July 1, 2016
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Hylenex

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Hylenex




Indications
Dosage
How Supplied

INDICATIONS

Subcutaneous Fluid Administration

HYLENEX recombinant is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration.

Dispersion And Absorption Of Injected Drugs

HYLENEX recombinant is indicated as an adjuvant to increase the dispersion and absorption of other injected drugs.

Subcutaneous Urography

HYLENEX recombinant is indicated as an adjunct in subcutaneous urography for improving resorption of radiopaque agents.

DOSAGE AND ADMINISTRATION

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.

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.

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.

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.

HOW SUPPLIED

Dosage Forms And Strengths

150 USP units/mL single dose vials

Storage And Handling

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.

Manufactured for and Marketed by: Halozyme Therapeutics, Inc., San Diego, CA 92121. Rev. Feb 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 6/30/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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