Discontinue HYLENEX recombinant (hyaluronidase human injection) if sensitization occurs.

Hyaluronidase should not be used to enhance the absorption and dispersion of dopamine and/or alpha agonist drugs.

Hyaluronidase should not be injected into or around an infected or acutely inflamed area because of the danger of spreading a localized infection.

Hyaluronidase should not be used to reduce the swelling of bites or stings.

Hyaluronidase should not be applied directly to the cornea.

Hyaluronidase should not be used for intravenous injections because the enzyme is rapidly inactivated.

Furosemide, the benzodiazepines and phenytoin have been found to be incompatible with hyaluronidase.

When considering the administration of any other drug with hyaluronidase, it is recommended that appropriate references first be consulted to determine the usual precautions for the use of the other drug; e.g., when epinephrine is injected along with hyaluronidase, the precautions for the use of epinephrine in cardiovascular disease, thyroid disease, diabetes, digital nerve block, ischemia of the fingers and toes, etc., should be observed.

Laboratory Tests

A preliminary skin test for hypersensitivity to HYLENEX recombinant can be performed. The skin test is made by an intradermal injection of approximately 0.02 mL (3 Units) of a 150 Unit/mL solution. (See DOSAGE AND ADMINISTRATION). A positive reaction consists of a wheal with pseudopods appearing within 5 minutes and persisting for 20 to 30 minutes and accompanied by localized itching. Transient vasodilation at the site of the test, i.e., erythema, is not a positive reaction.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to assess the carcinogenic or mutagenic potential of hyaluronidase. Hyaluronidase is found in most tissues of the body.

Long-term animal studies have not been performed to assess whether hyaluronidase impaired fertility; however, it has been reported that testicular degeneration may occur with the production of organ specific antibodies against this enzyme following repeated injections. Human studies on the effect of intravaginal hyaluronidase in sterility due to oligospermia indicated that hyaluronidase may have aided conception. Thus, it appears that hyaluronidase may not adversely affect fertility in females.

Pregnancy

Teratogenic Effects—Pregnancy Category C

No adequate and well controlled animal studies have been conducted with HYLENEX recombinant to determine reproductive effects. No adequate and well controlled studies have been conducted with HYLENEX recombinant in pregnant women. HYLENEX recombinant should be used during pregnancy only if clearly needed.

Labor and Delivery

Administration of hyaluronidase during labor was reported to cause no complications: no increase in blood loss or differences in cervical trauma were observed. It is not known whether hyaluronidase has an effect on the later growth, development, and functional maturation of the infant.

Nursing Mothers

It is not known whether hyaluronidase is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when hyaluronidase is administered to a nursing woman.

Pediatric Use

Hyaluronidase may be added to small volumes of solution (up to 200 mL), such as a small clysis for infants or solutions of drugs for subcutaneous injection. The potential for chemical or physical incompatibilities should be kept in mind (See DOSAGE AND ADMINISTRATION.)

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.

During hypodermoclysis, special care must be taken in pediatric patients to avoid over hydration by controlling the rate and total volume of the clysis. (See DOSAGE AND ADMINISTRATION, Hypodermoclysis)

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.

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