HYLENEX recombinant is indicated as an adjuvant to increase the absorption and dispersion of other injected drugs; for hypodermoclysis; and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents.

HYLENEX recombinant (hyaluronidase human injection) should be administered only as discussed below, since its effects relative to absorption and dispersion of other drugs are not produced when it is administered intravenously.

Absorption and Dispersion of Injected Drugs

Absorption and dispersion of other injected drugs may be enhanced by adding 50-300 U, most typically 150 U hyaluronidase, to the injection solution.

It is recommended that appropriate references be consulted regarding physical or chemical incompatibilities before adding HYLENEX recombinant to a solution containing another drug.

Hypodermoclysis

Insert needle with aseptic precautions. With tip lying free and movable between skin and muscle, begin clysis; fluid should start in readily without pain or lump. Then inject HYLENEX recombinant into rubber tubing close to needle.

An alternate method is to inject HYLENEX recombinant under skin prior to clysis. 150 U will facilitate absorption of 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, Ringers, etc.) must be adjusted carefully to the individual patient. When solutions devoid of inorganic electrolytes are given by hypodermoclysis, 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 (up to 200 mL), such as small clysis for infants or solutions of drugs for subcutaneous injection. For infants and children less than 3 years old, the volume of a single clysis should be limited to 200 mL; and in premature infants or during the neonatal period, the daily dosage should not exceed 25 mL/kg of body weight; the rate of administration should not be greater than 2 mL per minute. For older patients, the rate and volume of administration should not exceed those employed for intravenous infusion.

Subcutaneous Urography

The subcutaneous route of administration of urographic contrast media is indicated when intravenous administration cannot be successfully accomplished, particularly in infants and small children. With the patient prone, 75 U of HYLENEX recombinant is injected subcutaneously over each scapula, followed by injection of the contrast medium at the same sites.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

HYLENEX recombinant (hyaluronidase human injection) is supplied sterile as 150 USP units of nonpreserved recombinant human hyaluronidase per mL in a single-use 2 mL glass vial with a gray rubber stopper and aluminum flip-off seal.

1 mL Single Dose Vial available in boxes of 1 (NDC 60977-319-02)

1 mL Single Dose Vial available in boxes of 10 (NDC 60977-319-01)

Not Recommended for IV Use.

Store unopened in a refrigerator at 2° to 8°C (36° to 46°F).

DO NOT FREEZE.

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