Streptase

Name: Streptase

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of streptokinase in the pediatric population. Safety and efficacy have not been established .

Pregnancy

Information about this streptokinase-intravenous-route-intracoronary-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Streptase Overview

Streptase is a brand name medication. For more information about Streptase see its generic Streptokinase

Commonly used brand name(s)

In the U.S.

  • Streptase

Available Dosage Forms:

  • Powder for Solution

Therapeutic Class: Thrombolytic

Pharmacologic Class: Tissue Plasminogen Activator

Uses For Streptase

Streptokinase is used to dissolve blood clots that have formed in the blood vessels. It is used immediately after symptoms of a heart attack occur to improve patient survival. This medicine may also be used to treat blood clots in the lungs (pulmonary embolism) and in the legs (deep venous thrombosis) .

Streptokinase is also used to dissolve blood clots in tubes (catheters) that are inserted in blood vessels .

This medicine is available only with your doctor's prescription .

Proper Use of Streptase

A doctor or other trained health professional will give you this medicine. This medicine is given through a needle or tube placed into one of your blood vessels .

For Healthcare Professionals

Applies to streptokinase: injectable powder for injection

Hematologic

Predisposing risk factors for the development of intracranial hemorrhage during thrombolytic therapy for myocardial infarction have included body weight less than 70 kg, age greater than 65 years old, and preexisting anticoagulant therapy. The authors of GISSI concluded that the risk of hemorrhagic stroke is also directly related to Killip classification.

A meta-analysis of 30 studies dealing with proximal lower extremity deep vein thrombosis (DVT) has revealed the following relative risks for patients who received SK + heparin versus heparin alone: any major bleeding, 2.9; central nervous system (CNS) bleeding, 4.5; mortality from CNS bleeding, 4.0; pulmonary embolism (PE), 1.0; mortality from PE, 1.0; postphlebitic syndrome, 0.4.

The risk of hemorrhagic side effects from streptokinase (the active ingredient contained in Streptase) can be minimized with patient selection. Major risk factors for intracranial hemorrhage have included known intracranial tumor, prior neurosurgery, stroke within the past six months, head trauma within the past month. Other significant risk factors included severe, uncontrolled hypertension, a remote stroke known not to be hemorrhagic, recent transient ischemic attacks, advanced age, and female gender.[Ref]

Hematologic side effects of streptokinase (SK) have included minor and major bleeding. The risk of bleeding appears to be significantly increased when plasma fibrinogen levels fall below 250 mg/dl. Minor bleeding has occurred in up to 67% of patients, presenting as venipuncture or arterial cutdown site oozing, microscopic hematuria, hemoptysis, or hematemesis. Local bleeding usually has been controlled by manual compression for 20 to 30 minutes. Serious or major bleeding, including gastrointestinal, genitourinary, joint, retroperitoneal or intracerebral hemorrhage, has occurred in 0.3% to 6.0% of patients. Adjuvant heparin, but not aspirin, therapy appears to increase the risk of bleeding.

Intracranial hemorrhage in 0.1% to 1.0% of patients and rare cases of intramyocardial hemorrhage have been reported. Several fatalities due to intracranial or retroperitoneal hemorrhage have occurred during thrombolytic therapy.

Rare cases of embolization and anti-SK-mediated platelet aggregation during or after SK therapy have been reported. There is speculation that fibrinolysis could increase pericatheter thrombosis, which can result in local or distal thromboembolism.[Ref]

Hypersensitivity

The overall incidence of hypersensitivity reactions to SK from the ISIS-2, GISSI-1 and GISSI-2 data ranged from 1.6% to 4.4%. Smaller studies have reported an incidence of 2% to 6%. Acute allergic reactions to SK ranged from minor dyspnea, urticaria, pruritus, flushing, nausea, headache, or musculoskeletal pain to severe anaphylaxis, bronchospasm, or periorbital or angioneurotic edema. SK-induced fever has been reported in 30% to 50% of patients. Severe acute hypersensitivity reactions have usually required discontinuation of therapy, antihistamines, and/or corticosteroids. In rare cases, adrenergic agents have been required to treat anaphylactic shock.[Ref]

