Identification
- Summary
Sodium ferric gluconate complex is an iron complex used for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.
- Brand Names
- Ferrlecit
- Generic Name
- Sodium ferric gluconate complex
- DrugBank Accession Number
- DB09517
- Background
Sodium ferric gluconate complex is an iron replacement product for treatment of iron deficiency anemia. The stable macromolecular complex is negatively charged at alkaline pH with an apparent molecular weight of 289,000 – 440,000 daltons on gel chromatography. It is composed of iron (III) oxide hydrate directly bonded to sucrose with a chelating gluconate function in a molar ratio of two iron molecules to one gluconate. It is used in adult and in pediatric patients over the age of 6 years with chronic kidney disease (CKD) receiving hemodialysis and receiving supplemental epoetin therapy.
- Type
- Small Molecule
- Groups
- Approved
- Structure
Structure for Sodium ferric gluconate complex (DB09517)
- Weight
- Average: 2089.309
Monoisotopic: 2088.47592 - Chemical Formula
- C66H121Fe2NaO65
- Synonyms
- Ferric sodium gluconate complex
- Sodium ferric gluconate complex
Pharmacology
- Indication
Sodium ferric gluconate complex in sucrose injection is used to deplete the total body content of iron during iron deficiency anemia in patients aged 6 years and older with chronic kidney disease receiving hemodialysis and receiving supplemental epoetin therapy.6
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- Contraindications & Blackbox Warnings
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Sodium ferric gluconate complex is an exogenous epoetin that acts to restore the body's content of iron, which is essential for normal hemoglobin synthesis, oxygen transport, and enzymatic processes. The complex increases red blood cell production and increased iron utilization.
- Mechanism of action
The complex is endocytosed by macrophages of the reticuloendothelial system. Within an endosome of the macrophage , lysosome fuses with the endosome creating an acidic environment leading to the cleavage of the complex from iron. Iron is then incorporated in ferritin, transferrin or hemoglobin. Sodium ferric gluconate also normalizes RBC production by binding with hemoglobin
Target Actions Organism AFerritin light chain bindingHumans AHemoglobin subunit beta bindingHumans UHemoglobin subunit alpha bindingHumans - Absorption
Peak drug levels (Cmax) varied significantly by dosage and by rate of administration. Highest Cmax value is observed in the regimen in which 125 mg was administered in 7 minutes (19.0 mg/L).6
- Volume of distribution
Using single-dose pharmacokinetics of either 1.5 or 3 mg/kg in pediatric patients (mean age 12.3 ± 2.5 yr), the volume of distribution was estimated to be 1.6 ± 0.6 L.2
- Protein binding
It is bound to transferrin, ferritin and hemoglobin.6
- Metabolism
- Not Available
- Route of elimination
It is renally eliminated if it is greater than 18,000 Daltons.
