Hyaluronidase
Amphadase, Darzalex Faspro, Herceptin Hylecta, Phesgo, Vitrase (hyaluronidase) is an enzyme pharmaceutical. Hyaluronidase was first approved as Vitrase on 2004-05-05. It is used to treat extravasation of diagnostic and therapeutic materials in the USA.
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Commercial
Trade Name
FDA
EMA
Amphadase, Vitrase (discontinued: Hydase)
CombinationsDarzalex faspro, Herceptin hylecta, Phesgo
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Daratumumab
+
Hyaluronidase
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Darzalex Faspro | daratumumab and hyaluronidase-fihj | Johnson & Johnson | N-761145 RX | 2020-05-01 | 1 products |
Hyaluronidase
Hyaluronidase
+
Pertuzumab
+
Trastuzumab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Phesgo | pertuzumab, trastuzumab, and hyaluronidase-zzxf | Genentech | N-761170 RX | 2020-06-29 | 2 products |
Hyaluronidase
+
Trastuzumab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Herceptin Hylecta | trastuzumab and hyaluronidase-oysk | Genentech | N-761106 RX | 2019-02-28 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| amphadase | Biologic Licensing Application | 2020-05-28 |
| darzalex faspro | Biologic Licensing Application | 2022-01-26 |
| herceptin hylecta | Biologic Licensing Application | 2020-10-19 |
| phesgo | Biologic Licensing Application | 2020-06-29 |
| vitrase | Biologic Licensing Application | 2018-05-29 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| extravasation of diagnostic and therapeutic materials | — | D005119 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
daratumumab / hyaluronidase, Darzalex Faspro, Janssen Biotech, Inc. | |||
| 2028-01-15 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J1575 | Injection, immune globulin/hyaluronidase, (hyqvia), 100 mg immuneglobulin |
| J3470 | Injection, hyaluronidase, up to 150 units |
| J3471 | Injection, hyaluronidase, ovine, preservative free, per 1 usp unit (up to 999 usp units) |
| J3472 | Injection, hyaluronidase, ovine, preservative free, per 1000 usp units |
| J3473 | Injection, hyaluronidase, recombinant, 1 usp unit |
| J9144 | Injection, daratumumab, 10 mg and hyaluronidase-fihj |
| J9311 | Injection, rituximab 10 mg and hyaluronidase |
| J9316 | Injection, pertuzumab, trastuzumab, and hyaluronidase-zzxf, per 10 mg |
| J9356 | Injection, trastuzumab, 10 mg and hyaluronidase-oysk |
Clinical
Clinical Trials
129 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | 1 | 9 | 15 | 8 | 33 |
| Delirium | D003693 | R41.0 | — | 7 | 12 | 7 | 4 | 27 | |
| Psychotic disorders | D011618 | F20.81 | 1 | 1 | 4 | 7 | 1 | 14 | |
| Psychomotor agitation | D011595 | — | — | 1 | 2 | 2 | 5 | ||
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | — | 2 | 1 | 1 | 4 |
| Nausea | D009325 | HP_0002018 | R11.0 | 1 | — | 1 | 2 | — | 4 |
| Postoperative nausea and vomiting | D020250 | EFO_0004888 | — | — | — | 2 | 1 | 3 | |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | — | — | 3 | — | 3 |
| Cognitive dysfunction | D060825 | G31.84 | — | — | 1 | 1 | 1 | 3 | |
| Depression | D003863 | F33.9 | — | — | 1 | 1 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | — | 3 | 4 | — | 1 | 6 | |
| Confusion | D003221 | F44.89 | — | — | 2 | — | — | 2 | |
| Critical illness | D016638 | — | 1 | 1 | — | — | 2 | ||
| Dementia | D003704 | F03 | — | — | 1 | — | — | 1 | |
| Psychophysiologic disorders | D011602 | F45.9 | — | — | 1 | — | — | 1 | |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | — | 1 | — | — | 1 |
| Mood disorders | D019964 | EFO_0004247 | F30-F39 | — | 1 | 1 | — | — | 1 |
| Medication adherence | D055118 | EFO_0006344 | — | — | 1 | — | — | 1 | |
| Hip fractures | D006620 | EFO_0003964 | S72.00 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Movement disorders | D009069 | EFO_0004280 | G25 | — | 1 | — | — | 1 | 2 |
| Intellectual disability | D008607 | F73 | — | 1 | — | — | — | 1 | |
| Artificial respiration | D012121 | — | 1 | — | — | — | 1 | ||
| Critical care | D003422 | — | 1 | — | — | — | 1 | ||
| Ventilator weaning | D015300 | — | 1 | — | — | — | 1 | ||
| Gambling | D005715 | F63.0 | — | 1 | — | — | — | 1 | |
| Drug-induced akathisia | D017109 | EFO_1000903 | G25.71 | — | 1 | — | — | — | 1 |
| Cognition disorders | D003072 | — | 1 | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dyslipidemias | D050171 | HP_0003119 | — | — | — | — | 2 | 2 | |
| Insulin resistance | D007333 | EFO_0002614 | — | — | — | — | 2 | 2 | |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 1 | 1 |
| Female genital diseases | D005831 | EFO_0009549 | N85 | — | — | — | — | 1 | 1 |
| Recurrence | D012008 | — | — | — | — | 1 | 1 | ||
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | — | — | — | 1 | 1 |
| Lactic acidosis | D000140 | EFO_1000036 | E87.20 | — | — | — | — | 1 | 1 |
| Patient compliance | D010349 | — | — | — | — | 1 | 1 | ||
| Chorea | D002819 | EFO_0004152 | G25.5 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | HYALURONIDASE |
| INN | — |
| Description | Hyaluronidases are a family of enzymes that catalyse the degradation of hyaluronic acid. Karl Meyer classified these enzymes in 1971, into three distinct groups, a scheme based on the enzyme reaction products. The three main types of hyaluronidases are two classes of eukaryotic endoglycosidase hydrolases and a prokaryotic lyase-type of glycosidase.
|
| Classification | Enzyme |
| Drug class | enzymes |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | 1FCQ, 1FCU, 1FCV, 1I8Q, 1LOH, 1LXK, 1LXM, 1N7N, 1N7O, 1N7P, 1N7Q, 1N7R, 1OJM, 1OJN, 1OJO, 1OJP, 1W3Y, 2ATM, 2BRP, 2BRV, 2BRW, 2C3F, 2CBI, 2CBJ, 2DP5, 2J1A, 2J1E, 2J62, 2J7M, 2J88, 2JNK, 2OZN, 2PE4, 2WB3, 2WDB, 2WH7, 2YVV, 2YW0, 2YX2, 3EKA, 4D0Q, 4UFQ, 5DIY, 6WV2, 6WWX, 6WXA, 6X3M, 7EYO, 8C6I |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201636 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00070 |
| UNII ID | — |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Phesgo - Roche
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 29,311 documents
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Safety
Black-box Warning
Black-box warning for: Herceptin hylecta, Phesgo
Adverse Events
Top Adverse Reactions
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21,466 adverse events reported
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