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INFLIXIMAB STABILITY AFTER RECONSTITUTION, DILUTION, AND STORAGE UNDER REFRIGERATION

BEER, PAUL M. MD*; WONG, SUSAN J. PhD; SCHARTMAN, JEROME P. MD*; KULAS, KAREN E. BSc; HARTMAN, COBY L. DO*; GIGANTI, MONICA MD*; FALK, NAOMI S. MD, OD*

doi: 10.1097/IAE.0b013e3181b48fb4
Original Articles

Purpose: The purpose of this study was to investigate the stability of reconstituted infliximab solutions and determine whether infliximab is suitable for compounding for potential intravitreal use.

Methods: Infliximab was reconstituted, and the solution was aliquoted and stored refrigerated. On each day of testing, an aliquot was serially diluted to concentrations ranging from 50,000 pg/mL to 69 pg/mL. Each dilution was assayed by microsphere immunoassay daily for 5 days and weekly for a total of 6 weeks. The outcome measure was median fluorescence intensity measured by dual laser flow analysis of fluorochrome-labeled secondary antibodies to infliximab bound to tumor necrosis factor-α–coated microspheres.

Results: There was an increasing median fluorescence intensity for increasing infliximab concentration in a sigmoidal dose–response curve with a variable slope that was equivalent for each time point. Each respective concentration of infliximab showed nearly equivalent median fluorescence intensity for every time point over the 6-week period.

Conclusion: The authors found that the immunoreactivity of 2 different concentrations of infliximab stored at 4°C over a 6-week period remained stable. Infliximab is suitable for compounding and could be a cost-effective intravitreal medication for use in clinical practice if further study supports its safety and efficacy.

The authors found that the immunoreactivity of 2 different concentrations of infliximab stored at 4°C over a 6-week period remained stable. Infliximab is suitable for compounding and could be a cost-effective intravitreal medication for use in clinical practice if further study supports its safety and efficacy.

From *Retina Consultants, PLLC, 1220 New Scotland Rd., Slingerlands, New York; and †Wadsworth Center, New York State Department of Health, Albany, New York.

This research was supported by a grant from the Retina Research Foundation, Inc.

Reprint requests: Paul M. Beer, MD, 1220 New Scotland Road, Suite 201, Slingerlands, NY 12159; e-mail: drbeer@retinaconsultants.org

© The Ophthalmic Communications Society, Inc.