DIFICID®

(fidaxomicin) tablets, for oral use

Dosing

Twice-daily oral dosing

  • 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.

1 tablet (200 mg)

200 mg DIFICID® (fidaxomicin) Tablet

Not actual size.

Twice daily, orally, with or without food

The Recommended Dose of DIFICID® (fidaxomicin) is One 200-mg Tablet Orally Twice Daily for 10 Days, With or Without Food

10 days duration

Recommended Ten Day Duration for Dosing

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 with hypersensitivity to fidaxomicin.
  • DIFICID should not be used for systemic infections.
  • 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.
AINF-1245964-000007/18