- Hepatic adverse drug reactions: Elevated ALT, AST, alkaline phosphatase, and total bilirubin have been reported. Elevations in LFTs were reversible and did not require discontinuation of therapy. Hepatitis, cholestasis or hepatic failure including death have been reported in patients with serious underlying medical conditions such as hematologic malignancy. Evaluate LFTs at baseline and during therapy. Monitor the patients for hepatic injury. Discontinue therapy if clinical signs and symptoms consistent with liver disease develop
- Discontinue therapy if infusion-related reactions including hypotension, dyspnea, chills, dizziness, paresthesia, and hypoesthesia occur
- Hypersensitivity reactions: Discontinue therapy if severe skin reactions, such as anaphylaxis or Stevens Johnson syndrome occur. Use cautiously when prescribing to patients with hypersensitivity to other azoles
- Embryo-fetal toxicity: Therapy may cause fetal harm when administered to a pregnant woman; should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the fetus
- Drug monitoring and dose adjustment of immunosuppressants, such as tacrolimus, sirolimus, and cyclosporine, may be necessary when co-administered with isavuconazonium sulfate
- Drugs with a narrow therapeutic window that are P-gp substrates, such as digoxin, may require dose adjustment when co-administered with isavuconazonium sulfate
Cautions: Use cautiously in
- Severe hepatic impairment
- Hypersensitivity to other azoles
- Hematologic malignancy
- Familial short QT syndrome
- Coadministration with immunosuppressants (e.g., tacrolimus, sirolimus, cyclosporine)
- Coadministration with P-gp substrates (e.g., digoxin)
Pregnancy Category:C. However, isavuconazonium sulfate is predicted to have the potential for increasing the risk of adverse developmental outcomes above background risk.
Breastfeeding: Do not breast feed while on therapy. Isavuconazonium sulfate is excreted in milk of lactating rats following IV administration.
