ERAXIS for Injection is a sterile, lyophilized product for intravenous (IV) infusion
that contains anidulafungin. ERAXIS (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.
ERAXIS (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,
ERAXIS for Injection contains the following inactive ingredients:
50 mg/vial - 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.
100 mg/vial - fructose (100 mg), mannitol (500 mg), polysorbate 80 (250 mg), tartaric acid (11.2 mg),
and sodium hydroxide and/or hydrochloric acid for pH adjustment.
The empirical formula of anidulafungin is C58H73N7O17
and the formula weight is 1140.3.
The structural formula is:
Prior to administration, ERAXIS for Injection requires
reconstitution with sterile Water for Injection and subsequent dilution
with either 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (normal
saline).
DO NOT dilute with other solutions or co-infuse with other medications or electrolytes
(see DOSAGE AND ADMINISTRATION).