Home Contact Us ABOUT HALOZYME NEWSROOM TECHNOLOGY PRODUCTS & PIPELINE INVESTORS CAREERS INVESTIGATORS Products & Pipeline Products HYLENEX® recombinant Pipeline HYLENEX® recombinant Click here to go to Hylenex.com Hylenex® recombinant is a human recombinant formulation of hyaluronidase that has received FDA approval to facilitate 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. Hylenex® recombinant works by temporarily breaking down hyaluronic acid, a structural component of the subcutaneous space that is just beneath the outside surface of the human skin. This depolymerization opens microscopic channels, allowing fluid or drugs to be dispersed and absorbed into the body. The hyaluronic acid rebuilds naturally and is completely restored within 48 hours. Hylenex® recombinant Package Insert (PDF) Important Safety Information Contraindications Hylenex recombinant is contraindicated in patients with known hypersensitivity to hyaluronidase or any of the excipients in Hylenex recombinant. Discontinue Hylenex recombinant if sensitization occurs. Warnings and Precautions 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. Bites or Stings: Hyaluronidase should not be used to reduce the swelling of bites or stings. Ocular Damage: 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 used for intravenous administration 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. Adverse Reactions Allergic reactions have been reported in less than 0.1% of patients receiving hyaluronidase. Anaphylactic-like reactions following retrobulbar block or intravenous injections have occurred, rarely. The most frequently reported adverse reactions have been mild local injection site reactions, such as erythema and pain. Hyaluronidase has been reported to enhance the adverse reactions associated with co-administered drug products. Edema has been reported most frequently in association with subcutaneous fluid administration. When solutions devoid of inorganic electrolytes are administered subcutaneously, hypovolemia may occur. As with all parenteral fluid therapy, observe effect closely, with the same precautions for restoring fluid and electrolyte balance as in intravenous injections. Drug Interactions Furosemide, the benzodiazepines, and phenytoin are incompatible with hyaluronidase. Hyaluronidase should not be used to enhance the dispersion and absorption of dopamine and/or alpha agonist drugs. When used with local anesthetics, hyaluronidase hastens the onset of analgesia and shortens its duration of effect, and increases the incidence of systemic reactions. Patients receiving large doses of salicylates, cortisone, ACTH, estrogens or antihistamines may require larger amounts of hyaluronidase for equivalent dispersing effect. Use in Specific Populations Pediatric Use: The dosage of subcutaneous fluids administered is dependent upon the age, weight, and clinical condition of the patient. 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. Special care must be taken in pediatric patients to avoid over hydration by controlling the rate and total volume of the infusion. Website Design: Hane Chow Inc. © 2011, 2012 Halozyme, Inc. All rights reserved. All trademarks belong to their respective owners. Powered By Q4 Web Systems 4.1.1.49