Ferric Citrate
Generic Name: ferric citrate
Brand Names:
Auryxia
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.
Overview
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.
Uses
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
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.
Side Effects
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.
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.
Warnings
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 ) 5.1 Iron 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. 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 )
Pregnancy
8.1 Pregnancy 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.
Storage
16.2 Storage 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.
Frequently Asked Questions
What is Ferric Citrate used for?▼
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.
What are the side effects of Ferric Citrate?▼
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.
Can I take Ferric Citrate during pregnancy?▼
8.1 Pregnancy 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.
What are the important warnings for Ferric Citrate?▼
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 ) 5.1 Iron 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. 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 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.