- Half-life
The terminal elimination half-life for drug-bound iron was approximately 1 hour, with the value varying by dose but not by rate of administration. In adults, the shortest terminal elimination half-life of 0.825h occurs with the 62.5 mg/4 min dosing regimen and the longest value of 1.45h is achieved with 125 mg/7 min regimen. In pediatric patients, the half-life was 2 hours following administration of 1.5 mg/kg dose and 2.5 hours following administration of 3.0mg/kg dose.6
- Clearance
Total clearance ranges from 3.02 to 5.35 L/h in adult patients.6
- Adverse Effects
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The Ferrlecit iron complex is not dialyzable.6
No data is available regarding overdose of Ferrlecit in humans. Excessive dosages of Ferrlecit may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. Do not administer Ferrlecit to patients with iron overload [see Warnings and Precautions (5.3)].6
Individual doses exceeding 125 mg may be associated with a higher incidence and/or severity of adverse events [see Adverse Reactions (6.2)].6
Ferrlecit at elemental iron doses of 125 mg/kg, 78.8 mg/kg, 62.5 mg/kg, and 250 mg/kg caused deaths in mice, rats, rabbits, and dogs respectively. The major symptoms of acute toxicity were decreased activity, staggering, ataxia, increases in respiratory rate, tremors, and convulsions.6
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Drug Interaction Integrate drug-drug
interactions in your softwareAbaloparatide The risk or severity of hypotension can be increased when Sodium ferric gluconate complex is combined with Abaloparatide. Acebutolol The risk or severity of hypotension can be increased when Sodium ferric gluconate complex is combined with Acebutolol. Aldesleukin The risk or severity of hypotension can be increased when Sodium ferric gluconate complex is combined with Aldesleukin. Aliskiren The risk or severity of hypotension can be increased when Sodium ferric gluconate complex is combined with Aliskiren. Ambrisentan The risk or severity of hypotension can be increased when Sodium ferric gluconate complex is combined with Ambrisentan. Amifostine The risk or severity of hypotension can be increased when Sodium ferric gluconate complex is combined with Amifostine. Amiloride The risk or severity of hypotension can be increased when Sodium ferric gluconate complex is combined with Amiloride. Amiodarone The risk or severity of hypotension can be increased when Sodium ferric gluconate complex is combined with Amiodarone. Amlodipine The risk or severity of hypotension can be increased when Sodium ferric gluconate complex is combined with Amlodipine. Amphotericin B The risk or severity of hypotension can be increased when Sodium ferric gluconate complex is combined with Amphotericin B. 
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- No interactions found.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Active Moieties
Name Kind UNII CAS InChI Key Iron unknown E1UOL152H7 7439-89-6 XEEYBQQBJWHFJM-UHFFFAOYSA-N Ferric cation ionic 91O4LML611 20074-52-6 VTLYFUHAOXGGBS-UHFFFAOYSA-N - Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Ferrlecit Injection 12.5 mg/1mL Intravenous sanofi-aventis U.S. LLC 1999-02-18 2010-01-04 US 
Ferrlecit Injection 12.5 mg/1mL Intravenous sanofi-aventis U.S. LLC 2014-07-07 Not applicable US Ferrlecit Solution 12.5 mg Intravenous Sanofi Aventis 2005-03-02 Not applicable Canada 
Ferrlecit Injection 12.5 mg/1mL Intravenous sanofi-aventis U.S. LLC 2011-03-01 Not applicable US - Generic Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Nulecit Injection 12.5 mg/1mL Intravenous Actavis Pharma Company 2011-03-31 2013-05-31 US Sodium Ferric Gluconate Complex Injection 12.5 mg/1mL Intravenous Actavis Pharma, Inc. 2011-03-31 2019-06-30 US Sodium Ferric Gluconate Complex in Sucrose Injection 12.5 mg/1mL Intravenous Hikma Pharmaceuticals USA Inc. 2011-03-31 Not applicable US Sodium Ferric Gluconate Complex in Sucrose Injection 12.5 mg/1mL Intravenous Actavis Pharma, Inc. 2012-08-23 2019-06-30 US Sodium Ferric Gluconate Complex in Sucrose Injection 12.5 mg/1mL Intravenous Hikma Pharmaceuticals USA Inc. 2011-03-31 Not applicable US
Categories
- Drug Categories
- Chemical TaxonomyProvided by Classyfire
- Description
- This compound belongs to the class of organic compounds known as sugar acids and derivatives. These are compounds containing a saccharide unit which bears a carboxylic acid group.
