Product Dossier
DIFICID
Product Dossier for DIFICID (fidaxomicin, Merck Sharp & Dohme). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Merck Sharp & Dohme
- Active ingredient: fidaxomicin
- Therapeutic area: Infectious Disease
- Same area: RETROVIR
- Same area: Savacol Antiseptic Mouth & Throat Rinse
What it is
DIFICID contains fidaxomicin 200 mg as the active ingredient in film-coated tablets. The tablets are white to off-white, oblong, and debossed with "FDX" on one side and "200" on the other.
Approved indications
— Treatment of confirmed *Clostridium difficile* infection (CDI) in adults.
Dosing overview
The recommended dose is 200 mg (one tablet) administered twice daily (once every 12 hours) for 10 days. DIFICID can be taken before, during or after meals. No dose adjustment is recommended for elderly patients. No dose adjustment is recommended for patients with renal impairment, although DIFICID should be used with caution in patients with severe renal impairment. No dose adjustment is recommended for patients with hepatic impairment, although DIFICID should be used with caution in patients with moderate to severe hepatic impairment. Safety and efficacy in patients under 18 years of age have not been established, and DIFICID is not recommended for use in children.
Key safety warnings
Since there is minimal systemic absorption of fidaxomicin, DIFICID should not be used for the treatment of systemic infections. 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. Acute hypersensitivity reactions, such as dyspnoea, 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. Some patients with hypersensitivity reactions have reported a history of allergy to macrolides, and physicians prescribing DIFICID to patients with a known macrolide allergy should be aware of the possibility of hypersensitivity reactions.
Contraindications
DIFICID is contraindicated in patients who are hypersensitive to fidaxomicin or to any ingredient in the formulation or component of the container.
Regulatory history
DIFICID was approved by the TGA on 2013-04-18 for the treatment of confirmed *Clostridium difficile* infection (CDI) in adults. This approval followed a comprehensive evaluation with satisfactory quality, nonclinical, and clinical findings. ARTG registration 195623 for DIFICID fidaxomicin 200 mg tablets was first listed on 2013-04-23.