Compassionate use of voriconazole in newborn infants diagnosed with severe invasive fungal sepsis

I.H. Celik, G. Demirel, S.S. Oguz, N. Uras, O. Erdeve, U. Dilmen

Division of Neonatology, Neonatal Intensive Care Unit, Zekai Tahir Burak Maternity Teaching Hospital, Cebeci, Ankara, Turkey. istemihancelik@gmail.com

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• Pharmacology

BACKGROUND: Invasive fungal sepsis has become the third most common cause of late-onset infections in many neonatal intensive care units (NICU). The prevalence rate ranges from 2.6% to 16.7% among very-low-birth-weight infants and from 5.5% to 20% among extremely low-birth-weight infants. Despite the development of several new antifungal agents in the past few years, the management of serious fungal infections in the newborn continues to be problematic.

MATERIALS, METHODS AND RESULTS: Voriconazole treatment was given to 17 newborns with invasive fungal sepsis, in initial doses of 2-3 mg/kg twice daily. In spite of the complications of cholestasis and liver function abnormality in 2, the dose regimen was 4-6 mg/kg (loading dose), followed by initial doses of 2-3 mg/kg twice daily. Drug cessation did not occur, and no permanent side effects were observed. In the end, 12 patients had been cured with antifungal treatment.

CONCLUSIONS: Voriconazole at this dosage common with other antifungal agents or alone appears to be a safe and effective antifungal agent for neonatal invasive fungal sepsis. Based on relevant literature, to the best of our knowledge, ours is the largest case series to underline this issue. However, further studies are required to determine the pharmacokinetics (e.g. serum half-life, concentration, time of peak concentration, and distribution) of voriconazole use in newborns.

 

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