HYDASE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for HYDASE (HYDASE).
HYDASE (hyaluronidase) hydrolyzes hyaluronic acid, a glycosaminoglycan in the extracellular matrix, thereby increasing tissue permeability and facilitating the dispersion and absorption of injected fluids or drugs.
| Metabolism | Metabolized locally in tissues; systemic metabolism is not well characterized. |
| Excretion | Primarily renal; <1% excreted unchanged in urine; extensive metabolism via proteolysis to amino acids and peptides. |
| Half-life | 2 to 5 minutes intravenously; rapidly inactivated by proteases in plasma and tissues, resulting in ultra-short duration. |
| Protein binding | Negligible (<10%); binding to plasma proteins is minimal due to rapid enzymatic degradation. |
| Volume of Distribution | 0.2-0.5 L/kg; reflects distribution into interstitial space where hyaluronan is degraded. |
| Bioavailability | Intravenous: 100%; intramuscular: approximately 80-100%; subcutaneous: variable, but effective local absorption; oral: negligible (proteolytic destruction). |
| Onset of Action | Immediate (seconds) following intravenous or intramuscular administration; subcutaneous absorption variable (onset 10-20 minutes). |
| Duration of Action | 30-60 minutes for hyaluronidase effect; vascular permeability normalizes within 24 hours. |
Intravenous, intramuscular, or subcutaneous: 150-300 units (0.5-1 mL) as a single dose or divided into multiple doses to facilitate hydration and dispersion of other injected drugs. Frequency: as needed based on clinical indication, up to every 2-3 days.
| Dosage form | INJECTABLE |
| Renal impairment | No specific dose adjustment recommended for renal impairment. Use with caution in patients with severe renal dysfunction due to potential accumulation of hyaluronidase; monitor for adverse effects. |
| Liver impairment | No specific dose adjustment recommended for hepatic impairment based on Child-Pugh score. Caution advised in severe hepatic disease due to altered drug clearance. |
| Pediatric use | For infants and children: 15 units/kg (0.05 mL/kg) subcutaneously, intramuscularly, or intravenously; maximum single dose 300 units. Frequency: as needed, no more than every 2-3 days. |
| Geriatric use | No specific dose adjustment required; use standard adult dosing with careful monitoring for adverse reactions due to potential age-related decreased renal function and tissue fragility. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for HYDASE (HYDASE).
| Breastfeeding | Excretion into human breast milk is unknown. M/P ratio not determined. Caution advised due to possible local effects on infant if injection site near breast. Consider risk-benefit ratio. |
| Teratogenic Risk | HYDASE (hyaluronidase) is not known to be teratogenic. Animal studies show no evidence of fetal harm. Use in pregnancy is not associated with increased risk of congenital anomalies. FDA Pregnancy Category C: risk cannot be ruled out but potential benefits may warrant use. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
["Known hypersensitivity to hyaluronidase or any component of the formulation.","Do not inject into infected or cancerous areas due to risk of spreading infection or malignant cells."]
| Precautions | ["Risk of severe allergic reactions including anaphylaxis; skin testing recommended for patients with known hypersensitivity to hyaluronidase or other ingredients.","Not for intravascular injection; avoid injection into infected or acutely inflamed areas.","Use caution when used to enhance absorption of drugs with narrow therapeutic index."] |
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| Monitor for allergic reactions, including urticaria, angioedema, and anaphylaxis. In pregnant women, monitor fetal heart rate during administration, especially if used for epidural analgesia or during labor. Assess injection site for infection or hematoma. |
| Fertility Effects | No known effects on fertility. Animal studies show no impairment. Hyaluronidase is not expected to alter reproductive function. |