Isaconazonium sulfate (Cresemba) a antifungal for the treatment of adults with invasive aspergillosis and invasive mucormycosis, rare, but potentially life-threatening infections.
People with compromised immune systems are most at risk, as are uncontrolled diabetics and individuals who have burns, scrapes, or cuts are also at risk, according to the Centers for Disease Control and Prevention (CDC).
Aspergillosis, caused by the Aspergillus species, is a growing cause of life-threatening infections in immunocompromised individuals,
Mucormycosis, caused by the Mucorales fungi, has a mortality rate as high as 50%.
Belongs to a class of drugs called azole antifungal agents, which work by targeting the cell wall of the fungus.
It is available in oral and intravenous formulations.
Approval for invasive aspergillosis was based on the 516-patient SECURE trial which randomly assigned participants to either Cresemba or voriconazole:Cresemba demonstrated noninferiority on all-cause mortality.
All-cause mortality through that time period was 18.6% for Cresemba patients and 20.2% for voriconazole.
The mucormycosis approval was based on the single-arm VITAL study where 37 patients treated with Cresemba were compared with the natural disease progression associated with untreated mucormycosis.
In this study all-cause mortality for Cresemba patients was 38%.
Side effects include nausea, vomiting, diarrhea, headache, abnormal liver blood tests, hypokalemia, constipation, dyspnea, coughing, and peripheral edema, and more serious liver problems, infusion reactions, and severe allergic and skin reactions.
CYP3A4 inhibitors ketoconzole and Rifampin are contraindicated to used with isavuconazole.
Lopinavir/ritonavir are contraindicated with a 96% increase in exposure of isavuconazole.