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
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
Reduce drug development failure ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.- 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) •••••••••••• ••••• ••••••••• - Associated Therapies
- Contraindications & Blackbox Warnings
- Prevent Adverse Drug Events TodayTap into our Clinical API for life-saving information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events with our Clinical API
- Pharmacodynamics
Hyaluronidase cleaves hyaluronic acid in the extracellular matrix to improve the dispersion of injectable drugs.5,9 Hyaluronidase has a long duration of action7,8 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 modulatormetabolizerHumans and other mammals UTransforming growth factor beta-1 inhibitorHumans - 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
- Pharmacogenomic Effects/ADRs Browse all" title="About SNP Mediated Effects/ADRs" id="snp-actions-info" class="drug-info-popup" href="javascript:void(0);">
- 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.
Drug Interaction Integrate drug-drug
interactions in your software1,2-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
- Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.
- 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 US HYLENEX Recombinant Injection, solution 150 [USP'U]/1mL Subcutaneous Antares Pharma, Inc. 2005-12-02 Not applicable US HYLENEX Recombinant Injection, solution 150 [USP'U]/1mL Subcutaneous Halozyme, Inc. 2005-12-02 2016-12-31 US HYLENEX Recombinant Injection, solution 150 [USP'U]/1mL Subcutaneous Baxter Laboratories 2005-12-02 2016-12-31 US HYLENEX Recombinant Injection, solution 150 [USP'U]/1mL Subcutaneous A-S Medication Solutions 2005-12-02 Not applicable US - 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 US Herceptin Hylecta Hyaluronidase (human recombinant) (10000 U/5mL) + Trastuzumab (600 mg/5mL) Injection, solution Subcutaneous Genentech, Inc. 2019-02-28 Not applicable US 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 US Hyqvia Hyaluronidase (human recombinant) (1600 unit / 10 mL) + Human immunoglobulin G (20 g / 200 mL) Solution Subcutaneous Takeda 2023-11-07 Not applicable Canada 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 US
Categories
- Drug Categories
- 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
- 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]
- 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]
- 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]
- Walker K, Basehore BM, Goyal A, Bansal P, Zito PM: Hyaluronic Acid . [Article]
- Gilson RL, Zafar Gondal A: Hyaluronidase . [Article]
- 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]
- 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]
- 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]
- FDA Approved Drug Products: Vitrase Hyaluronidase Injection [Link]
- External Links
- PubChem Substance
- 347910342
- 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 US
Properties
- State
- Solid
- Experimental Properties
- Not Available
Targets
![](https://go.drugbank.com/assets/locked/DrugTargets2-682eb846d210ae4bf33ca03febccfb57bb1c61318e699b729e5df4dfab2c5b67.png)
References
- FDA Approved Drug Products: Amphadase (hyaluronidase) injection [Link]
- 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
- 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]
- 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]
- 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]
- 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]
Drug created at March 19, 2008 16:17 / Updated at January 25, 2024 05:59