Source: FDA, National Drug Code (US) Revision Year: 2019
Auryxia is indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis.
Auryxia is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis.
The recommended starting dose is 2 tablets orally 3 times per day with meals. Monitor serum phosphorus levels and titrate the Auryxia dose in decrements or increments of 1 to 2 tablets per day as needed to maintain serum phosphorus at target levels, up to a maximum dose of 12 tablets daily. Dose can be titrated at 1-week or longer intervals.
In a clinical trial, patients required an average of 8 to 9 tablets a day to control serum phosphorus levels.
The recommended starting dose is 1 tablet orally 3 times per day with meals. Titrate the dose of Auryxia as needed to achieve and maintain hemoglobin at target levels, up to a maximum dose of 12 tablets daily.
In a clinical trial in patients with chronic kidney disease not on dialysis (CKD-NDD), patients required an average of 5 tablets per day to increase hemoglobin levels.
No data are available regarding overdose of Auryxia in patients. In patients with chronic kidney disease, the maximum dose studied was 2,520 mg ferric iron (12 tablets of Auryxia) per day. Iron absorption from Auryxia may lead to excessive elevations in iron stores, especially when concomitant intravenous iron is used [see Warnings and Precautions (5.1)].
In clinical trials, one case of elevated iron in the liver as confirmed by biopsy was reported in a patient on dialysis administered intravenous iron and Auryxia.
Store at 20 to 25°C (68 to 77°F): excursions permitted to 15° to 30°C (59°F to 86°F) [See USP controlled room temperature]. Protect from moisture.
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