Drug: Abbokinase

Abbokinase Generic Name: urokinase (URE oh KYE nase)
Brand Name: Kinlytic What is Abbokinase (urokinase)? Urokinase is a man-made product developed using a protein that occurs naturally in the kidneys. Urokinase is a thrombolytic agent that works by dissolving blood clots. Urokinase is used to treat blood clots in the lungs. Urokinase may also be used for purposes not listed in this medication guide. What is the most important information I should know about Abbokinase (urokinase)? You should not use this medication if you have internal bleeding, a brain tumor or aneurysm, hemophilia or other bleeding disorder, arterial hypertension, or if you have recently had a stroke, brain or spinal surgery, or medical emergency requiring CPR (cardiopulmonary resuscitation). What should I discuss with my health care provider before I receive Abbokinase (urokinase)? You should not use this medication if you are allergic to urokinase, or if you have: internal bleeding; a brain tumor; a brain aneurysm (dilated blood vessel); a bleeding or blood clotting disorder (such as hemophilia); a condition called arterial hypertension; if you have had a recent medical emergency requiring CPR (cardiopulmonary resuscitation); if you have had a stroke, brain surgery, or spinal surgery within in the past 2 months. To make sure urokinase is safe for you, tell your doctor if you have: a history of stroke; severe liver or kidney disease; eye problems caused by diabetes; an infection of the lining of your heart (also called bacterial endocarditis); a blood clot of your heart; a recent history of stomach or intestinal bleeding; if you are pregnant or have had a baby within the past 10 days; or if you have had surgery or an organ transplant within the past 10 days. FDA pregnancy category B. Urokinase is not expected to be harmful to an unborn baby. However, your doctor should know if you are pregnant before you receive this medication. It is not known whether urokinase passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby. Urokinase is made from human kidney cells and albumin (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication. How is urokinase given? Urokinase is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. Urokinase is given slowly, usually over a period of 12 hours, using a continuous infusion pump. Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely while you are receiving urokinase. What happens if I miss a dose? Because you will receive urokinase in a clinical setting, you are not likely to miss a dose. What happens if I overdose? Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur. What should I avoid while receiving Abbokinase (urokinase)? Avoid taking aspirin or ibuprofen (Motrin, Advil) to treat a fever shortly after you have received urokinase. These medications can increase your risk of bleeding. Ask your doctor about other methods of treating a fever. Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth. Abbokinase (urokinase) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Urokinase increases your risk of bleeding, which can be severe or life-threatening. Call your doctor or seek emergency medical attention if you have bleeding that will not stop. Bleeding may occur from a surgical incision, or from the skin where a needle was inserted during a blood test or while receiving injectable medication. You may also have bleeding on the inside of your body, such as in your stomach or intestines, kidneys or bladder, brain, or within the muscles. Call your doctor at once if you have signs of bleeding inside your body, 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; red or pink urine; or sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance. Also call your doctor at once if you have: chest pain or heavy feeling, pain spreading to the jaw or shoulder, nausea, sweating, general ill feeling; fever, chills, flu symptoms, nausea, vomiting, back pain, or stomach pain; swelling, rapid weight gain, little or no urinating; 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. See also: Side effects (in more detail) What other drugs will affect Abbokinase (urokinase)? Tell your doctor about all medicines you use, and those you start or stop using during your treatment with urokinase, especially: NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or medication used to prevent blood clots--dabigatran, dalteparin, desirudin, enoxaparin, fondaparinux, tinzaparin, warfarin, Coumadin. This list is not complete. Other drugs may interact with urokinase, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

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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 ConsumerApplies 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 ProfessionalsApplies to urokinase: intravenous powder for injectionHematologicHematologic 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]CardiovascularA 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]HypersensitivityHypersensitivity 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]GastrointestinalGastrointestinal 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]RespiratoryThe 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]HepaticRare 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]

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Urokinase Pregnancy Warnings Urokinase has been assigned to pregnancy category B by the FDA. Animal data have failed to reveal evidence of teratogenicity or fetotoxicity. There are no controlled data in human pregnancy. Urokinase should only be given during pregnancy when benefit outweighs risk. Two cases in which urokinase was successfully and safely used to treat pulmonary emboli (PE) and two cases in which the drug was successfully and safely used to treat deep venous thrombi (DVT) during human pregnancy have been reported. In one case of acute PE, thrombolytic therapy was chosen for the treatment of PE in a 19-year-old at gestational age 29.2 weeks' because of the woman's tenuous hemodynamic status. The patient was given 4,400 intl units/kg over 10 minutes followed by a maintenance infusion of 4,400 intl units/kg per hour for 12 hours. Therapy was dramatically successful; the only complication was mild, self-limited macroscopic hematuria. A heparin infusion was begun at the end of urokinase therapy, and adjusted to maintain a partial thromboplastin time at one and one-half to two times the control value. The patient was discharged with subcutaneous heparin therapy. Aside from two brief hospital readmissions for adjustment of anticoagulant therapy, she did well. She subsequently had an uncomplicated vaginal delivery of a healthy term infant. Thrombolytic therapy using urokinase was chosen for the treatment of PE in a 20-year-old at 21 weeks' gestation because of clinical deterioration during heparin therapy. This patient was given the same regimen as in the case above, and showed marked hemodynamic improvement over the ensuing 12 hours. A second urokinase bolus was given for recurrent PE 6 hours later. The patient continued to receive subcutaneous heparin during the rest of her pregnancy. She delivered a healthy male infant (3,122 g) at term. Lower extremity DVT per history, physical and MRI was successfully treated in a heparinized 23-year-old woman at 33 weeks' gestation after urokinase 5,000 intl units/hr over 36 hours + dipyridamole. Six weeks after the urokinase infusion, the patient delivered a normal 3,540-gram male infant vaginally without complications. Upper extremity DVT per history, physical, and Doppler ultrasound was successfully treated in a heparinized 18-year-old woman at 11 weeks' gestation after urokinase + heparin therapy. Follow-up Doppler ultrasound shown recanalization of the problem vein, and, 7 months later, the patient delivered a normal 3,140-gram male infant. Urokinase Breastfeeding Warnings There are no data on the excretion of urokinase into human milk. The manufacturer recommends that caution be used when administering urokinase to nursing women.

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