HYLENEX RECOMBINANT

Clinical safety rating: caution

Comprehensive clinical and safety monograph for HYLENEX RECOMBINANT (HYLENEX RECOMBINANT).

How it works

HYLENEX RECOMBINANT is a recombinant human hyaluronidase that depolymerizes hyaluronan, a glycosaminoglycan in the extracellular matrix. By hydrolyzing hyaluronan, it temporarily increases tissue permeability and reduces the viscosity of hyaluronan, facilitating the dispersion and absorption of co-administered drugs or fluids.

What the body does with it

Metabolism	Hyaluronidase is degraded in the liver and kidney by enzymatic hydrolysis, specifically via hyaluronidases and other proteolytic enzymes; systemic metabolism results in small peptides and amino acids.
Excretion	Primarily metabolized by proteolysis in the liver and kidneys; less than 2% excreted unchanged in urine; no significant biliary or fecal elimination.
Half-life	Terminal half-life approximately 2.5 hours (range 2-3 hours); duration of enzymatic effect correlates with half-life, with clinically significant hyaluronidase activity lasting 24-48 hours.
Protein binding	Essentially negligible (<5%); not bound to plasma proteins.
Volume of Distribution	Approximately 0.6-0.8 L/kg; indicates distribution primarily into extracellular fluid spaces.
Bioavailability	Not applicable for intravenous use; subcutaneous and intradermal administration results in complete local absorption with systemic bioavailability assumed to be 100% at the site of action.
Onset of Action	Subcutaneous or intradermal: within 30-60 minutes; local infiltration: within 30 minutes.
Duration of Action	Subcutaneous or intradermal: 24-48 hours; effect on fluid dispersion lasts up to 48 hours, but enzymatic activity declines within 6-12 hours.

Classification & Brands

Dosing & administration

Subcutaneous or intradermal injection of 1 mL (150 U) at the site of extravasation or hyaluronic acid filler complication; may repeat if no improvement within 30-60 minutes.

Dosage form	INJECTABLE
Renal impairment	No dose adjustment required for renal impairment; pharmacokinetics not affected by GFR.
Liver impairment	No dose adjustment required for hepatic impairment; metabolism not liver-dependent.
Pediatric use	Pediatric dosing same as adult: 1 mL (150 U) subcutaneously or intradermally per site; maximum total dose 150 U per treatment area; safety not established in neonates.
Geriatric use	No specific geriatric dose adjustment; caution with volume status due to potential for rapid fluid redistribution; start with 1 mL (150 U) per site.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for HYLENEX RECOMBINANT (HYLENEX RECOMBINANT).

Breastfeeding	No data on excretion in human milk; M/P ratio unknown. Because of high molecular weight, secretion into breast milk is unlikely. Caution recommended; benefit-risk assessment needed.
Teratogenic Risk	Insufficient human data; animal studies not performed. Recombinant hyaluronidase is a high molecular weight protein unlikely to cross placenta in significant amounts. No known teratogenic risk identified; however, caution advised in first trimester due to general lack of data.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

None

Side Effect Profile

Serious Effects

Absolute Contraindications

["Known hypersensitivity to hyaluronidase or any ingredient in the formulation","Injection into or around infected or inflamed areas","Injection into tumors"]

Clinical Precautions

Precautions

["Do not inject into or around infected or acutely inflamed areas due to risk of spreading localized infection","Avoid injection into tumors because of risk of metastasis","Hypersensitivity reactions including anaphylaxis may occur; discontinue if signs of allergy appear","Not recommended for use in patients with known hypersensitivity to hyaluronidase or any component of the formulation","Use with caution in patients with bleeding disorders or receiving anticoagulants due to increased risk of bleeding at injection site"]

Clinical Tips & Counseling

Drug interactions

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HYLENEX RECOMBINANT

Clinical safety rating: caution

Comprehensive clinical and safety monograph for HYLENEX RECOMBINANT (HYLENEX RECOMBINANT).

How it works

What the body does with it

Metabolism	Hyaluronidase is degraded in the liver and kidney by enzymatic hydrolysis, specifically via hyaluronidases and other proteolytic enzymes; systemic metabolism results in small peptides and amino acids.
Excretion	Primarily metabolized by proteolysis in the liver and kidneys; less than 2% excreted unchanged in urine; no significant biliary or fecal elimination.
Half-life	Terminal half-life approximately 2.5 hours (range 2-3 hours); duration of enzymatic effect correlates with half-life, with clinically significant hyaluronidase activity lasting 24-48 hours.
Protein binding	Essentially negligible (<5%); not bound to plasma proteins.
Volume of Distribution	Approximately 0.6-0.8 L/kg; indicates distribution primarily into extracellular fluid spaces.
Bioavailability	Not applicable for intravenous use; subcutaneous and intradermal administration results in complete local absorption with systemic bioavailability assumed to be 100% at the site of action.
Onset of Action	Subcutaneous or intradermal: within 30-60 minutes; local infiltration: within 30 minutes.
Duration of Action	Subcutaneous or intradermal: 24-48 hours; effect on fluid dispersion lasts up to 48 hours, but enzymatic activity declines within 6-12 hours.

Classification & Brands

Dosing & administration

Subcutaneous or intradermal injection of 1 mL (150 U) at the site of extravasation or hyaluronic acid filler complication; may repeat if no improvement within 30-60 minutes.

Dosage form	INJECTABLE
Renal impairment	No dose adjustment required for renal impairment; pharmacokinetics not affected by GFR.
Liver impairment	No dose adjustment required for hepatic impairment; metabolism not liver-dependent.
Pediatric use	Pediatric dosing same as adult: 1 mL (150 U) subcutaneously or intradermally per site; maximum total dose 150 U per treatment area; safety not established in neonates.
Geriatric use	No specific geriatric dose adjustment; caution with volume status due to potential for rapid fluid redistribution; start with 1 mL (150 U) per site.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for HYLENEX RECOMBINANT (HYLENEX RECOMBINANT).

Breastfeeding	No data on excretion in human milk; M/P ratio unknown. Because of high molecular weight, secretion into breast milk is unlikely. Caution recommended; benefit-risk assessment needed.
Teratogenic Risk	Insufficient human data; animal studies not performed. Recombinant hyaluronidase is a high molecular weight protein unlikely to cross placenta in significant amounts. No known teratogenic risk identified; however, caution advised in first trimester due to general lack of data.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

None

Side Effect Profile

Serious Effects

Absolute Contraindications

["Known hypersensitivity to hyaluronidase or any ingredient in the formulation","Injection into or around infected or inflamed areas","Injection into tumors"]