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Kinlytic™
(urokinase) for Injection
Kinlytic™ (urokinase for injection) is a thrombolytic agent obtained from human neonatal kidney cells grown in tissue culture. The principal active ingredient of Kinlytic™ is the low molecular weight form of urokinase, and consists of an A chain of 2,000 daltons linked by a sulfhydryl bond to a B chain of 30,400 daltons. Kinlytic™ (urokinase injection) is supplied as a sterile lyophilized white powder containing 250,000 international units urokinase per vial, mannitol (25 mg/vial), Albumin (Human) (250 mg/vial), and sodium chloride (50 mg/vial).
Following reconstitution with 5 mL of Sterile Water for Injection, USP, Kinlytic™ (urokinase injection) is a clear, slightly straw-colored solution; each mL contains 50,000 international units of urokinase activity, 0.5% mannitol, 5% Albumin (Human), and 1% sodium chloride (pH range 6.0 to 7.5).
Thin translucent filaments may occasionally occur in reconstituted Kinlytic™ vials (see DOSAGE AND ADMINISTRATION).
Kinlytic™ (urokinase injection) is for intravenous infusion only.
Kinlytic™ (urokinase injection) is produced from human neonatal kidney cells (see WARNINGS). No fetal tissue is used in the production of Kinlytic™ (urokinase injection) . Kidney donations are obtained exclusively in the United States from neonates (birth to 28 days) for whom death has not been attributed to infectious causes and that have exhibited no evidence of an infectious disease based in part, on an examination of the maternal and neonatal donor medical records. The maternal and neonatal donor screening process also identifies specific risk factors for known infectious diseases and includes testing of sera for HBV, HCV, HIV-1, HIV-2, HTLV-I, HTLV-II, CMV, and EBV. Donors with sera testing positive or associated with other risk factors are excluded. During the manufacturing process, cells are tested at multiple stages for the presence of viruses using in vitro and in vivo tests that are capable of detecting a wide range of viruses. Cells are also screened for HPV using a DNA detection-based test and for reovirus using a polymerase chain reaction-based test. The manufacturing process used for this product has been validated in laboratory studies to inactivate and/or remove a diverse panel of spiked model enveloped and nonenveloped viruses, and includes purification steps and a heat treatment step (10 hours at 60°C in 2% sodium chloride). A single vial of Kinlytic™ contains urokinase produced using cells derived from one or two donors.
Kinlytic™ (urokinase injection) is indicated in adults:
The diagnosis should be confirmed by objective means, such as pulmonary angiography or noninvasive procedures such as lung scanning.
Kinlytic™ (urokinase injection) IS INTENDED FOR INTRAVENOUS INFUSION ONLY.
Kinlytic™ (urokinase injection) treatment should be instituted soon after onset of pulmonary embolism. Delay in instituting therapy may decrease the potential for optimal efficacy (see CLINICAL PHARMACOLOGY).
Administer Kinlytic™ (urokinase injection) with a programmable infusion pump only.
Change the infusion rate immediately after completion of the loading dose.
The following Dose Preparation-Pulmonary Embolism chart may be used as an aid in the preparation of Kinlytic™ (urokinase injection) for administration. For administration directions, see next section.
Dose Preparation-Pulmonary Embolism
For administration, use a programmable infusion pump only.
After ten minutes, change the initial loading dose rate to the maintenance
dose rate.
