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warnings and cautions
5 WARNINGS AND PRECAUTIONS • Spread of Localized Infection (5.1) • Ocular Damage (5.2) • Enzyme Inactivation with Intravenous Administration (5.3) 5.1 Spread of Localized Infection Hyaluronidase should not be injected into or around infected or acutely inflamed area because of the danger of spreading to a localized infection. Hyaluronidase should not be used to reduce the swelling of bites or stings. 5.2 Ocular Damage VITRASE should not be applied directly to the cornea. 5.3 Enzyme Inactivation with Intravenous Administration VITRASE should not be used for intravenous injections because the enzyme is rapidly inactivated.
6 ADVERSE REACTIONS The following adverse reactions have been identified during post-approval use of hyaluronidase products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most frequently reported adverse reactions have been local injection site reactions. Hyaluronidase has been reported to enhance the adverse reactions associated with co-administered drug products. Edema has been reported most frequently in association with hypodermoclysis. Allergic reactions (urticaria, angioedema) have been reported in less than 0.1% of patients receiving hyaluronidase. Anaphylactic-like reactions following retrobulbar block or intravenous injections have occurred, rarely. Allergic and anaphylactic-like reactions have been reported, rarely (6). To report SUSPECTED ADVERSE REACTIONS, contact ISTA Pharmaceuticals, Inc. at 1-877-788-2020, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .