Retavase Indications, Dosage, Storage, Stability - Reteplase

Retavase Indications, Dosage, Storage, Stability - Reteplase

INDICATIONS

RetavaseŽ (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).

RetavaseŽ (Reteplase) is for intravenous administration only. RetavaseŽ is administered as a 10 + 10 U double-bolus injection. 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 RetavaseŽ. There is no experience with patients receiving repeat courses of therapy with RetavaseŽ.

Heparin and RetavaseŽ are incompatible when combined in solution.   Do not administer heparin and RetavaseŽ simultaneously in the same intravenous line. If RetavaseŽ 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 RetavaseŽ injection.

Although the value of anticoagulants and antiplatelet drugs during and following administration of RetavaseŽ 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 RetavaseŽ without adjunctive therapy with heparin and aspirin have not been performed.

Reconstitution RetavaseŽ Kit and RetavaseŽ Half-Kit: Reconstitution should be carried out using the diluent and dispensing pin provided with RetavaseŽ. It is important that RetavaseŽ be reconstituted only with the supplied Sterile Water for Injection, USP (without preservatives). The reconstituted preparation results in a colorless solution containing RetavaseŽ 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 RetavaseŽ 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 RetavaseŽ Kit and RetavaseŽ Half-Kit:   Use aseptic technique throughout.

Safely discard all used reconstitution components and the empty RetavaseŽ vial according to institutional procedures.

RetavaseŽ, is supplied as a sterile, preservative-free, lyophilized powder in 10.4 unit (equivalent to 18.1 mg RetavaseŽ) vials without a vacuum, in the following packaging configurations:

RetavaseŽ Kit:   2 single-use RetavaseŽ 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:

RetavaseŽ Half-Kit:   1 single-use RetavaseŽ 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 RetavaseŽ 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.

References

1. Martin U, Sponer G, Strein K. Evaluation of thrombolytic and systemic effects of the novel recombinant plasminogen activator BM 06.022 compared with alteplase, anistreplase, streptokinase and urokinase in a canine model of coronary artery thrombosis. JACC. 1992;19:433-440.
2. Kohnert U, Rudolph R, Verheijen JH. Biochemical properties of the kringle 2 and protease domains are maintained in the refolded t-PA deletion variant BM 06.022. Protein Engineering. 1992; 5:93-100.
3. Smalling R, Bode C, Kalbfleisch J, et al. More rapid, complete, and stable coronary thrombolysis with bolus administration of reteplase compared with alteplase infusion in acute myocardial infarction. Circulation. 1995;91:2725-2732.
4. Bode C, Smalling R, Gunther B, et al. Randomized comparison of coronary thrombolysis achieved with double bolus reteplase (recombinant plasminogen activator) and front-loaded, accelerated alteplase (recombinant tissue plasminogen activator) in patients with acute myocardial infarction. Circulation. 1996;94:891-898.
5. INJECT Study Group. Randomised, double-blind comparison of reteplase double-bolus administration with streptokinase in acute myocardial infarction (INJECT): trial to investigate equivalence. Lancet. 1995;346:329-336.
6. Martin U, Gärtner D, Markl HJ, et al. D-PHE-PRO-ARGCHLOROMETHYLKETONE prevents in vitro fibrinogen reduction by the novel recombinant plasminogen activator BM 06.022. Ann Hematol. 1992;64(suppl)A47.

RetavaseŽ,
Reteplase, recombinant
Manufactured by:
Centocor, Inc.
Malvern, PA 19355