Auryxia 210 mg/1
ferric citrate · TABLET, FILM COATED · Akebia Therapeutics, Inc.
Auryxia is a tablet, film coated containing ferric citrate at 210 mg/1, taken oral. Manufactured by Akebia Therapeutics, Inc..
Key Facts
- Brand Name
- Auryxia
- Generic Name
- ferric citrate
- NDC Code (Product)
59922-631- Manufacturer
- Akebia Therapeutics, Inc.
- Strength
- 210 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA205874
- Marketing Start
- 09/17/2014
Recall History
Akebia Therapeutics dba Keryx Biopharmaceutials, Inc
Failed Dissolution Specifications
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Akebia Therapeutics dba Keryx Biopharmaceutials, Inc
CGMP Deviations
Keryx Biopharmaceuticals, Inc.
cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
Keryx Biopharmaceuticals, Inc.
Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Auryxia is a phosphate binder indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis. ( 1 ) Auryxia is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis. ( 1 ) 1.1 Hyperphosphatemia in Chronic Kidney Disease on Dialysis Auryxia is indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis. 1.2 Iron Deficiency Anemia in Chronic Kidney Disease Not on Dialysis Auryxia is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Hyperphosphatemia in Chronic Kidney Disease on Dialysis: Starting dose is 2 tablets orally 3 times per day with meals. ( 2.1 ) Adjust dose by 1 to 2 tablets as needed to maintain serum phosphorus at target levels, up to a maximum of 12 tablets daily. Dose can be titrated at 1-week or longer intervals. ( 2.1 ) Iron Deficiency Anemia in Chronic Kidney Disease Not on Dialysis: Starting dose is 1 tablet orally 3 times per day with meals. ( 2.2 ) Adjust dose as needed to achieve and maintain hemoglobin goal, up to a maximum of 12 tablets daily. ( 2.2 ) 2.1 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 and teeth. 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 …
Contraindications
4 CONTRAINDICATIONS Auryxia is contraindicated in patients with iron overload syndromes (e.g., hemochromatosis) [see Warnings and Precautions ( 5.1 )] . Iron overload syndromes (e.g., hemochromatosis). ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Table 2: Oral drugs that can be administered concomitantly with Auryxia Amlodipine Aspirin Atorvastatin Calcitriol Clopidogrel Digoxin Diltiazem Doxercalciferol Enalapril Fluvastatin Glimepiride Levofloxacin Losartan Metoprolol Pravastatin Propranolol Sitagliptin Warfarin Oral drugs that have to be separated from Auryxia and meals Dosing Recommendations Doxycycline Take at least 1 hour before Auryxia Ciprofloxacin Take at least 2 hours before or after Auryxia Oral medications not listed in Table 2 There are no empirical data on avoiding drug interactions between 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 the…
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥5%) are discolored feces, diarrhea, constipation, nausea, vomiting, cough, abdominal pain, and hyperkalemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Keryx Biopharmaceuticals at 1-844-445-3799 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to adverse reaction rates in the clinical trials of another drug and may not reflect the rates observed in practice. Hyperphosphatemia in Chronic Kidney Disease on Dialysis A total of 289 patients were treated with Auryxia and 149 patients were treated with active control (sevelamer carbonate and/or calcium acetate) during the 52-week, randomized, open-label, active control phase of a trial in patients on dialysis. A total of 322 patients were treated with Auryxia for up to 28 days in three short-term trials. Across these trials, 557 unique patients were treated with Auryxia; dosage regimens in these trials ranged from 210 mg to 2,520 mg of ferric iron per day, equivalent to 1 t…
Frequently Asked Questions
What is Auryxia used for?
Auryxia contains ferric citrate. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Auryxia a controlled substance?
Auryxia is not classified as a controlled substance by the DEA.
What is the generic name for Auryxia?
The generic name for Auryxia is ferric citrate. There are 2 other brand versions of ferric citrate.
What is the NDC code for Auryxia 210 mg/1?
The NDC (National Drug Code) for Auryxia 210 mg/1 is 59922-631, listed by Akebia Therapeutics, Inc..