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

Stem definition	Drug id	CAS RN
Vitamin D analogues/derivatives	464	19356-17-3

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: calcifediol calcidiol calderol	The major circulating metabolite of VITAMIN D3. It is produced in the LIVER and is the best indicator of the body's vitamin D stores. It is effective in the treatment of RICKETS and OSTEOMALACIA, both in azotemic and non-azotemic patients. Calcifediol also has mineralizing properties. Molecular weight: 400.65 Formula: C27H44O2 CLOGP: 7.27 LIPINSKI: 1 HAC: 2 HDO: 2 TPSA: 40.46 ALOGS: -5.26 ROTB: 6 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

calcifediol
calcidiol
calderol

The major circulating metabolite of VITAMIN D3. It is produced in the LIVER and is the best indicator of the body's vitamin D stores. It is effective in the treatment of RICKETS and OSTEOMALACIA, both in azotemic and non-azotemic patients. Calcifediol also has mineralizing properties.

Molecular weight: 400.65
Formula: C27H44O2
CLOGP: 7.27
LIPINSKI: 1
HAC: 2
HDO: 2
TPSA: 40.46
ALOGS: -5.26
ROTB: 6

Status: OFP

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

Drug dosage:

Dose	Unit	Route
30	mcg	O

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Aug. 5, 1980	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
Hyponatraemia	44.88	24.75	32	1798	111868	63375324
Acute kidney injury	36.04	24.75	41	1789	263374	63223818
Drug interaction	35.37	24.75	38	1792	229093	63258099
Spinal fracture	29.25	24.75	13	1817	18258	63468934
Thoracic vertebral fracture	29.13	24.75	9	1821	4583	63482609
Lumbar vertebral fracture	27.05	24.75	9	1821	5801	63481391
Confusional state	26.06	24.75	33	1797	236347	63250845
Hypertransaminasaemia	25.91	24.75	9	1821	6600	63480592
Hypervitaminosis D	25.42	24.75	4	1826	85	63487107
Metamorphopsia	25.17	24.75	6	1824	1157	63486035

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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
Plasma cell myeloma refractory	64.68	34.72	12	1141	603	34955175
Intracranial pressure increased	37.96	34.72	11	1142	3944	34951834
Thoracic vertebral fracture	36.64	34.72	9	1144	1721	34954057

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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
Thoracic vertebral fracture	62.98	23.85	18	3065	5235	79736070
Drug interaction	49.62	23.85	70	3013	415113	79326192
Acute kidney injury	47.10	23.85	77	3006	519327	79221978
Sopor	41.98	23.85	22	3061	32988	79708317
Hyponatraemia	37.49	23.85	40	3043	177808	79563497
Hypertensive crisis	29.75	23.85	15	3068	20755	79720550
Intracranial pressure increased	28.19	23.85	11	3072	8311	79732994
Spinal fracture	25.74	23.85	13	3070	18041	79723264
Eosinophilia	25.72	23.85	18	3065	45327	79695978
COVID-19	25.62	23.85	31	3052	157643	79583662

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	A11CC06	ALIMENTARY TRACT AND METABOLISM VITAMINS VITAMIN A AND D, INCL. COMBINATIONS OF THE TWO Vitamin D and analogues
ATC	H05BX05	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS CALCIUM HOMEOSTASIS ANTI-PARATHYROID AGENTS Other anti-parathyroid agents
CHEBI has role	CHEBI:25212	metabolites
CHEBI has role	CHEBI:50646	antiosteoporotic
CHEBI has role	CHEBI:50733	Dietary Supplement
CHEBI has role	CHEBI:75771	Mus musculus metabolites
CHEBI has role	CHEBI:77746	Homo sapiens metabolite
MeSH PA	D050071	Bone Density Conservation Agents
MeSH PA	D018977	Micronutrients
MeSH PA	D014815	Vitamins

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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
Hypophosphatemia	indication	4996001
Hypocalcemia	indication	5291005
Renal osteodystrophy	indication	16726004	DOID:13068
Rickets	indication	41345002	DOID:10609
Vitamin D deficiency	off-label use	34713006
Hyperphosphatemia	contraindication	20165001	DOID:0050459
Hypervitaminosis D	contraindication	27712000	DOID:9971
Sarcoidosis	contraindication	31541009	DOID:11335
Hypercalcemia	contraindication	66931009	DOID:12678
Kidney disease	contraindication	90708001	DOID:557

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

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Acid dissociation constants calculated using MoKa v3.0.0

