdrew from trials as a result of adverse reactions. Vomiting was the primary adverse reaction leading to discontinuation of dosing (incidence of 0.5% for DIFICID and vancomycin patients).

Indication

DIFICID is a macrolide antibacterial drug indicated in adults (≥18 years of age) for treatment of Clostridium difficile-associated diarrhea (CDAD). 

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 C. difficile.

Selected Safety Information

  • DIFICID is contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in DIFICID.
  • DIFICID should only be used for the treatment of C. difficile-associated diarrhea. DIFICID is not effective for treatment of other types of infections due to minimal systemic absorption of fidaxomicin.
  • Acute hypersensitivity reactions, including dyspnea, rash pruritus, and angioedema of the mouth, throat, and face have been reported with fidaxomicin. If a severe hypersensitivity reaction occurs, DIFICID should be discontinued and appropriate therapy should be instituted.
  • 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 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%).
  • Among patients receiving DIFICID, 33 (5.9%) withdrew from trials as a result of adverse reactions. Vomiting was the primary adverse reaction leading to discontinuation of dosing (incidence of 0.5% for both DIFICID and vancomycin patients).
  • The safety and effectiveness of DIFICID in patients <18 years of age have not been established.
  • The recommended dose of DIFICID is one 200 mg tablet orally twice daily for 10 days, with or without food.
  • No dose adjustment is recommended for patients ≥65 years of age.
  • No dose adjustment is recommended for patients with renal impairment.
  • No dosage adjustments are recommended when co-administering fidaxomicin with substrates of P-gp or CYP enzymes.
  • The impact of hepatic impairment on the pharmacokinetics of fidaxomicin has not been evaluated; however, because fidaxomicin and its active metabolite (OP-1118) do not appear to undergo significant hepatic metabolism, elimination of fidaxomicin and OP-1118 is not expected to be significantly affected by hepatic impairment.
Before prescribing DIFICID® (fidaxomicin), please read the Prescribing Information. The Patient Information also is available.
US-DIF-0022208/19