Ferric derisomaltose

WeightAverage: 562.297
Monoisotopic: 562.117975Chemical FormulaC₁₈H₃₄FeO₁₆

Monover, JAPAN 2022, 2022/3/28

Monoferric (TN);
Monover (TN)

Anti-anemic, Hematinic, Supplement (iron)

CAS 1345510-43-1

デルイソマルトース第二鉄

• NS32
• WHO 9712
• UNII-AHU547PI9H

Originator Company	Pharmacosmos
Active Companies	Nippon Shinyaku Co Ltd;Pharmacosmos A/S;Wasserburger Arzneimittelwerk Gmbh;Zealand University Hospital

iron(3+) (2S,3R,4R,5R)-6-{[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-({[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}methyl)oxan-2-yl]oxy}hexane-1,2,3,4,5-pentol

• alpha-D-Glucan, (1-6)-, reduced, reaction products with iron hydroxide (Fe(OH)3)

Ferric derisomaltose is an iron injection used in the treatment of iron deficiency anemia.

Ferric derisomaltose, sold under the brand name Monoferric, is a medication for the treatment of iron deficiency anemia (IDA) in adults who have intolerance to oral iron or have had unsatisfactory response to oral iron or who have non-hemodialysis dependent chronic kidney disease (NDD-CKD).^[1] It was approved for use in the United States in January 2020.^[1][2][3] It is given intravenously.^[1]

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.³

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.^8,9 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.^1,4

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.⁸ In Australia and United Kingdom, ferric derisomaltase is indicated for cases in which rapid delivery of iron is required.^10,11

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.

Monoferric is an iron replacement product containing ferric derisomaltose for intravenous infusion. Ferric derisomaltose is an iron carbohydrate complex with a matrix structure composed of interchanging layers of ferric hydroxide and the carbohydrate derisomaltose. Derisomaltose consists of linear, hydrogenated isomaltooligosaccharides with an average molecular weight of 1000 Da and a narrow molecular weight distribution that is almost devoid of mono-and disaccharides.

Ferric derisomaltose has an average molecular weight of 155,000 Da and has the following empirical formula:

{FeO_(1-3X) (OH)_(1+3X) (C₆H₅O₇^3-)_X}, (H₂0)_T, –
(C₆H₁₀O₆)_R(-C₆H₁₀O₅-)_Z(C₆H₁₃O₅)_R, (NaCl)_Y

X= 0.0311; T = 0.25; R = 0.14; Z = 0.49; Y = 0.14

Iron atoms placed in the electronegative cavities of the 3-D structure between and within the derisomaltose molecules. A schematic representation is presented below

Monoferric is a sterile, dark brown, non-transparent aqueous solution with pH 5.0-7.0, containing ferric derisomaltose dissolved in water for injections and filled into Type I glass vials.

Each 1 mL of solution contains 100 mg of elemental iron as ferric derisomaltose in water for injection.

Each 1 mL of solution contains 100 mg of elemental iron as ferric derisomaltose in water for injection.

Mkt. Status	Active Ingredient	Proprietary Name	Appl. No.	Dosage Form	Route	Strength	TE Code	RLD	RS	Applicant Holder
RX	FERRIC DERISOMALTOSE	MONOFERRIC	N208171	SOLUTION	INTRAVENOUS	1GM/10ML (100MG/ML)		RLD	RS	PHARMACOSMOS AS
DISCN	FERRIC DERISOMALTOSE	MONOFERRIC	N208171	SOLUTION	INTRAVENOUS	100MG/ML (100MG/ML)		RLD		PHARMACOSMOS AS
DISCN	FERRIC DERISOMALTOSE	MONOFERRIC	N208171	SOLUTION	INTRAVENOUS	500MG/5ML (100MG/ML)		RLD		PHARMACOSMOS AS
Mkt. Status	Active Ingredient	Proprietary Name	Appl. No.	Dosage Form	Route	Strength	TE Code	>RLD	RS	Applicant Holder

MONOFERRIC (FERRIC DERISOMALTOSE)
1GM/10ML (100MG/ML)
Marketing Status: Prescription

Active Ingredient: FERRIC DERISOMALTOSE
Proprietary Name: MONOFERRIC
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1GM/10ML (100MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N208171
Product Number: 003
Approval Date: Jan 16, 2020
Applicant Holder Full Name: PHARMACOSMOS AS
Marketing Status:  Prescription
Patent and Exclusivity Information

Patent and Exclusivity for: N208171

Product 003
FERRIC DERISOMALTOSE (MONOFERRIC) SOLUTION 1GM/10ML (100MG/ML)

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
003	8815301	08/14/2029	DS	DP	U-2734		02/14/2020
003	10414831	03/25/2029	DS	DP			02/14/2020

PATENT

AU2009342799B2

US10414831B2 

US2012010166A1 

 US2014303364A1 

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References

1. ^ Jump up to:^a b c d “Monoferric- ferric derisomaltose solution”. DailyMed. 24 January 2020. Retrieved 16 February 2020.
2. ^ “Monoferric approval letter” (PDF). U.S. Food and Drug Administration (FDA). 16 January 2020. Retrieved 16 February 2020.  This article incorporates text from this source, which is in the public domain.
3. ^ “Drug Approval Package: Monoferric Injection”. U.S. Food and Drug Administration (FDA). 7 May 2020. Retrieved 13 August 2020.

External links

• “Ferric derisomaltose”. Drug Information Portal. U.S. National Library of Medicine.

Clinical data
Trade names	Monoferric
AHFS/Drugs.com	Monograph
License data	US DailyMed: Ferric_derisomaltose
Routes of administration	Intravenous (IV)
ATC code	None
Legal status
Legal status	US: ℞-only [1]
Identifiers
showIUPAC name
CAS Number	1345510-43-1
PubChem CID	86278348
DrugBank	DB15617
UNII	AHU547PI9H
KEGG	D11808
Chemical and physical data
Formula	C18H34FeO16+3
Molar mass	562.299 g·mol−1
3D model (JSmol)	Interactive image
showSMILES
showInChI

/////////////Ferric derisomaltose, デルイソマルトース第二鉄 , APPROVALS 2022, JAPAN 2022, NS32, WHO 9712

[Fe+3].OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO[C@H]1O[C@H](CO[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@H](O)[C@H]1O