"SILVER SPRING, MD â€” The US Food and Drug Administration (FDA) is warning of several treatment-related serious adverse events in association with implantable left ventricular assist devices (LVADs) in heart-failure patients.
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Retavase® (Reteplase) is indicated for use in the management of acute myocardial infarction (AMI) in adults for the improvement of ventricular function following AMI, the reduction of the incidence of congestive heart failure and the reduction of mortality associated with AMI.Treatment should be initiated as soon as possible after the onset of AMI symptoms (see CLINICAL PHARMACOLOGY).
DOSAGE AND ADMINISTRATION
Retavase® (Reteplase) is for intravenous administration only. Retavase® (reteplase) is administered as a 10 +10 unit double-bolus injection.Two 10 unit bolus injections are required for a complete treatment. Each bolus is administered as an intravenous injection over 2 minutes. The second bolus is given 30 minutes after initiation of the first bolus injection. Each bolus injection should be given via an intravenous line in which no other medication is being simultaneously injected or infused. No other medication should be added to the injection solution containing Retavase® (reteplase) . There is no experience with patients receiving repeat courses of therapy with Retavase® (reteplase) . Heparin and Retavase® (reteplase) are incompatible when combined in solution. Do not administer heparin and Retavase® (reteplase) simultaneously in the same intravenous line.
If Retavase® (reteplase) is to be injected through an intravenous line containing heparin,a normal saline or 5% dextrose (D5W) solution should be flushed through the line prior to and following the Retavase® (reteplase) injection.
Although the value of anticoagulants and antiplatelet drugs during and following administration of Retavase® (reteplase) has not been studied,heparin has been administered concomitantly in more than 99% of patients. Aspirin has been given either during and/or following heparin treatment.Studies assessing the safety and efficacy of Retavase® (reteplase) without adjunctive therapy with heparin and aspirin have not been performed.
Reconstitution - Retavase ® Kit and Retavase® (reteplase) Half-Kit: Reconstitution should be carried out using the diluent and dispensing pin provided with Retavase® (reteplase) . It is important that Retavase® (reteplase) be reconstituted only with the supplied Sterile Water for Injection, USP (without preservatives). The reconstituted preparation results in a colorless solution containing Retavase® (reteplase) 1 unit/mL.Slight foaming upon reconstitution is not unusual; allowing the vial to stand undisturbed for several minutes is usually sufficient to allow dissipation of any large bubbles.
Because Retavase® (reteplase) contains no antibacterial preservatives, it should be reconstituted immediately before use. When reconstituted as directed, the solution may be used within 4 hours when stored at 2-30°C (36-86°F). Prior to administration, the product should be visually inspected for particulate matter and discoloration.
Reconstitution Instructions - Retavase ® Kit and Retavase® (reteplase) Half-Kit: Use aseptic technique throughout.
Step 1: Withdraw 10 mL of Sterile Water for Injection,USP(SWFI) from the supplied vial into a sterile 10 mL syringe.
Step 2: Open the package containing the dispensing pin. Remove the protective cap from the luer lock port of the dispensing pin and connect the sterile 10mL syringe to the dispensing pin. Remove the protective flip-cap from one vial of Retavase® (reteplase) .
Step 3: Remove the protective cap from the spike end of the dispensing pin, and insert the spike into the vial of Retavase® (reteplase) until the security clips lock onto the vial. Transfer the 10 mL of SWFI through the dispensing pin into the vial of Retavase® (reteplase) .
Step 4: With the dispensing pin and syringe still attached to the vial, swirl the vial gently to dissolve the Retavase® (reteplase) . DO NOT SHAKE.
Step 5: Withdraw 10 mL of Retavase® (reteplase) reconstituted solution back into the syringe. A small amount of solution will remain in the vial due to overfill.
Step 6: Detach the syringe from the dispensing pin,and attach a sterile needle.
Step 7: The 10 mL bolus dose is now ready for administration.
Safely discard all used reconstitution components and the empty Retavase® (reteplase) vial according to institutional procedures.
|Retavase® Kit||NDC 67286-0400-1|
|Retavase® Half-Kit||NDC 67286-0400-2|
Retavase® (reteplase) , is supplied as a sterile, preservative-free, lyophilized powder in 10.4 unit (equivalent to 18.1 mg Retavase® (reteplase) ) vials without a vacuum, in the following packaging configurations:
Retavase® (reteplase) Kit: 2 single-use Retavase® (reteplase) vials 10.4 units (18.1 mg), 2 single-use diluent vials for reconstitution (10 mL Sterile Water for Injection, USP), 2 sterile 10 mL syringes, 2 sterile dispensing pins, 4 sterile needles, 2 alcohol swabs and a package insert;
Retavase® (reteplase) Half-Kit: 1 single-use Retavase® (reteplase) vial 10.4 units (18.1 mg), 1 single-use diluent vial for reconstitution (10 mL Sterile Water for Injection, USP), a sterile dispensing pin and a package insert.
Storage: Store Retavase® (reteplase) at 2-25°C (36-77°F). The box should remain sealed until use to protect the lyophilisate from exposure to light.Do not use beyond the expiration date printed on the box.
Retavase®, Reteplase, recombinant Manufactured by: PDL BioPharma, Inc. Fremont, CA 94555. Manufactured at: Hospira, Inc., Mc Pherson, KS 67460. For questions of a medical nature, call 1-866-437-7742. Revised November 2006. FDA Rev date: 10/30/1996This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/15/2008
Additional Retavase Information
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