NEW YORK (Reuters Health) – Bevacizumab prepared in insulin syringes is associated with an increase in intravitreal silicone oil droplets in patients using the medication, as well as a higher risk of floaters, researchers in California say.
Although intravitreal bevacizumab is the most common intraocular medication used for retinal diseases in the United States, it is not approved by the U.S. Food and Drug Administration for intraocular use. Therefore, compounding pharmacies often prepare it, Dr. Rahul Khurana of Retina Vitreous Associates in Mountain View told Reuters Health.
“This report shows a dramatic increase (>57-fold) in the silicone oil droplets associated with intravitreal bevacizumab injected using insulin syringes,” he warned. “Physicians should counsel their patients of the risk of floaters with intravitreal bevacizumab preloaded with insulin syringes.”
Dr. Khurana and colleagues reviewed records of 60 patients (58% women, mostly white; mean age, 80) who experienced silicone oil droplets in the eye after intravitreal bevacizumab (1.25 mg/0.05 mL) injections in a single practice.
From October 2015 through November 2016, 6,632 injections were delivered in insulin syringes with 31-gauge needles.
As reported in JAMA Ophthalmology, online June 15, the incidence of silicone oil droplet injections was 0.03% from October 2015 to April 2016 and 1.7% from May to November 2016. In the latter period, not priming the syringe before the intravitreal injection conferred a higher risk of droplets compared with priming the syringe (6.4% versus 0.5%).
Sixty-eight percent of patients with silicone droplets were symptomatic. The main symptom was floaters with spots of light. Among those with floaters, 88% improved over time (two to eight months), even though droplets were still present on ophthalmoscopic examination.
Dr. Khurana said, “It is very important to raise awareness of this issue with physicians who use compounded bevacizumab and pharmacists who prepare the medication.”
Dr. Paul Sternberg, chairman of the Vanderbilt Eye Institute in Nashville, Tennessee, told Reuters Health, “Whenever drugs are prepared, there is concern about the transfer of lubricating agents from the syringe at the time of administration, so I am not surprised that this finding is being reported.”
“Different manufacturers use different lubricating substances in the barrel of the syringe,” he explained by email. “Rather than using an insulin syringe, our pharmacy prepares bevacizumab in tuberculin syringes for ophthalmic administration.”
“The possibility of silicone oil microdroplets was first reported in 2011,” he noted, referring to a paper in Retina (http://bit.ly/2sZUQtY). “Fortunately, we have not seen the problem of intravitreal silicone oil droplets in our patients. We are not certain if our ‘better’ experience is related to using a different syringe, to our using a shorter shelf life (60 hours) than a traditional compounding pharmacy may use, or other factors.”
Dr. Khurana receives fees from Genentech, which markets bevacizumab as Avastin. Dr. Khurana and one coauthor receive fees from Allergan, which is developing a bevacizumab biosimilar.
SOURCE: http://bit.ly/2t3BXaq
JAMA Ophthalmol 2017
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