MT2013-37R: Voriconazole Monitoring in Pediatric Stem Cell Transplant Patients

Inclusion Criteria:

- Any patient undergoing allogeneic hematopoietic stem cell transplantation (either 1st
or subsequent)

- Age ≤ 21 years

- Adequate organ function within 14 days of enrollment, i.e. Creatinine: < 1.5 x ULN and
Hepatic: ALT, AST and total bilirubin < 3 x ULN

- Requires voriconazole to prevent or treat invasive fungal infection after undergoing
stem cell transplantation

Exclusion Criteria:

- Has received voriconazole within 5 days prior to starting study therapy

- History of hypersensitivity or severe intolerance to azoles

- History, or current evidence, of cardiac arrhythmias defined as QTc ≥ 480 mm/sec

- Receiving the following drugs and cannot be discontinued at least 24 hours before
starting therapy: pimozide, quinidine, astemizole, ergot alkaloids.

- Received one or more of the following drugs within 14 days prior to starting study, as
they are potent inducers of hepatic microsomal enzymes: rifampin, rifabutin,
carbamazepine, phenytoin, nevirapine, long-acting barbiturates.

- Received sirolimus within the 14 days prior to starting study as voriconazole is a
potent inhibitor of sirolimus metabolism

- Receiving or anticipated need for methadone as co-administration with voriconazole
potentially increases methadone exposure