Hyaluronidase

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 2.1 Important Administration Instructions HYLENEX recombinant should not be administered intravenously.
• Its effects relative to dispersion and absorption of other drugs are not produced when it is administered intravenously because the enzyme is rapidly inactivated.
• HYLENEX recombinant may be administered for infiltration use, interstitial use, intramuscular use, intraocular use, peribulbar use, retrobulbar use, soft tissue use or subcutaneous use.
• Visually inspect parenteral drug products for particulate matter and discoloration prior to administration.
• Always use aseptic precautions.
• Lightly pinch the skin up into a small mound and insert the needle/catheter into the subcutaneous space.
• Inject HYLENEX recombinant through the catheter hub or injection port closest to the needle/catheter.
• Begin administration of solution.
• Solution should start in readily.
• 2.2 Subcutaneous Fluid Administration Inject 150 U of HYLENEX recombinant prior to start of subcutaneous fluid administration to facilitate absorption of up to 1,000 mL or more of solution.
• As with all parenteral fluid therapy, observe effect closely, with the same precautions for restoring fluid and electrolyte balance as in intravenous injections.
• The dose, the rate of injection, and the type of solution (saline, glucose, Ringer's, etc.) must be adjusted carefully to the individual patient.
• When solutions devoid of inorganic electrolytes are administered subcutaneously, hypovolemia may occur.
• This may be prevented by using solutions containing adequate amounts of inorganic electrolytes and/or controlling the volume and speed of administration.
• HYLENEX recombinant may be added to small volumes of solution, such as fluid replacement solutions or solutions of drugs for subcutaneous injection.
• Subcutaneous fluids should be administered as directed by a physician.
• The dosage of subcutaneous fluids administered is dependent upon the age, weight, and clinical condition of the patient as well as laboratory determinations.
• The rate and volume of subcutaneous fluid administration should not exceed those employed for intravenous infusion.
• For premature infants or during the neonatal period, the daily dosage should not exceed 25 mL/kg and the rate of administration should not be greater than 2 mL per minute.
• 2.3 Dispersion and Absorption of Injected Drugs Hylenex can be used to enhance the dispersion and absorption of other injected or subcutaneously infused drugs by pre-administration of HYLENEX recombinant or by adding 50-300 U, most typically 150 U hyaluronidase, to the injection solution prior to infiltration use, interstitial use, intramuscular use, intraocular use, retrobulbar use, soft tissue use or subcutaneous use.
• 2.4 Subcutaneous Urography The subcutaneous route of administration of urographic contrast media may be considered when intravenous administration cannot be successfully accomplished, particularly in infants and small children.
• With the patient prone, inject 75 U of HYLENEX recombinant subcutaneously over each scapula, followed by injection of the contrast medium at the same sites.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

Side effects

• The following adverse reactions have been identified during post-approval use of hyaluronidase products.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• The most frequently reported adverse reactions have been mild local injection site reactions such as erythema and pain.
• Hyaluronidase has been reported to enhance the adverse reactions associated with co-administered drug products.
• Edema has been reported most frequently in association with subcutaneous fluid administration.
• Allergic reactions (urticaria or angioedema) have been reported in less than 0.1% of patients receiving hyaluronidase.
• Anaphylactic-like reactions following retrobulbar block or intravenous injections have occurred, rarely.

Quoted from the official label, section “Adverse Reactions”.

Strengths and forms

FORMS & STRENGTHS 150 USP units/mL single dose vials

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• HYLENEX recombinant is supplied sterile as 150 USP units of nonpreserved recombinant human hyaluronidase per mL in a single-use glass vial.
• HYLENEX recombinant is supplied in the following packaging:
• 1 mL Single Dose Vial (NDC 18657-117-01) available in boxes of 4 (NDC 18657-117-04) Store unopened in a refrigerator at 2° to 8°C (36° to 46° F).
• DO NOT FREEZE.

Quoted from the official label, section “How Supplied”.

What is in it

• HYLENEX recombinant is a purified preparation of the enzyme recombinant human hyaluronidase.
• HYLENEX recombinant is produced by genetically engineered Chinese Hamster Ovary (CHO) cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20).
• The purified hyaluronidase glycoprotein contains 447 amino acids with an approximate molecular weight of 61,000 Daltons.
• HYLENEX recombinant is supplied as a sterile, clear, colorless, nonpreserved, ready-for-use solution.
• Each mL contains 150 USP units of recombinant human hyaluronidase with 8.5 mg sodium chloride, 1.4 mg dibasic sodium phosphate, 1 mg albumin human, 1.5 mg L-methionine, 0.2 mg polysorbate 80, and hydrochloric acid and sodium hydroxide added for pH adjustment.
• HYLENEX recombinant has an approximate pH of 7.0 and an osmolality of 280 to 340 mOsm/kg.

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Same active substance

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