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Anistreplase Side Effects

Applies to anistreplase: intravenous powder for injection

Hematologic

Hematologic side effects of anistreplase should be anticipated. Hemorrhage or hematoma formation has occurred at the site of venipuncture in up to 31% of patients. Hemorrhage requiring blood transfusion has been rare. Gastrointestinal, intracranial, pericardial, or other significant hemorrhage has occurred in less than 2% of patients, but has been life-threatening. Purpuric rashes have been reported in 0.8% of patients, and thrombocytopenia or megaloblastic anemia has been reported in less than 0.1% of patients. Patients with uncontrolled hypertension or a history of stroke appear to be at a significantly higher risk for intracranial hemorrhagic complications.[Ref]

A 62-year-old female with an acute myocardial infarction developed progressive dysphagia and anemia one day after receiving anistreplase and aspirin. A barium swallow revealed complete obstruction at T3. Esophagoscopy was unsuccessful. Computed tomography (CT) revealed a massively distended esophagus (55 mm), with an imaged density consistent with an organizing hematoma. Serial CT studies revealed a dissection of the esophageal mucosa with a false lumen and residual hematoma. The findings were attributed to anistreplase. The patient fully recovered over the ensuing five months.[Ref]

Cardiovascular

Since cardiovascular side effects may be more likely among the population of patients in whom anistreplase is indicated, a causal relationship to anistreplase is not always clear. Reperfusion arrhythmias have occurred during coronary thrombolysis. Bradycardia occurred in 13%, hypotension in 35%, and serious ventricular arrhythmias--including ventricular fibrillation--occurred in 8% to 14% of patients. Death from cardiogenic shock has been reported in less than 1% of patients. Approximately 1% to 2% of patients have developed hemopericardium.[Ref]

Hypersensitivity

Anistreplase is antigenic and has induced hypersensitivity reactions in 6% of patients. These reactions typically presented as rash or photosensitivity. Anaphylaxis has occurred in 1% to 4% of patients.[Ref]

Nervous system

A significant central nervous system side effect, hemorrhagic stroke, has been reported in 0.9% of patients. Headache, dizziness, fatigue and syncope each occurred in less than 1% of patients.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea or vomiting in 2% to 6%, and minor or major GI hemorrhage in less than 1% of patients. Rarely, liver enzyme elevations have been associated with the drug.[Ref]

Musculoskeletal

Musculoskeletal back pain has been reported rarely. The etiology is not known.[Ref]

Immunologic

Serum sickness and leukocytoclastic vasculitis have been associated with anistreplase and also with streptokinase, a closely related thrombolytic molecule.[Ref]

Immunologic changes following anistreplase have been extremely rare. Anistreplase antibodies may decrease the effectiveness of anistreplase when readministration occurs within 5 days to 12 months of a previous dosage. Cases of leukocytoclastic vasculitis and serum sickness have been reported[Ref]

Metabolic

Metabolic changes associated with anistreplase have included both hyper- and hypokalemia.[Ref]

Renal

New or worsened renal insufficiency has been reported in less than 0.1% of patients. Rare cases of acute interstitial nephritis have occurred.[Ref]

Respiratory

A case of adult respiratory distress syndrome associated with the use of anistreplase has been reported.[Ref]

The acute development of noncardiogenic pulmonary edema (pulmonary edema in the presence of normal cardiac ejection fraction, mean pulmonary capillary wedge pressure of 12 cm of water, and cardiac output of 7.4 L/min) was reported in a 56-year-old man 61 hours after he received anistreplase for an acute myocardial infarction. The authors of this case report suspected that the small peptides formed from anistreplase/plasmin-induced fibrinolysis promoted increased vascular permeability either by a direct effect on the pulmonary vasculature or by the activation of platelets and granulocytes.[Ref]

References

1. Dykewicz MS, Mcmorrow NKY, Davison R, Fintel DJ, Zull CC, Rutledge JL "Drug eruptions and isotypic antibody responses to streptokinase after infusions of anisoylated plasminogen-streptokinase complex (APSAC, anistreplase)." J Allergy Clin Immunol 95 (1995): 1020-8

