Fidaxomicin tablets launched for Clostridium difficile
Fidaxomicin tablets have been launched for the treatment of adults infected with Clostridium difficile.
Marketed by Astellas under the brand name Dificlir, the 200mg tablets are given twice daily for 10 days, with or without food. The drug has no contraindications, other than hypersensitivity, but should be used with caution in patients with severe kidney impairment, moderate-to-severe liver impairment, pseudomembranous colitis, and fulminant or life-threatening C difficile infection.
Caution is also advised when treating patients with inflammatory bowel disease, because of the risk of enhanced absorption and systemic adverse reactions.
Fidaxomicin is a substrate of P-glycoprotein and may be a mild-to-moderate inhibitor of the transporter protein in the intestine, the summary of product characteristics says.
Class: Macrocyclic antibacterial
Dose: 200mg twice daily
NHS list price: 20 x 200mg film-coated tablets, £1,350.00
Legal category: POM
In clinical trials, patients’ fidaxomicin exposure increased when the drug was co-administered with another P-glycoprotein inhibitor. Because the clinical relevance of this increase is unclear, fidaxomicin should not be co-administered with potent P-glycoprotein inhibitors, such as cyclosporine, ketoconazole, erythromycin, clarithromycin, verapamil, dronedarone and amiodarone.
Studies suggest that fidaxomicin treatment does not affect patients’ normal intestinal flora.
Citation: The Pharmaceutical Journal URI: 11102560
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