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Antimicrobial Agents and Chemotherapy, March 2001, p. 981-985, Vol. 45, No. 3
0066-4804/01/$04.00+0   DOI: 10.1128/AAC.45.3.981-985.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.

Pharmacokinetics and Safety of a 7-Day Administration of Intravenous Itraconazole followed by a 14-Day Administration of Itraconazole Oral Solution in Patients with Hematologic Malignancy

Marc A. Boogaerts,1,* Johan Maertens,1 Ronald Van Der Geest,1 Andre Bosly,2 Jean-Louis Michaux,3 Achiel Van Hoof,4 Myriam Cleeren,1 Robert Wostenborghs,5 and Karel De Beule5

Department of Hematology, University Hospital Gasthuisberg, Leuven,1 University Hospital, Mont-Godinne,2 University Hospital St. Luc, Brussels,3 Hospital St Jan, Bruges,4 and Janssen Research Foundation, Beerse,5 Belgium

Received 28 July 2000/Returned for modification 27 September 2000/Accepted 4 December 2000

The pharmacokinetics and safety of an intravenous hydroxypropyl-beta -cyclodextrin solution of itraconazole administered for 7 days followed by itraconazole oral solution administered at 200 mg once or twice daily for 14 days were assessed in 17 patients with hematologic malignancies. Steady-state plasma itraconazole concentrations were reached by 48 h after the start of intravenous treatment. The mean trough plasma itraconazole concentration at the end of the intravenous treatment was 0.54 ± 0.20 µg/ml. This concentration was not maintained during once-daily oral treatment but increased further in the twice-daily treatment group, with a trough itraconazole concentration of 1.12 ± 0.73 µg/ml at the end of oral treatment. As expected in the patient population studied, all patients experienced some adverse events (mainly gastrointestinal). Biochemical and hematologic abnormalities were frequent, but no consistent changes occurred. In conclusion, 7 days of intravenous treatment followed by 14 days of twice-daily oral treatment with itraconazole solution enables plasma itraconazole concentrations of at least 0.5 µg/ml to be reached rapidly and to be maintained. The regimen is well tolerated and has a good safety profile.

* Corresponding author. Mailing address: Department of Hematology, University Hospital Gasthuisberg, B-3000 Leuven, Belgium. Phone: 32 16 34 68 80. Fax: 32 16 34 68 81. E-mail: marc.boogaerts{at}med.kuleuven.ac.be.

Antimicrobial Agents and Chemotherapy, March 2001, p. 981-985, Vol. 45, No. 3
0066-4804/01/$04.00+0   DOI: 10.1128/AAC.45.3.981-985.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.


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