Auryxia (ferric citrate)

Common side effects of Auryxia include:

• diarrhea,
• nausea,
• constipation,
• vomiting,
• cough, and
• dark stools (related to the iron content).

Dosage For Hyperphosphatemia In Chronic Kidney Disease On Dialysis

• The recommended starting dose is 2 tablets, swallowed whole, 3 times per day with meals.
• Auryxia tablets must not be chewed or crushed because it may cause discoloration of mouth andteeth.
• 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.

Dosage For Iron Deficiency Anemia In Chronic Kidney Disease Not On Dialysis

• The recommended starting dose is 1 tablet, swallowed whole, 3 times per day with meals.
• Auryxia tablets must not be chewed or crushed because it may cause discoloration of mouth andteeth.
• Titrate the dose of Auryxia as needed to achieve and maintainhemoglobinat target levels, up to a maximum dose of 12 tablets daily.
• In a clinical trial in patients with chronic kidney disease not ondialysis(CKD-NDD), patients required an average of 5 tablets per day to increase hemoglobin levels.

Table 2: Oraldrugsthat can be administered concomitantly with Auryxia

Oral Medications Not Listed In Table 2

• There are no empirical data on avoidingdrug interactionsbetween Auryxia and most concomitant oral drugs.
• For oral medications where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, consider separation of the timing of the administration of the two drugs.
• The duration of separation depends upon the absorption characteristics of the medication concomitantly administered, such as the time to reach peak systemic levels and whether the drug is an immediate release or an extended release product.
• Consider monitoring clinical responses or blood levels of concomitant medications that have a narrow therapeutic range.

• There are no available data on Auryxia use inpregnantwomen to inform a drug-associated risk of majorbirth defectsandmiscarriage.
• There are no human data regarding the effect of Auryxia inhuman milk, the effects on thebreastfedchild, or the effects on milk production.