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

Stem definition	Drug id	CAS RN
	4233	343306-71-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: sugammadex bridion sugammadex sodium ORG 25969	Sugammadex is a modified gamma cyclodextrin which is a Selective Relaxant Binding Agent. It forms a complex with the neuromuscular blocking agents rocuronium or vecuronium in plasma and thereby reduces the amount of neuromuscular blocking agent available to bind to nicotinic receptors in the neuromuscular junction. This results in the reversal of neuromuscular blockade induced by rocuronium or vecuronium. Molecular weight: 2002.12 Formula: C72H112O48S8 CLOGP: -11.90 LIPINSKI: 3 HAC: 48 HDO: 24 TPSA: 769.76 ALOGS: -1.88 ROTB: 40

Molecule

Description

Molfile Inchi Smiles

Synonyms:

sugammadex
bridion
sugammadex sodium
ORG 25969

Sugammadex is a modified gamma cyclodextrin which is a Selective Relaxant Binding Agent. It forms a complex with the neuromuscular blocking agents rocuronium or vecuronium in plasma and thereby reduces the amount of neuromuscular blocking agent available to bind to nicotinic receptors in the neuromuscular junction. This results in the reversal of neuromuscular blockade induced by rocuronium or vecuronium.

Molecular weight: 2002.12
Formula: C72H112O48S8
CLOGP: -11.90
LIPINSKI: 3
HAC: 48
HDO: 24
TPSA: 769.76
ALOGS: -1.88
ROTB: 40

Drug dosage:

None

ADMET properties:

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Property	Value	Reference
t_half (Half-life)	2.53 hours	Lombardo F, Berellini G, Obach RS
CL (Clearance)	1.28 mL/min/kg	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	0.18 L/kg	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
Dec. 15, 2015	FDA	ORGANON USA INC
July 25, 2008	EMA	MERCK SHARP & DOHME LIMITED

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
Recurrence of neuromuscular blockade	296.45	51.36	36	1531	108	63487347
Anaphylactic reaction	203.92	51.36	72	1495	66028	63421427
Anaphylactic shock	143.07	51.36	43	1524	23590	63463865
Bradycardia	142.51	51.36	57	1510	73170	63414285
Bronchospasm	133.49	51.36	38	1529	17242	63470213
Neuromuscular block prolonged	97.48	51.36	16	1551	526	63486929
Drug reaction with eosinophilia and systemic symptoms	71.42	51.36	28	1539	33808	63453647
Cardiac arrest	68.71	51.36	37	1530	92508	63394947
Hypoventilation	62.84	51.36	16	1551	4738	63482717
Clonus	58.32	51.36	15	1552	4621	63482834

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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
Recurrence of neuromuscular blockade	247.79	59.46	34	1312	191	34955394
Anaphylactic shock	235.54	59.46	64	1282	15877	34939708
Anaphylactic reaction	227.47	59.46	73	1273	32228	34923357
Bronchospasm	157.83	59.46	43	1303	10688	34944897
Negative pressure pulmonary oedema	142.10	59.46	21	1325	212	34955373
Cardiac arrest	132.23	59.46	67	1279	96092	34859493
Bradycardia	107.73	59.46	54	1292	75364	34880221
Neuromuscular block prolonged	84.95	59.46	15	1331	486	34955099
Kounis syndrome	81.51	59.46	19	1327	2499	34953086
Oxygen saturation decreased	81.02	59.46	40	1306	53778	34901807

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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
Recurrence of neuromuscular blockade	403.74	43.42	54	2785	265	79741284
Anaphylactic reaction	370.47	43.42	131	2708	83612	79657937
Anaphylactic shock	343.13	43.42	101	2738	35895	79705654
Bradycardia	206.50	43.42	99	2740	135458	79606091
Bronchospasm	203.00	43.42	62	2777	24797	79716752
Cardiac arrest	172.95	43.42	95	2744	172001	79569548
Neuromuscular block prolonged	171.41	43.42	30	2809	1000	79740549
Negative pressure pulmonary oedema	151.06	43.42	22	2817	216	79741333
Oxygen saturation decreased	104.52	43.42	62	2777	128985	79612564
Kounis syndrome	97.67	43.42	24	2815	4258	79737291

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	V03AB35	VARIOUS ALL OTHER THERAPEUTIC PRODUCTS ALL OTHER THERAPEUTIC PRODUCTS Antidotes
CHEBI has role	CHEBI:51372	neuromuscular agent
FDA CS	M0081434	gamma-Cyclodextrins

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

Disease	Relation	SNOMED_ID	DOID
Reversal of neuromuscular blockade	indication	241703000

