June 2013
Volume 54, Issue 15
Free
ARVO Annual Meeting Abstract  |   June 2013
Safety, sterility and stability of direct- from- vial multiple dosing intravitreal injection of bevacizumab
Author Affiliations & Notes
  • Taraprasad Das
    Retina Vitreous Services, LV Prasad Eye Institute, Bhubaneswar, India
  • Srinivas Volety
    Center for Cellular and Molecular Biology, Hyderabad, India
  • Saad Ahsan
    Center for Cellular and Molecular Biology, Hyderabad, India
  • Abhay Thakur
    Center for Cellular and Molecular Biology, Hyderabad, India
  • Savitri Sharma
    Retina Vitreous Services, LV Prasad Eye Institute, Bhubaneswar, India
  • Soumyava Basu
    Retina Vitreous Services, LV Prasad Eye Institute, Bhubaneswar, India
  • Tapas Padhi
    Retina Vitreous Services, LV Prasad Eye Institute, Bhubaneswar, India
  • Mohan Rao
    Center for Cellular and Molecular Biology, Hyderabad, India
Investigative Ophthalmology & Visual Science June 2013, Vol.54, 4931. doi:
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      Taraprasad Das, Srinivas Volety, Saad Ahsan, Abhay Thakur, Savitri Sharma, Soumyava Basu, Tapas Padhi, Mohan Rao; Safety, sterility and stability of direct- from- vial multiple dosing intravitreal injection of bevacizumab. Invest. Ophthalmol. Vis. Sci. 2013;54(15):4931.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: To determine the stability, sterility and safety of bevacizumab multiple dosing from a single vial without prior aliquoting.

Methods: Six bevacizumab vials, used in multiple patients on a single day by direct withdrawal from the vial, and stored in 4 degree C up to six months, were tested for stability (High Performance Liquid Chromatography, (HPLC) and mass spectrometry, sterility (Culture), conformational stability by circular dichroism and fluorescence spectroscopy and the rubber cap structural integrity (Electron Microscopy, EM).

Results: HPLC of all six samples along with controls were similar. The culture was negative. The EM of the rubber cap did not show an open communication. Spectroscopic studies suggested the conformational stability of the drug. Further there was no infection or inflammation in 221 consecutive patients (973 injections) when bevacizumab was stored at 4 degree C and used for one week.

Conclusions: Bevacizumab does not lose stability when stored at 4 degree C for six months. It may be used for a week by direct withdrawal from the vial without fear of infection or inflammation if all standard precautions related to intravitreal injection are adhered to.

Keywords: 561 injection • 763 vitreous • 748 vascular endothelial growth factor  
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