Now recommended in updated IDSA/SHEA* guidelines for adult patients with Clostridium difficile infection (CDI)¹

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.