PRESCRIBING INFORMATION:

For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only.

ANIDULAFUNGIN FOR INJECTION 100 MG

B-DULA 100
Combipack
For I.V. Infusion only
Lyophilized
Single use vial

COMPOSITION
Each Combipack contains:
Anidulafungin for injection 100 mg (Lyophilized)
Each vial contains:
Anidulafungin 100 mg
Excipients Q.s.
Sterile Water for Injections IP 30 ml
Each Ampoule contains:
Sterile Water for Injections IP 30 ml

DOSAGE FORM: Powder for concentrate for infusion.

DESCRIPTION AND CHEMISTRY: B-DULA 100 a sterile, lyophilized product for intravenous (IV)
infusion that contains anidulafungin. B-DU LA 100 is a semi-synthetic lipopeptide synthesized
from a fermentation product of Aspergillus nidulans. The empirical formula of anidulafungin is
C58H73N7017 and the formula weight is 1140.3.The structural formula is:

GRAPH
CLINICAL PHARMACOLOGY
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 1,3-13-D-glucan, an essential component of the fungal cell wall.

Activity in Vitro and in Clinical Infections

Anidulafungin has been shown to be active against Candida albicans, C. glabrata, C. parapsilosis,
and C. tropicalis both in vitro and in clinical infections. Because of the potential for reduced
susceptibility to anidulafungin, it is recommended that susceptibility be determined by a
standardized method.

Drug Resistance
Echinocandin resistance is due to point mutations within the genes (FKS1 and FKS2) encoding for
subunits in the glucan synthase enzyme complex. There have been reports of Candida isolates
with reduced susceptibility to anidulafungin, suggesting a potential for development of drug
resistance. The clinical significance of this observation is not fully understood.