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Bevacizumab sterility in multiple doses from a single-use vial
Kemal Ornek1, Zeynep Ceren Karahan, Ahmet Ergin
1Department of Ophthalmology, School of Medicine, Kirikkale University, Kirikkale, Turkey. kemalornek@hotmail.com
The Annals of Pharmacotherapy
|September 4, 2008
Summary
Refrigerated bevacizumab (Avastin) remains sterile when multiple doses are drawn from single-use vials for up to 15 days. This study found no microbial contamination, supporting safe multi-dose vial use in clinical practice.
Area of Science:
- Ophthalmology
- Pharmacology
- Microbiology
Background:
- Bevacizumab (Avastin) efficacy is maintained for 3 weeks when refrigerated.
- Sterility of bevacizumab multi-dose use from single-use vials is not previously reported.
Purpose of the Study:
- To assess the sterility of bevacizumab when administered as multiple doses from a single-use vial.
Main Methods:
- Simulated storage and use of bevacizumab in 4 groups (11 doses each).
- Daily cultures for 10 days and one 15-day culture per group.
- Used MacConkey agar, blood agar, thioglycollate broth, and Sabouraud medium for bacterial and fungal growth assessment.
Main Results:
- 44 bevacizumab samples were tested across 4 growth media.
- All samples demonstrated no microbial growth.
- No significant differences observed between groups, though in vitro limitations were noted.
Conclusions:
- Multi-dose bevacizumab use from single-use vials appears safe regarding microbial contamination.
- Findings support the clinical practice of using single-use vials for multiple administrations.
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