In the 8,592 patients in the ISIS-2 trial who received SK there were no confirmed incidences of anaphylactic shock. The GISSI study 7 incidents of nonfatal anaphylactic reactions among 5,860 patients who had received SK (0.1%), though 99 patients (1.7%) had allergic reactions severe enough to discontinue therapy and another 42 (0.7%) were identified retrospectively. Skin testing immediately before SK therapy appears to be a practical, sensitive, and specific tool to help identify patients at risk for anaphylaxis.[Ref]

Cardiovascular

Since cardiovascular side effects may be more likely among the population of patients in whom SK in indicated, a cause-and-effect relationship to the drug is not always clear. Transient hypotension has been reported during SK therapy in approximately 40% of patients (anterior or inferior wall MI). Hypotension has been associated with reperfusion, which has been associated with decreased in-hospital mortality. Reperfusion of the myocardium has resulted in arrhythmias in 80% of patients who experience reperfusion. The most common reperfusion arrhythmia is a transient accelerated idioventricular rhythm, which is typically clinically benign. Premature ventricular depolarizations during reperfusion do not necessarily predict severe ventricular arrhythmias.

Dyspnea, cyanosis, rare cases of hemorrhagic myocardial infarction, serious ventricular arrhythmias, hemopericardium, and death from cardiogenic shock have been associated with thrombolytic therapy, in general.

Rare cases of cholesterol embolization syndrome have been associated with SK and other thrombolytic agents.[Ref]

Cholesterol embolization, a rare syndrome that typically presents with painful ischemia or necrosis of the digits, myalgias, skin changes of livedo reticularis and often progresses to renal failure and death, has occurred. Other findings have included cyanosis, ulcers, gangrene of the hands and feet, myalgias, intestinal infarction or eosinophilia. The exact mechanism is not known, but is believed to be due to physical disruption of atheromatous plaques by lysis of platelet-fibrin thrombi.[Ref]

Renal

New or worsened renal impairment has been associated with SK-induced immune complex disease. Rare cases of mild and transient acute renal insufficiency with proteinuria without evidence of hypersensitivity have been described after SK therapy.[Ref]

The differential diagnosis of acute renal failure following SK therapy includes ischemic injury, immunologic injury, and postrenal obstruction. Ischemia may be due to low cardiac output or hypotension secondary to acute myocardial infarction (if present), a direct effect of SK, reperfusion-induced hypotension, or hemorrhagic shock. These conditions may cause acute tubular necrosis. Ischemia may also be due to emboli from mural thrombi (if present), cholesterol emboli syndrome, or myoglobinuria.

Immunologic injury to the kidney may be related to SK-induced serum sickness, Schonlein-Henoch purpura, or immune complex nephritis.

Retroperitoneal hemorrhage or ureter thrombosis during or following SK therapy can cause postrenal obstruction.[Ref]

Nervous system

In one case of Guillain-Barre syndrome (GBS) associated with SK oligoclonal IgG bands in the cerebrospinal fluid and serum were shown to be specific for streptokinase (the active ingredient contained in Streptase) Clinical symptoms of GBS were thought to result from SK-antibody complex-mediated damage to the local blood-nerve barrier.[Ref]

Hemorrhagic stroke, a potentially serious nervous system side effect, has affected approximately 0.1% to 1.0% of patients. Extremely rare cases of Guillain-Barre syndrome have been associated with the use of SK.[Ref]

Gastrointestinal

Gastrointestinal side effects have been rare. Hemorrhagic gastritis has been associated with the thrombolytic state. Nausea or vomiting has been reported during thrombolytic therapy. Unusual cases of hemorrhagic splenic rupture and subcapsular hepatic hematoma have occurred.[Ref]

