Abbokinase Side Effects

Generic Name: urokinase

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

Not all side effects for Abbokinase may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to urokinase: intravenous powder for solution

In addition to its needed effects, some unwanted effects may be caused by urokinase (the active ingredient contained in Abbokinase). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking urokinase, check with your doctor or nurse immediately:

More common
  • Bleeding gums
  • coughing up blood
  • difficulty with breathing or swallowing
  • dizziness
  • headache
  • increased menstrual flow or vaginal bleeding
  • nosebleeds
  • paralysis
  • prolonged bleeding from cuts
  • red or black, tarry stools
  • red or dark brown urine
  • shortness of breath
Rare
  • Cough
  • fast heartbeat
  • hives or welts
  • itching skin
  • noisy breathing
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness of the skin
  • skin rash
  • tightness in the chest
  • unusual tiredness or weakness
  • wheezing
Incidence not known
  • Blue lips and fingernails
  • blurred vision
  • chest pain or discomfort
  • confusion
  • convulsions
  • coughing that sometimes produces a pink frothy sputum
  • difficult, fast, or noisy breathing, sometimes with wheezing
  • fainting
  • fast, irregular, pounding, or racing heartbeat or pulse
  • inability to speak
  • increased sweating
  • low blood pressure or pulse
  • numbness or tingling in the face, arms, or legs
  • pale skin
  • severe or sudden headache
  • severe or sudden weakness in the arm or leg on one side of the body
  • slurred speech
  • swelling in the legs and ankles
  • trouble with walking or speaking
  • unconsciousness

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

References

1. Pavlides GS, Schreiber TL, Gangadharan V, Puchrowicz S, O'Neill WW "Safety and efficacy of urokinase during elective coronary angioplasty." Am Heart J 121 (1991): 731-7

2. Barberena J "Intraarterial infusion of urokinase in the treatment of acute pulmonary thromboembolism: preliminary observations." AJR Am J Roentgenol 140 (1983): 883-6

3. Hirsch DR, Goldhaber SZ "Bleeding time and other laboratory tests to monitor the safety and efficacy of thrombolytic therapy." Chest 97 (1990): s124-31

4. Ambrose JA, Almeida OD, Sharma SK, Torre SR, Marmur JD, Israel DH, Ratner DE, Weiss MB, Hjemdahlmonsen CE, Myler RK, Mos "Adjunctive thrombolytic therapy during angioplasty for ischemic rest angina - results of the TAUSA trial." Circulation 90 (1994): 69-77

5. Mathey DG, Schofer J, Sheehan FH, Becher H, Tilsner V, Dodge HT "Intravenous urokinase in acute myocardial infarction." Am J Cardiol 55 (1985): 878-82

6. Fiessinger JN, Vayssairat M, Juillet Y, Aiach M, Janneau D, Cormier JM, Housset E "Local urokinase in arterial thromboembolism." Angiology 31 (1980): 715-20

7. Price C, Jacocks MA, Tytle T "Thrombolytic therapy in acute arterial thrombosis." Am J Surg 156 (1988): 488-91

8. Erlemeier HH, Zangemeister W, Burmester L, Schofer J, Mathey DG, Bleifeld W "Bleeding after thrombolysis in acute myocardial infarction." Eur Heart J 10 (1989): 16-23

9. Fiessinger JN, Vitoux JF, Pernes JM, Roncato M, Aiach M, Gaux JC "Complications of intraarterial urokinase-lys-plasminogen infusion therapy in arterial ischemia of lower limbs." AJR Am J Roentgenol 146 (1986): 157-9

10. Levine SR, Brott TG "Thrombolytic therapy in cerebrovascular disorders." Prog Cardiovasc Dis 34 (1992): 235-62

11. Sherry S "Appraisal of various thrombolytic agents in the treatment of acute myocardial infarction." Am J Med 83 (1987): 31-46

12. Genton E "Thrombolytic therapy of pulmonary thromboembolism." Prog Cardiovasc Dis 21 (1979): 333-41

13. "Product Information. Abbokinase (urokinase)." Abbott Pharmaceutical, Abbott Park, IL.

