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.
Ocular Damage: Hyaluronidase should not be applied directly to the cornea. It is not for topical use.
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.
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.
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.
Hylenex recombinant (hyaluronidase human injection) is a tissue permeability modifier indicated as an adjuvant to increase the dispersion and absorption of other injected drugs.
You may report an adverse event related to Hylenex recombinant by calling 1-877-877-1679. If you prefer, you may contact the FDA directly.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.