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

Stem definition	Drug id	CAS RN
diagnostic agents, gadolinium derivatives	4179	770691-21-9

Description:

Molecule	Description
Synonyms: gadobutrol gadavist gadograf gadovist protovist	Gadobutrol is indicated for use with magnetic resonance imaging (MRI) in adult and pediatric patients (including term neonates) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system. Molecular weight: 604.72 Formula: C18H31GdN4O9 CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: 181.08 ALOGS: ROTB: None

Molecule

Description

Synonyms:

gadobutrol
gadavist
gadograf
gadovist
protovist

Gadobutrol is indicated for use with magnetic resonance imaging (MRI) in adult and pediatric patients (including term neonates) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.

Molecular weight: 604.72
Formula: C18H31GdN4O9
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA: 181.08
ALOGS:
ROTB: None

Drug dosage:

None

ADMET properties:

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Property	Value	Reference
CL (Clearance)	2 mL/min/kg	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	1.30 hours	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	1 %	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	0.22 L/kg	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
March 14, 2011	FDA	BAYER HLTHCARE

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
Urticaria	1219.14	50.96	473	4968	165329	63318252
Pruritus	428.26	50.96	304	5137	361149	63122432
Contrast media reaction	294.43	50.96	55	5386	1070	63482511
Erythema	261.77	50.96	171	5270	175580	63308001
Gadolinium deposition disease	256.49	50.96	35	5406	64	63483517
Vomiting	224.78	50.96	256	5185	559361	62924220
Nausea	220.34	50.96	313	5128	854158	62629423
Contrast media allergy	192.45	50.96	44	5397	2357	63481224
Nontherapeutic agent urine positive	173.86	50.96	22	5419	13	63483568
Throat irritation	171.01	50.96	77	5364	37570	63446011

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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
Urticaria	519.74	46.86	190	2507	62187	34892047
Vomiting	236.33	46.86	175	2522	247446	34706788
Nausea	219.66	46.86	191	2506	339717	34614517
Pruritus	187.80	46.86	123	2574	141858	34812376
Contrast media deposition	122.32	46.86	17	2680	44	34954190
Contrast media allergy	106.15	46.86	20	2677	455	34953779
Erythema	102.65	46.86	71	2626	88709	34865525
Sneezing	95.46	46.86	29	2668	5213	34949021
Contrast media reaction	81.27	46.86	18	2679	928	34953306
Gadolinium deposition disease	72.48	46.86	10	2687	24	34954210

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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
Urticaria	1563.89	39.32	608	7260	184593	79551927
Pruritus	591.11	39.32	405	7463	394243	79342277
Vomiting	351.91	39.32	376	7492	665452	79071068
Nausea	350.46	39.32	447	7421	956749	78779771
Erythema	317.81	39.32	223	7645	223067	79513453
Gadolinium deposition disease	307.18	39.32	43	7825	84	79736436
Contrast media reaction	298.55	39.32	63	7805	2007	79734513
Contrast media allergy	253.19	39.32	57	7811	2465	79734055
Contrast media deposition	232.34	39.32	33	7835	75	79736445
Sneezing	212.36	39.32	78	7790	19605	79716915

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	V08CA09	VARIOUS CONTRAST MEDIA MAGNETIC RESONANCE IMAGING CONTRAST MEDIA Paramagnetic contrast media
FDA EPC	N0000183362	Gadolinium-based Contrast Agent
FDA MoA	N0000175862	Magnetic Resonance Contrast Activity
MeSH PA	D003287	Contrast Media
MeSH PA	D064907	Diagnostic Uses of Chemicals

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

Disease	Relation	SNOMED_ID	DOID
Magnetic resonance imaging	indication	113091000

🐶 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
008334	NDDF
180514	MMSL
18728	MMSL
1BJ477IO2L	UNII
369624	MMSL
4030851	VUID
4030851	VANDF
407976008	SNOMEDCT_US
418351005	SNOMEDCT_US
6102852	PUBCHEM_CID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Gadavist	HUMAN PRESCRIPTION DRUG LABEL	1	50419-325	INJECTION	604.72 mg	INTRAVENOUS	NDA	28 sections
Gadavist	HUMAN PRESCRIPTION DRUG LABEL	1	50419-325	INJECTION	604.72 mg	INTRAVENOUS	NDA	28 sections
Gadavist	HUMAN PRESCRIPTION DRUG LABEL	1	50419-325	INJECTION	604.72 mg	INTRAVENOUS	NDA	28 sections
Gadavist	HUMAN PRESCRIPTION DRUG LABEL	1	50419-325	INJECTION	604.72 mg	INTRAVENOUS	NDA	28 sections
Gadavist	HUMAN PRESCRIPTION DRUG LABEL	1	50419-325	INJECTION	604.72 mg	INTRAVENOUS	NDA	28 sections
Gadavist	HUMAN PRESCRIPTION DRUG LABEL	1	50419-325	INJECTION	604.72 mg	INTRAVENOUS	NDA	28 sections
Gadavist	HUMAN PRESCRIPTION DRUG LABEL	1	50419-325	INJECTION	604.72 mg	INTRAVENOUS	NDA	28 sections
Gadavist	HUMAN PRESCRIPTION DRUG LABEL	1	50419-325	INJECTION	604.72 mg	INTRAVENOUS	NDA	28 sections
Gadavist	HUMAN PRESCRIPTION DRUG LABEL	1	50419-325	INJECTION	604.72 mg	INTRAVENOUS	NDA	28 sections
Gadobutrol	HUMAN PRESCRIPTION DRUG LABEL	1	65219-281	INJECTION	604.72 mg	INTRAVENOUS	ANDA	28 sections

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