14. van de Loo JC, Kriessmann A, Trubestein G, Knoch K, de Swart CA, Asbeck F, Marbet GA, Schmitt HE, Sewell AF, Duckert F, et al "Controlled multicenter pilot study of urokinase- heparin and streptokinase in deep vein thrombosis." Thromb Haemost 50 (1983): 660-3

15. Goldhaber SZ, Polak JF, Feldstein ML, Meyerovitz MF, Creager MA "Efficacy and safety of repeated boluses of urokinase in the treatment of deep venous thrombosis." Am J Cardiol 73 (1994): 75-9

16. Bedotto JB, Rutherford BD, Hartzler GO "Intramyocardial hemorrhage due to prolonged intracoronary infusion of urokinase into a totally occluded saphenous vein bypass graft." Cathet Cardiovasc Diagn 25 (1992): 52-6

17. Belkin M, Belkin B, Bucknam CA, Straub JJ, Lowe R "Intra-arterial fibrinolytic therapy. Efficacy of streptokinase vs urokinase." Arch Surg 121 (1986): 769-73

18. Zidar FJ, Kaplan BM, Oneill WW, Jones DE, Schreiber TL, Safian RD, Ajluni SC, Sobolski J, Timmis GC, Grines CL "Prospective, randomized trial of prolonged intracoronary urokinase infusion for chronic total occlusions in native coronary arteries." J Am Coll Cardiol 27 (1996): 1406-12

19. Ejaz AA, Aijaz M, Nawab ZM, Leehey DJ, Ing TS "Hemorrhagic bullae as a complication of urokinase therapy for hemodialysis catheter thrombosis." Am J Nephrol 15 (1995): 178-9

20. Kase CS, Furlan AJ, Wechsler LR, et al. "Cerebral hemorrhage after intra-arterial thrombolysis for ischemic stroke: The PROACT II trial." Neurology 57 (2001): 1603-10

21. Hanaway J, Torack R, Fletcher AP, Landau WM "Intracranial bleeding associated with urokinase therapy for acute ischemic hemispheral stroke." Stroke 7 (1976): 143-6

22. Wall TC, Phillips HR, 3d Stack RS, Mantell S, Aronson L, Boswick J, Sigmon K, DiMeo M, Chaplin D, Whitcomb D, et al "Results of high dose intravenous urokinase for acute myocardial infarction." Am J Cardiol 65 (1990): 124-31

23. Carmody TJ, Wergowske GL, Joffe CD "Unusual nodular pulmonary lesions associated with thrombolytic therapy." Cathet Cardiovasc Diagn 10 (1984): 485-8

24. Harrington RA, Sane DC, Califf RM, Sigmon KN, Abbottsmith CW, Candela RJ, Lee KL, Topol EJ "Clinical importance of thrombocytopenia occurring in the hospital phase after administration of thrombolytic therapy for acute myocardial infarction." J Am Coll Cardiol 23 (1994): 891-8

25. Watabe S, Uwatoko M, Tsunekawa A, Izumi S, Osugi J, Takatsu F, Ishikawa H, Nagaya T "A case of normal coronary infarction after intracoronary thrombolysis with urokinase." Cathet Cardiovasc Diagn 9 (1983): 501-5

26. Ward GL, Heiselman DE, White LJ "Pulsus paradoxus in anaphylactic shock due to urokinase administration." Chest 101 (1992): 589

27. Blankenship JC, Modesto TA, Madigan NP "Acute myocardial infarction complicating urokinase infusion for total saphenous vein graft occlusion." Cathet Cardiovasc Diagn 28 (1993): 39-43

28. Shibley MH, Clifton GD "Febrile reaction associated with urokinase." Pharmacotherapy 14 (1994): 123-5

29. Vidovich RR, Heiselman DE, Hudock D "Treatment of urokinase-related anaphylactoid reaction with intravenous famotidine." Ann Pharmacother 26 (1992): 782-3

30. Matsumoto AH, Selby JB, Tegtmeyer CJ, Rosser SW, England MB, Farr BM, Angle JF, Scheld WM "Recent development of rigors during infusion of urokinase - is it related to an endotoxin." J Vasc Interv Radiol 5 (1994): 433-8

31. Matsis P, Mann S "Rigors and bronchospasm with urokinase after streptokinase." Lancet 340 (1992): 1552

32. Frye MD, Jarratt M, Sahn SA "Acute hypoxemic respiratory failure following intrapleural thrombolytic therapy for hemothorax." Chest 105 (1994): 1595-6

33. Perez-Calvo J, Santisteban M, Lopez-Picazo JM, Martin-Algarra S "Pulmonary embolism after local urokinase instillation in a Hickman catheter." Bone Marrow Transplant 28 (2001): 112-3

34. Pavlou H, Pangiotopoulos A, Graham A, Alexopoulos D "Urokinase-induced cyto-hepatolysis in a patient with acute myocardial-infarction." Eur Heart J 16 (1995): 291-2

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