Hyaluronidase (human recombinant)

Identification

Summary

Hyaluronidase (human recombinant) is an enzyme used to improve the absorption and dispersion of parenterally administered fluids, drugs, and contrast agents.

Brand Names

Darzalex Faspro, Herceptin Hylecta, Hylenex, Hyqvia 5 G / 50 Ml Kit, Phesgo, Rituxan Hycela, Vyvgart Hytrulo

Generic Name

Hyaluronidase (human recombinant)

DrugBank Accession Number

DB06205

Background

A purified preparation of the enzyme recombinant human hyaluronidase. Hyaluronidase (human recombinant) (INN 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).¹ Hyaluronidase is an enzyme used to improve the absorption and dispersion of parenterally administered fluids, drugs, and contrast agents.⁹ The action of hyaluronidase was first described in 1936, and named in 1939.³ Early research into hyaluronidase identified it as a "spreading factor" which allowed for increased permeability of the connective tissue.³ Hyaluronidase has been used in surgical settings for at least the past 60 years to improve the diffusion of local anesthetics.⁶

Hyaluronidase was first used in prescription products in the United States on 5 May 2004.⁹

Type

Biotech

Groups

Approved, Investigational

Biologic Classification

Protein Based Therapies
Recombinant Enzymes

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

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Pharmacology

Indication

Hyaluronidase is indicated for subcutaneous fluid administration for hydration, and increasing resorption of radiopaque agents in subcutaneous urography.⁹ Hyaluronidase is also indicated by multiple routes to increase the dispersion of other injectable drugs.⁹

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Associated Conditions

Indication Type	Indication	Combined Product Details	Approval Level	Age Group	Patient Characteristics	Dose Form
Management of	Drug extravasation		••• •••••
Used in combination to treat	Early breast cancer	Combination Product in combination with: Pertuzumab (DB06366), Trastuzumab (DB00072)	••••••••••••	•••••	•••• •••• •• ••••••••••	•••••••••
Used in combination to treat	Early breast cancer	Combination Product in combination with: Pertuzumab (DB06366), Trastuzumab (DB00072)	••••••••••••	•••••		•••••••••
Used in combination to treat	Inflammatory breast cancer (ibc)	Combination Product in combination with: Pertuzumab (DB06366), Trastuzumab (DB00072)	••••••••••••	•••••		•••••••••
Used in combination to treat	Locally advanced breast cancer (labc)	Combination Product in combination with: Pertuzumab (DB06366), Trastuzumab (DB00072)	••••••••••••	•••••		•••••••••

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Associated Therapies

• Parenteral rehydration therapy
• Improving resorption of radiopaque agents
• To increase percutaneous drug absorption therapy

Contraindications & Blackbox Warnings

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Pharmacodynamics

Hyaluronidase cleaves hyaluronic acid in the extracellular matrix to improve the dispersion of injectable drugs.^5,9 Hyaluronidase has a long duration of action^7,8 and a wide therapeutic window.⁹ Patients should be counselled regarding the risk of spread of localized infection, ocular corneal damage, and inactivation by intravenous administration.⁹

Mechanism of action

Hyaluronidase cleaves hyaluronic acid at the glucosaminidic bond between C1 of glucosamine and C4 of glucuronic acid.^5,9 Hyaluronic acid is a key component of the extracellular matrix.⁴ Injection of hyaluronidase with other fluids, drugs, or radiopaque agents improves the ability of these other compounds to permeate the extracellular space more easily.^5,9

Target	Actions	Organism
AHyaluronic acid	modulator metabolizer	Humans and other mammals
UTransforming growth factor beta-1	inhibitor	Humans

Absorption

Data regarding the absorption of hyaluronidase are not readily available due to hyaluronidase being inactivated in blood.⁹

Volume of distribution

Data regarding the volume of distribution of hyaluronidase are not readily available due to hyaluronidase being inactivated in blood.⁹

Protein binding

Data regarding the protein binding of hyaluronidase are not readily available due to hyaluronidase being inactivated in blood.⁹

