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When administered at high doses to pregnant rats (≥40 mg/kg/day) and mice (≥80 mg/kg/day), itraconazole was shown to increase the incidence of foetal abnormalities and did produce adverse effects on the embryo. Studies of the use of itraconazole in pregnant women are not available. Therefore, Sporanox should only be given in life-threatening cases of systemic mycosis and when in these cases, the potential benefit outweighs the potential harm to the foetus.
A very small amount of itraconazole is excreted in human milk. The expected benefits of Sporanox therapy should therefore be weighed against the potential risk of breastfeeding. In case of doubt, the patient should not breastfeed.
