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

Stem definition	Drug id	CAS RN
enzymes	5340	None

Description:

Molecule	Description
Synonyms: pegvaliase palynziq pegvaliase-pqpz	The active substance in Palynziq, pegvaliase, is a bacterial enzyme that can break down phenylalanine, thereby stopping phenylalanine from building up in the body and helping to relieve the symptoms of phenylketonuria. The enzyme in pegvaliase is ‘pegylated’ (attached to a chemical called PEG), allowing it to remain in the body and to act for longer Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

pegvaliase
palynziq
pegvaliase-pqpz

The active substance in Palynziq, pegvaliase, is a bacterial enzyme that can break down phenylalanine, thereby stopping phenylalanine from building up in the body and helping to relieve the symptoms of phenylketonuria. The enzyme in pegvaliase is ‘pegylated’ (attached to a chemical called PEG), allowing it to remain in the body and to act for longer

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

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Date	Agency	Company
March 27, 2023	PMDA	BioMarin Pharmaceutical Japan K.K.
May 24, 2018	FDA	BIOMARIN PHARM
May 3, 2019	EMA	BIOMARIN INTERNATIONAL LIMITED

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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
Amino acid level decreased	133.61	57.48	15	981	33	63487993
Arthralgia	97.95	57.48	76	920	569634	62918392
Injection site erythema	85.35	57.48	36	960	83138	63404888
Injection site reaction	68.98	57.48	28	968	58496	63429530
Injection site swelling	67.39	57.48	26	970	47546	63440480
Anaphylactic reaction	59.12	57.48	26	970	66074	63421952

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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
Amino acid level decreased	154.07	61.28	20	982	97	34955832
Arthralgia	120.85	61.28	69	933	169972	34785957
Amino acid level increased	105.59	61.28	17	985	425	34955504
Injection site erythema	84.02	61.28	27	975	15872	34940057
Injection site swelling	79.46	61.28	24	978	11503	34944426
Anaphylactic reaction	75.70	61.28	30	972	32271	34923658
Urticaria	74.47	61.28	36	966	62341	34893588
Injection site reaction	72.39	61.28	23	979	13010	34942919
Throat tightness	64.51	61.28	19	983	8339	34947590

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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
Anaphylactic reaction	132.93	58.56	53	1532	83690	79659113
Arthralgia	126.93	58.56	98	1487	571705	79171098
Amino acid level decreased	111.36	58.56	13	1572	33	79742770
Throat tightness	106.85	58.56	34	1551	27873	79714930
Injection site swelling	89.40	58.56	34	1551	47098	79695705
Injection site erythema	88.68	58.56	39	1546	78158	79664645
Injection site reaction	87.91	58.56	35	1550	54750	79688053
Urticaria	71.88	58.56	45	1540	185156	79557647
Amino acid level increased	62.02	58.56	11	1574	717	79742086

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	A16AB19	ALIMENTARY TRACT AND METABOLISM OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS Enzymes
FDA CS	M0016545	Phenylalanine Ammonia-Lyase
FDA EPC	N0000193858	Phenylalanine Metabolizing Enzyme

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

Disease	Relation	SNOMED_ID	DOID
Classical phenylketonuria	indication	7573000

🐶 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)

None

Bioactivity Summary:

None

External reference:

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ID	Source
017571	NDDF
1585984-95-7	SECONDARY_CAS_RN
2046360	RXNORM
279595	MMSL
34260	MMSL
4037606	VANDF
770965008	SNOMEDCT_US
771573001	SNOMEDCT_US
86278362	PUBCHEM_CID
9875	INN_ID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Palynziq	HUMAN PRESCRIPTION DRUG LABEL	1	68135-058	INJECTION, SOLUTION	2.50 mg	SUBCUTANEOUS	BLA	29 sections
Palynziq	HUMAN PRESCRIPTION DRUG LABEL	1	68135-058	INJECTION, SOLUTION	2.50 mg	SUBCUTANEOUS	BLA	29 sections
Palynziq	HUMAN PRESCRIPTION DRUG LABEL	1	68135-673	INJECTION, SOLUTION	20 mg	SUBCUTANEOUS	BLA	29 sections
Palynziq	HUMAN PRESCRIPTION DRUG LABEL	1	68135-673	INJECTION, SOLUTION	20 mg	SUBCUTANEOUS	BLA	29 sections
Palynziq	HUMAN PRESCRIPTION DRUG LABEL	1	68135-756	INJECTION, SOLUTION	10 mg	SUBCUTANEOUS	BLA	29 sections
Palynziq	HUMAN PRESCRIPTION DRUG LABEL	1	68135-756	INJECTION, SOLUTION	10 mg	SUBCUTANEOUS	BLA	29 sections

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