Metabolism

Data regarding the metabolism of hyaluronidase is not readily available.⁹ However, protein drugs are expected to be degraded by proteases and other catalytic enzymes to smaller peptides and amino acids.²

Route of elimination

After nonspecific proteolysis, the amino acids from protein drugs are reused for protein synthesis or further broken down and eliminated by the kidneys.^2,8

Half-life

Hyaluronidase has a half life of two minutes, but a duration of action of 24-48 hours due to its high potency.^7,8

Clearance

Data regarding the clearance of hyaluronidase are not readily available.⁹

Adverse Effects

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Toxicity

Data regarding overdose of hyaluronidase is not readily available.⁹ In the even of an overdose, treat patients with symptomatic and supportive measures.

Pathways

Not Available

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Not Available

Interactions

Drug Interactions Learn More" title="About Drug Interactions" id="structured-interactions-info" class="drug-info-popup" href="javascript:void(0);">

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.

• Approved
• Vet approved
• Nutraceutical
• Illicit
• Withdrawn
• Investigational
• Experimental
• All Drugs

Drug	Interaction
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1,2-Benzodiazepine	The therapeutic efficacy of 1,2-Benzodiazepine can be decreased when used in combination with Hyaluronidase (human recombinant).
Acetylsalicylic acid	The therapeutic efficacy of Hyaluronidase (human recombinant) can be decreased when used in combination with Acetylsalicylic acid.
Amitriptyline	The therapeutic efficacy of Hyaluronidase (human recombinant) can be decreased when used in combination with Amitriptyline.
Antazoline	The therapeutic efficacy of Hyaluronidase (human recombinant) can be decreased when used in combination with Antazoline.
Aripiprazole	The therapeutic efficacy of Hyaluronidase (human recombinant) can be decreased when used in combination with Aripiprazole.

Food Interactions

No interactions found.

Products

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International/Other Brands

Chemophase (Halozyme Therapeutics, Inc) / Enhanze SC (Halozyme Therapeutics, Inc)

Brand Name Prescription Products

Name	Dosage	Strength	Route	Labeller	Marketing Start	Marketing End	Region	Image
Hyaluronidase	Injection, solution	150 [USP'U]/1mL	Subcutaneous	HF Acquisition Co LLC, DBA HealthFirst	2021-06-04	Not applicable
HYLENEX Recombinant	Injection, solution	150 [USP'U]/1mL	Subcutaneous	Antares Pharma, Inc.	2005-12-02	Not applicable
HYLENEX Recombinant	Injection, solution	150 [USP'U]/1mL	Subcutaneous	Halozyme, Inc.	2005-12-02	2016-12-31
HYLENEX Recombinant	Injection, solution	150 [USP'U]/1mL	Subcutaneous	Baxter Laboratories	2005-12-02	2016-12-31
HYLENEX Recombinant	Injection, solution	150 [USP'U]/1mL	Subcutaneous	A-S Medication Solutions	2005-12-02	Not applicable

Mixture Products

Name	Ingredients	Dosage	Route	Labeller	Marketing Start	Marketing End	Region	Image
Darzalex Faspro	Hyaluronidase (human recombinant) (30000 U/15mL) + Daratumumab (1800 mg/15mL)	Injection	Subcutaneous	Janssen Biotech, Inc.	2020-05-01	Not applicable
Herceptin Hylecta	Hyaluronidase (human recombinant) (10000 U/5mL) + Trastuzumab (600 mg/5mL)	Injection, solution	Subcutaneous	Genentech, Inc.	2019-02-28	Not applicable
Hyqvia	Hyaluronidase (human recombinant) (160 [USP'U]/1mL) + Human immunoglobulin G (100 mg/1mL)	Kit; Solution	Subcutaneous	Takeda Pharmaceuticals America, Inc.	2014-09-12	Not applicable
Hyqvia	Hyaluronidase (human recombinant) (1600 unit / 10 mL) + Human immunoglobulin G (20 g / 200 mL)	Solution	Subcutaneous	Takeda	2023-11-07	Not applicable
Hyqvia	Hyaluronidase (human recombinant) (160 [USP'U]/1mL) + Human immunoglobulin G (100 mg/1mL)	Kit; Solution	Subcutaneous	Takeda Pharmaceuticals America, Inc.	2014-09-12	Not applicable