- Kingdom
- Organic compounds
- Super Class
- Organic oxygen compounds
- Class
- Organooxygen compounds
- Sub Class
- Carbohydrates and carbohydrate conjugates
- Direct Parent
- Sugar acids and derivatives
- Alternative Parents
- C-glycosyl compounds / Disaccharides / O-glycosyl compounds / Medium-chain hydroxy acids and derivatives / Medium-chain fatty acids / Beta hydroxy acids and derivatives / Hydroxy fatty acids / Ketals / Oxanes / Oxolanes show 13 more
- Substituents
- Acetal / Alcohol / Aliphatic heteromonocyclic compound / Beta-hydroxy acid / C-glycosyl compound / Carbonyl group / Carboxylic acid / Carboxylic acid derivative / Carboxylic acid salt / Disaccharide show 25 more
- Molecular Framework
- Not Available
- External Descriptors
- Not Available
- Affected organisms
- Not Available
Chemical Identifiers
- UNII
- CC9149U2QX
- CAS number
- 34089-81-1
- InChI Key
- MQBDAEHWGRMADS-XNHLMZCASA-M
- InChI
- InChI=1S/5C12H22O11.C6H12O7.2Fe.Na.3O/c5*13-1-4-6(16)8(18)9(19)11(21-4)23-12(3-15)10(20)7(17)5(2-14)22-12;7-1-2(8)3(9)4(10)5(11)6(12)13;;;;;;/h5*4-11,13-20H,1-3H2;2-5,7-11H,1H2,(H,12,13);;;;;;/q;;;;;;2*+3;+1;3*-2/p-1/t5*4-,5-,6-,7-,8+,9-,10+,11-,12+;2-,3-,4+,5-;;;;;;/m111111....../s1
- IUPAC Name
- diiron(3+) ion sodium pentakis((2R,3R,4S,5S,6R)-2-{[(2S,3S,4S,5R)-3,4-dihydroxy-2,5-bis(hydroxymethyl)oxolan-2-yl]oxy}-6-(hydroxymethyl)oxane-3,4,5-triol) (2R,3S,4R,5R)-2,3,4,5,6-pentahydroxyhexanoate trioxidandiide
- SMILES
- [O--].[O--].[O--].[Na+].[Fe+3].[Fe+3].OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O.OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O.OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O.OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O.OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O.OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O
References
- Synthesis Reference
Geisser, Peter, and Susanna Burckhardt. "The Pharmacokinetics And Pharmacodynamics Of Iron Preparations". Pharmaceutics 3.4 (2011): 12-33. Web. 14 Apr. 2017.
- General References
- Tenenbein M: Hepatotoxicity in acute iron poisoning. J Toxicol Clin Toxicol. 2001;39(7):721-6. [Article]
- Warady BA, Seligman PA, Dahl NV: Single-dosage pharmacokinetics of sodium ferric gluconate complex in iron-deficient pediatric hemodialysis patients. Clin J Am Soc Nephrol. 2007 Nov;2(6):1140-6. Epub 2007 Oct 17. [Article]
- Faich G, Strobos J: Sodium ferric gluconate complex in sucrose: safer intravenous iron therapy than iron dextrans. Am J Kidney Dis. 1999 Mar;33(3):464-70. [Article]
- Henry DH, Dahl NV, Auerbach M, Tchekmedyian S, Laufman LR: Intravenous ferric gluconate significantly improves response to epoetin alfa versus oral iron or no iron in anemic patients with cancer receiving chemotherapy. Oncologist. 2007 Feb;12(2):231-42. [Article]
- Warady BA, Zobrist RH, Wu J, Finan E: Sodium ferric gluconate complex therapy in anemic children on hemodialysis. Pediatr Nephrol. 2005 Sep;20(9):1320-7. Epub 2005 Jun 22. [Article]
- SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE MONOGRAPH [Link]
- FDA Approved Drug Products: FERRLECIT (sodium ferric gluconate complex in sucrose), injection, for intravenous use [Link]
- External Links
- PubChem Compound
- 76968835
- PubChem Substance
- 347827872
- ChemSpider
- 34989638
- 261435
- Wikipedia
- Sodium_ferric_gluconate_complex
- FDA label
- Download (86.7 KB)
- MSDS
- Download (957 KB)
