Presentation and Status in Health Basket
Film Coated Tablets
20 x 200 mg
Adults and older people (≥ 65 years of age): The recommended dose is 200 mg (one tablet) administered twice daily (once every 12 hours) for 10 days.
Paediatric population: The safety and efficacy of fidaxomicin in children aged below 18 years has not yet been established. No data are available.
Renal impairment: No dose adjustment is considered necessary. Due to the limited clinical data in this population, fidaxomicin should be used with caution in patients with severe renal impairment.
Hepatic impairment: No dose adjustment is considered necessary. Due to the limited clinical data in this population, fidaxomicin should be used with caution in patients with moderate to severe hepatic impairment.
Method of administration: The drug is intended for oral administration, can be taken with or without food.
Treatment of Clostridium difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD).
Hypersensitivity to the active substance or to any of the excipients.
Hypersensitivity reactions including severe angioedema have been reported. If a severe allergic reaction occurs during treatment with fidaxomicin, the medicinal product should be discontinued and appropriate measures taken.
Some patients with hypersensitivity reactions reported a history of allergy to macrolides. Fidaxomicin should be used with caution in patients with a known macrolides allergy. Due to limited clinical data, fidaxomicin should be used with caution in patients with severe renal impairment or moderate to severe hepatic impairment.
Due to limited clinical data, fidaxomicin should be used with caution in patients with severe renal impairment or moderate to severe hepatic impairment.
Due to limited clinical data, fidaxomicin should be used with caution in patients with pseudomembranous colitis, fulminant or life threatening CDI.
There are no data in patients with concomitant inflammatory bowel disease. Fidaxomicin should be used with caution in these patients due to the risk of enhanced absorption and potential risk of systemic adverse reactions.
Co-administration of potent P-glycoprotein inhibitors such as cyclosporine, ketoconazole, erythromycin, clarithromycin, verapamil, dronedarone and amiodarone is not recommended.
See prescribing information for full details.
The most common treatment related adverse reactions were vomiting (1.2%), nausea (2.7%) and constipation (1.2%).
See prescribing information for full details.
Effect of P-gp inhibitors on fidaxomicin: Fidaxomicin is a substrate of P-gp. Co-administration of single doses of the P-gp inhibitor cyclosporine A and DIFICLIR in healthy volunteers, resulted in a 4- and 2-fold increase in fidaxomicin Cmax and AUC, respectively and in a 9.5 and 4-fold increase in Cmax and AUC, respectively, of the main active metabolite OP-1118. As the clinical relevance of this increase in exposure is unclear, co-administration of potent inhibitors of P-gp, such as cyclosporine, ketoconazole, erythromycin, clarithromycin, verapamil, dronedarone and amiodarone are not recommended.
Effect of fidaxomicin on P-gp substrates: Fidaxomicin may be a mild to moderate inhibitor of intestinal P-gp.
DIFICLIR (200 mg twice daily) had a small but not clinically relevant effect on digoxin exposure. However, a larger effect on P-gp substrates with lower bioavailability more sensitive to intestinal P-gp inhibition such as dabigatran etexilat cannot be excluded.
Effect of fidaxomicin on other transporters: Fidaxomicin does not have a clinically significant effect on the exposure of rosuvastatin, a substrate for the transporters OATP2B1 and BCRP. Co-administration of 200 mg fidaxomicin twice daily with a single dose of 10 mg rosuvastatin to healthy subjects did not have an effect on the AUCinf of rosuvastatin. The Cmax of rosuvastatin increased by approx. 17%, indicating that an increase in the rate of absorption cannot be excluded.
Pregnancy and Lactation
Pregnancy: There are no data available from the use of fidaxomicin in pregnant women. Animal studies did not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of DIFICLIR during pregnancy.
Breast-feeding: It is unknown whether fidaxomicin and its metabolites are excreted in human milk. Although no effects on the breastfed newborns/infants are anticipated since the systemic exposure to fidaxomicin is low, a risk to the newborns/infants cannot be excluded. A decision must be made whether to
discontinue breast-feeding or to discontinue/abstain from DIFICLIR therapy, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
No cases of acute overdose have been reported.
Storage: Store below 25°C.