Auryxia ferric citrate 210 mg Tablet, Film Coated, 200-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Drugs for treatment of hyperkalemia and hyperphosphatemia class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Ferric citrate is used to control high blood levels of phosphorus in people with chronic kidney disease who are on dialysis (medical treatment to clean the blood when the kidneys are not working properly). Ferric citrate is also used to treat iron-deficiency anemia (a lower than normal number of red blood cells due to too little iron) in adults with chronic kidney disease (damage to the kidneys which may worsen over time and may cause the kidneys to stop working) who are not on dialysis. Ferric citrate is in a class of medications called phosphate binders and iron replacement products. It work...
Read the full MedlinePlus article ↗- Not at all — this is completely expected and one of the most common things people notice when they start ferric citrate. The iron in the medication causes stools to turn dark or ev...
- Why are my stools turning dark or black — is that dangerous?
- You should always take ferric citrate with meals — that's an important part of how it works, especially for controlling phosphorus. The medication binds to phosphate from the food...
- Do I have to take it with food, or can I take it on an empty stomach?
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Supplement & herbal interactions
Some supplements/herbs that may interact with Ferric Citrate — tap one for details:
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $7.481 | $1,496.20 / 200 tablets |
| Medicaid paysCMS SDUD · 12 mo | $5.87 | $1,173.78 / 200 tablets |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ferric Citrate 210 mg 00378-2895-20 | Mylan | 200 tablets | $6.254 | AB | Availability likely | save 16% |
| Ferric Citrate 210 mg 00480-2996-97 | Teva | 200 tablets | $6.254 | AB | Availability likely | save 16% |
| Auryxia 210 mgthis 59922-0631-01 | Akebia | 200 tablets | $7.481 | AB | Availability likely | — |
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⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 8093423 ↗ | Method of use | U-1577 | Apr 21, 2026 |
| US 10300039 ↗ | Method of use | U-2549 | Jul 21, 2030 |
| US 9387191 ↗ | Drug product | — | Jul 21, 2030 |
Is there a generic version of AURYXIA 210 MG TABLET?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 59922-0631-01 You're viewing this | 200 TABLET, FILM COATED in 1 BOTTLE (59922-631-01) | 2014-09-17 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and 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 )
1.1Hyperphosphatemia 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.
1.2Iron 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 and 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 )
2.1Dosage 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 phosphorus levels.
2.2Dosage 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 and teeth. 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.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Tablets: Auryxia 210 mg ferric iron, equivalent to 1 g ferric citrate, film-coated, peach-colored, and oval-shaped tablet debossed with “KX52.” Tablets: 210 mg ferric iron, equivalent to 1 g ferric citrate. ( 3 )
⛔ 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 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Iron overload: Monitor ferritin and TSAT. Patients may require a reduction in dose or discontinuation of intravenous iron. ( 5.1 ) Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. ( 5.2 )
5.1Iron Overload Iron absorption from Auryxia may lead to excessive elevations in iron stores. Increases in serum ferritin and transferrin saturation (TSAT) levels were observed in clinical trials. In a 56-week safety and efficacy trial evaluating the control of serum phosphate levels in patients with chronic kidney disease on dialysis in which concomitant use of intravenous iron was permitted, 55 (19%) of patients treated with Auryxia had a ferritin level >1500 ng/mL as compared with 13 (9%) of patients treated with active control.
Assess iron parameters (e.g., serum ferritin and TSAT) prior to initiating Auryxia and monitor iron parameters while on therapy [see Contraindications ( 4 ), Overdosage ( 10 ) and Clinical Pharmacology ( 12.2 )] . Patients receiving intravenous iron may require a reduction in dose or discontinuation of intravenous iron therapy.
5.2Risk of Overdosage in Children Due to Accidental Ingestion Accidental ingestion and resulting overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age [see Overdosage ( 10 )] . Advise patients of the risks to children and to keep Auryxia out of the reach of children.
🤒 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
6.1Clinical 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 to 12 tablets of Auryxia. Adverse reactions reported in more than 5% of patients treated with Auryxia in these trials included diarrhea (21%), discolored feces (19%), nausea (11%), constipation (8%), vomiting (7%), and cough (6%).
During the 52-week, active-control period, 61 patients (21%) on Auryxia discontinued study drug because of an adverse reaction, as compared to 21 patients (14%) in the active control arm. Patients who were previously intolerant to any of the active control treatments (calcium acetate and sevelamer carbonate) were not eligible to enroll in the study. Gastrointestinal adverse reactions were the most common reason for discontinuing Auryxia (14%).
Iron Deficiency Anemia in Chronic Kidney Disease Not on Dialysis Across two trials, 190 patients with CKD-NDD were treated with Auryxia. This included a study of 117 patients treated with Auryxia and 116 patients treated with placebo in a 16-week, randomized, double-blind period and a study of 75 patients treated with Auryxia and 73 treated with placebo in a 12-week randomized double-blind period. Dosage regimens in these trials ranged from 210 mg to 2,520 mg of ferric iron per day, equivalent to 1 to 12 tablets of Auryxia.
