Identification
- Summary
Ferric carboxymaltose is an iron replacement therapy used to treat iron deficiency anemia in children and adults with intolerance or inadequate clinical response to oral iron, and in adult patients who have non-dialysis dependent chronic kidney disease.
- Brand Names
- Injectafer
- Generic Name
- Ferric carboxymaltose
- DrugBank Accession Number
- DB08917
- Background
Ferric Carboxymaltose is an iron replacement product and chemically, an iron carbohydrate complex. FDA approved on July 25, 2013.
- Type
- Small Molecule
- Groups
- Approved
- Synonyms
- Ferric carboxymaltose
- Iron carboxymaltose
- Iron dextri-maltose
- External IDs
- VIT 45
Pharmacology
- Indication
Ferric carboxymaltose is an iron replacement product indicated for the treatment of iron deficiency anemia in patients ≥1 year of age who have an intolerance to, or unsatisfactory response from, oral iron therapy.1 It is also indicated in adult patients who have non-dialysis-dependent chronic kidney disease.1
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- Contraindications & Blackbox Warnings
Avoid life-threatening adverse drug eventsImprove clinical decision support with information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events & improve clinical decision support.- Pharmacodynamics
When measured using positron emission tomography (PET), the red cell uptake of 59-Fe and 52-Fe from INJECTAFER ranged from 61% to 99%. In patients with iron deficiency, the red cell uptake ranged from 91% to 99%. In patients with renal anemia, the red cell uptake ranged from 61% to 84%.
- Mechanism of action
Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that release iron.
- Absorption
When a single dose of 100 to 1000 mg of iron was given to iron deficient patients, the maximum serum concentration (Cmax) was 37 μg/mL to 333 μg/mL. These levels were obtained 15 minutes to 1.21 hours post dose (Tmax).
- Volume of distribution
3 L
- Protein binding
Not Available
- Metabolism
- Not Available
- Route of elimination
Renal elimination of iron was negligible.
- Half-life
7 to 12 hours.
- Clearance
Not Available
- Adverse Effects
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The most common adverse reactions (>2%) are nausea, hypertension, flushing, hypophosphatemia, and dizziness.
- 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 softwareCalcium Phosphate Ferric carboxymaltose can cause a decrease in the absorption of Calcium Phosphate resulting in a reduced serum concentration and potentially a decrease in efficacy. Calcium phosphate dihydrate Ferric carboxymaltose can cause a decrease in the absorption of Calcium phosphate dihydrate resulting in a reduced serum concentration and potentially a decrease in efficacy. Carbidopa Ferric carboxymaltose can cause a decrease in the absorption of Carbidopa resulting in a reduced serum concentration and potentially a decrease in efficacy. Cinoxacin Ferric carboxymaltose can cause a decrease in the absorption of Cinoxacin resulting in a reduced serum concentration and potentially a decrease in efficacy. Ciprofloxacin Ferric carboxymaltose can cause a decrease in the absorption of Ciprofloxacin resulting in a reduced serum concentration and potentially a decrease in efficacy. Deferiprone The serum concentration of Deferiprone can be decreased when it is combined with Ferric carboxymaltose. Delafloxacin Ferric carboxymaltose can cause a decrease in the absorption of Delafloxacin resulting in a reduced serum concentration and potentially a decrease in efficacy. Dimercaprol Dimercaprol may increase the nephrotoxic activities of Ferric carboxymaltose. Dipotassium phosphate Ferric carboxymaltose can cause a decrease in the absorption of Dipotassium phosphate resulting in a reduced serum concentration and potentially a decrease in efficacy. Enoxacin Ferric carboxymaltose can cause a decrease in the absorption of Enoxacin resulting in a reduced serum concentration and potentially a decrease in efficacy. 
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- No interactions found.
Products
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Name Kind UNII CAS InChI Key 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 Injectafer Injection, solution 50 mg/1mL Intravenous AMERICAN REGENT, INC. 2021-06-01 Not applicable US 
Injectafer Injection, solution 50 mg/1mL Intravenous AMERICAN REGENT, INC. 2013-08-12 Not applicable US Injectafer Injection, solution 50 mg/1mL Intravenous AMERICAN REGENT, INC. 2022-06-01 Not applicable US
Categories
- Drug Categories
- Classification
- Not classified
- Affected organisms
- Humans and other mammals
Chemical Identifiers
- UNII
- 6897GXD6OE
- CAS number
- 9007-72-1
- InChI Key
- Not Available
- InChI
- Not Available
- IUPAC Name
- Not Available
- SMILES
- Not Available
References
- General References
- FDA Approved Drug Products: Injectafer (ferric carboxymaltose) for intravenous injection [Link]
- External Links
- KEGG Drug
- D08920
- PubChem Substance
- 347910386
- 1433693
- ChEMBL
- CHEMBL2108597
- Drugs.com
- Drugs.com Drug Page
- Wikipedia
- Iron_supplement
- FDA label
- Download (269 KB)
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Active Not Recruiting Treatment Endothelial Dysfunction / Iron Toxicity / Renal Anemia / Stress Oxidative 1 4 Completed Prevention Iron Deficiency Anemia (IDA) 1 4 Completed Treatment Anemia of Chronic Kidney Disease 1 4 Completed Treatment Anemia / Colorectal Neoplasms 2 4 Completed Treatment Anemia / Heart Failure / Iron Deficiency (ID) 1 4 Completed Treatment Anemia / Iron Deficiency (ID) 2 4 Completed Treatment Chronic Heart Failure (CHF) / Iron Deficiency (ID) 1 4 Completed Treatment Cystic Fibrosis (CF) / Iron Deficiency (ID) 1 4 Completed Treatment Fatigue 1 4 Completed Treatment Heart Failure 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection Intravenous Injection, solution Intravenous 50 mg/mL Injection, solution; injection, solution, concentrate Intravenous Injection, solution Intravenous bolus; Intravenous drip 50 mg/ml Solution Intravenous 500 mg Solution Intravenous 50 mg Injection, solution Intravenous 50 mg/1mL - Prices
- Not Available
- Patents
Patent Number Pediatric Extension Approved Expires (estimated) Region US8895612 No 2014-11-25 2027-01-08 US US7754702 No 2010-07-13 2027-02-13 US US7612109 No 2009-11-03 2024-02-05 US US9376505 No 2016-06-28 2023-10-20 US US10519252 No 2019-12-31 2023-10-20 US US11123321 No 2021-09-21 2023-10-20 US US11291645 No 2003-10-20 2023-10-20 US US11433091 No 2007-01-08 2027-01-08 US US11478502 No 2007-01-08 2027-01-08 US US11590097 No 2003-10-20 2023-10-20 US
Properties
- State
- Solid
- Experimental Properties
- Not Available
- Predicted Properties
- Not Available
- Predicted ADMET Features
- Not Available
Spectra
- Mass Spec (NIST)
- Not Available
- Spectra
- Not Available
Drug created at August 01, 2013 05:33 / Updated at January 08, 2022 03:27