FIDAXOMICIN

The pharmacokinetic parameters of fidaxomicin and its main metabolite OP-1118 following a single dose of 200 mg in healthy adult males (N=14) are summarized in Table 4.

Table 4Mean (± Standard Deviation) Pharmacokinetic Parameters of Fidaxomicin 200 mg in Healthy Adult Males Parameter Fidaxomicin OP- 1118 N Value N Value C max (ng/mL) 14 5.20 ± 2.81 14 12.0 ± 6.06 T max (h)* 14 2.00 (1.00-5.00) 14 1.02 (1.00-5.00) AUC 0-t (ng-h/mL) 14 48.3 ± 18.4 14 103 ± 39.4 AUC 0-∞ (ng-h/mL) 9 62.9 ± 19.5 1...

14.1 Clinical Studies of Fidaxomicin Tablets in Adult Patients with CDAD In two randomized, double-blinded trials, a non-inferiority design was utilized to demonstrate the efficacy of fidaxomicin tablets (200 mg tablets twice daily for 10 days) compared to vancomycin (125 mg four times daily for 10 days) in adults with CDAD. Enrolled patients were 18 years of age or older and received no more than 24 hours of pretreatment with vancomycin or metronidazole. CDAD was defined by >3 unformed bowel movements (or >200 mL of unformed stool for subjects having rectal collection devices) in the 24 hours...

The most common adverse reactions in adults (incidence ≥2%) are nausea, vomiting, abdominal pain, gastrointestinal hemorrhage, anemia, and neutropenia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp., at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the c...

Fidaxomicin tablets are contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in fidaxomicin tablets [see Warnings and Precautions ( 5.1 )]. Fidaxomicin tablets are contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in fidaxomicin tablets. ( 4 )

Acute hypersensitivity reactions (angioedema, dyspnea, pruritus, and rash) have been reported. If a severe hypersensitivity reaction occurs, discontinue fidaxomicin tablets. ( 5.1 ) Fidaxomicin tablets is not expected to be effective for the treatment of other types of infections due to minimal systemic absorption of fidaxomicin. Fidaxomicin tablets should only be used for the treatment of C. difficile -associated diarrhea. ( 5.2 ) Development of drug-resistant bacteria: Only use fidaxomicin tab...

7 DRUG INTERACTIONS Fidaxomicin and its main metabolite, OP-1118, are substrates of the efflux transporter, P-glycoprotein (P-gp), which is expressed in the gastrointestinal tract. 7.1 Cyclosporine Cyclosporine is an inhibitor of multiple transporters, including P-gp. When cyclosporine was co-administered with fidaxomicin tablets, plasma concentrations of fidaxomicin and OP-1118 were significantly...