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

Stem definition	Drug id	CAS RN
antivirals carbocyclic nucleosides	34	136470-78-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: 1592U89 abacavir abacavir sulfate ziagen abacavir succinate	a carbocyclic nucleoside with potent selective anti-HIV activity; structure given in first source Molecular weight: 286.34 Formula: C14H18N6O CLOGP: 0.81 LIPINSKI: 0 HAC: 7 HDO: 3 TPSA: 101.88 ALOGS: -2.37 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

1592U89
abacavir
abacavir sulfate
ziagen
abacavir succinate

a carbocyclic nucleoside with potent selective anti-HIV activity; structure given in first source

Molecular weight: 286.34
Formula: C14H18N6O
CLOGP: 0.81
LIPINSKI: 0
HAC: 7
HDO: 3
TPSA: 101.88
ALOGS: -2.37
ROTB: 4

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.60	g	O

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	83 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
S (Water solubility)	77 mg/mL	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	29.93 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
CL (Clearance)	13 mL/min/kg	Lombardo F, Berellini G, Obach RS
EoM (Fraction excreted unchanged in urine)	1.20 %	Benet LZ, Broccatelli F, Oprea TI
t_half (Half-life)	1 hours	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
Vd (Volume of distribution)	0.84 L/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.50 %	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
Dec. 17, 1998	FDA	VIIV HLTHCARE
July 8, 1999	EMA

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
Exposure during pregnancy	423.97	28.17	275	9480	155272	63323995
Hypomania	346.28	28.17	96	9659	6234	63473033
Jaundice cholestatic	332.43	28.17	96	9659	7228	63472039
Viral mutation identified	323.05	28.17	71	9684	1739	63477528
Schizophrenia	307.55	28.17	97	9658	9855	63469412
Virologic failure	261.22	28.17	60	9695	1802	63477465
Hepatotoxicity	243.05	28.17	117	9638	36924	63442343
Abortion spontaneous	227.48	28.17	121	9634	47074	63432193
Psychotic disorder	224.32	28.17	99	9656	25613	63453654
Blood bilirubin increased	207.01	28.17	105	9650	37035	63442232

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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
Lipodystrophy acquired	592.45	15.27	161	15686	3183	34937901
Immune reconstitution inflammatory syndrome	526.82	15.27	184	15663	8575	34932509
Mitochondrial toxicity	418.22	15.27	117	15730	2582	34938502
Virologic failure	414.87	15.27	123	15724	3357	34937727
Viral mutation identified	337.29	15.27	101	15746	2853	34938231
Progressive external ophthalmoplegia	320.32	15.27	83	15764	1352	34939732
Eyelid ptosis	285.72	15.27	105	15742	5661	34935423
Pathogen resistance	209.87	15.27	97	15750	9385	34931699
Diplopia	183.43	15.27	107	15740	16736	34924348
Polydactyly	115.13	15.27	36	15811	1177	34939907

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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
Lipodystrophy acquired	713.87	16.60	176	20717	4149	79719346
Immune reconstitution inflammatory syndrome	696.18	16.60	222	20671	13619	79709876
Viral mutation identified	662.08	16.60	162	20731	3696	79719799
Virologic failure	604.00	16.60	153	20740	4038	79719457
Mitochondrial toxicity	490.09	16.60	122	20771	2992	79720503
Pathogen resistance	381.61	16.60	143	20750	14199	79709296
Progressive external ophthalmoplegia	370.32	16.60	84	20809	1361	79722134
Hypomania	278.96	16.60	96	20797	7448	79716047
Eyelid ptosis	275.25	16.60	105	20788	10939	79712556
Drug resistance	263.13	16.60	154	20739	42059	79681436

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	J05AF06	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Nucleoside and nucleotide reverse transcriptase inhibitors
ATC	J05AR02	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR04	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR13	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
CHEBI has role	CHEBI:36044	antiviral drugs
CHEBI has role	CHEBI:53756	reverse transcriptase inhibitors
CHEBI has role	CHEBI:88188	allergenic drug
FDA EPC	N0000175462	Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
FDA MoA	N0000009947	Nucleoside Reverse Transcriptase Inhibitors
FDA MoA	N0000193954	Cytochrome P450 1A1 Inhibitors

