Tnkase Indications, Dosage, Storage, Stability - Tenecteplase

Tnkase Indications, Dosage, Storage, Stability - Tenecteplase

INDICATIONS

TNKase is indicated for use in the reduction of mortality associated with acute myocardial infarction (AMI). Treatment should be initiated as soon as possible after the onset of AMI symptoms (see CLINICAL STUDIES ).

Dosage

TNKase is for intravenous administration only. The recommended total dose should not exceed 50 mg and is based upon patient weight.

A single bolus dose should be administered over 5 seconds based on patient weight. Treatment should be initiated as soon as possible after the onset of AMI symptoms (see CLINICAL STUDIES ).

The safety and efficacy of TNKase has only been investigated with concomitant administration of heparin and aspirin as described in CLINICAL STUDIES .

Reconstitution

NOTE:   Read all instructions completely before beginning reconstitution and administration.

1. Remove the shield assembly from the supplied B-D® 10 cc syringe with TwinPak™ Dual Cannula Device and aseptically withdraw 10 mL of Sterile Water for Injection (SWFI), USP, from the supplied diluent vial using the red hub cannula syringe filling device. Do not use Bacteriostatic Water for Injection, USP.
   Note: Do not discard the shield assembly.
2. Inject the entire contents of the syringe (10 mL) into the TNKase vial directing the diluent stream into the powder. Slight foaming upon reconstitution is not unusual; any large bubbles will dissipate if the product is allowed to stand undisturbed for several minutes.
3. Gently swirl until contents are completely dissolved. DO NOT SHAKE. The reconstituted preparation results in a colorless to pale yellow transparent solution containing TNKase at 5 mg/mL at a pH of approximately 7.3. The osmolality of this solution is approximately 290 mOsm/kg.
4. Determine the appropriate dose of TNKase (see Dose Information Table) and withdraw this volume (in milliliters) from the reconstituted vial with the syringe. Any unused solution should be discarded.
5. Once the appropriate dose of TNKase is drawn into the syringe, stand the shield vertically on a flat surface (with green side down) and passively recap the red hub cannula.
6. Remove the entire shield assembly, including the red hub cannula, by twisting counterclockwise. Note: The shield assembly also contains the clear-ended blunt plastic cannula; retain for split septum IV access.

Administration

1. The product should be visually inspected prior to administration for particulate matter and discoloration. TNKase may be administered as reconstituted at 5 mg/mL.
2. Precipitation may occur when TNKase is administered in an IV line containing dextrose. Dextrose-containing lines should be flushed with a saline-containing solution prior to and following single bolus administration of TNKase.
3. Reconstituted TNKase should be administered as a single IV bolus over 5 seconds.
4. Because TNKase contains no antibacterial preservatives, it should be reconstituted immediately before use. If the reconstituted TNKase is not used immediately, refrigerate the TNKase vial at 2-8°C (36-46°F) and use within 8 hours.
5. Although the supplied syringe is compatible with a conventional needle, this syringe is designed to be used with needleless IV systems. From the information below, follow the instructions applicable to the IV system in use.
   
   

   Split septum IV system:	· Remove the green cap. · Attach the clear-ended blunt plastic cannula to the syringe. · Remove the shield and use the blunt plastic cannula to access the split septum injection port. · Because the blunt plastic cannula has two side ports, air or fluid expelled through the cannula will exit in two sideways directions; direct away from face or mucous membranes.
   Luer-Lok® system:	Connect syringe directly to IV port.
   Conventional needle (not supplied in this kit):	Attach a large bore needle, e.g., 18 gauge, to the syringe's universal Luer-Lok®.

   
   
6. Dispose of the syringe, cannula, and shield per established procedures.

TNKase is supplied as a sterile, lyophilized powder in a 50 mg vial under partial vacuum. Each 50 mg vial of TNKase is packaged with one 10 mL vial of Sterile Water for Injection, USP, for reconstitution, The B-D® 10 cc Syringe with TwinPak™ Dual Cannula Device, and three alcohol prep pads. NDC 50242-038-61.

Stability and Storage

Store lyophilized TNKase at controlled room temperature not to exceed 30°C (86°F) or under refrigeration 2-8°C (36-46°F). Do not use beyond the expiration date stamped on the vial.

REFERENCES

1. ASSENT-2 Investigators. Single-bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: the ASSENT-2 double-blind randomised trial. Lancet 1999;354:716-22.
2. Cannon CP, Gibson CM, McCabe CH, Adgey AAJ, Schweiger MJ, Sequeira RF, et al. TNK-tissue plasminogen activator compared with front-loaded alteplase in acute myocardial infarction. Results of the TIMI 10B trial. Circulation 1998;98:2805-14.
3. Van de Werf F, Cannon CP, Luyten A, Houbracken K, McCabe CH, Berioli S, et al. Safety assessment of a single bolus administration of TNK-tissue plasminogen activator in acute myocardial infarction: the ASSENT-1 trial. Am Heart J 1999;137:786-91.

TNKase™

Tenecteplase

Manufactured by:

Genentech, Inc.                                    

1 DNA Way                                        
Jun 2000

South San Francisco, CA 94080-4990

©2000 Genentech, Inc.