Kinlytic: Package Insert and Label Information (Page 2 of 2)

Immunogenicity

The immunogenicity of Kinlytic™ has not been studied.

DOSAGE AND ADMINISTRATION

Kinlytic™ IS INTENDED FOR INTRAVENOUS INFUSION ONLY.

Kinlytic™ treatment should be instituted soon after onset of pulmonary embolism. Delay in instituting therapy may decrease the potential for optimal efficacy (see CLINICAL PHARMACOLOGY).

Dosing

  • A loading dose of 4,400 international units per kilogram of Kinlytic™ is given at a rate of 90 mL per hour over a period of 10 minutes. This is followed by a continuous infusion of 4,400 international units per kilogram per hour at a rate of 15 mL for 12 hours.
  • Administration of Kinlytic™ may be repeated as necessary.
  • A dosing and preparation chart for patients who weigh 37 to 114 kilograms (81 to 250 pounds) is provided as a guide in the Preparation Section that follows below. If the patient is outside of these weights, calculate with dosing information provided above.

Preparation

  • The Dose Preparation-Pulmonary Embolism chart is a guidance tool/aid provided for the convenience of the practitioner and may not be complete for every patient.
  • Kinlytic™ contains no preservatives. Do not reconstitute until immediately before use. Any unused portion of the reconstituted material should be discarded.
  • Reconstitute Kinlytic™ by aseptically adding 5 mL of Sterile Water for Injection, USP, without preservatives, to the vial. DO NOT USE Bacteriostatic Water for Injection, USP.
  • After reconstitution, the drug product will contain 50,000 international units per milliliter.
  • After reconstituting, visually inspect each vial of Kinlytic™ for discoloration and for the presence of particulate material. The solution should be pale and straw-colored; highly colored solutions should not be used. Thin translucent filaments may occasionally occur in reconstituted Kinlytic™ vials, but do not indicate any decrease in potency of this product. To minimize formation of filaments, avoid shaking the vial during reconstitution. Roll and tilt the vial to enhance reconstitution. The solution may be terminally filtered, for example, through a 0.45 micron or smaller cellulose membrane filter.
  • No other medication should be added to this solution.
  • Prior to infusing, dilute the reconstituted Kinlytic™ with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP.

The following Dose Preparation-Pulmonary Embolism chart may be used as an aid in the preparation of Kinlytic™ for administration. For administration directions, see next section.

Dose Preparation-Pulmonary Embolism
a Loading Dose + dose administered during 12-hour period.
b Each vial is reconstituted with 5 mL of Sterile Water for Injection, USP, without preservatives. (See Preparation.)
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 Reconstitutionof Kinlytic™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

Administration

  • Kinlytic™ is administered using a constant infusion pump that is capable of delivering a total volume of 195 mL.
  • The loading dose of Kinlytic™ admixture (4,400 international units per kilogram) should be delivered at a rate of 90 mL per hour over a period of 10 minutes.
  • This is followed by a continuous infusion of 4,400 international units per kilogram per hour of Kinlytic™ at a rate of 15 mL per hour for 12 hours.
  • Since some of the Kinlytic™ admixture will remain in the tubing at the end of an infusion pump delivery cycle, the following flush procedure should be performed to insure that the total dose of Kinlytic™ is administered. A solution of 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP, approximately equal in amount to the volume of the tubing in the infusion set should be administered via the pump to flush the Kinlytic™ admixture from the entire length of the infusion set. The pump should be set to administer the flush solution at the continuous rate of 15 mL per hour.
  • No other drug products/solutions may be administered in the same line with Kinlytic™.

Anticoagulation After Terminating Kinlytic™ Treatment

After infusing Kinlytic™, 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.

HOW SUPPLIED

Kinlytic™ 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™ 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.

Rx

©ImaRx Therapeutics, Inc. 2007

Printed in USA

ImaRx Therapeutics, Inc. Tucson Arizona, 85719, USA

Ref: 80003 V:01 June 2007

KINLYTIC urokinase injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24430-1003
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UROKINASE (urokinase) urokinase 250000 [iU] in 5 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL 25 mg in 5 mL
albumin (human) 250 mg in 5 mL
SODIUM CHLORIDE 50 mg in 5 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24430-1003-1 5 mL (5 MILLILITER) in 1 VIAL None
Labeler — ImaRx Therapeutics, Inc.

Revised: 06/2007 ImaRx Therapeutics, Inc.

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