2. Relik-van Wely L, Visser RF, van der Pol JM, Bartholomeus I, Couvee JE, Drost H, Vet AJ, Klomps HC, van Ekelen WA, van den Berg F, et al "Angiographically assessed coronary arterial patency and reocclusion in patients with acute myocardial infarction treated with anistreplase: results of the anistreplase reocclusion multicenterstudy (ARMS)." Am J Cardiol 68 (1991): 296-300

3. Renkin J, de Bruyne B, Benit E, Joris JM, Carlier M, Col J "Cardiac tamponade early after thrombolysis for acute myocardial infarction: a rare but not reported hemorrhagic complication." J Am Coll Cardiol 17 (1991): 280-5

4. Hannaford P, Vincent R, Ferry S, Hirsch S, Kay C "Assessment of the practicality and safety of thrombolysis with anistreplase given by general practitioners." Br J Gen Pract 45 (1995): 175-9

5. Jishi F, Sissons CE, Silverstone EJ, Coakley JF, Fraser F "Oesophageal dissection after thrombolytic treatment for myocardial infarction." Thorax 47 (1992): 835-6

6. Klauser R, Roggla G, Pidlich J, Leithner C, Frass M "Massive upper airway bleeding after thrombolytic therapy: successful airway management with the Combitube." Ann Emerg Med 21 (1992): 431-3

7. Lardoux H, Louvard Y, de Vernejoul D, Picot C, Baudet M, Hiltgen M, Houplon M, Ponsonnaille J, Richard M, Luccioni R, et al "French multicenter trial of anistreplase versus heparin in acute myocardial infarction." Cardiovasc Drugs Ther 4 (1990): 1337-44

8. Carlson TA, Ferguson JJ "Clinical experience with intracoronary tissue plasminogen activator: results of a multicenter registry." Cathet Cardiovasc Diagn 34 (1995): 196-201

9. "Product Information. Eminase (anistreplase)." SmithKline Beecham, Philadelphia, PA.

10. McNeill AJ, Roberts MJ, Wilson CM, Dalzell GW, Dickey W, Flannery DJ, Campbell NP, Khan MM, Molajo AO, Patterson GC, et al "Anistreplase in early acute myocardial infarction and the one-year follow-up." Int J Cardiol 31 (1991): 39-49

11. Vogt P, Monnier P, Schaller MD, Goy JJ, Beuret P, Essinger A, Bachmann F, Hauert J, Perret C, Sigwart U, et al "Comparison of results of intravenous infusion of anistreplase versus streptokinase in acute myocardial infarction." Am J Cardiol 71 (1993): 274-80

12. Silber H, Hausmann MJ, Katz A, Gilutz H, Zucker N, Ovsyshcher I "Short- and long-term comparative study of anistreplase versus streptokinase in acute myocardial infarction." Angiology 43 (1992): 572-7

13. Brenot F, Pacouret G, Meyer G, Sors H, Charbonnier B, Simonneau G "Adverse reactions with anistreplase." Lancet 338 (1991): 114-5

14. GREAT Group "Feasibility, safety, and efficacy of domiciliary thrombolysis by general practitioners: Grampian region early anistreplase trial. GREAT Group." BMJ 305 (1992): 548-53

15. Le SP, Chatterjee K, Wolfe CL "Adult respiratory distress syndrome following thrombolytic therapy with APSAC for acute myocardial infarction." Am Heart J 123 (1992): 1368-9

16. Hannaford P, Kay CR "Back pain and thrombolysis." BMJ 304 (1992): 915

17. Burrows N, Jones RR "Rash after treatment with anistreplase." Br Heart J 64 (1990): 289-90

18. Burrows N, Jones RR "Vasculitis occurring after intravenous anistreplase." J Am Acad Dermatol 26 (1992): 508

19. Lear J, Rajapakse R "Low back pain associated with anistreplase." BMJ 306 (1993): 896

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

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