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

Stem definition	Drug id	CAS RN
antivirals bicyclic heterocycle compounds	2798	124832-27-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: valacyclovir valaciclovir valcivir valacyclovir hydrochloride valacyclovir HCl	A prodrug of acyclovir that is used in the treatment of HERPES ZOSTER and HERPES SIMPLEX VIRUS INFECTION of the skin and mucous membranes, including GENITAL HERPES. Molecular weight: 324.34 Formula: C13H20N6O4 CLOGP: -1.22 LIPINSKI: 0 HAC: 10 HDO: 3 TPSA: 146.85 ALOGS: -1.97 ROTB: 8 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

valacyclovir
valaciclovir
valcivir
valacyclovir hydrochloride
valacyclovir HCl

A prodrug of acyclovir that is used in the treatment of HERPES ZOSTER and HERPES SIMPLEX VIRUS INFECTION of the skin and mucous membranes, including GENITAL HERPES.

Molecular weight: 324.34
Formula: C13H20N6O4
CLOGP: -1.22
LIPINSKI: 0
HAC: 10
HDO: 3
TPSA: 146.85
ALOGS: -1.97
ROTB: 8

Status: OFP

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

Drug dosage:

Dose	Unit	Route
3	g	O

ADMET properties:

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Property	Value	Reference
S (Water solubility)	174 mg/mL	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	154.16 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
fu (Fraction unbound in plasma)	1 %	Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0.50 %	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

Date	Agency	Company	Orphan
June 23, 1995	FDA	GLAXOSMITHKLINE

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
Plasma cell myeloma	352.15	10.02	318	78426	35587	63374691
Acute kidney injury	327.63	10.02	887	77857	262528	63147750
Altered state of consciousness	305.29	10.02	252	78492	24978	63385300
Febrile neutropenia	296.58	10.02	529	78215	117920	63292358
Contraindicated product administered	224.17	10.02	11	78733	217637	63192641
Cytokine release syndrome	218.51	10.02	164	78580	14150	63396128
Neurotoxicity	216.67	10.02	175	78569	16815	63393463
Pemphigus	212.20	10.02	3	78741	183723	63226555
Encephalopathy	207.95	10.02	248	78496	38372	63371906
Toxic encephalopathy	200.14	10.02	116	78628	6463	63403815

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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
Febrile neutropenia	421.05	11.29	791	57723	136058	34762359
Plasma cell myeloma	316.93	11.29	371	58143	41666	34856751
Cytokine release syndrome	292.19	11.29	268	58246	22609	34875808
Neurotoxicity	235.86	11.29	214	58300	17796	34880621
Neutropenia	220.90	11.29	669	57845	156109	34742308
Thrombocytopenia	175.19	11.29	617	57897	155630	34742787
Pyrexia	162.38	11.29	1031	57483	331982	34566435
Agranulocytosis	156.19	11.29	196	58318	23625	34874792
Acute generalised exanthematous pustulosis	153.62	11.29	111	58403	6665	34891752
Encephalopathy	152.86	11.29	238	58276	35081	34863336

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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
Febrile neutropenia	719.00	9.87	1210	109750	229789	79403639
Plasma cell myeloma	493.50	9.87	481	110479	52778	79580650
Cytokine release syndrome	483.79	9.87	401	110559	35597	79597831
Neurotoxicity	472.28	9.87	379	110581	32139	79601289
Acute kidney injury	387.42	9.87	1587	109373	517817	79115611
Neutropenia	353.14	9.87	1038	109922	286672	79346756
Drug reaction with eosinophilia and systemic symptoms	296.74	9.87	405	110555	63839	79569589
Agranulocytosis	294.66	9.87	338	110622	44692	79588736
Encephalopathy	289.07	9.87	410	110550	66987	79566441
Thrombocytopenia	288.89	9.87	918	110042	264341	79369087

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	J05AB11	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Nucleosides and nucleotides excl. reverse transcriptase inhibitors
FDA EPC	N0000175468	Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor
FDA EPC	N0000180187	Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor
FDA EPC	N0000180188	Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor
FDA EXT	N0000175459	Nucleoside Analog
FDA MoA	N0000020060	DNA Polymerase Inhibitors
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D000998	Antiviral 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
Herpes labialis	indication	1475003
Herpes zoster	indication	4740000	DOID:8536
Genital herpes simplex	indication	33839006	DOID:8704
Varicella	indication	38907003	DOID:8659
Recurrent genital herpes simplex	indication	402894005
Suppression of Recurrent Herpes Simplex Infection in HIV	indication
Suppression of Recurrent Herpes Simplex Infection	indication
Prevention of Cytomegalovirus Disease	off-label use
Prevention of Herpes Zoster in Immunocompromised Patient	off-label use
Dehydration	contraindication	34095006

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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	8.97	acidic
pKa2	7.83	Basic
pKa3	3.83	Basic
pKa4	2.12	Basic

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Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
DNA polymerase catalytic subunit	Enzyme		DPOL_HHV11	INHIBITOR				WOMBAT-PK	CHEMBL

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External reference:

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ID	Source
TXC	PDB_CHEM_ID
005049	NDDF
005050	NDDF
124832-26-4	SECONDARY_CAS_RN
135398742	PUBCHEM_CID
169290	MMSL
236081	RXNORM
324820003	SNOMEDCT_US
4020944	VANDF
4024006	VUID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Valacyclovir	HUMAN PRESCRIPTION DRUG LABEL	1	31722-704	TABLET, FILM COATED	500 mg	ORAL	ANDA	24 sections
Valacyclovir	HUMAN PRESCRIPTION DRUG LABEL	1	31722-705	TABLET, FILM COATED	1 g	ORAL	ANDA	24 sections
Valacyclovir Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0378-4275	TABLET, FILM COATED	500 mg	ORAL	ANDA	27 sections
Valacyclovir Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0378-4275	TABLET, FILM COATED	500 mg	ORAL	ANDA	27 sections
Valacyclovir Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0378-4276	TABLET, FILM COATED	1 g	ORAL	ANDA	27 sections
Valacyclovir Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0378-4276	TABLET, FILM COATED	1 g	ORAL	ANDA	27 sections
Valacyclovir Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0781-5208	TABLET	500 mg	ORAL	ANDA	25 sections
Valacyclovir Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0781-5209	TABLET	1 g	ORAL	ANDA	25 sections
Valacyclovir Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6565	TABLET, FILM COATED	500 mg	ORAL	ANDA	25 sections
Valacyclovir Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6565	TABLET, FILM COATED	500 mg	ORAL	ANDA	25 sections

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