calcitonin (salmon synthetic) 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
Vitamin D analogues/derivatives	2989	47931-85-1

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: calcitonin (salmon) calcitonin (salmon synthetic) calcitonin salmon salmon calcitonin calcitonin salmon recombinant miacalcin calcimar	Molecular weight: 3431.90 Formula: C145H240N44O48S2 CLOGP: LIPINSKI: 3 HAC: 92 HDO: 52 TPSA: 1508.21 ALOGS: -4.12 ROTB: 98

Molecule

Description

Molfile Inchi Smiles

Synonyms:

calcitonin (salmon)
calcitonin (salmon synthetic)
calcitonin salmon
salmon calcitonin
calcitonin salmon recombinant
miacalcin
calcimar

Molecular weight: 3431.90
Formula: C145H240N44O48S2
CLOGP:
LIPINSKI: 3
HAC: 92
HDO: 52
TPSA: 1508.21
ALOGS: -4.12
ROTB: 98

Drug dosage:

Dose	Unit	Route
200	U	N
100	U	P

ADMET properties:

Property	Value	Reference
S (Water solubility)	1 mg/mL	Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Bocci G, Oprea TI, Benet LZ

Approvals:

Date	Agency	Company	Orphan
April 17, 1978	FDA	SANOFI AVENTIS US

FDA Adverse Event Reporting System (Female)

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
Hip fracture	55.82	14.64	36	6568	29438	63452980
Neonatal hypocalcaemia	46.57	14.64	7	6597	25	63482393
Femur fracture	44.56	14.64	36	6568	41720	63440698
Product complaint	43.88	14.64	23	6581	12786	63469632
Spinal compression fracture	38.81	14.64	22	6582	14261	63468157
Low turnover osteopathy	38.55	14.64	15	6589	4170	63478248
Rib fracture	36.50	14.64	25	6579	22572	63459846
Neonatal cholestasis	35.74	14.64	6	6598	49	63482369
Bone density decreased	33.09	14.64	20	6584	14592	63467826
Compression fracture	32.30	14.64	15	6589	6433	63475985
Off label use	32.25	14.64	15	6589	674447	62807971
Stress fracture	32.22	14.64	16	6588	7947	63474471
Coronary artery disease	30.55	14.64	26	6578	32351	63450067
Nasal discomfort	29.99	14.64	13	6591	4747	63477671
Foot fracture	26.31	14.64	21	6583	23893	63458525
Body height decreased	25.98	14.64	15	6589	10063	63472355
Osteoporosis	24.47	14.64	30	6574	57308	63425110
Blood calcium increased	24.32	14.64	14	6590	9336	63473082
Foetal heart rate deceleration abnormality	22.44	14.64	6	6598	503	63481915
Fall	21.38	14.64	89	6515	392245	63090173
Device failure	21.18	14.64	11	6593	6000	63476418
Fracture	21.12	14.64	17	6587	19567	63462851
Osteopenia	20.97	14.64	17	6587	19768	63462650
Intramedullary rod insertion	20.94	14.64	8	6596	2115	63480303
Thoracic vertebral fracture	20.90	14.64	10	6594	4582	63477836
Product odour abnormal	20.79	14.64	7	6597	1289	63481129
Osteoarthritis	20.38	14.64	36	6568	95307	63387111
Gastrooesophageal reflux disease	20.30	14.64	36	6568	95603	63386815
Pelvic fracture	19.75	14.64	14	6590	13334	63469084
Cerebrovascular accident	19.59	14.64	38	6566	107986	63374432
Hypercalcaemia	19.38	14.64	19	6585	28303	63454115
Jaundice neonatal	18.90	14.64	6	6598	919	63481499
Transient ischaemic attack	18.16	14.64	21	6583	37732	63444686
Dementia Alzheimer's type	18.09	14.64	6	6598	1054	63481364
Back pain	17.69	14.64	64	6540	264081	63218337
Open reduction of fracture	17.55	14.64	6	6598	1156	63481262
Anaemia postoperative	17.05	14.64	7	6597	2235	63480183
Hyperlipidaemia	17.01	14.64	15	6589	19556	63462862
Lumbar vertebral fracture	15.92	14.64	9	6595	5801	63476617
Bone disorder	15.90	14.64	15	6589	21311	63461107
Nocturia	15.54	14.64	10	6594	8131	63474287

