Identification

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Name
Vorhyaluronidase alfa
Accession Number
DB06205
Type
Biotech
Groups
Approved, Investigational
Biologic Classification
Protein Based Therapies
Recombinant Enzymes
Description

A purified preparation of the enzyme recombinant human hyaluronidase. Vorhyaluronidase alfa is produced by genetically engineered Chinese Hamster Ovary (CHO) cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). The purified hyaluronidase glycoprotein contains 447 amino acids with an approximate molecular weight of 61,000 Daltons.

Protein chemical formula
Not Available
Protein average weight
61000.0 Da
Sequences
Not Available
Synonyms
  • Hyaluronidase (human recombinant)
  • Hyaluronidase human recombinant
  • Hyaluronidase recombinant human
  • Hyaluronidase, human
  • Recombinant human hyaluronidase
  • Vorhyaluronidase alfa
External IDs
RHUPH-20 / rHuPH20
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
HYLENEX RecombinantInjection, solution150 [USP'U]/1mLSubcutaneousA-S Medication Solutions2005-12-02Not applicableUs
HYLENEX RecombinantInjection, solution150 [USP'U]/1mLSubcutaneousHalozyme, Inc.2005-12-02Not applicableUs
HYLENEX RecombinantInjection, solution150 [USP'U]/1mLSubcutaneousBaxter Laboratories2005-12-022016-12-31Us
HYLENEX RecombinantInjection, solution150 [USP'U]/1mLSubcutaneousHalozyme, Inc.2005-12-022016-12-31Us
HYLENEX Recombinant Professional SampleInjection, solution150 [USP'U]/1mLSubcutaneousHalozyme, Inc.2005-12-022015-03-31Us
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
Herceptin HylectaVorhyaluronidase alfa (10000 U/5mL) + Trastuzumab (600 mg/5mL)Injection, solutionSubcutaneousGenentech, Inc.2019-02-28Not applicableUs
HyqviaVorhyaluronidase alfa (160 [USP'U]/1mL) + Human immunoglobulin G (100 mg/1mL)KitSubcutaneousBaxalta US Inc.2014-09-12Not applicableUs
HyqviaVorhyaluronidase alfa (160 [USP'U]/1mL) + Human immunoglobulin G (100 mg/1mL)KitSubcutaneousBaxalta US Inc.2014-09-12Not applicableUs
HyqviaVorhyaluronidase alfa (160 [USP'U]/1mL) + Human immunoglobulin G (100 mg/1mL)KitSubcutaneousBaxalta US Inc.2014-09-12Not applicableUs
HyqviaVorhyaluronidase alfa (160 [USP'U]/1mL) + Human immunoglobulin G (100 mg/1mL)KitSubcutaneousBaxalta US Inc.2014-09-12Not applicableUs
HyqviaVorhyaluronidase alfa (160 [USP'U]/1mL) + Human immunoglobulin G (100 mg/1mL)KitSubcutaneousBaxalta US Inc.2014-09-12Not applicableUs
International/Other Brands
Chemophase (Halozyme Therapeutics, Inc) / Enhanze SC (Halozyme Therapeutics, Inc)
Categories
UNII
743QUY4VD8
CAS number
757971-58-7

Pharmacology

Indication

Indicated as an adjuvant to increase the absorption and dispersion of other injected drugs; for hypodermoclysis; and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents.

Associated Conditions
Associated Therapies
Pharmacodynamics

Hyaluronidase hydrolyzes hyaluronic acid and increase diffusion of injected drugs, thus facilitating their absorption. Hyaluronidase is used for enhancing absorption and distribution of other injected drugs.

Mechanism of action

The family of hyaluronidase enzymes hydrolyzes hyaluronic acid (a glucoseaminoglycan) which is a major constituent of the interstitial barrier. Hyaluronidase (Human Recombinant) is a highly purified recombinant human hyluronidase which lowers the viscosity of the interstitial barrier by breaking down hyaluronic acid and is under investigation as a chemoadjuvant to facilitate local interstitial drug delivery as well as increase bioavilability.

TargetActionsOrganism
AHyaluronanNot AvailableHumans
UTransforming growth factor beta-1
inhibitor
Humans
Additional Data Available
Adverse Effects

Comprehensive structured data on known drug adverse effects with statistical prevalence. MedDRA and ICD10 ids are provided for adverse effect conditions and symptoms.

