is a medicine approved for treating patients who have been diagnosed with hereditary orotic aciduria
• Contraindications – None
• Warning and Precautions – None
• Adverse reactions – No adverse reactions were reported with XURIDEN in patients with HOA
• Pregnancy (Section 8.1) – There are no available data on XURIDEN use in pregnant women to inform drug-associated risk
Lactation (Section 8.3) – There are no data on the presence of XURIDEN
in human milk, the effect on the breast-fed infant or the effect on
milk production. The development and health benefits of breastfeeding
should be considered along with the mother’s clinical need for XURIDEN
and any potential adverse effects on the breastfed infant from XURIDEN
or from the underlying maternal condition.
• Pediatric (Section 8.4) – The safety and effectiveness of XURIDEN have been established in pediatric patients.
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