FDA Adverse Event Reporting System (Male)

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
Respiratory tract infection bacterial	98.34	27.88	19	767	1763	34954382
Respiratory tract infection viral	97.66	27.88	20	766	2497	34953648
Respiratory tract infection	60.74	27.88	21	765	19691	34936454

FDA Adverse Event Reporting System (Geriatric)

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
Respiratory tract infection bacterial	76.04	15.69	19	4930	2058	79737381
Respiratory tract infection viral	66.83	15.69	20	4929	4239	79735200
Hip fracture	63.05	15.69	33	4916	30728	79708711
Product complaint	51.02	15.69	22	4927	13327	79726112
Spinal compression fracture	34.19	15.69	18	4931	16940	79722499
Bone density decreased	29.30	15.69	15	4934	13332	79726107
Thoracic vertebral fracture	28.04	15.69	11	4938	5242	79734197
Respiratory tract infection	26.75	15.69	23	4926	48666	79690773
Compression fracture	25.84	15.69	11	4938	6449	79732990
Femur fracture	24.85	15.69	20	4929	38632	79700807
Osteoporosis	24.65	15.69	23	4926	54089	79685350
Stress fracture	22.55	15.69	10	4939	6470	79732969
Low turnover osteopathy	21.40	15.69	7	4942	1979	79737460
Blood calcium increased	20.85	15.69	11	4938	10389	79729050
Pelvic fracture	19.20	15.69	11	4938	12193	79727246
Fall	19.12	15.69	70	4879	487559	79251880
Lumbar vertebral fracture	18.69	15.69	9	4940	7013	79732426
Off label use	17.93	15.69	18	4931	907197	78832242
Fracture	17.78	15.69	13	4936	21788	79717651
Bone disorder	16.97	15.69	12	4937	19101	79720338
Toxicity to various agents	16.72	15.69	3	4946	421537	79317902
Coronary artery disease	15.96	15.69	20	4929	65454	79673985

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	H05BA01	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS CALCIUM HOMEOSTASIS ANTI-PARATHYROID AGENTS Calcitonin preparations
FDA CS	M0003145	Calcitonin
CHEBI has role	CHEBI:25212	metabolites
CHEBI has role	CHEBI:50646	antiosteoporotic
MeSH PA	D050071	Bone Density Conservation Agents
MeSH PA	D000077264	Calcium-Regulating Hormones and Agents
FDA EPC	N0000175942	Calcitonin

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

Disease	Relation	SNOMED_ID	DOID
Osteitis deformans	indication	2089002	DOID:5408
Postmenopausal osteoporosis	indication	102447009
Hypercalcemia Treatment Adjunct	indication
Osteogenesis imperfecta	off-label use	78314001	DOID:12347
Secondary generalized osteoporosis	off-label use	240157009
Hypocalcemia	contraindication	5291005

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	3.97	acidic
pKa2	9.82	acidic
pKa3	11.87	acidic
pKa4	11.89	acidic
pKa5	12.24	acidic
pKa6	12.48	acidic
pKa7	12.51	acidic
pKa8	12.78	acidic
pKa9	12.85	acidic
pKa10	13.1	acidic
pKa11	13.1	acidic
pKa12	13.14	acidic
pKa13	13.34	acidic
pKa14	13.39	acidic
pKa15	13.5	acidic
pKa16	13.56	acidic
pKa17	13.68	acidic
pKa18	13.74	acidic
pKa19	13.76	acidic
pKa20	13.91	acidic
pKa21	13.96	acidic
pKa22	11.25	Basic
pKa23	10.81	Basic
pKa24	10.31	Basic
pKa25	7.22	Basic
pKa26	6.54	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Calcitonin receptor	GPCR	P30988	CALCR_HUMAN	AGONIST	EC50	11.09	SCIENTIFIC LITERATURE	DRUG LABEL
Amylin receptor AMY1	GPCR	P30988 O60894	CALCR_HUMAN RAMP1_HUMAN	AGONIST	IC50	9.65	SCIENTIFIC LITERATURE
Amylin receptor AMY2	GPCR	P30988 O60895	CALCR_HUMAN RAMP2_HUMAN	AGONIST	IC50	9.87	SCIENTIFIC LITERATURE
Amylin receptor AMY3	GPCR	P30988 O60896	CALCR_HUMAN RAMP3_HUMAN	AGONIST	IC50	9.50	SCIENTIFIC LITERATURE

