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

Stem definition	Drug id	CAS RN
steroids, progestogens	1110	54048-10-1

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: etonogestrel implanon 3-Oxodesogestrel	metabolite of DESOGESTREL; structure given in first source; Implanon: implant containing etonogestrel (3-keto-desogestrel) Molecular weight: 324.46 Formula: C22H28O2 CLOGP: 3.35 LIPINSKI: 0 HAC: 2 HDO: 1 TPSA: 37.30 ALOGS: -4.64 ROTB: 1 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

etonogestrel
implanon
3-Oxodesogestrel

metabolite of DESOGESTREL; structure given in first source; Implanon: implant containing etonogestrel (3-keto-desogestrel)

Molecular weight: 324.46
Formula: C22H28O2
CLOGP: 3.35
LIPINSKI: 0
HAC: 2
HDO: 1
TPSA: 37.30
ALOGS: -4.64
ROTB: 1

Status: OFP

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

Drug dosage:

Dose	Unit	Route
68	mcg	s.c. implant

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	76 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
t_half (Half-life)	25 hours	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	2.87 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	2 mL/min/kg	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.51 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0.10 %	Benet LZ, Broccatelli F, Oprea TI
fu (Fraction unbound in plasma)	0.02 %	Lombardo F, Berellini G, Obach RS
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.01 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

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Approvals:

Date	Agency	Company	Orphan
Oct. 3, 2001	FDA

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
No adverse event	21125.29	34.30	5655	73944	35750	63373673
Complication associated with device	17034.72	34.30	3994	75605	12984	63396439
Incorrect product administration duration	12170.02	34.30	2831	76768	8715	63400708
Device breakage	11821.19	34.30	2765	76834	8777	63400646
Product quality issue	11262.45	34.30	3363	76236	32502	63376921
Device difficult to use	10856.46	34.30	2633	76966	10163	63399260
Device deployment issue	10644.79	34.30	2097	77502	1805	63407618
Complication of device removal	10271.33	34.30	2132	77467	3010	63406413
Complication of device insertion	9505.87	34.30	2142	77457	5422	63404001
Pregnancy with implant contraceptive	8518.47	34.30	1638	77961	1045	63408378

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FDA Adverse Event Reporting System (Male)

None

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
No adverse event	13244.22	41.50	3356	49839	33836	79657357
Complication associated with device	10966.50	41.50	2496	50699	15000	79676193
Product quality issue	8601.27	41.50	2343	50852	31597	79659596
Device difficult to use	8419.41	41.50	1917	51278	11468	79679725
Device deployment issue	8277.88	41.50	1489	51706	1723	79689470
Complication of device insertion	7613.80	41.50	1548	51647	4802	79686391
Complication of device removal	7390.53	41.50	1394	51801	2495	79688698
Device breakage	7334.96	41.50	1644	51551	9031	79682162
Incorrect product administration duration	7097.66	41.50	1636	51559	10386	79680807
Implant site pain	6046.76	41.50	1070	52125	1027	79690166

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	G03AC08	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens
CHEBI has role	CHEBI:49323	contraceptive drugs
CHEBI has role	CHEBI:49324	female contraceptive drugs
CHEBI has role	CHEBI:59826	progestins
FDA CS	M0447349	Progesterone Congeners
FDA EPC	N0000175602	Progestin
MeSH PA	D003270	Contraceptive Agents
MeSH PA	D003271	Contraceptive Agents, Female
MeSH PA	D000080066	Contraceptive Agents, Hormonal
MeSH PA	D012102	Reproductive Control Agents

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

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Disease	Relation	SNOMED_ID	DOID
Contraception	indication	13197004
Heart valve disorder	contraindication	368009	DOID:4079
Hypercholesterolemia	contraindication	13644009
Toxic shock syndrome	contraindication	18504008	DOID:14115
Myocardial infarction	contraindication	22298006	DOID:5844
Diplopia	contraindication	24982008
Retinal hemorrhage	contraindication	28998008
Depressive disorder	contraindication	35489007
Migraine	contraindication	37796009	DOID:6364
Hypertensive disorder	contraindication	38341003	DOID:10763

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	13.93	acidic

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
68MG/IMPLANT	IMPLANON	ORGANON	N021529	July 17, 2006	DISCN	IMPLANT	IMPLANTATION	9757552	July 28, 2030	PREVENTION OF PREGNANCY
68MG/IMPLANT	NEXPLANON	ORGANON	N021529	May 31, 2011	RX	IMPLANT	IMPLANTATION	9757552	July 28, 2030	PREVENTION OF PREGNANCY

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Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Progesterone receptor	Nuclear hormone receptor	P06401	PRGR_HUMAN	AGONIST			WOMBAT-PK	CHEMBL
Estrogen receptor	Nuclear hormone receptor	P03372	ESR1_HUMAN				WOMBAT-PK
Sex hormone-binding globulin	Secreted	P04278	SHBG_HUMAN		Kd	8.23	CHEMBL

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External reference:

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ID	Source
007906	NDDF
14584	RXNORM
16189	MMSL
304GTH6RNH	UNII
326451000	SNOMEDCT_US
396050000	SNOMEDCT_US
4021294	VUID
4021294	VANDF
51895	MMSL
6832	INN_ID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
EluRyng	HUMAN PRESCRIPTION DRUG LABEL	2	65162-469	RING	0.12 mg	VAGINAL	ANDA	29 sections
EluRyng	HUMAN PRESCRIPTION DRUG LABEL	2	65162-469	RING	0.12 mg	VAGINAL	ANDA	29 sections
EnilloRing	HUMAN PRESCRIPTION DRUG LABEL	2	70700-156	RING	0.12 mg	VAGINAL	ANDA	22 sections
Etonogestrel and Ethinyl Estradiol	HUMAN PRESCRIPTION DRUG LABEL	2	0093-7679	INSERT, EXTENDED RELEASE	0.12 mg	VAGINAL	ANDA	29 sections
Etonogestrel and Ethinyl Estradiol	HUMAN PRESCRIPTION DRUG LABEL	2	0093-7679	INSERT, EXTENDED RELEASE	0.12 mg	VAGINAL	ANDA	29 sections
Etonogestrel/Ethinyl Estradiol	HUMAN PRESCRIPTION DRUG LABEL	2	50090-5959	INSERT, EXTENDED RELEASE	0.12 mg	VAGINAL	NDA AUTHORIZED GENERIC	29 sections
Etonogestrel/Ethinyl Estradiol	HUMAN PRESCRIPTION DRUG LABEL	2	66993-605	INSERT, EXTENDED RELEASE	0.12 mg	VAGINAL	NDA AUTHORIZED GENERIC	30 sections
Etonogestrel/Ethinyl Estradiol	HUMAN PRESCRIPTION DRUG LABEL	2	66993-605	INSERT, EXTENDED RELEASE	0.12 mg	VAGINAL	NDA AUTHORIZED GENERIC	30 sections
Etonogestrel/Ethinyl Estradiol	HUMAN PRESCRIPTION DRUG LABEL	2	66993-605	INSERT, EXTENDED RELEASE	0.12 mg	VAGINAL	NDA AUTHORIZED GENERIC	30 sections
Etonogestrel/Ethinyl Estradiol	HUMAN PRESCRIPTION DRUG LABEL	2	66993-605	INSERT, EXTENDED RELEASE	0.12 mg	VAGINAL	NDA AUTHORIZED GENERIC	30 sections

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