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Abbokinase (Urokinase) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Abbokinase® 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

ABBOKINASE® IS INTENDED FOR INTRAVENOUS INFUSION ONLY.

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

PREPARATION

Abbokinase® contains no preservatives. Do not reconstitute until immediately before use. Any unused portion of the reconstituted material should be discarded.

Reconstitute Abbokinase® by aseptically adding 5 mL of Sterile Water for Injection, USP, to the vial. Abbokinase® should be reconstituted with Sterile Water for Injection, USP, without preservatives. Do not use Bacteriostatic Water for Injection, USP. After reconstituting, visually inspect each vial of Abbokinase® 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 Abbokinase® 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.

ADMINISTRATION

Prior to infusing, dilute the reconstituted Abbokinase® with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. The following table may be used as an aid in the preparation of Abbokinase® for administration.

Dose Preparation-Pulmonary Embolism
Patient
Weight
(pounds)
Total Dosea
Abbokinase®
(IU)
Number of
Vials of
Abbokinase®
Volume of
Abbokinase®
After
Reconstitution
(mL) b
+ Volume of
Diluent
(mL)
= Final
Volume
(mL)
81-90 2,250,000 9 45 150 195
91-100 2,500,000 10 50 145 195
101-110 2,750,000 11 55 140 195
111-120 3,000,000 12 60 135 195
121-130 3,250,000 13 65 130 195
131-140 3,500,000 14 70 125 195
141-150 3,750,000 15 75 120 195
151-160 4,000,000 16 80 115 195
161-170 4,250,000 17 85 110 195
171-180 4,500,000 18 90 105 195
181-190 4,750,000 19 95 100 195
191-200 5,000,000 20 100 95 195
201-210 5,250,000 21 105 90 195
211-220 5,500,000 22 110 85 195
221-230 5,750,000 23 115 80 195
231-240 6,000,000 24 120 75 195
241-250 6,250,000 25 125 70 195
Infusion Rate: Loading Dose
15 mL/10 min c
Dose for 12-Hour Period
15 mL/hr for 12 hrs     
a Loading dose + dose administered during 12-hour period.
b After addition of 5 mL of Sterile Water for Injection, USP, per vial. (See Preparation.)
c Pump rate = 90 mL/hr

Abbokinase® is administered using a constant infusion pump that is capable of delivering a total volume of 195 mL. A loading dose of 2,000 IU/lb (4,400 IU/kg) of Abbokinase® is given as the Abbokinase® 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP, admixture at a rate of 90 mL/hour over a period of 10 minutes. This is followed by a continuous infusion of 2,000 IU/lb/hr (4,400 IU/kg/hr) of Abbokinase® at a rate of 15 mL/hour for 12 hours. Since some Abbokinase® 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 Abbokinase® 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 Abbokinase® 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/hour.

ANTICOAGULATION AFTER TERMINATING ABBOKINASE® TREATMENT

After infusing Abbokinase®, 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

Abbokinase® is supplied as a sterile lyophilized preparation (NDC 0074-6109-05). Each vial contains 250,000 IU urokinase activity, 25 mg mannitol, 250 mg Albumin (Human), and 50 mg sodium chloride. Refrigerate Abbokinase® powder at 2° to 8°C (36° to 46°F) (see USP).

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