2/22/11 Nearly 900 injectable pens containing the biologic drug Simponi are being recalled in the U.S. because a defect in the delivery device may prevent the administration of a full dose of the medication – a TNF-alpha inhibitor approved to treat rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
The company that markets Simponi, or golimumab, stresses that most of the affected medication-filled pens were quarantined at the wholesale level before making their way into the hands of patients.
“Nearly 80 percent of the affected unit was quarantined at the wholesale level, and we are working with wholesalers and distributors to recapture the remaining 165 affected units,” explains Monica Neufang, a spokesperson for the drug’s marketer, Centocor Ortho Biotech Inc.
Neufang says the manufacturing defect was detected during regular quality testing in one lot of 50 mg single dose SmartJect autoinjectors, distributed beginning January 26. There were 839 devices in the lot. The lot number is 09D071.AC and can be located on the lower left hand corner of the carton’s back panel.
“I think what’s important to note is it’s a defect in the autoinjector. It has nothing to do with the Simponi medication,” Neufang explains.
Neufang says the self-injectable device is designed to display a yellow indicator in the viewing window when the injection is complete. So if patients get an insufficient dose, the yellow indicator shouldn’t appear. If that happens, she recommends patients talk with their doctor before administering another dose.
As a result of the recall, there is a temporary shortage of the autoinjector pens, according to the Simponi website. However, the drug also comes in a prefilled syringe, which Neufang recommends patients use if they need more medication right now.
“There might be a chance that patients might have to use a prefilled syringe for one month’s therapy, but we will have autoinjectors back for physicians and patients by the end of March,” Nefuang says.
The good news is patients will still be able to get the medication they need. The downside is that using a prefilled syringe means patients will have to see the needle. “The autoinjector is structured in a way that you don’t see the needle entering the skin,” Nefuang says. So some people prefer that because it’s less noticeable that they are giving themselves an injection, but there’s no difference in terms of the medication. It’s simply the route of administration.”
Anyone with any other questions can direct them to the company at 1/877-526-7736 or by visiting the company’s website at www.simponi.com.
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