Micafungin Safety in Pediatric Patients in Clinical Practice

Ref ID: 18717

Author:

A. C. Arrieta, MD – Professor1, N. ASshouri, MD – Associate 1, D. J. Nieves, MD – Associate 1, J. Singh, MD – Associate 1, F. Adler, MD – Associate 1, O. Vargas-Shiraishi, BS – Clinical research Coordinator 2;

Author address:

1CHOC Children’s Hosp. of Orange County, Orange, CA, 2Children’s Hosp. of Orange County, Orange, CA.

Full conference title:

52nd Annual ICAAC

Date: 9 September 2014

Abstract:

Background: Currently available pediatric safety data on micafungin is limited to patients enrolled in clinical trials during the development of this agent. Data has since emerged suggesting higher doses are necessary for target attainment associated with clinical cure. Safety information regarding this agent during clinical practice is needed. Methods: Retrospective chart review of patients receiving > 1 dose of micafungin for the treatment of proven or suspected Candida and Aspergillus infection, antifungal prophylaxis in bone marrow transplant and febrile/neutropenic patients. Renal, hepatic and hematological safety data was collected. Results: 243 subjects (age 7.1 + 5.5 y; range 4 m – 17 y; 118 female) received micafungin during 326 admissions. Mean duration of treatment = 14.3 + 14.6 days (1-115); mean daily dose was 79.1 + 47.5 (4-200)/3.3 + 1.3 (0.8-7.8) and; mean cumulative dose was 1124.1 + 1463 (8-11600)/47.9+ 63.2 (1.8-609) in mg and mg/kg respectively. Marrow toxicity was not noted (mean decrease in hemoglobin = 1.8g, white blood cells = 2.5 K/mm3 and platelets = 55.7 K/mm3. The table below summarizes renal and liver safety data. *Values shown are mean + SD (range) 284/326 treatments were completed as planned and was discontinued due to possible drug related toxicity 3 times; 34 patients died. Conclusion: Micafungin is a safe antifungal agent when use at doses likely to provide similar drug exposure to those associated with clinical success in adults.

Abstract Number: G3-1560

Conference Year: 2012

Link to conference website: NULL

New link: NULL

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