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

Stem definition	Drug id	CAS RN
peptides and glycopeptides	4514	52232-67-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: teriparatide recombinant human forsteo teriparatide teriparatide acetate hPTH 1-34 parathar	A polypeptide that consists of the 1-34 amino-acid fragment of human PARATHYROID HORMONE, the biologically active N-terminal region. The acetate form is given by intravenous infusion in the differential diagnosis of HYPOPARATHYROIDISM and PSEUDOHYPOPARATHYROIDISM. (Reynolds JEF(Ed): Martindale: The Extra Pharmacopoeia (electronic version). Micromedex, Inc, Englewood, CO, 1995) Molecular weight: 4117.77 Formula: C181H291N55O51S2 CLOGP: LIPINSKI: None HAC: 106 HDO: 60 TPSA: 1752.65 ALOGS: ROTB: 144

Molecule

Description

Molfile Inchi Smiles

Synonyms:

teriparatide recombinant human
forsteo
teriparatide
teriparatide acetate
hPTH 1-34
parathar

A polypeptide that consists of the 1-34 amino-acid fragment of human PARATHYROID HORMONE, the biologically active N-terminal region. The acetate form is given by intravenous infusion in the differential diagnosis of HYPOPARATHYROIDISM and PSEUDOHYPOPARATHYROIDISM. (Reynolds JEF(Ed): Martindale: The Extra Pharmacopoeia (electronic version). Micromedex, Inc, Englewood, CO, 1995)

Molecular weight: 4117.77
Formula: C181H291N55O51S2
CLOGP:
LIPINSKI: None
HAC: 106
HDO: 60
TPSA: 1752.65
ALOGS:
ROTB: 144

Drug dosage:

Dose	Unit	Route
20	mcg	P

ADMET properties:

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Property	Value	Reference
CL (Clearance)	21.40 mL/min/kg	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	0.17 L/kg	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	0.14 hours	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company
July 23, 2019	PMDA	Eli Lilly Japan
June 10, 2003	EMA
Nov. 26, 2002	FDA	LILLY

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
Fall	1369.87	13.47	1864	65160	390470	63031528
Product complaint	1259.23	13.47	483	66541	12326	63409672
Blood calcium increased	956.36	13.47	363	66661	8987	63413011
Hip fracture	792.67	13.47	453	66571	29021	63392977
Bone pain	761.05	13.47	555	66469	54086	63367912
Muscle spasms	526.51	13.47	732	66292	155418	63266580
Therapy cessation	520.90	13.47	351	66673	30106	63391892
Drug ineffective	491.87	13.47	247	66777	1044518	62377480
Injection site haemorrhage	491.08	13.47	311	66713	24003	63397995
Spinal fracture	470.21	13.47	273	66751	17998	63404000

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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
Hip fracture	137.03	20.90	58	6076	11867	34938930
Hospitalisation	120.62	20.90	91	6043	56811	34893986
Product complaint	114.77	20.90	42	6092	5848	34944949
Bone pain	101.08	20.90	56	6078	20630	34930167
Fall	89.59	20.90	141	5993	202744	34748053
Spinal fracture	81.24	20.90	35	6099	7463	34943334
Therapy cessation	69.61	20.90	41	6093	16932	34933865
Spinal operation	61.09	20.90	22	6112	2922	34947875
Bone density decreased	53.89	20.90	18	6116	1911	34948886
Death	49.20	20.90	167	5967	397882	34552915

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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
Product complaint	1576.91	13.71	489	43125	12860	79687914
Fall	798.98	13.71	1145	42469	486484	79214290
Blood calcium increased	605.05	13.71	224	43390	10176	79690598
Bone pain	509.14	13.71	339	43275	55403	79645371
Hip fracture	436.71	13.71	248	43366	30513	79670261
Injection site haemorrhage	423.64	13.71	235	43379	27635	79673139
Product storage error	419.89	13.71	196	43418	16030	79684744
Spinal fracture	405.95	13.71	198	43416	17856	79682918
Muscle spasms	382.28	13.71	474	43140	174256	79526518
Therapy cessation	334.57	13.71	225	43389	37337	79663437

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	H05AA02	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS CALCIUM HOMEOSTASIS PARATHYROID HORMONES AND ANALOGUES Parathyroid hormones and analogues
FDA CS	M0015931	Parathyroid Hormone
FDA EPC	N0000180852	Parathyroid Hormone Analog
MeSH PA	D050071	Bone Density Conservation Agents
MeSH PA	D000077264	Calcium-Regulating Hormones and 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
Postmenopausal osteoporosis	indication	102447009
Hypogonadal Osteoporosis in Males	indication
Glucocorticoid Induced Osteoporosis	indication
Osteitis deformans	contraindication	2089002	DOID:5408
Osteomalacia	contraindication	4598005	DOID:10573
Renal osteodystrophy	contraindication	16726004	DOID:13068
Hepatic osteodystrophy	contraindication	28193003
Rickets	contraindication	41345002	DOID:10609
Low blood pressure	contraindication	45007003
Metabolic bone disease	contraindication	50279003

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🐶 Veterinary Drug Use

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🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	3.23	acidic
pKa10	12.63	acidic
pKa11	12.75	acidic
pKa12	12.78	acidic
pKa13	12.93	acidic
pKa14	13.16	acidic
pKa15	13.18	acidic
pKa16	13.37	acidic
pKa17	13.37	acidic
pKa18	13.44	acidic

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Orange Book patent data (new drug applications)

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Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Parathyroid hormone/parathyroid hormone-related peptide receptor	GPCR	Q03431	PTH1R_HUMAN	AGONIST	IC50	7.40	IUPHAR	CHEMBL
Parathyroid hormone 2 receptor	GPCR	P49190	PTH2R_HUMAN	AGONIST	IC50	7.80	IUPHAR
Parathyroid hormone 2 receptor	GPCR		PTH2R_RAT	AGONIST	IC50	6.30	IUPHAR
Parathyroid hormone/parathyroid hormone-related peptide receptor	GPCR		PTH1R_RAT	AGONIST	IC50	8.70	IUPHAR

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External reference:

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ID	Source
002142	NDDF
004944	NDDF
109198008	SNOMEDCT_US
10T9CSU89I	UNII
114260	RXNORM
16132393	PUBCHEM_CID
17041	MMSL
336918	MMSL
398823001	SNOMEDCT_US
4019512	VUID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Forteo	HUMAN PRESCRIPTION DRUG LABEL	1	0002-8400	INJECTION, SOLUTION	250 ug	SUBCUTANEOUS	NDA	35 sections
teriparatide	HUMAN PRESCRIPTION DRUG LABEL	1	47781-652	INJECTION, SOLUTION	250 ug	SUBCUTANEOUS	NDA	30 sections
teriparatide	HUMAN PRESCRIPTION DRUG LABEL	1	47781-652	INJECTION, SOLUTION	250 ug	SUBCUTANEOUS	NDA	30 sections

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