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Additional Data Available
Contraindications

Structured data covering drug contraindications. Each contraindication describes a scenario in which the drug is not to be used. Includes restrictions on co-administration, contraindicated populations, and more.

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Additional Data Available
Blackbox Warnings

Structured data representing warnings from the black box section of drug labels. These warnings cover important and dangerous risks, contraindications, or adverse effects.

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Absorption
Not Available
Volume of distribution
Not Available
Protein binding
Not Available
Metabolism
Not Available
Route of elimination
Not Available
Half life
Not Available
Clearance
Not Available
Toxicity
Not Available
Affected organisms
  • Humans and other mammals
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Not Available
Food Interactions
Not Available

References

General References
  1. Bookbinder LH, Hofer A, Haller MF, Zepeda ML, Keller GA, Lim JE, Edgington TS, Shepard HM, Patton JS, Frost GI: A recombinant human enzyme for enhanced interstitial transport of therapeutics. J Control Release. 2006 Aug 28;114(2):230-41. Epub 2006 Jun 7. [PubMed:16876899]
  2. Frost GI: Recombinant human hyaluronidase (rHuPH20): an enabling platform for subcutaneous drug and fluid administration. Expert Opin Drug Deliv. 2007 Jul;4(4):427-40. [PubMed:17683255]
  3. Link [Link]
External Links
PubChem Substance
347910342
Wikipedia
Hyaluronidase

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
0CompletedTreatmentType 1 Insulin-Dependent Diabetes Mellitus1
0TerminatedTreatmentMalignant Neoplasm of Pancreas / Pancreatic Ductal Adenocarcinoma1
1Active Not RecruitingTreatmentMalignancies1
1CompletedNot AvailableDiabetes Mellitus (DM)1
1CompletedNot AvailableHealthy Volunteers1
1CompletedBasic ScienceType 1 Insulin-Dependent Diabetes Mellitus1
1CompletedHealth Services ResearchDiabetes Mellitus (DM)1
1CompletedOtherHealthy Volunteers2
1CompletedOtherRisk Factors for or a Diagnosis of Osteoporosis1
1CompletedTreatmentHealthy Volunteers1
1CompletedTreatmentSuperficial Bladder Cancer1
1RecruitingOtherHealthy Volunteers1
1RecruitingTreatmentDisseminated Sclerosis1
1RecruitingTreatmentMultiple Myeloma (MM)1
1TerminatedBasic ScienceHealthy Volunteers / High Cholesterol1
1TerminatedTreatmentLung Cancer Non-Small Cell Cancer (NSCLC)1
1, 2Active Not RecruitingTreatmentPancreatic Adenocarcinoma Metastatic1
1, 2CompletedPreventionBladder Cancers1
1, 2CompletedTreatmentPrimary Immune Deficiency (PID) / Primary Immunodeficiency Diseases (PID)1
1, 2CompletedTreatmentStage IV Pancreatic Cancer1
1, 2RecruitingTreatmentCancer, Advanced1
1, 2RecruitingTreatmentGastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma1
1, 2RecruitingTreatmentLung Cancer Non-Small Cell Cancer (NSCLC)1
1, 2RecruitingTreatmentMalignant Solid Tumours1
1, 2RecruitingTreatmentNeoplasms by Site1
1, 2TerminatedSupportive CareLymphedema / Neoplasms, Malignant1
2CompletedNot AvailableHereditary Angioedema1
2CompletedNot AvailableType 1 Insulin-Dependent Diabetes Mellitus1
2CompletedNot AvailableType 2 Diabetes Mellitus1
2CompletedPreventionHereditary Angioedema / Hereditary Angioedema (HAE)1
2CompletedTreatmentAllergic Contact Dermatitis1
2CompletedTreatmentType 1 Insulin-Dependent Diabetes Mellitus2
2CompletedTreatmentType 2 Diabetes Mellitus1
2Not Yet RecruitingTreatmentPancreatic Adenocarcinoma Metastatic / Stage IV Pancreatic Cancer AJCC v81
2TerminatedTreatmentPancreatic Adenocarcinoma Non-resectable1
2, 3CompletedTreatmentPrimary Immunodeficiency Diseases (PID) / Primary Immunodeficiency Disorders1
3Active Not RecruitingPreventionPrimary Immunodeficiency Diseases (PID)1
3Active Not RecruitingTreatmentSmoldering Multiple Myeloma (SMM)1
3CompletedTreatmentPrimary Immunodeficiency Diseases (PID)2
3RecruitingTreatmentMultiple Myeloma (MM)1
3RecruitingTreatmentPolyradiculoneuropathy, Chronic Inflammatory Demyelinating2
4CompletedTreatmentDehydration3
4CompletedTreatmentHealthy Volunteers1
4CompletedTreatmentType 1 Insulin-Dependent Diabetes Mellitus2
4RecruitingTreatmentPrimary Immunodeficiency Diseases (PID)1
4TerminatedTreatmentDehydration1
4Unknown StatusTreatmentType 1 Insulin-Dependent Diabetes Mellitus1
4WithdrawnTreatmentDehydration1
Not AvailableActive Not RecruitingNot AvailableExposure During Pregnancy1
Not AvailableCompletedTreatmentPain Management1
Not AvailableNot Yet RecruitingTreatmentMultifocal Motor Neuropathy (MMN)1
Not AvailableRecruitingNot AvailableCongenital Immunodeficiency / Secondary Immune Deficiency1
Not AvailableWithdrawnTreatmentUpper Eyelid Surgery1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
Injection, solutionSubcutaneous
Injection, solutionSubcutaneous150 [USP'U]/1mL
KitSubcutaneous
Prices
Not Available
Patents
Patent NumberPediatric ExtensionApprovedExpires (estimated)
US7767429No2010-08-032027-09-23Us
Additional Data Available
  • Filed On
    Filed On

