Compatibility of argatroban with abciximab, eptifibatide, or tirofiban during simulated Y-site administration.

Purpose: The physical and chemical compatibility of argatroban with abciximab, eptifibatide, or tirofiban during simulated Y-site administration was studied.

Methods: Test solutions of argatroban 1 mg/mL, abciximab 36 microg/mL, eptifibatide 2 mg/mL, and tirofiban 50 microg (as the hydrochloride salt) per milliliter in 5% dextrose injection (D5W) and in 0.9% sodium chloride injection (saline) were prepared in duplicate by using aseptic technique. Argatroban solution was mixed with abciximab, eptifibatide, or tirofiban solution, each at a ratio of 1:1 by volume, and at 4:1 with abciximab solution, 8:1 with tirofiban solution, and 16:1 with eptifibatide solution. Compatibility was evaluated immediately after solution preparation and after storage for four hours at 20-25 degrees C. Physical compatibility was determined with the unaided eye and with a particle counter, and chemical compatibility was measured with high-performance liquid chromatography. The chemical compatibility of argatroban and abciximab was not tested because of the poor stability or recovery of abciximab in the test diluents.

Results: Argatroban was physically compatible with abciximab, eptifibatide, and tirofiban in D5W at each ratio tested and in saline at a 1:1 ratio. Argatroban was chemically compatible with eptifibatide and tirofiban. No significant impurities were detected, except for a single impurity in argatroban-eptifibatide 1:1 admixtures.

Conclusion: At concentrations commonly used in practice, argatroban was physically compatible with abciximab and physically and chemically compatible with eptifibatide and tirofiban for four hours at 20-25 degrees C.