[medical citation needed] Caspofungin was the first inhibitor of fungal (1→3)-β-D-glucan synthesis to be approved by the United States Food and Drug Administration.
[7] Caspofungin acetate for injection was initially approved by both the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA) in 2001.
[citation needed] Its approved therapeutic indications by both organizations include the empirical therapy of presumed fungal infections in febrile, neutropenic adults and for salvage therapy in people treatment of invasive aspergillosis in adults whose disease is refractory to, or who are intolerant of, other antifungal agents (i.e., conventional or lipid formulations of amphotericin B and/or itraconazole).
[medical citation needed] Additionally, the FDA approval includes indication for the treatment of candidemia and some specific Candida infections (intra-abdominal abscesses, peritonitis, pleural cavity infections, and esophagitis) and the EMA approval includes indication for the treatment of general invasive candidiasis in adults.
In clinical studies and postmarketing reports, the side effects seen in 1% or more of the patients were as follows:[medical citation needed] Additionally, infrequent cases of symptomatic liver damage, peripheral edema and swelling, and hypercalcemia have been seen.
[medical citation needed] The concomitant use of caspofungin and ciclosporin in healthy volunteers led to a more frequent increase of liver enzymes (ALT=SGPT and AST=SGOT) than noted with cyclosporine alone.
[medical citation needed] Reactions due to histamine release (rash, facial swelling, pruritus, sensation of warmth) have been seen.