ferumoxytol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	5204	722492-56-0

Description:

Molecule	Description
Synonyms: ferumoxytol rienso ferumoxytol non-stoichiometric magnetite feraheme	Ferumoxytol consists of a superparamagnetic iron oxide that is coated with a carbohydrate shell, which helps to isolate the bioactive iron from plasma components until the iron-carbohydrate complex enters the reticuloendothelial system macrophages of the liver, spleen and bone marrow. The iron is released from the iron-carbohydrate complex within vesicles in the macrophages. Iron then either enters the intracellular storage iron pool (e.g., ferritin) or is transferred to plasma transferrin for transport to erythroid precursor cells for incorporation into hemoglobin. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

ferumoxytol
rienso
ferumoxytol non-stoichiometric magnetite
feraheme

Ferumoxytol consists of a superparamagnetic iron oxide that is coated with a carbohydrate shell, which helps to isolate the bioactive iron from plasma components until the iron-carbohydrate complex enters the reticuloendothelial system macrophages of the liver, spleen and bone marrow. The iron is released from the iron-carbohydrate complex within vesicles in the macrophages. Iron then either enters the intracellular storage iron pool (e.g., ferritin) or is transferred to plasma transferrin for transport to erythroid precursor cells for incorporation into hemoglobin.

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
June 15, 2012	EMA	Takeda Pharma A/S
June 30, 2009	FDA	AMAG PHARMS INC

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Flushing	242.79	53.59	95	2314	74992	63411621
Dyspnoea	202.87	53.59	179	2230	661134	62825479
Anaphylactic reaction	169.86	53.59	71	2338	66029	63420584
Unresponsive to stimuli	161.18	53.59	57	2352	33759	63452854
Infusion related reaction	127.12	53.59	91	2318	245430	63241183
Chest discomfort	104.77	53.59	60	2349	109909	63376704
Back pain	86.86	53.59	75	2334	264070	63222543
Hypersensitivity	72.58	53.59	71	2338	292614	63193999
Hypotension	69.20	53.59	67	2342	272537	63214076
Pulse absent	67.43	53.59	19	2390	5355	63481258

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Unresponsive to stimuli	145.82	52.62	50	1263	27519	34928099
Anaphylactic reaction	115.92	52.62	44	1269	32257	34923361
Flushing	97.96	52.62	39	1274	32381	34923237
Hypotension	88.85	52.62	70	1243	221579	34734039
Dyspnoea	79.84	52.62	83	1230	376699	34578919
Infusion related reaction	61.99	52.62	33	1280	53024	34902594
Back pain	58.50	52.62	43	1270	121746	34833872

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Flushing	312.05	48.26	125	3467	88143	79652653
Unresponsive to stimuli	261.14	48.26	97	3495	55691	79685105
Anaphylactic reaction	236.14	48.26	101	3491	83642	79657154
Dyspnoea	235.47	48.26	236	3356	856789	78884007
Infusion related reaction	178.49	48.26	117	3475	230120	79510676
Hypotension	139.81	48.26	132	3460	440185	79300611
Back pain	134.14	48.26	110	3482	304070	79436726
Chest discomfort	128.78	48.26	79	3513	137965	79602831
Pulse absent	104.69	48.26	32	3560	10071	79730725
Hyperhidrosis	98.01	48.26	69	3523	151423	79589373

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
FDA CS	M0011718	Iron
FDA EPC	N0000177913	Parenteral Iron Replacement
MeSH PA	D006397	Hematinics
MeSH PA	D006401	Hematologic Agents
MeSH PA	D057947	Parenteral Nutrition Solutions
MeSH PA	D019999	Pharmaceutical Solutions

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Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Iron deficiency anemia	indication	87522002

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

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ID	Source
013180	NDDF
166183	MMSL
348766	MMSL
4028919	VANDF
442951001	SNOMEDCT_US
442952008	SNOMEDCT_US
473387	RXNORM
49868115	PUBCHEM_CID
C0060274	UMLSCUI
CHEBI:46726	CHEBI

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Feraheme	HUMAN PRESCRIPTION DRUG LABEL	1	59338-775	INJECTION	510 mg	INTRAVENOUS	NDA	28 sections
Feraheme	HUMAN PRESCRIPTION DRUG LABEL	1	59338-775	INJECTION	510 mg	INTRAVENOUS	NDA	28 sections
Feraheme	HUMAN PRESCRIPTION DRUG LABEL	1	59338-775	INJECTION	510 mg	INTRAVENOUS	NDA	28 sections
Ferumoxytol	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3154	INJECTION	510 mg	INTRAVENOUS	ANDA	27 sections
Ferumoxytol	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3154	INJECTION	510 mg	INTRAVENOUS	ANDA	27 sections
Ferumoxytol	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3154	INJECTION	510 mg	INTRAVENOUS	ANDA	27 sections

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