Abbokinase Side Effects

Generic name: urokinase

Note: This document contains side effect information about urokinase. Some of the dosage forms listed on this page may not apply to the brand name Abbokinase.

Some side effects of Abbokinase may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to urokinase: intravenous powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking urokinase (the active ingredient contained in Abbokinase) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have a serious side effect such as:

• easy bruising or bleeding (nosebleeds, bleeding gums, bleeding from a wound, incision, catheter, or needle injection );

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

• sudden headache or problems with speech, vision, or balance;

• fever, chills, flu symptoms, nausea, vomiting, back pain, or stomach pain;

• drowsiness, confusion, mood changes, increased thirst, loss of appetite;

• swelling, weight gain, feeling short of breath;

• urinating less than usual or not at all;

• red or purple discoloration of fingers or toes;

• weak or shallow breathing, blue-colored lips or fingernails;

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure); or

• pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to urokinase: intravenous powder for injection

Hematologic

Hematologic side effects of urokinase (the active ingredient contained in Abbokinase) are unusual, but can be serious. Hemorrhage requiring blood transfusion is rare. Minor bleeding at venipuncture or arterial cutdown sites, macroscopic hematuria, or epistaxis is observed in 9% of patients. Serious hemorrhage occurs in 5% to 7% of patients. Intracranial hemorrhage in up to 1% of patients and rare cases of intramyocardial hemorrhage have been reported. Patients with uncontrolled hypertension or a history of stroke appear to be at a significantly higher risk for intracranial hemorrhagic complications. Several fatalities due to intracranial or retroperitoneal hemorrhage have occurred during thrombolytic therapy.

Rare cases of embolization during or after urokinase therapy have been reported. There is speculation that fibrinolysis could increase pericatheter thrombosis, which can result in local or distal thromboembolism.

Should serious bleeding occur, urokinase should be discontinued and, if necessary, blood loss and reversal of the bleeding tendency can be effectively managed with whole blood (fresh blood is preferable), packed red blood cells, and cryoprecipitate or fresh frozen plasma.

In a study (PROACT II trial) involving patients with acute ischemic stroke, symptomatic intracerebral hemorrhage (ICH) occurred in 10.9% of patients receiving intra-arterial urokinase at a mean 10.2 hours after the start of therapy. Mortality associated with urokinase-induced ICH was 83%. Patients with a blood glucose of greater than 200 mg/dL at stroke onset may be at an increased risk of developing symptomatic ICH.

Cardiovascular

A 67-year-old man with severe coronary artery disease, post-coronary artery bypass grafting presented with unstable angina, and was found to have a completely occluded saphenous vein graft to the right coronary artery (RCA). The patient's history, electrocardiogram, and creatine kinase CK isoenzymes were diagnostic of infarction. During catheterization, fresh thrombus was observed in the RCA. Because the patient was a suboptimal surgical candidate, intracoronary urokinase (the active ingredient contained in Abbokinase) 50,000 intl units/hr was initiated. The dosage was titrated upward to 300,000 intl units/hr because of new angina that began one hour after the urokinase infusion was started. New myocardial infarction (MI) was diagnosed, with CK enzymes peaking at 2,060 intl units/L (positive MB isoenzymes) 13 hours after urokinase therapy was started. Repeat arteriography revealed significant resolution of thrombus in the graft, but residual intraluminal filling defects. No distal embolization was seen.

The authors of this report reviewed 72 reported cases of urokinase infusions for chronic total saphenous vein graft occlusions, and found a 17% incidence of thromboembolic or MI events associated with urokinase therapy.

Since cardiovascular side effects may be more likely among the population of patients in whom urokinase is indicated, their relationship to the drug is not always clear. Transient hyper- or hypotension, dyspnea, tachycardia, and cyanosis, and rare cases of myocardial infarction have been associated with urokinase. Serious ventricular arrhythmias, including ventricular fibrillation, hemopericardium, and death from cardiogenic shock have been associated with thrombolytic therapy, in general.

Hypersensitivity

Hypersensitivity reactions are unusual because, unlike some thrombolytic agents, urokinase (the active ingredient contained in Abbokinase) does not appear to induce the formation of antibodies. Infusions may be associated with fevers, chills, or rigors. Relative mild rashes or cases of bronchospasm and rare cases of anaphylaxis have been reported.

Gastrointestinal

Gastrointestinal side effects include hemorrhagic gastritis associated with the thrombolytic state. Nausea and vomiting have been reported during urokinase (the active ingredient contained in Abbokinase) infusions.

Respiratory

The authors of this case report speculated that thrombolytic therapy may have caused local pulmonary parenchymal hemorrhage or encapsulated blood. The nodular lesion spontaneously resolved after one month.

Pulmonary embolism occurred in a patient with a Hickman catheter following local instillation of urokinase (the active ingredient contained in Abbokinase) to restore permeability of the catheter.

Respiratory complications associated with urokinase, such as dyspnea, may be representative of the underlying disease rather than drug therapy. A single case of a nodular density on tomography has been associated with urokinase in a young male who had been treated for massive pulmonary embolism.

Hepatic

Rare cases of jaundice, hyperbilirubinemia, and elevated hepatic transaminases have been associated with infusions of urokinase (the active ingredient contained in Abbokinase) or streptokinase. It has been suggested that hepatic dysfunction may not be caused by the toxic or allergic effects of the drugs themselves, but by the high activities of the proteolytic enzymes, plasminogen activator, and plasmin which are generated by the action of these drugs.

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