Categories

Drug Categories

• Blood and Blood Forming Organs
• Carbon-Oxygen Lyases
• Enzymes
• Enzymes and Coenzymes
• Glycoside Hydrolases
• Hyaluronoglucosaminidase, antagonists & inhibitors
• Hydrolases
• Lyases
• Polysaccharide-Lyases

Chemical TaxonomyProvided by Classyfire

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

Affected organisms

• Humans and other mammals

Chemical Identifiers

UNII

743QUY4VD8

CAS number

757971-58-7

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. [Article]
2. Katsila T, Siskos AP, Tamvakopoulos C: Peptide and protein drugs: the study of their metabolism and catabolism by mass spectrometry. Mass Spectrom Rev. 2012 Jan-Feb;31(1):110-33. doi: 10.1002/mas.20340. Epub 2011 Jun 22. [Article]
3. Duran-Reynals F: TISSUE PERMEABILITY AND THE SPREADING FACTORS IN INFECTION : A Contribution to the Host:Parasite Problem. Bacteriol Rev. 1942 Dec;6(4):197-252. [Article]
4. Walker K, Basehore BM, Goyal A, Bansal P, Zito PM: Hyaluronic Acid . [Article]
5. Gilson RL, Zafar Gondal A: Hyaluronidase . [Article]
6. Buhren BA, Schrumpf H, Hoff NP, Bolke E, Hilton S, Gerber PA: Hyaluronidase: from clinical applications to molecular and cellular mechanisms. Eur J Med Res. 2016 Feb 13;21:5. doi: 10.1186/s40001-016-0201-5. [Article]
7. King M, Convery C, Davies E: This month's guideline: The Use of Hyaluronidase in Aesthetic Practice (v2.4). J Clin Aesthet Dermatol. 2018 Jun;11(6):E61-E68. Epub 2018 Jun 1. [Article]
8. Cavallini M, Gazzola R, Metalla M, Vaienti L: The role of hyaluronidase in the treatment of complications from hyaluronic acid dermal fillers. Aesthet Surg J. 2013 Nov 1;33(8):1167-74. doi: 10.1177/1090820X13511970. Epub 2013 Nov 6. [Article]
9. FDA Approved Drug Products: Vitrase Hyaluronidase Injection [Link]

External Links

PubChem Substance

347910342

RxNav

1300478

Wikipedia

Hyaluronidase

Clinical Trials

Clinical Trials Learn More" title="About Clinical Trials" id="clinical-trials-info" class="drug-info-popup" href="javascript:void(0);">

Phase	Status	Purpose	Conditions	Count
4	Completed	Treatment	Dehydration	3
4	Completed	Treatment	Healthy Subjects (HS)	1
4	Completed	Treatment	Primary Immune Deficiency Disorders (PIDD)	1
4	Completed	Treatment	Type 1 Diabetes Mellitus	3
4	Terminated	Treatment	Dehydration	1

Pharmacoeconomics

Manufacturers

Not Available

Packagers

Not Available

Dosage Forms

Form	Route	Strength
Injection	Subcutaneous
Injection, solution	Subcutaneous
Injection, solution	Subcutaneous	150 [USP'U]/1mL
Kit; solution	Subcutaneous
Solution	Subcutaneous

Prices

Not Available

Patents

Patent Number	Pediatric Extension	Approved	Expires (estimated)	Region
US7767429	No	2010-08-03	2027-09-23

Properties

State

Solid

Experimental Properties

Not Available

Targets

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Details1. Hyaluronic acid

Kind

Small molecule

Organism

Humans and other mammals

Pharmacological action

Yes

Actions

Modulator

Metabolizer

References

1. FDA Approved Drug Products: Amphadase (hyaluronidase) injection [Link]

Details2. Transforming growth factor beta-1

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. [Article]
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. [Article]
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. [Article]
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. [Article]

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Drug created at March 19, 2008 16:17 / Updated at January 25, 2024 05:59