Overview
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). Hyaluronidase is an enzyme used to improve the absorption and dispersion of parenterally administered fluids, drugs, and contrast agents. The action of hyaluronidase was first described in 1936, and named in 1939. Early research into hyaluronidase identified it as a "spreading factor" which allowed for increased permeability of the connective tissue. Hyaluronidase has been used in surgical settings for at least the past 60 years to improve the diffusion of local anesthetics. Hyaluronidase was first used in prescription products in the United States on 5 May 2004.
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). Hyaluronidase is an enzyme used to improve the absorption and dispersion of parenterally administered fluids, drugs, and contrast agents. The action of hyaluronidase was first described in 1936, and named in 1939. Early research into hyaluronidase identified it as a "spreading factor" which allowed for increased permeability of the connective tissue. Hyaluronidase has been used in surgical settings for at least the past 60 years to improve the diffusion of local anesthetics. Hyaluronidase was first used in prescription products in the United States on 5 May 2004.
Indication
Hyaluronidase is indicated for subcutaneous fluid administration for hydration, and increasing resorption of radiopaque agents in subcutaneous urography. Hyaluronidase is also indicated by multiple routes to increase the dispersion of other injectable drugs.
Associated Conditions
- Drug Extravasation
- Generalized Myasthenia Gravis
- Inflammatory Breast Cancer (IBC)
- Locally Advanced Breast Cancer (LABC)
- Metastatic Breast Cancer
- Primary Immune Deficiency Disorders (PIDD)
- Primary Immunodeficiency
- Secondary humoral immunodeficiency
- Stage I Breast Cancer
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/06/03 | Phase 2 | Recruiting | |||
2024/03/15 | Phase 1 | Recruiting | |||
2023/12/15 | Phase 2 | Recruiting | MedSIR | ||
2023/10/05 | Phase 2 | Recruiting | |||
2023/08/18 | Phase 2 | Active, not recruiting | |||
2023/06/08 | Phase 3 | Recruiting | |||
2022/11/22 | Phase 3 | Active, not recruiting | |||
2022/06/14 | Phase 1 | Recruiting | |||
2022/05/31 | Phase 1 | Completed | |||
2022/04/18 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Genentech, Inc. | 50242-245 | SUBCUTANEOUS | 30000 U in 15 mL | 11/16/2022 | |
| Janssen Biotech, Inc. | 57894-503 | SUBCUTANEOUS | 30000 U in 15 mL | 11/28/2023 | |
| Genentech, Inc. | 50242-109 | SUBCUTANEOUS | 2000 U in 1 mL | 11/16/2022 | |
| Genentech, Inc. | 50242-108 | SUBCUTANEOUS | 2000 U in 1 mL | 11/16/2022 | |
| Genentech, Inc. | 50242-260 | SUBCUTANEOUS | 20000 U in 10 mL | 11/16/2022 | |
| Antares Pharma, Inc. | 18657-117 | SUBCUTANEOUS | 150 [USP'U] in 1 mL | 1/24/2024 | |
| Genentech, Inc. | 50242-077 | SUBCUTANEOUS | 10000 U in 5 mL | 10/19/2020 | |
| HF Acquisition Co LLC, DBA HealthFirst | 51662-1555 | SUBCUTANEOUS | 150 [USP'U] in 1 mL | 6/4/2021 | |
| A-S Medication Solutions | 50090-4534 | SUBCUTANEOUS | 150 [USP'U] in 1 mL | 2/1/2016 | |
| argenx US | 73475-3102 | SUBCUTANEOUS | 2000 U in 1 mL | 1/23/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||