| Patient Weight [kilograms (pounds)] | Total Dosea (Loading and Continuous Infusion) | Number of Kinlytic™ Vials Needed for Total Dose | Total Volume of Sterile Water for Injection needed for Reconstitution of Kinlytic™ (urokinase injection) Vialsb | + | Volume of 0.9% Sodium Chloride or 5% Dextrose Injection, USP for Infusion (mL) | = | Final Volume (mL) for Loading and Continuous Infusion |
| 37-40 (81-90) | 2,250,000 | 9 | 45 | 150 | 195 | ||
| 41-45 (91-100) | 2,500,000 | 10 | 50 | 145 | 195 | ||
| 46-50 (101-110) | 2,750,000 | 11 | 55 | 140 | 195 | ||
| 51-54(111-120) | 3,000,000 | 12 | 60 | 135 | 195 | ||
| 55-59(121-130) | 3,250,000 | 13 | 65 | 130 | 195 | ||
| 60-64 (131-140) | 3,500,000 | 14 | 70 | 125 | 195 | ||
| 65-68(141-150) | 3,750,000 | 15 | 75 | 120 | 195 | ||
| 69-73 (151-160) | 4,000,000 | 16 | 80 | 115 | 195 | ||
| 74-77 (161-170) | 4,250,000 | 17 | 85 | 110 | 195 | ||
| 78-82 (171-180) | 4,500,000 | 18 | 90 | 105 | 195 | ||
| 83-86 (181-190) | 4,750,000 | 19 | 95 | 100 | 195 | ||
| 87-91 (191-200) | 5,000,000 | 20 | 100 | 95 | 195 | ||
| 92-95 (201-210) | 5,250,000 | 21 | 105 | 90 | 195 | ||
| 96-100 (211-220) | 5,500,000 | 22 | 110 | 85 | 195 | ||
| 101-104 (221-230) | 5,750,000 | 23 | 115 | 80 | 195 | ||
| 105-109 (231-240) | 6,000,000 | 24 | 120 | 75 | 195 | ||
| 110-114 (241-250) | 6,250,000 | 25 | 125 | 70 | 195 | ||
| aLoading Dose + dose administered during 12-hour
period. bEach vial is reconstituted with 5 mL of Sterile Water for Injection, USP, without preservatives. (See Preparation.) |
|||||||
After infusing Kinlytic™ (urokinase injection) , anticoagulation treatment is recommended to prevent recurrent thrombosis. Do not begin anticoagulation until the aPTT has decreased to less than twice the normal control value. If heparin is used, do not administer a loading dose of heparin. Treatment should be followed by oral anticoagulants.
Kinlytic™ (urokinase injection) is supplied as a sterile lyophilized preparation (NDC 24430-1003-1). Each vial contains 250,000 international units urokinase activity, 25 mg mannitol, 250 mg Albumin (Human), and 50 mg sodium chloride.
Refrigerate Kinlytic™ (urokinase injection) powder at 2° to 8°C (36° to 46°F) (See USP).
REFERENCES
1. Sato S. et al. Elevated Urokinase-Type Plasminogen Activator Plasma Levels Are Associated With Deterioration of Liver Function But Not With Hepatocellular Carcinoma. J Gastroenterology, 1994; 29:745-750.
2. Bell WR. Thrombolytic Therapy: A Comparison Between Urokinase and Streptokinase. Sem Thromb Hemost. 1975; 2:1-13.
3. Sasahara AA, Hyers TM, Cole CM, et al. The Urokinase Pulmonary Embolism Trial. Circulation. 1973; 47 (suppl. 2):1-108.
4. Daniels LB, Parker JA, Patel SR, Grodstein F, Goldhaber SZ. Relation of Duration of Symptoms With Response to Thrombolytic Therapy in Pulmonary Embolism. Am J Cardiol. 1997; 80:184-188.
5. Urokinase Pulmonary Embolism Trial Study Group: Urokinase-Streptokinase Embolism Trial. JAMA. 1974; 229:1606-1613.
6. Sasahara AA, Bell WR, Simon TL, et al. The Phase II Urokinase-Streptokinase Pulmonary Embolism Trial. Thrombos Diathes Haemorrh (Stuttg). 1975; 33:464-476.
ImaRx Therapeutics, Inc. Tucson, Arizona 85718, USA. July 2008. FDA revision date: 07/18/08
The most serious adverse reactions reported with Kinlytic™ (urokinase injection) administration include fatal hemorrhage and anaphylaxis (see WARNINGS).
