VITRASE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VITRASE (VITRASE).
VITRASE (hyaluronidase) hydrolyzes hyaluronic acid, a component of the extracellular matrix, thereby increasing tissue permeability to fluids and facilitating the absorption and dispersion of injected drugs.
| Metabolism | Not fully characterized; presumed to be metabolized locally at injection site and in the liver via proteolysis. |
| Excretion | Renal: <10% unchanged; remainder metabolized locally. |
| Half-life | Approximately 24 hours for the enzymatic activity; clinical effect persists beyond half-life due to drug action. |
| Protein binding | Minimal, if any; specific binding proteins not well characterized. |
| Volume of Distribution | Not applicable; acts locally at injection site; systemic distribution negligible. |
| Bioavailability | Subcutaneous: 100% at local site; Intravitreal: 100% locally; not systemically available. |
| Onset of Action | Subcutaneous: Within minutes for spreading effect; Intravitreal: Immediate enzymatic dissolution. |
| Duration of Action | Subcutaneous: 24-48 hours for spreading effect; Intravitreal: Single administration usually sufficient for vitreous liquefaction. |
Intravenous administration of 150 units as a bolus injection prior to subcutaneous fluid or medication administration to increase absorption and dispersion.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for renal impairment; Vitrase is not renally cleared. |
| Liver impairment | No dose adjustment required for hepatic impairment; metabolism is not hepatic-dependent. |
| Pediatric use | Intravenous administration of 150 units as a bolus injection prior to subcutaneous fluid or medication administration; same dosing as adults. |
| Geriatric use | No specific dose adjustment; standard adult dose of 150 units intravenously is appropriate. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for VITRASE (VITRASE).
| Breastfeeding | No data on excretion into human milk. Caution advised. M/P ratio unknown. |
| Teratogenic Risk | Vitrase (hyaluronidase) is classified as FDA Pregnancy Category C. Animal studies have shown no teratogenic effects, but no adequate human data exist. Risk cannot be ruled out; use only if clearly needed. |
| Fetal Monitoring | Monitor for signs of hypersensitivity, local adverse reactions. No specific fetal monitoring required. |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to hyaluronidase or any component of the product.","Infected or inflamed injection sites.","Do not inject into thrombophlebitic or varicose veins.","Do not use for enhancing absorption of drugs not approved for subcutaneous administration."]
| Precautions | ["Hypersensitivity reactions, including anaphylaxis, have been reported.","Do not use in patients with known hypersensitivity to hyaluronidase or any ingredient in the formulation.","Avoid injection into or around infected or inflamed areas.","Use with caution in patients with thrombophlebitis or venous insufficiency.","Fertility and pregnancy: Category C; use only if clearly needed."] |
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| Fertility Effects | No studies on fertility effects. Potential for local inflammation possibly affecting conception. |