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Completed Treatment Anemia 2 4 Completed Treatment Chronic Kidney Disease (CKD) / Iron Deficiency Anemia (IDA) 1 4 Completed Treatment Heart Failure 1 4 Completed Treatment Heart Failure / Iron Deficiency Anemia (IDA) 1 4 Completed Treatment Iron Deficiency Anemia (IDA) / Renal Failure, Chronic Renal Failure 2 4 Recruiting Treatment Aortic Stenosis / Iron Deficiency Anemia Due to Blood Loss 1 4 Terminated Treatment Anemia 1 3 Completed Supportive Care Anemia / Leukemias / Lymphoma / Lymphoproliferative Disorders / Multiple Myeloma and Plasma Cell Neoplasm / Precancerous Conditions / Unspecified Adult Solid Tumor, Protocol Specific 1 3 Completed Treatment Anemia 1 3 Recruiting Treatment Inflammatory Bowel Diseases (IBD) / Iron Deficiency Anemia (IDA) 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Solution Intravenous 40 mg/3.2ml Solution Intravenous; Oral 177.5 mg/5ml Capsule Oral 40 mg Capsule Oral 62.5 mg Powder Oral 20 mg Syrup Oral 113.6 mg/8ml Syrup Oral 177.5 mg/8ml Syrup Oral 2218.7 mg/100mL Solution Intravenous 12.5 mg Injection Intravenous 12.5 mg/1mL Capsule Oral - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Liquid
- Experimental Properties
- Not Available
- Predicted Properties
Property Value Source Water Solubility 824.0 mg/mL ALOGPS logP -2.6 ALOGPS logP -4.5 Chemaxon logS 0.38 ALOGPS pKa (Strongest Acidic) 11.84 Chemaxon pKa (Strongest Basic) -3 Chemaxon Physiological Charge 0 Chemaxon Hydrogen Acceptor Count 11 Chemaxon Hydrogen Donor Count 8 Chemaxon Polar Surface Area 189.53 Å2 Chemaxon Rotatable Bond Count 30 Chemaxon Refractivity 68.77 m3·mol-1 Chemaxon Polarizability 30.86 Å3 Chemaxon Number of Rings 10 Chemaxon Bioavailability 0 Chemaxon Rule of Five No Chemaxon Ghose Filter No Chemaxon Veber's Rule No Chemaxon MDDR-like Rule Yes Chemaxon - Predicted ADMET Features
- Not Available
Spectra
- Mass Spec (NIST)
- Not Available
- Spectra
- Not Available
Targets
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Yes
- Actions
- Binding
- General Function
- Iron ion binding
- Specific Function
- Stores iron in a soluble, non-toxic, readily available form. Important for iron homeostasis. Iron is taken up in the ferrous form and deposited as ferric hydroxides after oxidation. Also plays a ro...
- Gene Name
- FTL
- Uniprot ID
- P02792
- Uniprot Name
- Ferritin light chain
- Molecular Weight
- 20019.49 Da
References
- The Pharmacokinetics And Pharmacodynamics Of Iron Preparations [Link]
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Yes
- Actions
- Binding
- General Function
- Oxygen transporter activity
- Specific Function
- Involved in oxygen transport from the lung to the various peripheral tissues.LVV-hemorphin-7 potentiates the activity of bradykinin, causing a decrease in blood pressure.Spinorphin: functions as an...
- Gene Name
- HBB
- Uniprot ID
- P68871
- Uniprot Name
- Hemoglobin subunit beta
- Molecular Weight
- 15998.34 Da
References
- The Pharmacokinetics And Pharmacodynamics Of Iron Preparations [Link]
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Unknown
- Actions
- Binding
- General Function
- Oxygen transporter activity
- Specific Function
- Involved in oxygen transport from the lung to the various peripheral tissues.
- Gene Name
- HBA1
- Uniprot ID
- P69905
- Uniprot Name
- Hemoglobin subunit alpha
- Molecular Weight
- 15257.405 Da
References
- The Pharmacokinetics And Pharmacodynamics Of Iron Preparations [Link]
Drug created at November 30, 2015 19:10 / Updated at February 08, 2023 20:46