Hepatic

Rare cases of SK-induced hepatic dysfunction have been reported . Some experts believe that mild, transient liver function test elevations indicative of cholestasis do not appear to be caused by toxic or allergic effects of SK itself, but by the high activities of the proteolytic enzymes, plasminogen activator and plasmin. Rare cases of jaundice have been reported.[Ref]

In a prospective study of 24 nonselected patients with peripheral arterial occlusions undergoing SK therapy, 18 had significant liver enzyme elevations typical of cholestasis and impaired hepatocellular integrity and function, but none became jaundiced.[Ref]

Musculoskeletal

Rare cases of musculoskeletal back pain have been reported. In some cases bleeding into the iliopsoas muscles was discovered, but in most reported cases, there was no evidence of allergy, aortic dissection, worsened myocardial infarction or retroperitoneal hemorrhage.[Ref]

Genitourinary

A genitourinary concern for menstruating women who are considered for thrombolytic therapy has been whether SK can safely be used during menses. The drug has been used safely during menses, perhaps because hemostasis of the uterine endothelium after the first day of menses depends on arteriolar vasoconstriction more than the formation of fibrin.[Ref]

Respiratory

Adult respiratory distress syndrome (ARDS) has been rarely associated with the use of SK. ARDS is a known complication of hypersensitivity to SK.[Ref]

Dermatologic

Dermatologic side effects have included rare cases of dermal microemboli. Some cases have progressed to dermal necrosis.[Ref]

Immunologic

SK is antigenic and may induce the formation of antibodies. Delayed hypersensitivity reactions may result in the development of immune complex disease, presenting as fever, vasculitic or purpuric rashes, abnormal renal and liver function tests, arthralgias, serum sickness, and/or a syndrome resembling adult respiratory distress syndrome. A case of SK-induced direct antiglobulin test-positive hemolysis has been reported.[Ref]

General

The production of the general body symptom, fever, has also been associated with urokinase, which is not antigenic. While the mechanism of fever is not known, this suggests that fever may be due to breakdown products of thrombi rather than to thrombolytic drugs.[Ref]

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

Streptokinase Pregnancy Warnings

Streptokinase (SK) has been assigned to pregnancy category C by the FDA. Animal reproduction studies have not been conducted with SK. Successful use of streptokinase during human pregnancy without adverse fetal effects has been reported. There are no controlled data in human pregnancy. Streptokinase should be given during pregnancy only when benefit outweighs risk.

The human placenta essentially prevents passage of SK to the fetus. The minimal amount of SK that reaches the fetal circulation is not enough to cause fibrinolytic effects in the fetus. There are no reports of adverse effects on the fetus associated with the use of SK. Although little SK crosses the placenta, pregnancy is considered a minor contraindication to the use of SK, and obstetrical delivery within 10 days is considered a major contraindication. Antibodies to SK cross the human placenta. Passive sensitization with anti-SK antibodies would have clinical importance only if the newborn subsequently required thrombolytic therapy with this drug. In one study, 24 patients with deep vein thrombosis were treated with SK in the second and third trimesters without fetal complications. Pfeifer has reported the successful use of SK to treat deep vein thrombosis and acute pulmonary embolism in a limited number of patients. Pfeifer also reports the use of SK to treat placental insufficiency in a single case (controversial indication). There is no mention of fetotoxicity or teratogenicity from these data. Cases of acute massive pulmonary embolism during pregnancy that were successfully treated by SK without adverse effects on the fetus have been reported. When SK was administered near delivery, slow but severe postpartum hemorrhage (due to the thrombolytic state) and/or partial uterine atony (thought to be due to fibrin degradation products) have been reported. In one case (McTaggart and Ingram, 1977), SK was used to treat massive pulmonary embolism associated with shock in a 24-year-old woman at 34 weeks' gestation. Fetal heart sounds were absent eight hours after admission and between four and eight hours after streptokinase was started. After an otherwise uneventful recovery, the patient spontaneously delivered a stillborn female 18 days later.

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