- 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.
DIFICID®
(fidaxomicin) tablets, for oral use
Selected Safety Information
DIFICID®
US-DIF-0022208/19