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Ferric derisomaltose

Generic Name
Ferric derisomaltose
Drug Type
Small Molecule
Chemical Formula
C18H34FeO16
CAS Number
1345510-43-1
Unique Ingredient Identifier
AHU547PI9H

Overview

Iron deficiency is an extremely common condition and is the most frequent cause of anemia worldwide. Iron deficiency results when iron intake, iron stores, and loss of iron from the body do not adequately support production of erythrocytes, also known as red blood cells. Though it is generally considered non life-threatening, iron deficiency may considerably affect quality of life. Ferric derisomaltose is a form of iron used in the treatment of iron deficiency. This drug is a complex of iron (III) hydroxide and derisomaltose. The latter is an iron carbohydrate oligosaccharide that works to release iron. Ferric derisomaltose was developed by Pharmacosmos Therapeutics ad was granted FDA approval in January 2020. Clinical trials show that it is non-inferior to iron sucrose, another form of iron that is often administered in iron deficiency, and less likely to cause serious hypersensitivity that is associated with other forms of injectable iron.

Background

Iron deficiency is an extremely common condition and is the most frequent cause of anemia worldwide. Iron deficiency results when iron intake, iron stores, and loss of iron from the body do not adequately support production of erythrocytes, also known as red blood cells. Though it is generally considered non life-threatening, iron deficiency may considerably affect quality of life. Ferric derisomaltose is a form of iron used in the treatment of iron deficiency. This drug is a complex of iron (III) hydroxide and derisomaltose. The latter is an iron carbohydrate oligosaccharide that works to release iron. Ferric derisomaltose was developed by Pharmacosmos Therapeutics ad was granted FDA approval in January 2020. Clinical trials show that it is non-inferior to iron sucrose, another form of iron that is often administered in iron deficiency, and less likely to cause serious hypersensitivity that is associated with other forms of injectable iron.

Indication

This drug is indicated for the treatment of iron deficiency anemia in adult patients who have experienced intolerance to oral iron preparations or insufficient clinical response to orally administered iron. Ferric derisomaltase is also indicated for patients with non-hemodialysis dependent chronic kidney disease. In Australia and United Kingdom, ferric derisomaltase is indicated for cases in which rapid delivery of iron is required.

Associated Conditions

  • Iron Deficiency Anemia (IDA)
  • Requirement for rapid iron delivery

FDA Approved Products

Monoferric
Manufacturer:Pharmacosmos Therapeutics Inc.
Route:INTRAVENOUS
Strength:100 mg in 1 mL
Approved: 2024/01/16
NDC:73594-9301
Monoferric
Manufacturer:Pharmacosmos Therapeutics Inc.
Route:INTRAVENOUS
Strength:1000 mg in 10 mL
Approved: 2024/01/16
NDC:73594-9310
Monoferric
Manufacturer:Pharmacosmos Therapeutics Inc.
Route:INTRAVENOUS
Strength:500 mg in 5 mL
Approved: 2024/01/16
NDC:73594-9305

Singapore Approved Products

MONOFER® SOLUTION FOR INJECTION OR INFUSION 100 MG/ML
Manufacturer:Wasserburger Arzneimittelwerk GmbH
Form:INJECTION, SOLUTION
Strength:100 mg/ml
Online:Yes
Approved: 2019/11/14
Approval:SIN15855P

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