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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
Human immunodeficiency virus infection	indication	86406008	DOID:526
Toxic amblyopia	contraindication	965003
Myositis	contraindication	26889001	DOID:633
Hepatic failure	contraindication	59927004
Pancreatitis	contraindication	75694006	DOID:4989
Large liver	contraindication	80515008
Kidney disease	contraindication	90708001	DOID:557
Lactic acidosis	contraindication	91273001	DOID:3650
Disorder of muscle	contraindication	129565002	DOID:423
Steatosis of liver	contraindication	197321007

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🐶 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	13.09	acidic
pKa2	5.64	Basic
pKa3	0.88	Basic
pKa4	0.28	Basic

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Orange Book patent data (new drug applications)

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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 600MG BASE;EQ 50MG BASE;300MG	TRIUMEQ	VIIV HLTHCARE	N205551	Aug. 22, 2014	RX	TABLET	ORAL	June 15, 2026	INFORMATION ADDED TO THE LABELING REGARDING THE RESULT OF STUDY 205860
EQ 600MG BASE;EQ 50MG BASE;300MG	TRIUMEQ	VIIV HLTHCARE	N205551	Aug. 22, 2014	RX	TABLET	ORAL	Dec. 15, 2026	PEDIATRIC EXCLUSIVITY
EQ 60MG BASE;EQ 5MG BASE;30MG	TRIUMEQ PD	VIIV HLTHCARE	N215413	March 30, 2022	RX	TABLET, FOR SUSPENSION	ORAL	June 15, 2026	NEW PATIENT POPULATION
EQ 60MG BASE;EQ 5MG BASE;30MG	TRIUMEQ PD	VIIV HLTHCARE	N215413	March 30, 2022	RX	TABLET, FOR SUSPENSION	ORAL	Dec. 15, 2026	PEDIATRIC EXCLUSIVITY

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Bioactivity Summary:

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Target	Class	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Reverse transcriptase/RNaseH	Enzyme	Q72547_9HIV1	INHIBITOR	EC50	5.28	CHEMBL	CHEMBL
Gag-Pol polyprotein	Polyprotein	POL_HV1A2		EC50	5.28	WOMBAT-PK
Reverse transcriptase	Enzyme	Q9WKE8_9HIV1		IC50	6.89	CHEMBL

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External reference:

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ID	Source
1KX	PDB_CHEM_ID
007687	NDDF
007688	NDDF
11152	IUPHAR_LIGAND_ID
116084008	SNOMEDCT_US
14010	MMSL
168146-84-7	SECONDARY_CAS_RN
188062-50-2	SECONDARY_CAS_RN
190521	RXNORM
191490	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Abacavir	HUMAN PRESCRIPTION DRUG LABEL	1	0121-0897	SOLUTION	20 mg	ORAL	ANDA	28 sections
Abacavir	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6874	TABLET, FILM COATED	300 mg	ORAL	ANDA	28 sections
Abacavir	Human Prescription Drug Label	1	31722-557	TABLET	300 mg	ORAL	ANDA	27 sections
Abacavir	Human Prescription Drug Label	1	31722-562	SOLUTION	20 mg	ORAL	ANDA	28 sections
Abacavir	HUMAN PRESCRIPTION DRUG LABEL	1	50268-049	TABLET	300 mg	ORAL	ANDA	27 sections
Abacavir	HUMAN PRESCRIPTION DRUG LABEL	1	50268-049	TABLET	300 mg	ORAL	ANDA	27 sections
Abacavir and Lamivudine	Human Prescription Drug Label	2	35573-402	TABLET, FILM COATED	600 mg	ORAL	ANDA	29 sections
Abacavir and Lamivudine	Human Prescription Drug Label	2	35573-430	TABLET, FILM COATED	600 mg	ORAL	ANDA	27 sections
Abacavir and Lamivudine	Human Prescription Drug Label	2	35573-430	TABLET, FILM COATED	600 mg	ORAL	ANDA	27 sections
Abacavir and Lamivudine	HUMAN PRESCRIPTION DRUG LABEL	2	42291-115	TABLET, FILM COATED	600 mg	ORAL	ANDA	28 sections

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