- Hypersensitivity to hyaluronidase or any other ingredient in the formulation is a contraindication to the use of this product.
- Discontinue Hylenex recombinant 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 used for intravenous injections because the enzyme is rapidly inactivated.
- Furosemide, the benzodiazepines and phenytoin have been found to be incompatible with hyaluronidase.
- Anaphylactic-like reactions following retrobulbar block or intravenous injections have occurred, rarely.
- Hyaluronidase should not be applied directly to the cornea. It is not for topical use.
The most frequently reported adverse reactions have been local injection site reactions, such as erythema and pain. Hyaluronidase has been reported to enhance the adverse reactions associated with co-administered drug products.
Patients receiving large doses of salicylates, cortisone, ACTH, estrogens or antihistamines may require larger amounts of hyaluronidase for equivalent dispersing effect, since these drugs apparently render tissues partly resistant to the action of hyaluronidase.
Edema has been reported most frequently in association with subcutaneous fluid administration. The rate and volume of subcutaneous fluid administration should not exceed those employed for intravenous infusion. As with all parenteral fluid therapy, observe effect closely, with the same precautions for restoring fluid and electrolyte balance as in intravenous injections. Special care must be taken in pediatric patients to avoid over hydration by controlling the rate and total volume of infusion. When solutions devoid of inorganic electrolytes are administered subcutaneously, hypovolemia may occur.
Hylenex recombinant contains albumin, which is a derivative of human blood that may carry a remote risk of transmitting infectious agents, e.g., viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. No cases of transmission of viral diseases, CJD, or variant CJD (vCJD) have ever been identified for licensed albumin or albumin contained in other licensed products.
Hylenex recombinant (hyaluronidase human injection) is a tissue permeability modifier indicated as an adjuvant in subcutaneous fluid administration for achieving hydration, to increase the dispersion and absorption of other injected drugs, and in subcutaneous urography for improving resorption of radiopaque agents.
You may report an adverse event related to Hylenex recombinant by calling 1-855-HYLENEX. If you prefer, you may contact the FDA directly.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.