Description

DESCRIPTION DULATECT for Injection is a sterile, lyophilized product for intravenous (IV) infusion that contains anidulafungin. DULATECT (anidulafungin) is a semi-synthetic lipopeptide synthesized from a fermentation product of Aspergillus nidulans. Anidulafungin is an echinocandin, a class of antifungal drugs that inhibits the synthesis of 1,3-β-D-glucan, an essential component of fungal cell walls. DULATECT (anidulafungin) is 1-[(4R,5R)-4,5-Dihydroxy-N2 -[[4"-(pentyloxy)[1,1':4',1"-terphenyl]- 4-yl]carbonyl]-L-ornithine]echinocandin B. Anidulafungin is a white to off-white powder that is practically insoluble in water and slightly soluble in ethanol. In addition to the active ingredient, anidulafungin, DULATECT for Injection contains the following inactive ingredients: fructose (50 mg), mannitol (250 mg), polysorbate 80 (125 mg), tartaric acid (5.6 mg), and sodium hydroxide and/or hydrochloric acid for pH adjustment. CLINICAL PHARMACOLOGY Pharmacokinetics The pharmacokinetics of anidulafungin following IV administration have been characterized in healthy subjects, special populations and patients. Systemic exposures of anidulafungin are doseproportional and have low intersubject variability The pharmacokinetics of anidulafungin following IV administration are characterized by a short distribution half-life (0.5-1 hour) and a volume of distribution of 30-50 L that is similar to total body fluid volume. Anidulafungin is moderately bound to plasma proteins in humans (84%). Excretion In a single-dose clinical study, radiolabeled (14C) anidulafungin was administered to healthy subjects. Approximately 30% of the administered radioactive dose was eliminated in the feces over 9 days, of which less than 10% was intact drug. Less than 1% of the administered radioactive dose was excreted in the urine. Anidulafungin concentrations fell below the lower limits of quantitation 6 days post-dose. Negligible amounts of drug-derived radioactivity were recovered in blood, urine, and feces 8 weeks post-dose. MICROBIOLOGY Mechanism of action Anidulafungin is a semi-synthetic echinocandin with antifungal activity. Anidulafungin inhibits glucan synthase, an enzyme present in fungal, but not mammalian cells. This results in inhibition of the formation of 1,3-β-D-glucan, an essential component of the fungal cell wall. Drug Resistance Emergence of resistance to anidulafungin has not been studied. Anidulafungin was active against Candida albicans resistant to fluconazole. Cross resistance with other echinocandins has not been studied. Dosage Forms & Strengths injection, lyophilized powder for reconstitution • 100mg/vial Candidemia Indicated for treatment of candidemia and intra-abdominal abscess and peritonitis caused by Candida infections Day 1: 200 mg IV infusion, THEN Day 2 and thereafter: 100 mg/day IV Generally continue 14 days after last positive culture Esophageal Candidiasis Indicated for treatment of esophageal candidiasis Day 1: 100 mg IV infusion, THEN Day 2 and thereafter: 50 mg/day IV Minimum 14 day treatment, at least 7 days following resolution of symptoms Owing to risk of relapse of esophageal candidiasis in patients with HIV infection, consider suppressive antifungal therapy after treatment course Candida auris (Off-label) Based on the limited data, an echinocandin drug (eg, anidulafungin, caspofungin, micafungin) is recommended by the CDC as initial therapy for treatment of C auris infections Day 1: 200 mg IV Day 2 and thereafter: 100 mg IV qDay