Summary of the safety profile: The frequency of adverse reactions shown in Table 3 is based on data from 403 patients with invasive fungal infections treated with CRESEMBA in Phase 3 studies.
The most common treatment-related adverse reactions were elevated liver chemistry tests (7.9%), nausea (7.4%), vomiting (5.5%), dyspnea (3.2%), abdominal pain (2.7%), diarrhea (2.7%), injection site reaction (2.2%), headache (2.0%), hypokalaemia (1.7%) and rash (1.7%).
The adverse reactions which most often led to permanent discontinuation of CRESEMBA treatment were confusional state (0.7%), acute renal failure (0.7%), increased blood bilirubin (0.5%), convulsion (0.5%), dyspnea (0.5%), epilepsy (0.5%), respiratory failure (0.5%) and vomiting (0.5%).
Tabulated list of adverse reactions: Table 3 presents adverse reactions with isavuconazole in the treatment of invasive fungal infections, by System Organ Class and frequency.
The frequency of adverse reactions is defined as follow: very common (≥1/10); common (≥1/100 to <1/10); and uncommon (≥1/1,000 to <1/100).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 3.)
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Description of selected adverse reactions: Delirium includes reactions of confusional state.
Elevated liver chemistry tests includes events of alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased, blood lactate dehydrogenase increased, gamma-glutamyltransferase increased, hepatic enzyme increased, hepatic function abnormal, hyperbilirubinemia, liver function test abnormal, and transaminases increased.
Laboratory effects: In a double-blind, randomized, active-controlled clinical study of 516 patients with invasive fungal disease caused by Aspergillus species or other filamentous fungi, elevated liver transaminases (alanine aminotransferase or aspartate aminotransferase) >3 x Upper Limit of Normal (ULN) were reported at the end of study treatment in 4.4% of patients who received CRESEMBA. Marked elevations of liver transaminases >10 x ULN developed in 1.2% of patients on patients on isavuconazole.