None

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
0.03MG	RAYALDEE	EIRGEN	N208010	June 17, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9943530	Feb. 2, 2027	MAINTAINING SERUM 25-HYDROXYVITAMIN D AT A LEVEL OF AT LEAST 30 NG/ML WITH ORAL, SUSTAINED RELEASE 25-HYDROXYVITAMIN D
0.03MG	RAYALDEE	EIRGEN	N208010	June 17, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	11154509	April 25, 2028	TREATING SECONDARY HYPERPARATHYROIDISM IN STAGE 3/4 CHRONIC KIDNEY DISEASE WITH SUSTAINED RELEASE 25-HYDROXYVITAMIN D TO REDUCE THE PATIENTS SERUM PARATHYROID HORMONE LEVEL WHILE AVOIDING PTH OVERSUPPRESSION
0.03MG	RAYALDEE	EIRGEN	N208010	June 17, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	8207149	April 25, 2028	TREATMENT OF SECONDARY HYPERPARATHYROIDISM IN PATIENTS WITH STAGE 3 OR 4 CHRONIC KIDNEY DISEASE USING CONTROLLED RELEASE, ORAL 25-HYDROXYVITAMIN D
0.03MG	RAYALDEE	EIRGEN	N208010	June 17, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	8778373	April 25, 2028	ADMINISTRATION OF 25-HYDROXYVITAMIN D3 BY CONTROLLED RELEASE
0.03MG	RAYALDEE	EIRGEN	N208010	June 17, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9408858	April 25, 2028	USE OF CONTROLLED RELEASE 25-HYDROXYVITAMIN D IN TREATING SECONDARY HYPERPARATHYROIDISM IN PATIENTS HAVING CHRONIC KIDNEY DISEASE
0.03MG	RAYALDEE	EIRGEN	N208010	June 17, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9498486	April 25, 2028	USE OF EXTENDED RELEASE ORAL 25-HYDROXYVITAMIN D3 IN TREATING SECONDARY HYPERPARATHYROIDISM IN ADULT PATIENTS HAVING CHRONIC KIDNEY DISEASE STAGE 3 OR STAGE 4
0.03MG	RAYALDEE	EIRGEN	N208010	June 17, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9925147	April 25, 2028	TREATING SECONDARY HYPERPARATHYROIDISM IN CHRONIC KIDNEY DISEASE WITH SUSTAINED RELEASE 25-HYDROXYVITAMIN D TO REDUCE THE PATIENTS SERUM PARATHYROID HORMONE LEVEL AND CMAX IS REDUCED COMPARED TO BOLUS IV INJECTION AND IMMEDIATE-RELEASE, ORAL DOSING
0.03MG	RAYALDEE	EIRGEN	N208010	June 17, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9925147	April 25, 2028	TREATING SECONDARY HYPERPARATHYROIDISM IN CHRONIC KIDNEY DISEASE WITH SUSTAINED RELEASE 25-HYDROXYVITAMIN D TO REDUCE THE PATIENTS SERUM PARATHYROID HORMONE LEVEL AND THE SUSTAINED RELEASE IS OVER AT LEAST 10 HOURS
0.03MG	RAYALDEE	EIRGEN	N208010	June 17, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9925147	April 25, 2028	TREATING SECONDARY HYPERPARATHYROIDISM IN CKD WITH SUSTAINED RELEASE CALCIFEDIOL TO REDUCE THE PATIENTS SERUM PARATHYROID HORMONE LEVEL AND CMAX24HR/C24HR IS REDUCED COMPARED TO BOLUS IV INJECTION AND IMMEDIATE-RELEASE, ORAL DOSING
0.03MG	RAYALDEE	EIRGEN	N208010	June 17, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9925147	April 25, 2028	TREATING SECONDARY HYPERPARATHYROIDISM IN CKD WITH SUSTAINED RELEASE CALCIFEDIOL TO REDUCE THE PATIENTS SERUM PARATHYROID HORMONE LEVEL AND TMAX IS INCREASED COMPARED TO BOLUS IV INJECTION AND IMMEDIATE-RELEASE, ORAL DOSING

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Orange Book exclusivity data (new drug applications)

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Vitamin D3 receptor	Nuclear hormone receptor	P11473	VDR_HUMAN	AGONIST			CHEMBL	CHEMBL
Sterol regulatory element-binding protein 1	Unclassified	P36956	SRBP1_HUMAN		IC50	5.93	CHEMBL
Vitamin D3 receptor	Nuclear hormone receptor		VDR_MOUSE		EC50	6.22	CHEMBL

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External reference:

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ID	Source
001016	NDDF
1889	RXNORM
259337002	SNOMEDCT_US
399	MMSL
4021905	VANDF
4022405	VUID
4022405	VANDF
4321	MMSL
5283731	PUBCHEM_CID
63283-36-3	SECONDARY_CAS_RN

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Rayaldee	HUMAN PRESCRIPTION DRUG LABEL	1	70301-1001	CAPSULE, EXTENDED RELEASE	30 ug	ORAL	NDA	26 sections

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