Bevacizumab Safe, Stable for Multiple Dosing From Single Vial
No evidence of infection, inflammation when bevacizumab is stored at 4° Celsius for a week
THURSDAY, July 23, 2015 (HealthDay News) -- Bevacizumab is safe and stable when stored at 4 degrees Celsius, even with multiple dosing from a single vial, according to a study published in the July issue of Clinical & Experimental Ophthalmology.
Taraprasad Das, M.D., from the L.V. Prasad Eye Institute in Bhubaneswar, India, and colleagues determined the stability, sterility, and safety of bevacizumab multiple dosing from a single vial. Six bevacizumab vials were used in multiple patients on a single day, with direct withdrawal from the vial. Vials were stored at 4 degrees Celsius up to a variable period.
The researchers found that high-performance liquid chromatography tests of all six samples of used bevacizumab and the control bevacizumab were similar, with negative cultures and no evidence of open communication on electron microscopy of rubber corks. Drug conformational stability was seen in spectroscopic studies. In 221 patients with 973 injections, there was no evidence of infection or inflammation when bevacizumab was stored at 4 degrees Celsius and used for one week.
"The information obtained from this study indicates that bevacizumab could be directly withdrawn from the multi-dose vial, that it could be stored in a normal refrigerator (4 degrees Celsius), and that withdrawing multiple times for one week is possible without fear of loss of bevacizumab stability and sterility if proper precautions are taken during withdrawal from the multi-dose vial and during intravitreal injections into the human eye," the authors write.