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Kinlytic (Urokinase) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Kinlytic™ is indicated in adults:

  • For the lysis of acute massive pulmonary emboli, defined as obstruction of blood flow to a lobe or multiple segments.
  • For the lysis of pulmonary emboli accompanied by unstable hemodynamics, i.e., failure to maintain blood pressure without supportive measures.

The diagnosis should be confirmed by objective means, such as pulmonary angiography or non-invasive procedures such as lung scanning.

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
Reconstitution
of 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)2,250,000945150195
41-45 (91-100)2,500,0001050145195
46-50 (101-110)2,750,0001155140195
51-54(111-120)3,000,0001260135195
55-59(121-130)3,250,0001365130195
60-64 (131-140)3,500,0001470125195
65-68(141-150)3,750,0001575120195
69-73 (151-160)4,000,0001680115195
74-77 (161-170)4,250,0001785110195
78-82 (171-180)4,500,0001890105195
83-86 (181-190)4,750,0001995100195
87-91 (191-200)5,000,0002010095195
92-95 (201-210)5,250,0002110590195
96-100 (211-220)5,500,0002211085195
101-104 (221-230)5,750,0002311580195
105-109 (231-240)6,000,0002412075195
110-114 (241-250)6,250,0002512570195

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).

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