ferric citrate (Rx)

Brand and Other Names:Auryxia
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 210mg ferric iron (equivalent to 1g ferric citrate)

Hyperphosphatemia

Indicated for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis

Initial: 420 mg (2 tablets) PO TID with meals

Monitor serum phosphorus levels and adjust dose at ≥1-week intervals in decrements or increments of 1 to 2 tablets/day PRN to maintain serum phosphorus at target levels

Not to exceed 12 tablets/day

Iron Deficiency Anemia

Indicated for treatment of iron deficiency anemia in adults with CKD not on dialysis (CKD-NDD)

Initial: 210 mg (1 tablet) PO TID with meals

Titrate as needed to achieve and maintain hemoglobin at target levels

Not to exceed 12 tablets/day

In clinical trial, average dose was 5 tablets/day

Safety and efficacy not established

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Interactions

Interaction Checker

and ferric citrate

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (0)

              Serious - Use Alternative (2)

              • baloxavir marboxil

                ferric citrate will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.

              • erdafitinib

                ferric citrate, erdafitinib. Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid coadministration during initial dosing adjustment period (ie, first 21 days). Increases in serum phosphate levels are a pharmacodynamic effect of FGFR inhibition. Serum phosphate binders may obscure decisions regarding initial dosage increase.

              Monitor Closely (11)

              • ciprofloxacin

                ferric citrate will decrease the level or effect of ciprofloxacin by drug binding in GI tract. Use Caution/Monitor. Take at least 2 hours before or after ferric citrate

              • deferiprone

                ferric citrate decreases levels of deferiprone by enhancing GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Deferiprone may bind polyvalent cations (eg, iron, aluminum, and zinc), separate administration by at least 4 hr between deferiprone and other medications (eg, antacids), or supplements containing these polyvalent cations.

              • doxycycline

                ferric citrate will decrease the level or effect of doxycycline by drug binding in GI tract. Use Caution/Monitor. Administer doxycycline at least 1 hr before ferric citrate

              • gemifloxacin

                ferric citrate will decrease the level or effect of gemifloxacin by drug binding in GI tract. Use Caution/Monitor. Administer at least 2 hours before or after ferric citrate

              • levofloxacin

                ferric citrate will decrease the level or effect of levofloxacin by drug binding in GI tract. Use Caution/Monitor. Administer at least 2 hours before or after ferric citrate

              • moxifloxacin

                ferric citrate will decrease the level or effect of moxifloxacin by drug binding in GI tract. Use Caution/Monitor. Administer at least 2 hours before or after ferric citrate

              • ofloxacin

                ferric citrate will decrease the level or effect of ofloxacin by drug binding in GI tract. Use Caution/Monitor. Administer at least 2 hours before or after ferric citrate

              • omadacycline

                ferric citrate will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.

              • sarecycline

                ferric citrate will decrease the level or effect of sarecycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.

              • sodium sulfate/?magnesium sulfate/potassium chloride

                sodium sulfate/?magnesium sulfate/potassium chloride increases toxicity of ferric citrate by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.

                sodium sulfate/?magnesium sulfate/potassium chloride decreases levels of ferric citrate by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Administer iron products at least 2 hr before and no less than 6 hr after each dose to avoid chelation with magnesium. .

              • sodium sulfate/potassium sulfate/magnesium sulfate

                sodium sulfate/potassium sulfate/magnesium sulfate decreases levels of ferric citrate by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Administer iron products at least 2 hr before and no less than 6 hr after each dose to avoid chelation with magnesium. .

                sodium sulfate/potassium sulfate/magnesium sulfate increases toxicity of ferric citrate by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.

              Minor (0)

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                Adverse Effects

                >10%

                Discolored feces (22%)

                Diarrhea (21%)

                Constipation (8-18%)

                Nausea (10-11%)

                1-10%

                Vomiting (7%)

                Cough (6%)

                Hyperkalemia (5%)

                Abdominal pain (5%)

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                Warnings

                Contraindications

                Iron overload syndromes (eg, hemochromatosis)

                Cautions

                Iron absorption from ferric citrate may lead to excessive elevations in iron stores; assess iron parameters (eg, serum ferritin, TSAT) before initiating drug and monitor parameters while on therapy; patients receiving IV iron may require a reduced dose or discontinuation

                Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children younger than 6 yr; keep out of the reach of children

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                Pregnancy & Lactation

                Pregnancy

                There are no available data regarding use in pregnant women

                An overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes, and fetal malformation

                Lactation

                There are no human data regarding the effect 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); therefore, there is a possibility of infant exposure

                The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child or from the underlying maternal condition

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                Hyperphosphatemia in CKD on dialysis

                • Phosphate binder; ferric iron binds dietary phosphate in the GI tract and precipitates as ferric phosphate, which is insoluble and is excreted in the feces
                • By binding phosphate in the GI tract and decreasing absorption, ferric citrate lowers the phosphate concentration in the serum

                Iron deficiency anemia in CKD 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

                Absorption

                Shown to increase serum iron parameters, including ferritin, iron, and TSAT

                In a 52-week clinical trial, mean ferritin levels rose from 593 ng/mL to 895 ng/mL, mean TSAT levels rose from 31% to 39%, and mean iron levels rose from 73 mcg/dL to 88 mcg/dL

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                Administration

                Oral Administration

                Take with meals

                Do not chew or crush tablets because tablets may cause discoloration of mouth and teeth

                Storage

                Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)

                Protect from moisture

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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Auryxia oral
                -
                210 mg iron tablet

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                ferric citrate oral

                FERRIC CITRATE - ORAL

                (FER-us SI-trate)

                COMMON BRAND NAME(S): Ferric Citrate

                WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children younger than 6 years. Keep this product out of reach of children. If overdose does occur, get medical help right away or call a poison control center.

                USES: Ferric citrate is used to lower high blood phosphate levels in people who are on dialysis due to severe kidney disease. Dialysis removes some phosphate from your blood, but it is difficult to remove enough to keep your phosphate levels balanced. Decreasing blood phosphate levels can help keep your bones strong, prevent unsafe buildup of minerals in your body, and may decrease the risk of heart disease and strokes that can result from high phosphate levels. This medication works by binding to phosphate in the foods you eat. The phosphate then passes out of your body in your stool.Ferric citrate is a form of iron. This medication is also used to treat low blood levels of iron (anemia) in people with long-term kidney disease who are not on dialysis. Iron is an important mineral that your body needs to produce red blood cells and keep you in good health.

                HOW TO USE: See also Drug Interactions section.Take this medication by mouth, usually 3 times daily with a meal and some fluids as directed by your doctor. Do not lie down for at least 10 minutes after taking your dose.Swallow the tablets whole. Do not crush or chew the tablets. Crushing or chewing the tablets may cause your mouth or teeth to change color.Take this medication regularly to get the most benefit from it. The dosage is based on your medical condition, response to treatment, and lab test results. Do not take more of this medication than prescribed.

                SIDE EFFECTS: Nausea, diarrhea, constipation, or vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.The iron in this medication may cause your stools to turn black. This effect is harmless.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                PRECAUTIONS: Before taking ferric citrate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal problems (such as ulcers, bleeding), high level of iron in the blood.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

                DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.This product can make it hard for your body to absorb many other drugs, including bisphosphonates (such as alendronate), certain quinolone antibiotics (such as ciprofloxacin), thyroid medications (such as levothyroxine), tetracycline antibiotics (such as doxycycline), among others. Separate your doses of these medications as far as possible from your doses of ferric citrate. Ask your doctor or pharmacist about how long you should wait between doses and for help finding a dosing schedule that will work with all your medications.

                OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                NOTES: Your doctor may tell you to follow a special diet to help lower your blood phosphate levels. Follow the diet closely.Do not share this medication with others.Laboratory and/or medical tests (such as phosphate and iron blood levels) should be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details.

                MISSED DOSE: If you miss a dose, skip the missed dose unless you have just eaten. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

                STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

                Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

                IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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                NC NOT COVERED – Drugs that are not covered by the plan.
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