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

Stem definition	Drug id	CAS RN
Vitamin D analogues/derivatives	2066	131918-61-1

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: zemplar paricalcitol-d6 paricalcitol	suppressed immunoglobulin production & thymic lymphocyte proliferation in vivo Molecular weight: 416.65 Formula: C27H44O3 CLOGP: 5.69 LIPINSKI: 1 HAC: 3 HDO: 3 TPSA: 60.69 ALOGS: -4.79 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

zemplar
paricalcitol-d6
paricalcitol

suppressed immunoglobulin production & thymic lymphocyte proliferation in vivo

Molecular weight: 416.65
Formula: C27H44O3
CLOGP: 5.69
LIPINSKI: 1
HAC: 3
HDO: 3
TPSA: 60.69
ALOGS: -4.79
ROTB: 5

Status: OFP

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

Drug dosage:

Dose	Unit	Route
2	mcg	O
2	mcg	P

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	72 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
t_half (Half-life)	5.30 hours	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
CL (Clearance)	0.89 mL/min/kg	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	0.41 L/kg	Lombardo F, Berellini G, Obach RS
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.00 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
fu (Fraction unbound in plasma)	0.00 %	Lombardo F, Berellini G, Obach RS
EoM (Fraction excreted unchanged in urine)	0 %	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

Date	Agency	Company	Orphan
April 17, 1998	FDA	ABBVIE

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
Death	3210.85	24.54	1261	5713	373120	63108928
Cardiac disorder	460.01	24.54	182	6792	50634	63431414
Infarction	331.21	24.54	73	6901	2568	63479480
Sepsis	234.79	24.54	167	6807	152956	63329092
Myocardial infarction	164.59	24.54	114	6860	99779	63382269
Cardiac failure	159.34	24.54	107	6867	89035	63393013
Cardiovascular disorder	148.84	24.54	54	6920	11758	63470290
Cardio-respiratory arrest	147.19	24.54	88	6886	59871	63422177
Calciphylaxis	146.69	24.54	39	6935	3033	63479015
Adverse event	145.02	24.54	91	6883	67468	63414580

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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
Death	3904.40	27.18	1857	6729	396192	34552153
Cardiac disorder	705.14	27.18	296	8290	42830	34905515
Infarction	487.42	27.18	117	8469	2636	34945709
Myocardial infarction	312.69	27.18	249	8337	120836	34827509
Cardiovascular disorder	236.52	27.18	90	8496	9966	34938379
Adverse event	212.29	27.18	100	8486	18777	34929568
Sepsis	176.10	27.18	210	8376	166351	34781994
Cardiac failure	162.37	27.18	152	8434	91096	34857249
Respiratory arrest	151.18	27.18	91	8495	27952	34920393
Cardio-respiratory arrest	140.61	27.18	113	8473	55160	34893185

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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
Myocardial infarction	364.78	21.20	231	8114	183898	79552145
Death	354.16	21.20	360	7985	566154	79169889
Cardio-respiratory arrest	281.31	21.20	162	8183	108348	79627695
Cardiac disorder	251.01	21.20	127	8218	65630	79670413
Calciphylaxis	222.09	21.20	56	8289	3714	79732329
Infarction	206.49	21.20	55	8290	4527	79731516
Sepsis	196.52	21.20	187	8158	269241	79466802
Respiratory arrest	162.56	21.20	91	8254	57459	79678584
Cardiac failure	161.89	21.20	132	8213	154710	79581333
Nephrogenic systemic fibrosis	159.67	21.20	48	8297	6112	79729931

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	H05BX02	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS CALCIUM HOMEOSTASIS ANTI-PARATHYROID AGENTS Other anti-parathyroid agents
CHEBI has role	CHEBI:50827	antiparathyroid drugs
FDA CS	M0007651	Ergocalciferols
FDA EPC	N0000175849	Vitamin D Analog
FDA EPC	N0000175907	Vitamin D2 Analog

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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
Hyperparathyroidism Secondary to Chronic Renal Failure	indication
Poisoning by digitalis glycoside	contraindication	12876009
Hyperphosphatemia	contraindication	20165001	DOID:0050459
Hypervitaminosis D	contraindication	27712000	DOID:9971
Hypercalcemia	contraindication	66931009	DOID:12678

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

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
0.002MG/ML (0.002MG/ML)	ZEMPLAR	ABBVIE	N020819	Feb. 1, 2000	RX	SOLUTION	INTRAVENOUS	Oct. 18, 2023	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
0.005MG/ML (0.005MG/ML)	ZEMPLAR	ABBVIE	N020819	April 17, 1998	RX	SOLUTION	INTRAVENOUS	Oct. 18, 2023	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
0.01MG/2ML (0.005MG/ML)	ZEMPLAR	ABBVIE	N020819	Feb. 1, 2000	RX	SOLUTION	INTRAVENOUS	Oct. 18, 2023	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
1MCG	ZEMPLAR	ABBVIE	N021606	May 26, 2005	RX	CAPSULE	ORAL	Oct. 18, 2023	INDICATED IN PEDIATRIC PATIENTS 10 YEARS AND OLDER FOR THE PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD) STAGES 3 AND 4 AND CKD STAGE 5 IN PATIENTS ON HEMODIALYSIS OR PERITONEAL DIALYSIS
2MCG	ZEMPLAR	ABBVIE	N021606	May 26, 2005	RX	CAPSULE	ORAL	Oct. 18, 2023	INDICATED IN PEDIATRIC PATIENTS 10 YEARS AND OLDER FOR THE PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD) STAGES 3 AND 4 AND CKD STAGE 5 IN PATIENTS ON HEMODIALYSIS OR PERITONEAL DIALYSIS
4MCG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ZEMPLAR	ABBVIE	N021606	May 26, 2005	DISCN	CAPSULE	ORAL	Oct. 18, 2023	INDICATED IN PEDIATRIC PATIENTS 10 YEARS AND OLDER FOR THE PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD) STAGES 3 AND 4 AND CKD STAGE 5 IN PATIENTS ON HEMODIALYSIS OR PERITONEAL DIALYSIS

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Vitamin D3 receptor	Nuclear hormone receptor	P11473	VDR_HUMAN	AGONIST	EC50	8.70		WOMBAT-PK	CHEMBL

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External reference:

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ID	Source
007498	NDDF
108946001	SNOMEDCT_US
11702	MMSL
126233000	SNOMEDCT_US
206206	MMSL
221005	RXNORM
2791	IUPHAR_LIGAND_ID
4021107	VUID
4021107	VANDF
5234	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Paricalcitol	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9596	INJECTION	5 ug	INTRAVENOUS	NDA	24 sections
Paricalcitol	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9624	INJECTION	5 ug	INTRAVENOUS	NDA	24 sections
Paricalcitol	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9625	INJECTION	2 ug	INTRAVENOUS	NDA	24 sections
Paricalcitol	HUMAN PRESCRIPTION DRUG LABEL	1	0409-1007	INJECTION, SOLUTION	2 ug	INTRAVENOUS	NDA	29 sections
Paricalcitol	HUMAN PRESCRIPTION DRUG LABEL	1	0409-1008	INJECTION, SOLUTION	5 ug	INTRAVENOUS	NDA	29 sections
Paricalcitol	HUMAN PRESCRIPTION DRUG LABEL	1	10888-5001	CAPSULE, LIQUID FILLED	1 ug	ORAL	ANDA	26 sections
Paricalcitol	HUMAN PRESCRIPTION DRUG LABEL	1	10888-5002	CAPSULE, LIQUID FILLED	2 ug	ORAL	ANDA	26 sections
Paricalcitol	HUMAN PRESCRIPTION DRUG LABEL	1	10888-5003	CAPSULE, LIQUID FILLED	4 ug	ORAL	ANDA	26 sections
Paricalcitol	HUMAN PRESCRIPTION DRUG LABEL	1	16729-310	INJECTION, SOLUTION	2 ug	INTRAVENOUS	NDA	24 sections
Paricalcitol	HUMAN PRESCRIPTION DRUG LABEL	1	16729-310	INJECTION, SOLUTION	2 ug	INTRAVENOUS	NDA	24 sections

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