Simponi and Quarantine? | Arthritis Information

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This is really weird.

I have a new insurance plan and they require that I get my Simponi filled at the local pharmacy, not the specialty pharmacy.  So, I transferred my prescription.
 
I went to pick it up today and the pharmacist kindly told me that the drug was in quarantine and she couldn't dispense it.  What?  Quarantine?  They are going to call me when I can get it filled. 
 
Has anyone else had a problem getting their Simponi filled?
I get my Simponi from Curascript, my specialty pharmacy, and have had no problems. I just got a delivery on Wed.  Pharmacist just called and said they talked with the manufacturer and the device is defective in Simponi and they manufacturer won't have any more until at least the end of March.

For those of you who were able to get yours refilled, you're lucky!  Hope they actually work for you!
I've moved to taking it every two weeks, so I have enough for two weeks from now. Wonder if I'll have problems with the new order. It actually isn't working that great for me, hence the every two week dose. Hoping to go on Actemra soon.
 

J&J Recalls Certain Simponi Auto-Injection Products



By Peter Loftus, Of DOW JONES NEWSWIRES

Johnson & Johnson (JNJ) has recalled at least 395 injection devices containing rheumatoid-arthritis drug Simponi in the U.S. and Germany, due to a potential defect that could result in an insufficient dose of the drug.

European health authorities warned Friday that the manufacturing snafu could cause a temporary shortage of the Simponi injector devices. As an alternative, patients are being advised to use prefilled syringes of Simponi.

The Simponi recall is the latest in a series of product recalls at J&J due to manufacturing-quality lapses, which have hurt sales and damaged the company's reputation. The biggest impact has been on J&J's over-the-counter medicine brands including Tylenol. But recalls also have been issued for other J&J products, including certain pharmaceutical and device products earlier this month.

Simponi, which went on sale in 2009, is approved to treat rheumatoid arthritis and other inflammatory conditions. It's typically injected monthly, either through prefilled syringes or pre-filled "pens," which are devices that allow patients to press a button to deliver the dose.

J&J recently identified a manufacturing problem at a plant in Switzerland that could result in an incomplete dose of the drug delivered by the pens, said spokesman Brian Kenney. The problem was discovered in routine quality testing.

J&J was able to quarantine the bulk of the affected lots, but some got past the wholesale level, which J&J is now recalling. The recall affects about 230 Simponi pens in Germany and 165 pens in the U.S. that were distributed beyond the wholesale level.

The European Medicines Agency said Friday that only certain Simponi pens were being recalled, and that other pens currently on the market aren't affected and should continue to be used.

J&J will start to make new prefilled pens of Simponi available by the end of February, the EMA said, but not all European countries will have regular supplies until May. The EMA recommended no new patients should start treatment with the pens until the supply problems

levlarry2011-02-18 13:40:30I started Simponi last September, it seems to be working the same as the Remicade, but so much better to be able to take it at home. Gale, I didn't know you could take it more often than once a month, maybe my RD will change the frquency when I see him in April. The specialty pharmacy always calls ahead of time to tell me it's coming, so I guess I'll find out if there's a problem in the coming week. So far it's gone smoothly, although Fed Ex overnight delivery to Alaska, has got to cost alot more than if I got it at my local pharmacy. Thanks for all the infomation.
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