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	7.58	acidic
pKa10	13.65	acidic
pKa11	13.89	acidic
pKa2	7.94	acidic
pKa3	8.0	acidic
pKa4	8.0	acidic
pKa5	8.0	acidic
pKa6	8.0	acidic
pKa7	8.0	acidic
pKa8	8.0	acidic

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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
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	BRIDION	MSD SUB MERCK	N022225	Dec. 15, 2015	RX	SOLUTION	INTRAVENOUS	RE44733	Jan. 27, 2026	REVERSAL OF DRUG-INDUCED NEUROMUSCULAR BLOCK
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	BRIDION	MSD SUB MERCK	N022225	Dec. 15, 2015	RX	SOLUTION	INTRAVENOUS	RE44733	Jan. 27, 2026	REVERSAL OF DRUG-INDUCED NEUROMUSCULAR BLOCK

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	BRIDION	MSD SUB MERCK	N022225	Dec. 15, 2015	RX	SOLUTION	INTRAVENOUS	June 9, 2023	REVISIONS TO THE USE IN SPECIFIC POPULATIONS SECTION OF THE PACKAGE INSERT TO INCLUDE THE RESULT OF STUDY P146 TO FULFILL THE REQUIREMENTS OF PMR 3003-4
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	BRIDION	MSD SUB MERCK	N022225	Dec. 15, 2015	RX	SOLUTION	INTRAVENOUS	Jan. 22, 2024	REVISIONS TO THE USE IN SPECIFIC POPULATIONS SECTION OF THE PACKAGE INSERT TO INCLUDE THE RESULT OF STUDY P145
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	BRIDION	MSD SUB MERCK	N022225	Dec. 15, 2015	RX	SOLUTION	INTRAVENOUS	June 25, 2024	NEW PATIENT POPULATION
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	BRIDION	MSD SUB MERCK	N022225	Dec. 15, 2015	RX	SOLUTION	INTRAVENOUS	June 9, 2023	REVISIONS TO THE USE IN SPECIFIC POPULATIONS SECTION OF THE PACKAGE INSERT TO INCLUDE THE RESULT OF STUDY P146 TO FULFILL THE REQUIREMENTS OF PMR 3003-4
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	BRIDION	MSD SUB MERCK	N022225	Dec. 15, 2015	RX	SOLUTION	INTRAVENOUS	Jan. 22, 2024	REVISIONS TO THE USE IN SPECIFIC POPULATIONS SECTION OF THE PACKAGE INSERT TO INCLUDE THE RESULT OF STUDY P145
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	BRIDION	MSD SUB MERCK	N022225	Dec. 15, 2015	RX	SOLUTION	INTRAVENOUS	June 25, 2024	NEW PATIENT POPULATION

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Bioactivity Summary:

None

External reference:

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ID	Source
012914	NDDF
012915	NDDF
1172425006	SNOMEDCT_US
159483	MMSL
1726987	RXNORM
26064	MMSL
31376	MMSL
31381	MMSL
343306-79-6	SECONDARY_CAS_RN
361LPM2T56	UNII

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
BRIDION	HUMAN PRESCRIPTION DRUG LABEL	1	0006-5423	INJECTION, SOLUTION	100 mg	INTRAVENOUS	NDA	29 sections
BRIDION	HUMAN PRESCRIPTION DRUG LABEL	1	0006-5423	INJECTION, SOLUTION	100 mg	INTRAVENOUS	NDA	29 sections
BRIDION	HUMAN PRESCRIPTION DRUG LABEL	1	0006-5423	INJECTION, SOLUTION	100 mg	INTRAVENOUS	NDA	29 sections
BRIDION	HUMAN PRESCRIPTION DRUG LABEL	1	0006-5425	INJECTION, SOLUTION	100 mg	INTRAVENOUS	NDA	29 sections
BRIDION	HUMAN PRESCRIPTION DRUG LABEL	1	0006-5425	INJECTION, SOLUTION	100 mg	INTRAVENOUS	NDA	29 sections
BRIDION	HUMAN PRESCRIPTION DRUG LABEL	1	0006-5425	INJECTION, SOLUTION	100 mg	INTRAVENOUS	NDA	29 sections
BRIDION	HUMAN PRESCRIPTION DRUG LABEL	1	71872-7187	INJECTION, SOLUTION	100 mg	INTRAVENOUS	NDA	28 sections
BRIDION	HUMAN PRESCRIPTION DRUG LABEL	1	71872-7187	INJECTION, SOLUTION	100 mg	INTRAVENOUS	NDA	28 sections
Sugammadex	HUMAN PRESCRIPTION DRUG LABEL	1	31722-254	INJECTION	100 mg	INTRAVENOUS	ANDA	27 sections
Sugammadex	HUMAN PRESCRIPTION DRUG LABEL	1	31722-255	INJECTION, SOLUTION	100 mg	INTRAVENOUS	ANDA	27 sections

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