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In controlled clinical studies using a 12-hour infusion of urokinase for the treatment of pulmonary embolism (UPET and USPET),3,5,6 bleeding resulting in at least a 5% decrease in hematocrit was reported in 52 of 141 urokinase-treated patients. Significant bleeding events requiring transfusion of greater than 2 units of blood were observed during the 14-day study period in 3 of 141 urokinasetreated patients in these studies. Multiple bleeding events may have occurred in an individual patient. Most bleeding occurred at sites of external incisions and vascular puncture, with lesser frequency in gastrointestinal, genitourinary, intracranial, retroperitoneal, and intramuscular sites.
Sources of Information on Adverse Reactions
There are limited well-controlled clinical studies performed using urokinase. The adverse reactions described in the following sections reflect both the clinical use of Kinlytic™ (urokinase injection) in the general population and limited controlled study data. Because post-marketing reports of adverse reactions are voluntary and the population is of uncertain size, it is not always possible to reliably estimate the frequency of the reaction or establish a causal relationship to drug exposure.
Other Adverse Reactions
Other adverse events occurring in patients receiving Kinlytic™ (urokinase injection) therapy in clinical studies, regardless of causality, include myocardial infarction, recurrent pulmonary embolism, hemiplegia, stroke, decreased hematocrit, substernal pain, thrombocytopenia, and diaphoresis.
Additional adverse reactions reported from post-marketing experience include cardiac arrest, vascular embolization (cerebral and distal) including cholesterol emboli (see WARNINGS), cerebral vascular accident, pulmonary edema, reperfusion ventricular arrhythmias and chest pain. A cause and effect relationship has not been established.
The immunogenicity of Kinlytic™ (urokinase injection) has not been studied.
Read the Kinlytic (urokinase injection) Side Effects Center for a complete guide to possible side effects
Anticoagulants and agents that alter platelet function (such as aspirin, other non-steroidal antiinflammatory agents, dipyridamole, and GP IIb/IIIa inhibitors) may increase the risk of serious bleeding.
Administration of Kinlytic™ (urokinase injection) prior to, during, or after thrombolytic agents may increase the risk of serious bleeding.
Because concomitant use of Kinlytic™ (urokinase injection) 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 Kinlytic™ (urokinase injection) with other drugs has not been studied and is not known.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 8/7/2008
Additional Kinlytic Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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