Ferric citrate

Ferric Citrate may be found in some form under the following brand names:

• Auryxia

Ferric citrate contains iron that binds to the phosphates you take in through food, which helps your body absorb fewer phosphates. This can lower the amount of phosphorus (a mineral) in your blood.

Ferric citrate is used to control phosphorus levels in people with chronic kidney disease who are on dialysis.

Ferric citrate may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Ferric citrate works best if you take it with meals.

Ferric citrate contains iron, which is absorbed and stored by your body while you are taking this medicine. To make sure your body is not storing too much iron, you will need frequent blood tests to check your iron levels.

Store this medicine in the original container at room temperature away from moisture and heat.

Keep the bottle tightly closed and out of the reach of children. Accidental iron overdose is a leading cause of death in children younger than 6 years old.

Hyperphosphatemia

Reduction of serum phosphorus in patients with chronic kidney disease who are undergoing dialysis.1 4 5

Administration

Oral Administration

Administer orally in divided doses with meals.1

Dosage

Adults

Initially, 2 g 3 times daily.1

Monitor serum phosphorus concentrations and titrate dosage at intervals of 1 week or longer in decrements or increments of 1–2 g daily as needed to maintain target serum phosphorus concentrations.1

Average dosage of 8–9 g daily was required to control serum phosphorus concentrations in a clinical study.1

Prescribing Limits

Adults

Maximum 12 g daily.1

Special Populations

No special population dosage recommendations.1

Storage

Oral

20–25°C (may be exposed to 15–30°C).1 Protect from moisture.1

• Importance of adhering to instructions about diet.1

• Importance of taking ferric citrate as directed with meals.1

• Importance of instructing patients about any concomitantly used drugs that should be taken at a different time of day than when ferric citrate is taken.1

• Potential for ferric citrate to cause discolored (dark) stools.1

• Potential for ferric citrate to cause diarrhea, nausea, constipation, and vomiting.1 Importance of reporting severe or persistent GI symptoms to clinician.1

• Risk of fatal iron poisoning in children <6 years of age.1 Importance of keeping ferric citrate out of reach of children.1 Contact a clinician or poison control center immediately in case of accidental overdosage.1

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

• Importance of advising clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

Ferric citrate is used to control the phosphorus levels in the blood of patients with chronic kidney disease that are on dialysis.

ferric citrate is available only with your doctor's prescription.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take ferric citrate or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to ferric citrate. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Iron overload syndromes (eg, hemochromatosis)

Alpha-Lipoic Acid: Iron Salts may decrease the absorption of Alpha-Lipoic Acid. Alpha-Lipoic Acid may decrease the absorption of Iron Salts. Consider therapy modification

Bisphosphonate Derivatives: Iron Salts may decrease the serum concentration of Bisphosphonate Derivatives. Management: Avoid administration of oral iron supplements within: 2 hours before or after tiludronate/clodronate/etidronate; 60 minutes after oral ibandronate; or 30 minutes after alendronate/risedronate. Exceptions: Pamidronate; Zoledronic Acid. Consider therapy modification

Cefdinir: Iron Salts may decrease the serum concentration of Cefdinir. Red-appearing, non-bloody stools may also develop due to the formation of an insoluble iron-cefdinir complex. Management: Avoid concurrent cefdinir and oral iron when possible. Separating doses by several hours may minimize interaction. Iron-containing infant formulas do not appear to interact with cefdinir. Consider therapy modification

Deferiprone: Iron Salts may decrease the serum concentration of Deferiprone. Management: Separate administration of deferiprone and oral medications or supplements that contain polyvalent cations by at least 4 hours. Consider therapy modification

Dimercaprol: May enhance the nephrotoxic effect of Iron Salts. Avoid combination

Dolutegravir: Iron Salts may decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after oral iron. Alternatively, dolutegravir and oral iron can be taken together with food. Consider therapy modification

Eltrombopag: Iron Salts may decrease the serum concentration of Eltrombopag. Management: Administer eltrombopag at least 2 hours before or 4 hours after oral administration of any iron-containing product. Consider therapy modification

Entacapone: Iron Salts may decrease the serum concentration of Entacapone. Management: Consider separating doses of the agents by 2 or more hours to minimize the effects of this interaction. Monitor for decreased therapeutic effects of levodopa during concomitant therapy, particularly if doses cannot be separated. Consider therapy modification

Ferric Hydroxide Polymaltose Complex: May decrease the serum concentration of Iron Salts. Specifically, the absorption of oral iron salts may be reduced. Management: Do not administer intravenous (IV) ferric hydroxide polymaltose complex with other oral iron salts. Therapy with oral iron salts should begin 1 week after the last dose of IV ferric hydroxide polymaltose complex. Consider therapy modification

Levodopa: Iron Salts may decrease the serum concentration of Levodopa. Only applies to oral iron preparations. Management: Consider separating doses of the agents by 2 or more hours to minimize the effects of this interaction. Monitor for decreased therapeutic effects of levodopa during concomitant therapy, particularly if doses cannot be separated. Consider therapy modification

Levothyroxine: Iron Salts may decrease the serum concentration of Levothyroxine. Management: Separate oral administration of iron salts and levothyroxine by at least 4 hours. Separation of doses is not required with parenterally administered iron salts or levothyroxine. Consider therapy modification

Methyldopa: Iron Salts may decrease the serum concentration of Methyldopa. Consider therapy modification

PenicillAMINE: Iron Salts may decrease the absorption of PenicillAMINE. Only oral iron salts are a concern. Consider therapy modification

Phosphate Supplements: Iron Salts may decrease the absorption of Phosphate Supplements. Management: This applies only to oral phosphate and iron administration. Administer oral phosphate supplements at least 1 hour before, or 2 hours after, oral iron salt administration. Exceptions: Sodium Glycerophosphate Pentahydrate. Consider therapy modification

Quinolone Antibiotics: Iron Salts may decrease the serum concentration of Quinolone Antibiotics. Management: Administer oral quinolones at least several hours before (4 h for moxi- and sparfloxacin, 2 h for others) or after (8 h for moxi-, 6 h for cipro/dela-, 4 h for lome-, 3 h for gemi-, and 2 h for levo-, nor-, or ofloxacin or nalidixic acid) oral iron salts. Exceptions: LevoFLOXacin (Oral Inhalation). Consider therapy modification

Tetracycline Derivatives: May decrease the absorption of Iron Salts. Iron Salts may decrease the serum concentration of Tetracycline Derivatives. Consider therapy modification

Trientine: May decrease the serum concentration of Iron Salts. Iron Salts may decrease the serum concentration of Trientine. Management: Trientine manufacturer recommends avoiding concurrent use with oral iron salts due to the risk for impaired GI absorption of both trientine and the iron salt. Short courses of iron may be used; however, separate administration by at least 2 hours. Consider therapy modification