Reteplase is available as a lyophilized powder in preservative-free, single-dose vials containing reteplase 10 units with overfill to ensure that 10 units of drug can be delivered.2719 Following reconstitution, each 10 mL contains reteplase 10 units with dipotassium hydrogen phosphate 131 mg, phosphoric acid 49.3 mg, polysorbate 80 5 mg, sucrose 350 mg, and tranexamic acid 8 mg.2719
The vials are packaged with a sterile water for injection diluent in kits containing 2 vials of drug and 2 10-mL prefilled syringes of diluent along with syringes and dispensing pins or in half-kits containing a single vial of drug and a 10-mL prefilled syringe of diluent along with with a syringe and dispensing pin.2719 Reconstitute the reteplase vials using the diluent and dispensing pin provided to yield a 1-unit/mL solution.2719 After transferring the diluent to the vial, swirl the vial gently until the contents are fully dissolved and the solution is clear and colorless; this may take up to 2 minutes.2719 Do not shake.2719 If slight foaming occurs, the vials should be allowed to stand for several minutes to allow dissipation of large bubbles.2719
pH
The reconstituted solution has a pH from 5.7 to 6.3.2719
Trade Name(s)
Retavase
Reteplase is administered intravenously as a double bolus injection, with each injection delivered over 2 minutes.2719 The second injection is given 30 minutes after the first injection.2719 The manufacturer recommends no other drugs be administered simultaneously or admixed with reteplase.2719
Intact packages should be stored between 2 and 25°C.2719 The boxes should stay sealed until use to protect from light.2719
Reteplase should be reconstituted immediately before use.2719
Y-Site Injection Compatibility (1:1 Mixture)
Additional Compatibility Information
Heparin Sodium
Heparin and reteplase are stated to be incompatible; reteplase should not be administered through an intravenous line containing heparin.2719
For a list of references cited in the text of this monograph, search the monograph titled References.