External reference:

ID	Source
4018748	VUID
N0000179235	NUI
D00249	KEGG_DRUG
4018748	VANDF
C0073994	UMLSCUI
CHEBI:3306	CHEBI
CHEMBL1201661	ChEMBL_ID
CHEMBL3989767	ChEMBL_ID
DB00017	DRUGBANK_ID
C028815	MESH_SUPPLEMENTAL_RECORD_UI
6973	IUPHAR_LIGAND_ID
218351	RXNORM
1074	MMSL
1124	MMSL
4323	MMSL
6069	MMSL
002144	NDDF
127384006	SNOMEDCT_US
325936007	SNOMEDCT_US
713394005	SNOMEDCT_US
CHEMBL4594242	ChEMBL_ID
16220016	PUBCHEM_CID
7SFC6U2VI5	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Calcitonin Salmon	HUMAN PRESCRIPTION DRUG LABEL	1	24201-400	INJECTION, SOLUTION	200 [USPU]	INTRAMUSCULAR	ANDA	26 sections
Calcitonin Salmon	HUMAN PRESCRIPTION DRUG LABEL	1	24201-400	INJECTION, SOLUTION	200 [USPU]	INTRAMUSCULAR	ANDA	26 sections
Calcitonin Salmon	HUMAN PRESCRIPTION DRUG LABEL	1	42023-205	INJECTION, SOLUTION	200 [iU]	INTRAMUSCULAR	ANDA	26 sections
CALCITONIN SALMON	HUMAN PRESCRIPTION DRUG LABEL	1	49884-161	SPRAY, METERED	200 [iU]	NASAL	ANDA	26 sections
CALCITONIN SALMON	HUMAN PRESCRIPTION DRUG LABEL	1	49884-161	SPRAY, METERED	200 [iU]	NASAL	ANDA	26 sections
Fortical	HUMAN PRESCRIPTION DRUG LABEL	1	54868-5499	SPRAY, METERED	2200 [iU]	NASAL	NDA	24 sections
CALCITONIN SALMON	HUMAN PRESCRIPTION DRUG LABEL	1	54868-6323	SPRAY, METERED	200 [iU]	NASAL	ANDA	20 sections
Calcitonin Salmon	HUMAN PRESCRIPTION DRUG LABEL	1	60505-0823	SPRAY, METERED	200 [iU]	NASAL	ANDA	26 sections
Calcitonin Salmon	HUMAN PRESCRIPTION DRUG LABEL	1	60505-0823	SPRAY, METERED	200 [iU]	NASAL	ANDA	26 sections
CALCITONIN SALMON	HUMAN PRESCRIPTION DRUG LABEL	1	63629-2152	SPRAY, METERED	200 [iU]	NASAL	ANDA	26 sections
CALCITONIN SALMON	HUMAN PRESCRIPTION DRUG LABEL	1	63629-2152	SPRAY, METERED	200 [iU]	NASAL	ANDA	26 sections
Miacalcin	HUMAN PRESCRIPTION DRUG LABEL	1	67457-675	INJECTION, SOLUTION	200 [USPU]	INTRAMUSCULAR	NDA	26 sections
Miacalcin	HUMAN PRESCRIPTION DRUG LABEL	1	72078-038	INJECTION, SOLUTION	200 [USPU]	INTRAMUSCULAR	NDA	26 sections
Miacalcin	HUMAN PRESCRIPTION DRUG LABEL	1	72078-038	INJECTION, SOLUTION	200 [USPU]	INTRAMUSCULAR	NDA	26 sections
Miacalcin	HUMAN PRESCRIPTION DRUG LABEL	1	72078-039	INJECTION, SOLUTION	200 [USPU]	INTRAMUSCULAR	NDA	26 sections
Miacalcin	HUMAN PRESCRIPTION DRUG LABEL	1	72078-039	INJECTION, SOLUTION	200 [USPU]	INTRAMUSCULAR	NDA	26 sections