Bleeding is the most frequent adverse reaction associated with Kinlytic™ and can be fatal (see WARNINGS).
In controlled clinical studies using a 12-hour infusion of urokinase for the treatment of pulmonary embolism (UPET and USPET),3,5,6 bleeding resulting in at least a 5% decrease in hematocrit was reported in 52 of 141 urokinase-treated patients. Significant bleeding events requiring transfusion of greater than 2 units of blood were observed during the 14-day study period in 3 of 141 urokinasetreated patients in these studies. Multiple bleeding events may have occurred in an individual patient. Most bleeding occurred at sites of external incisions and vascular puncture, with lesser frequency in gastrointestinal, genitourinary, intracranial, retroperitoneal, and intramuscular sites.
There are limited well-controlled clinical studies performed using urokinase. The adverse reactions described in the following sections reflect both the clinical use of Kinlytic™ (urokinase injection) in the general population and limited controlled study data. Because post-marketing reports of adverse reactions are voluntary and the population is of uncertain size, it is not always possible to reliably estimate the frequency of the reaction or establish a causal relationship to drug exposure.
Rare cases of fatal anaphylaxis have been reported (see WARNINGS). In controlled clinical trials, allergic reaction was reported in 1 of 141 patients ( < 1%).
The following allergic-type reactions have been observed in clinical trials and/or post-marketing experience: bronchospasm, orolingual edema, urticaria, skin rash, and pruritus (see WARNINGS).
Infusion reaction symptoms include hypoxia, cyanosis, dyspnea, tachycardia, hypotension, hypertension, acidosis, fever and/or chills/rigors, back pain, vomiting, and nausea (see WARNINGS).
Other adverse events occurring in patients receiving Kinlytic™ (urokinase injection) therapy in clinical studies, regardless of causality, include myocardial infarction, recurrent pulmonary embolism, hemiplegia, stroke, decreased hematocrit, substernal pain, thrombocytopenia, and diaphoresis.
Additional adverse reactions reported from post-marketing experience include cardiac arrest, vascular embolization (cerebral and distal) including cholesterol emboli (see WARNINGS), cerebral vascular accident, pulmonary edema, reperfusion ventricular arrhythmias and chest pain. A cause and effect relationship has not been established.
The immunogenicity of Kinlytic™ (urokinase injection) has not been studied.
Anticoagulants and agents that alter platelet function (such as aspirin, other non-steroidal antiinflammatory agents, dipyridamole, and GP IIb/IIIa inhibitors) may increase the risk of serious bleeding.
Administration of Kinlytic™ (urokinase injection) prior to, during, or after thrombolytic agents may increase the risk of serious bleeding.
Because concomitant use of Kinlytic™ (urokinase injection) with agents that alter coagulation, inhibit platelet function, or are thrombolytic may further increase the potential for bleeding complications, careful monitoring for bleeding is recommended.
The interaction of Kinlytic™ (urokinase injection) with other drugs has not been studied and is not known.
The risk of serious bleeding is increased with use of Kinlytic™ (urokinase injection) . Fatalities due to hemorrhage, including intracranial and retroperitoneal, have been reported in association with urokinase therapy.
Concurrent administration of Kinlytic™ (urokinase injection) with other thrombolytic agents, anticoagulants, or agents inhibiting platelet function may further increase the risk of serious bleeding.
Kinlytic™ (urokinase injection) therapy requires careful attention to all potential bleeding sites (including catheter insertion sites, arterial and venous puncture sites, cutdown sites, and other needle puncture sites).
Intramuscular injections and nonessential handling of the patient must be avoided during treatment with Kinlytic™ (urokinase injection) . Venipunctures should be performed as infrequently as possible and with care to minimize bleeding.
Should an arterial puncture be necessary, upper extremity vessels are preferable. Direct pressure should be applied for at least 30 minutes, a pressure dressing applied, and the puncture site checked frequently for evidence of bleeding.
In the following conditions, the risk of bleeding may be increased and should be weighed against the anticipated benefits:
