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

Stem definition	Drug id	CAS RN
perfluorinated compounds used as blood substitutes and/or diagnostic agents	2104	76-19-7

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: luminity perflutren octafluoropropane perfluoropropane	Perflutren lipid microspheres exhibit lower acoustic impedance than blood and enhance the intrinsic backscatter of blood. These physical acoustic properties of activated perflutren provide contrast enhancement of the left ventricular chamber and aid delineation of the left ventricular endocardial border during echocardiography. Molecular weight: 188.02 Formula: C3F8 CLOGP: 2.85 LIPINSKI: 0 HAC: 0 HDO: 0 TPSA: ALOGS: -3.11 ROTB: 2 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

luminity
perflutren
octafluoropropane
perfluoropropane

Perflutren lipid microspheres exhibit lower acoustic impedance than blood and enhance the intrinsic backscatter of blood. These physical acoustic properties of activated perflutren provide contrast enhancement of the left ventricular chamber and aid delineation of the left ventricular endocardial border during echocardiography.

Molecular weight: 188.02
Formula: C3F8
CLOGP: 2.85
LIPINSKI: 0
HAC: 0
HDO: 0
TPSA:
ALOGS: -3.11
ROTB: 2

Status: ONP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

None

ADMET properties:

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Property	Value	Reference
CL (Clearance)	590.71 mL/min/kg	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	1.60 L/kg	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	0.02 hours	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
July 31, 2001	FDA	LANTHEUS MEDCL

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
Back pain	771.57	48.30	282	1514	263863	63223363
Flushing	133.49	48.30	57	1739	75030	63412196
Muscle spasms	120.71	48.30	67	1729	156083	63331143
Neck pain	92.21	48.30	43	1753	69275	63417951
Dyspnoea	89.95	48.30	101	1695	661212	62826014
Chest pain	66.06	48.30	52	1744	215907	63271319
Contrast media reaction	59.26	48.30	12	1784	1113	63486113
Pain in extremity	52.26	48.30	55	1741	331431	63155795
Urticaria	50.78	48.30	40	1756	165762	63321464

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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
Back pain	791.53	58.87	266	1327	121523	34833815
Muscle spasms	196.98	58.87	86	1507	74915	34880423
Flushing	107.38	58.87	44	1549	32376	34922962
Urticaria	102.75	58.87	52	1541	62325	34893013
Neck pain	79.10	58.87	33	1560	25316	34930022
Anaphylactic reaction	65.22	58.87	31	1562	32270	34923068
Pain in extremity	62.22	58.87	49	1544	126464	34828874

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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
Back pain	1378.02	53.32	494	2747	303686	79437461
Muscle spasms	311.68	53.32	148	3093	174582	79566565
Flushing	224.46	53.32	96	3145	88172	79652975
Neck pain	146.48	53.32	68	3173	75349	79665798
Urticaria	112.68	53.32	78	3163	185123	79556024
Dyspnoea	100.01	53.32	146	3095	856879	78884268
Pain in extremity	95.47	53.32	94	3147	364444	79376703
Contrast media reaction	95.07	53.32	21	3220	2049	79739098
Anaphylactic reaction	80.09	53.32	47	3194	83696	79657451
Chest pain	77.91	53.32	75	3166	282229	79458918

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FDA Adverse Event Reporting System (Pediatric)

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Pharmacologic Action:

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Source	Code	Description
ATC	V08DA01	VARIOUS CONTRAST MEDIA ULTRASOUND CONTRAST MEDIA Ultrasound contrast media
ATC	V08DA04	VARIOUS CONTRAST MEDIA ULTRASOUND CONTRAST MEDIA Ultrasound contrast media
FDA EPC	N0000175864	Contrast Agent for Ultrasound Imaging
FDA MoA	N0000010259	Ultrasound 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
Echocardiography	indication	40701008

🐶 Veterinary Drug Use

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🐶 Veterinary products

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Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
6.52MG/ML	DEFINITY	LANTHEUS MEDCL	N021064	July 31, 2001	RX	INJECTABLE	INTRAVENOUS	10583207	Dec. 28, 2035	METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING
6.52MG/ML	DEFINITY RT	LANTHEUS MEDCL	N021064	Nov. 17, 2020	RX	INJECTABLE	INTRAVENOUS	10583207	Dec. 28, 2035	METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING
6.52MG/ML	DEFINITY RT	LANTHEUS MEDCL	N021064	Nov. 17, 2020	RX	INJECTABLE	INTRAVENOUS	11395856	Dec. 28, 2035	METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING
6.52MG/ML	DEFINITY	LANTHEUS MEDCL	N021064	July 31, 2001	RX	INJECTABLE	INTRAVENOUS	10583208	March 16, 2037	METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING
6.52MG/ML	DEFINITY RT	LANTHEUS MEDCL	N021064	Nov. 17, 2020	RX	INJECTABLE	INTRAVENOUS	10583208	March 16, 2037	METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING
6.52MG/ML	DEFINITY	LANTHEUS MEDCL	N021064	July 31, 2001	RX	INJECTABLE	INTRAVENOUS	11266750	March 16, 2037	METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING
6.52MG/ML	DEFINITY RT	LANTHEUS MEDCL	N021064	Nov. 17, 2020	RX	INJECTABLE	INTRAVENOUS	11266750	March 16, 2037	METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING
6.52MG/ML	DEFINITY	LANTHEUS MEDCL	N021064	July 31, 2001	RX	INJECTABLE	INTRAVENOUS	11529431	March 16, 2037	METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING
6.52MG/ML	DEFINITY RT	LANTHEUS MEDCL	N021064	Nov. 17, 2020	RX	INJECTABLE	INTRAVENOUS	11529431	March 16, 2037	METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING
6.52MG/ML	DEFINITY	LANTHEUS MEDCL	N021064	July 31, 2001	RX	INJECTABLE	INTRAVENOUS	9789210	March 16, 2037	METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING

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Orange Book exclusivity data (new drug applications)

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Bioactivity Summary:

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External reference:

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ID	Source
009302	NDDF
16500	MMSL
283753	RXNORM
4021302	VANDF
4021353	VANDF
4024282	VUID
4024282	VANDF
409291008	SNOMEDCT_US
409292001	SNOMEDCT_US
6432	PUBCHEM_CID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Definity	HUMAN PRESCRIPTION DRUG LABEL	1	11994-011	INJECTION, SUSPENSION	6.52 mg	INTRAVENOUS	NDA	25 sections
Definity	HUMAN PRESCRIPTION DRUG LABEL	1	11994-011	INJECTION, SUSPENSION	6.52 mg	INTRAVENOUS	NDA	25 sections
Definity	HUMAN PRESCRIPTION DRUG LABEL	1	11994-011	INJECTION, SUSPENSION	6.52 mg	INTRAVENOUS	NDA	25 sections
DEFINITY RT	HUMAN PRESCRIPTION DRUG LABEL	1	11994-017	INJECTION, SUSPENSION	6.52 mg	INTRAVENOUS	NDA	27 sections
DEFINITY RT	HUMAN PRESCRIPTION DRUG LABEL	1	11994-017	INJECTION, SUSPENSION	6.52 mg	INTRAVENOUS	NDA	27 sections
Optison Perflutren Protein-Type A Microspheres	HUMAN PRESCRIPTION DRUG LABEL	2	0407-2707	INJECTION, SOLUTION	0.22 mg	INTRAVENOUS	NDA	28 sections
Optison Perflutren Protein-Type A Microspheres	HUMAN PRESCRIPTION DRUG LABEL	2	0407-2707	INJECTION, SOLUTION	0.22 mg	INTRAVENOUS	NDA	28 sections

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