Sporanox Use In Pregnancy & Lactation

Pregnancy: SPORANOX must not be used during pregnancy except for life-threatening cases where the potential benefit to the mother outweighs the potential harm to the fetus (See Contraindications).
In animal studies itraconazole has shown reproduction toxicity (See Pharmacology: Toxicology: Non-Clinical Information under Actions).
There is limited information on the use of SPORANOX during pregnancy. During post-marketing experience, cases of congenital abnormalities have been reported. These cases included skeletal, genitourinary tract, cardiovascular and ophthalmic malformations as well as chromosomal and multiple malformations. A causal relationship with SPORANOX has not been established.
Epidemiological data on exposure to SPORANOX during the first trimester of pregnancy - mostly in patients receiving short-term treatment for vulvovaginal candidosis - did not show an increased risk for malformations as compared to control subjects not exposed to any known teratogens. Itraconazole has been shown to cross the placenta in a rat model.
Women of childbearing potential: Women of childbearing potential taking SPORANOX capsules should use contraceptive precautions. Highly effective contraception should be continued until the menstrual period following the end of SPORANOX therapy.
Breast-feeding: A very small amount of itraconazole is excreted in human milk. The expected benefits of SPORANOX capsules therapy should therefore be weighed against the potential risk of breast-feeding. In case of doubt, the patient should not breast-feed.
Fertility: Capsule: Refer to Pharmacology: Toxicology: Non-Clinical Information under Actions for in animal fertility information relevant to itraconazole.
Oral solution: Refer to Pharmacology: Toxicology: Non-Clinical Information under Actions for in animal fertility information relevant to itraconazole and hydroxypropyl-β-cyclodextrin.