    The date on which a patent was filed with the relevant government.

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Properties

State
Solid
Experimental Properties
Not Available

Taxonomy

Description
Not Available
Kingdom
Organic Compounds
Super Class
Organic Acids
Class
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Peptides
Alternative Parents
Not Available
Substituents
Not Available
Molecular Framework
Not Available
External Descriptors
Not Available

Targets

Kind
Small molecule
Organism
Humans
Pharmacological action
Yes
Kind
Protein
Organism
Humans
Pharmacological action
Unknown
Actions
Inhibitor
General Function
Type iii transforming growth factor beta receptor binding
Specific Function
Multifunctional protein that controls proliferation, differentiation and other functions in many cell types. Many cells synthesize TGFB1 and have specific receptors for it. It positively and negati...
Gene Name
TGFB1
Uniprot ID
P01137
Uniprot Name
Transforming growth factor beta-1
Molecular Weight
44340.685 Da
References
  1. Chang NS: Hyaluronidase activation of c-Jun N-terminal kinase is necessary for protection of L929 fibrosarcoma cells from staurosporine-mediated cell death. Biochem Biophys Res Commun. 2001 May 4;283(2):278-86. [PubMed:11327694]
  2. Locci P, Marinucci L, Lilli C, Martinese D, Becchetti E: Transforming growth factor beta 1-hyaluronic acid interaction. Cell Tissue Res. 1995 Aug;281(2):317-24. [PubMed:7648625]
  3. Chang NS: Hyaluronidase enhancement of TNF-mediated cell death is reversed by TGF-beta 1. Am J Physiol. 1997 Dec;273(6 Pt 1):C1987-94. [PubMed:9435505]
  4. Chang NS: Transforming growth factor-beta protection of cancer cells against tumor necrosis factor cytotoxicity is counteracted by hyaluronidase (review). Int J Mol Med. 1998 Dec;2(6):653-9. [PubMed:9850732]

Carriers

Kind
Protein
Organism
Humans
Pharmacological action
Unknown
Actions
Inhibitor
General Function
Toxic substance binding
Specific Function
Serum albumin, the main protein of plasma, has a good binding capacity for water, Ca(2+), Na(+), K(+), fatty acids, hormones, bilirubin and drugs. Its main function is the regulation of the colloid...
Gene Name
ALB
Uniprot ID
P02768
Uniprot Name
Serum albumin
Molecular Weight
69365.94 Da
References
  1. Maingonnat C, Victor R, Bertrand P, Courel MN, Maunoury R, Delpech B: Activation and inhibition of human cancer cell hyaluronidase by proteins. Anal Biochem. 1999 Mar 1;268(1):30-4. [PubMed:10036158]
  2. Parameswaran S, Brown LV, Ibbott GS, Lai-Fook SJ: Effect of concentration and hyaluronidase on albumin diffusion across rabbit mesentery. Microcirculation. 1999 Jun;6(2):117-26. [PubMed:10466114]

Drug created on March 19, 2008 10:17 / Updated on December 02, 2019 07:19