"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Spread of Localized Infection
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. It is not for topical use.
Enzyme Inactivation with Intravenous Administration
HYLENEX recombinant (hyaluronidase human injection) 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.
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.
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.
Use In Specific Populations
Pregnancy Category C. Animal reproductions studies have not been conducted with HYLENEX recombinant (hyaluronidase human injection) . It is also not known whether HYLENEX (hyaluronidase human injection) recombinant can cause fetal harm when administered to a pregnant woman. HYLENEX (hyaluronidase human injection) recombinant should be given to a pregnant woman 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 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.
Clinical hydration requirements for children can be achieved through administration of subcutaneous fluids facilitated with HYLENEX (hyaluronidase human injection) recombinant.
The dosage of subcutaneous fluids administered is dependent upon the age, weight, and clinical condition of the patient as well as laboratory determinations. The potential for chemical or physical incompatibilities should be kept in mind [See DRUG INTERACTIONS].
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 of body weight, and the rate of administration should not be greater than 2 mL per minute.
During subcutaneous fluid administration, special care must be taken in pediatric patients to avoid over hydration by controlling the rate and total volume of the infusion. [See DOSAGE AND ADMINISTRATION].
No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.
Last reviewed on RxList: 12/29/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Hylenex Information
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