Hyaluronidase, Ovine

1 INDICATIONS AND USAGE VITRASE is an endoglycosidase indicated as an adjuvant: in subcutaneous fluid administration for achieving hydration. ( 1.1 ) for increasing the dispersion and absorption of other injected drugs. ( 1.2 ) for improving resorption of radiopaque agents, in subcutaneous urography. ( 1.3 ) 1.1 Subcutaneous Fluid Administration (Hypodermoclysis) VITRASE ® (hyaluronidase injection) is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration. 1.2 Dispersion and Absorption of Injected Drugs VITRASE is indicated as an adjuvant to increase the dispersion and absorption of other injected drugs. 1.3 Subcutaneous Urography VITRASE is indicated as an adjuvant in subcutaneous urography for improving resorption of radiopaque agents.

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 (e.g., urticaria, angioedema) have been reported in less than 0.1% of patients receiving hyaluronidase.

8.1 Pregnancy Risk Summary Human studies of hyaluronidase as an aid to conception and as an aid to delivery have been conducted without reports of maternal or fetal harm. Non-human animal reproduction studies have not been conducted with VITRASE. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies.

5 WARNINGS AND PRECAUTIONS Spread of Localized Infection ( 5.1 ) Ocular Cornea 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 Cornea 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. 4 CONTRAINDICATIONS VITRASE is contraindicated in patients with known hypersensitivity to hyaluronidase or any other ingredient in the formulation. Discontinue VITRASE if sensitization occurs. Hypersensitivity ( 4 )