Precautions:
Angikinase should be used in hospitals where the recommended diagnostic and monitoring techniques are available.
The clinical response and vital signs should be observed frequently during and following Sedonase infusion. Blood pressure should not be taken in the lower extremities to avoid dislodgement of possible deep vein thrombi.

Laboratory Tests:
Before beginning thrombolytic therapy, obtain a hematocrit, platelet count, and an activated partial thromboplastin time (aPTT). If heparin has been given, it should be discontinued and the aPTT should be less than twice the normal control value before thrombolytic therapy is started.
Following the intravenous infusion of Angikinase, before (re) instituting anticoagulants, the aPTT should be less than twice the normal control value.
Results of coagulation tests and measures of fibrinolytic activity do not reliably predict either efficacy or risk of bleeding for patients receiving Sedonase.

Drug Interactions:
Anticoagulants and agents that alter platelet function (such as aspirin, other non-steroidal anti-inflammatory agents, dipyridamole, and GP IIb/IIIa inhibitors) may increase the risk of serious bleeding.

Administration of Angikinase prior to, during, or after other thrombolytic agents may increase the risk of serious bleeding.

Because concomitant use of Angikinase with agents that alter coagulation, inhibit platelet function, or are thrombolytic may further increase the potential for bleeding complications, careful monitoring for bleeding is recommended.

The interaction of Sedonase with other drugs has not been studied and is not known.

Carcinogenicity:
Adequate data are not available on the long-term potential for carcinogenicity in animals or humans.

Pregnancy:
Pregnancy Category B:
Reproduction studies have been performed in mice and rats at doses up to 1,000 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Angikinase.
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers:
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Angikinase is administered to a nursing woman.

Pediatric Use:
Safety and effectiveness in pediatric patients have not been established.

Geriatric Use :
Clinical studies of Urokinase did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Urokinase should be used with caution in elderly patients.

References:
1.Sato S, et al. Elevated Urokinase-Type Plasminogen Activator Plasma Levels Are Associated With Deterioration of Liver Function But Not With Hepatocellular Carcinoma. J Gastroenterology . 1994; 29: 745-750. 2.Bell WR. Thrombolytic Therapy: A Comparison Between Urokinase and Streptokinase. Sem Thromb Hemost . 1975; 2:1-13. 3. Sasahara AA, Hyers TM, Cole CM, et al. The Urokinase Pulmonary Embolism Trial. Circulation . 1973; 47 (suppl. 2): 1-108. 4. Daniels LB, Parker JA, Patel SR, Grodstein F, Goldhaber SZ. Relation of Duration of Symptoms With Response to Thrombolytic Therapy in Pulmonary Embolism. Am J Cardiol . 1997; 80:184-188. 5.Urokinase Pulmonary Embolism Trial Study Group: Urokinase-Streptokinase Embolism Trial. JAMA . 1974; 229:1606-1613. 6.Sasahara AA, Bell WR, Simon TL, et al. The Phase II Urokinase-Streptokinase Pulmonary Embolism Trial. Thrombos Diathes Haemorrh (Stuttg). 1975; 33:464-476. ©Abbott 2002 ABBOTT LABORATORIES, NORTH CHICAGO, IL 60064, USA Reference 58-6978-R4-Rev. October, 2002

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