Adverse reactions reported in at least 5% of patients treated with Auryxia in these trials are listed in Table 1. Table 1: Adverse Events Reported in Two Clinical Trials in at least 5% of patients receiving Auryxia Body System Adverse Reaction Auryxia % (N=190) Placebo % (N=188) Any Adverse Reaction 75 62 Metabolism and Nutrition Disorders Hyperkalemia 5 3 Gastrointestinal Disorders Discolored feces 22 0 Diarrhea 21 12 Constipation 18 10 Nausea 10 4 Abdominal Pain 5 2 During the 16-week, placebo-control trial, 12 patients (10%) on Auryxia discontinued study drug because of an adverse reaction, as compared to 10 patients (9%) in the placebo control arm.
Diarrhea was the most common adverse reaction leading to discontinuation of Auryxia (2.6%).
🔄 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 therapeutic range.
When clinically significant drug interactions are expected, consider separation of the timing of administration. Consider monitoring clinical responses or blood levels of the concomitant medication. ( 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data on Auryxia use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. Animal reproduction studies have not been conducted using Auryxia. Skeletal and encephalic malformation was observed in neonatal mice when ferric gluconate was administered intraperitoneally to gravid dams on gestation days 7-9.
However, oral administration of other ferric or ferrous compounds to gravid CD1-mice and Wistar-rats caused no fetal malformation. An overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. Clinical Considerations The effect of Auryxia on the absorption of vitamins and other nutrients has not been studied in pregnant women.
Requirements for vitamins and other nutrients are increased in pregnancy.
8.2Lactation Risk Summary There are no human data regarding the effect of Auryxia in human milk, the effects on the breastfed child, or the effects on milk production. Data from rat studies have shown the transfer of iron into milk by divalent metal transporter-1 (DMT-1) and ferroportin-1 (FPN-1). Hence, there is a possibility of infant exposure when Auryxia is administered to a nursing woman.
The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for Auryxia and any potential adverse effects on the breastfed child from Auryxia or from the underlying maternal condition.
8.4Pediatric Use The safety and efficacy of Auryxia have not been established in pediatric patients. Juvenile Animal Toxicity Data In animal studies, greater gastrointestinal toxicity was observed when ferric citrate was administered by gavage as compared to administration with solid food. Because Auryxia is recommended to be taken with meals and patients under 6 months of age are unlikely to be eating solid food, they may be at greater risk of gastrointestinal toxicity.
8.5Geriatric Use Clinical studies of Auryxia included 292 subjects aged 65 years and older (104 subjects aged 75 years and older). Overall, the clinical study experience has not identified any obvious differences in responses between the elderly and younger patients in the tolerability or efficacy of Auryxia.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data on Auryxia use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. Animal reproduction studies have not been conducted using Auryxia. Skeletal and encephalic malformation was observed in neonatal mice when ferric gluconate was administered intraperitoneally to gravid dams on gestation days 7-9.
However, oral administration of other ferric or ferrous compounds to gravid CD1-mice and Wistar-rats caused no fetal malformation. An overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. Clinical Considerations The effect of Auryxia on the absorption of vitamins and other nutrients has not been studied in pregnant women.
Requirements for vitamins and other nutrients are increased in pregnancy.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and efficacy of Auryxia have not been established in pediatric patients. Juvenile Animal Toxicity Data In animal studies, greater gastrointestinal toxicity was observed when ferric citrate was administered by gavage as compared to administration with solid food. Because Auryxia is recommended to be taken with meals and patients under 6 months of age are unlikely to be eating solid food, they may be at greater risk of gastrointestinal toxicity.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of Auryxia included 292 subjects aged 65 years and older (104 subjects aged 75 years and older). Overall, the clinical study experience has not identified any obvious differences in responses between the elderly and younger patients in the tolerability or efficacy of Auryxia.
🆘 Overdosage ▾
10 OVERDOSAGE 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Hyperphosphatemia in Chronic Kidney Disease on Dialysis Ferric iron binds dietary phosphate in the GI tract and precipitates as ferric phosphate. This compound is insoluble and is excreted in the stool. By binding phosphate in the GI tract and decreasing absorption, ferric citrate lowers the phosphate concentration in the serum.
Iron Deficiency Anemia in Chronic Kidney Disease Not on Dialysis Ferric iron is reduced from the ferric to the ferrous form by ferric reductase in the GI tract. After transport through the enterocytes into the blood, oxidized ferric iron circulates bound to the plasma protein transferrin, and can be incorporated into hemoglobin.
12.2Pharmacodynamics Hyperphosphatemia in Chronic Kidney Disease on Dialysis Auryxia reduces serum phosphorus levels and has also been shown to increase serum iron parameters, including ferritin, iron and TSAT. In dialysis patients treated with Auryxia for hyperphosphatemia in a 52-week study in which intravenous iron could also be administered, mean (SD) ferritin levels rose from 593 (293) ng/mL to 895 (482) ng/mL, mean (SD) TSAT levels rose from 31% (11) to 39% (17) and mean (SD) iron levels rose from 73 (29) mcg/dL to 88 (42) mcg/dL.
In contrast, in patients treated with active control, these parameters remained relatively constant [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )] . Iron Deficiency Anemia in Chronic Kidney Disease Not on Dialysis Auryxia may increase hemoglobin levels and has also been shown to reduce serum phosphorus levels. In chronic kidney disease patients not on dialysis treated with Auryxia for iron deficiency anemia in a 16-week placebo-controlled study, mean (SD) phosphorus levels decreased from 4.23 (0.91) mg/dL at baseline to 3.72 (0.60) mg/dL.
In comparison, in patients treated with placebo control, mean (SD) phosphorus levels decreased from 4.12 (0.68) mg/dL at baseline to 3.87 (0.68) mg/dL.
12.3Pharmacokinetics Absorption and Distribution Formal pharmacokinetic studies have not been performed with Auryxia. Examination of serum iron parameters has shown that there is systemic absorption of iron from Auryxia [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ) and Clinical Pharmacology ( 12.2 )] . Drug Interaction Studies In vitro Of the drugs screened for an interaction with ferric citrate in vitro, only doxycycline showed the potential for interaction with at least 70% decrease in its concentration.
This interaction can be avoided by spacing the administration of doxycycline and ferric citrate [see Drug Interactions ( 7 )] . In vivo Six drug interaction studies (N=26-60/study) were conducted to establish the effects of Auryxia (administered as 3 x 2 g/day with meals) on the disposition of concomitantly orally administered clopidogrel, ciprofloxacin, digoxin, diltiazem, glimepiride and losartan in healthy subjects. With the exception of ciprofloxacin, Auryxia did not alter the systemic exposure of the tested drugs, as measured by the area under the curve (AUC) and C max of the tested drugs when either co-administered with Auryxia or given 2 hours later.
Auryxia decreased the relative bioavailability of concomitantly administered ciprofloxacin by approximately 45%. However, there was no interaction when Auryxia and ciprofloxacin were taken 2 hours apart. Consequently, ciprofloxacin should be taken at least 2 hours before or after Auryxia is dosed [see Drug Interactions ( 7 )].
🧬 Mechanism of Action ▾
12.1Mechanism of Action Hyperphosphatemia in Chronic Kidney Disease on Dialysis Ferric iron binds dietary phosphate in the GI tract and precipitates as ferric phosphate. This compound is insoluble and is excreted in the stool. By binding phosphate in the GI tract and decreasing absorption, ferric citrate lowers the phosphate concentration in the serum.
Iron Deficiency Anemia in Chronic Kidney Disease Not on Dialysis Ferric iron is reduced from the ferric to the ferrous form by ferric reductase in the GI tract. After transport through the enterocytes into the blood, oxidized ferric iron circulates bound to the plasma protein transferrin, and can be incorporated into hemoglobin.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied Tablets: Auryxia 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400cc high-density polyethylene bottles. The 210 mg ferric iron tablets are film-coated, peach-colored, and oval-shaped tablets debossed with “KX52.” 1 Bottle of 200-count 210 mg ferric iron tablets (NDC 59922-631-01)
16.2Storage and Handling Storage: Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP controlled room temperature]. Protect from moisture.
📦 Storage and Handling ▾
16.2Storage and Handling Storage: Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP controlled room temperature]. Protect from moisture.
📋 Description ▾
11 DESCRIPTION Auryxia (ferric citrate), a phosphate binder and iron replacement product, is known chemically as iron (+3), x (1, 2, 3-propanetricarboxylic acid, 2 hydroxy-), y (H 2 O) Auryxia 210 mg ferric iron tablets for oral administration, equivalent to 1g ferric citrate, are film-coated, peach-colored, and oval-shaped tablets debossed with “KX52.” The inactive ingredients are pregelatinized starch and calcium stearate. In addition, the film-coating contains the following inactive ingredients: hypromellose, titanium dioxide, triacetin, and FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, FD&C Red #40/Allura Red AC Aluminum Lake, and FD&C Blue #2/Indigo Carmine Aluminum Lake.
Ferric Citrate Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Dosing Recommendations Instruct patients to take Auryxia as directed with meals and adhere to their prescribed diets. Instruct patients on concomitant medications that should be dosed apart from Auryxia [see Dosage and Administration ( 2 )] . Instruct patients to swallow the tablets whole, not to chew or crush Auryxia because it may cause discoloration of mouth and teeth.
Adverse Reactions Advise patients that Auryxia may cause discolored (dark) stools, but this staining of the stool is considered normal with oral medications containing iron. Auryxia may cause diarrhea, nausea, constipation, vomiting, hyperkalemia, abdominal pain, and cough. Advise patients to report severe or persistent gastrointestinal symptoms to their physician [see Adverse Reactions ( 6.1 )] .
Accidental Ingestion Advise patients to keep this product out of the reach of children and to seek immediate medical attention in case of accidental ingestion by a child. Manufactured for: KERYX BIOPHARMACEUTICALS, INC., a wholly-owned subsidiary of Akebia Therapeutics, Inc., Cambridge, MA 02142 Issued 01/2024 Rev 8.0