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Sodium ferric gluconate complex
Identification
- Name
- Sodium ferric gluconate complex
- Accession Number
- DB09517
- Description
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
Used to replete the total body content of iron during iron deficiency anemia in patients age 6 years and older with chronic kidney disease receiving hemodialysis and receiving supplemental epoetin therapy.
- Associated Conditions
- Contraindications & Blackbox Warnings
Learn about our commercial Contraindications & Blackbox Warnings data.
Learn More- Pharmacodynamics
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 UHemoglobin subunit alpha bindingHumans AHemoglobin subunit beta 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).
- Volume of distribution
The initial volume of distribution is 6L which correlates well with the calculated blood volume.
- Protein binding
It is bind to transferrin, ferritin and hemoglobin.
- 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.
- Clearance
Total clearance ranges from 3.02 to 5.35 L/h in adult patients.
- Adverse Effects
Learn about our commercial Adverse Effects data.
Learn More- Toxicity
Overdosage of iron causes cardiovascular toxicity and hepatic necrosis. The lowest lethal dose (LDLo) following intravenous administration is 78.8mg/kg in rats and 250mg/kg in dogs. Adverse effects from sodium ferric gluconate therapy include hypersensitivity reactions, nausea, vomiting, diarrhea, pain, peripheral swelling and hypotension. Dosages in excess of iron needs may lead to accumulation of iron in iron storage sites and hemosiderosis.
- Affected organisms
- Not Available
- 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 Unlock Additional DataCinoxacin Sodium ferric gluconate complex can cause a decrease in the absorption of Cinoxacin resulting in a reduced serum concentration and potentially a decrease in efficacy. Ciprofloxacin Sodium ferric gluconate complex can cause a decrease in the absorption of Ciprofloxacin resulting in a reduced serum concentration and potentially a decrease in efficacy. Delafloxacin Sodium ferric gluconate complex can cause a decrease in the absorption of Delafloxacin resulting in a reduced serum concentration and potentially a decrease in efficacy. Enoxacin Sodium ferric gluconate complex can cause a decrease in the absorption of Enoxacin resulting in a reduced serum concentration and potentially a decrease in efficacy. Gatifloxacin Sodium ferric gluconate complex can cause a decrease in the absorption of Gatifloxacin resulting in a reduced serum concentration and potentially a decrease in efficacy. Gemifloxacin Sodium ferric gluconate complex can cause a decrease in the absorption of Gemifloxacin resulting in a reduced serum concentration and potentially a decrease in efficacy. Grepafloxacin Sodium ferric gluconate complex can cause a decrease in the absorption of Grepafloxacin resulting in a reduced serum concentration and potentially a decrease in efficacy. Levofloxacin Sodium ferric gluconate complex can cause a decrease in the absorption of Levofloxacin resulting in a reduced serum concentration and potentially a decrease in efficacy. Lomefloxacin Sodium ferric gluconate complex can cause a decrease in the absorption of Lomefloxacin resulting in a reduced serum concentration and potentially a decrease in efficacy. Moxifloxacin Sodium ferric gluconate complex can cause a decrease in the absorption of Moxifloxacin resulting in a reduced serum concentration and potentially a decrease in efficacy. Additional Data Available- Extended DescriptionExtended Description
Extended description of the mechanism of action and particular properties of each drug interaction.
Learn more - Severity
- Evidence Level
- ActionAction
An effect category for each drug interaction. Know how this interaction affects the subject drug.
Learn more
- Food Interactions
- No interactions found.
Products
- 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 Unlock Additional DataFerrlecit Liquid 12.5 mg Intravenous Sanofi Aventis 2005-03-02 Not applicable Canada 
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 Injection 12.5 mg/1mL Intravenous sanofi-aventis U.S. LLC 2011-03-01 Not applicable US Additional Data Available- Application NumberApplication Number
A unique ID assigned by the FDA when a product is submitted for approval by the labeller.
Learn more - Product CodeProduct Code
A governmentally-recognized ID which uniquely identifies the product within its regulatory market.
Learn more
- Generic Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Unlock Additional DataNulecit 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 West-Ward Pharmaceuticals Corp 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 Additional Data Available- Application NumberApplication Number
A unique ID assigned by the FDA when a product is submitted for approval by the labeller.
Learn more - Product CodeProduct Code
A governmentally-recognized ID which uniquely identifies the product within its regulatory market.
Learn more
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
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[[email protected]@H](O)[[email protected]@H](O)[[email protected]](O)[[email protected]@H](O)C([O-])=O.OC[[email protected]]1O[[email protected]@](CO)(O[[email protected]]2O[[email protected]](CO)[[email protected]@H](O)[[email protected]](O)[[email protected]]2O)[[email protected]@H](O)[[email protected]@H]1O.OC[[email protected]]1O[[email protected]@](CO)(O[[email protected]]2O[[email protected]](CO)[[email protected]@H](O)[[email protected]](O)[[email protected]]2O)[[email protected]@H](O)[[email protected]@H]1O.OC[[email protected]]1O[[email protected]@](CO)(O[[email protected]]2O[[email protected]](CO)[[email protected]@H](O)[[email protected]](O)[[email protected]]2O)[[email protected]@H](O)[[email protected]@H]1O.OC[[email protected]]1O[[email protected]@](CO)(O[[email protected]]2O[[email protected]](CO)[[email protected]@H](O)[[email protected]](O)[[email protected]]2O)[[email protected]@H](O)[[email protected]@H]1O.OC[[email protected]]1O[[email protected]@](CO)(O[[email protected]]2O[[email protected]](CO)[[email protected]@H](O)[[email protected]](O)[[email protected]]2O)[[email protected]@H](O)[[email protected]@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. [PubMed:11778670]
- 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. [PubMed:17942782]
- 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. [PubMed:10070910]
- 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. [PubMed:17296819]
- 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. [PubMed:15971073]
- SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE MONOGRAPH [Link]
- External Links
- PubChem Compound
- 76968835
- PubChem Substance
- 347827872
- ChemSpider
- 34989638
- 261435
- Wikipedia
- Sodium_ferric_gluconate_complex
- AHFS Codes
- 20:04.04 — Iron Preparations
- 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 Renal Failure (CRF) / Iron Deficiency Anemia (IDA) / Iron-Deficiency Anemias 2 4 Completed Treatment Heart Failure / Iron Deficiency Anemia (IDA) 1 4 Not Yet Recruiting Treatment Heart Failure 1 4 Unknown Status Treatment Anemia 1 3 Completed Supportive Care Anemia / Disorders, Lymphoproliferative / Leukemias / Malignant Lymphomas / Multiple Myeloma and Plasma Cell Neoplasm / Precancerous Conditions / Unspecified Adult Solid Tumor, Protocol Specific 1 3 Completed Treatment Anemia 1 2 Withdrawn Treatment Anemia 1 2, 3 Completed Treatment Iron Deficiency Anemia (IDA) 1 1 Completed Basic Science Chronic Renal Failure (CRF) / Iron Deficiency Anemia (IDA) / Iron-Deficiency Anemias 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Liquid Intravenous 12.5 mg Injection Intravenous 12.5 mg/1mL - 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
- 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]
- 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]
Drug created on November 30, 2015 12:10 / Updated on September 22, 2020 02:10
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