"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
Dotarem is a gadolinium-based"...
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 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.
Products Containing Plasma-derived Albumin
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Hyaluronidase is found in most tissues of the body. Long-term animal studies have not been performed to assess the carcinogenic or mutagenic potential of hyaluronidase.
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. In addition, when recombinant human hyaluronidase was administered to cynomolgus monkeys for 39 weeks at dose levels up to 220,000 U/kg, no evidence of toxicity to the male or female reproductive system was found through periodic monitoring of in-life parameters, e.g., semen analyses, hormone levels, menstrual cycles, and also from gross pathology, histopathology and organ weight data.
Use In Specific Populations
Pregnancy Category C
In an embryo-fetal study, mice have been dosed daily by subcutaneous injection with recombinant human hyaluronidase at dose levels up to 2,200,000 U/kg. The study found no evidence of teratogenicity. Reduced fetal weight and increased numbers of fetal resorptions were observed, with no effects found at a daily dose of 360,000 U/kg, which represents several orders of magnitude over the suggested human dose range of 50-300 U of HYLENEX recombinant (0.8-5 U/kg in a 60 kg subject).
In a pre- and postnatal development study, mice have been dosed daily by subcutaneous injection with recombinant human hyaluronidase at dose levels up to 1,100,000 U/kg. The study found no adverse effects on sexual maturation, learning and memory of offspring, or their ability to produce another generation of offspring.
It is also not known whether HYLENEX recombinant can cause fetal harm when administered to a pregnant woman. HYLENEX recombinant should be given to a pregnant woman only if clearly needed.
Labor And Delivery
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 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.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/15/2016
Additional Hylenex Information
Report Problems to the Food and Drug Administration
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