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 More on Pradaxa VERY IMPORTANT

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PostSubject: More on Pradaxa VERY IMPORTANT   Mon Feb 07, 2011 3:15 pm

Pradaxa in bottles must be used within 30 days

February 4, 2011 | Lisa Nainggolan

Ingelheim, Germany - Healthcare professionals say that patients in the US taking the new anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim) should be aware that if their medication comes in a bottle, it should be used within 30 days of opening. This is unusual—most medications are stable for at least a year after package opening. Dabigatran was approved by the US FDA for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF) in October of last year and became available shortly afterward.

Pradaxa in bottle and blister pack


However, this issue will only affect those whose dabigatran is dispensed in a bottle—the customary method in retail pharmacies in the US, Boehringer Ingelheim's head of cardiovascular public relations, Dr Reinhard Malin, told heartwire. In all other markets, dabigatran comes only in blister packs, he stressed.

The drug is dispensed in bottles containing 60 capsules, a one-month supply. Concern that the unusual 30-day expiration might easily be overlooked was raised in a recent news item on pharmacist.com, an American Pharmacists Association website.

Kevin Adams (pharmacy director, TJ Samson Hospital, Glasgow, KY) said his institution originally got its first batch of dabigatran in bottles, but he was not aware of the rapid expiry of the product in this format. "We had bottles in front of us when the [sales] rep was talking to us, but they never even said a word about this." Luckily, one of his pharmacy staff noticed this was the case and pointed it out to Adams. "We had never opened the bottles, so we sent them back and got the blister packs instead."

It will be vital that anyone dispensing this product in bottles and anyone receiving it this way is informed of this expiry issue, he says, adding, "It's kind of an expensive bottle. There are not too many products that are like that. Patients have got exactly 30 days to be perfectly compliant, which doesn't always happen."
This is a very important piece of information that should be shared with each patient newly starting dabigatran.

theheart.org's forum moderator and blogger, Dr Melissa Walton-Shirley, who works with Adams at TJ Samson Hospital, told heartwire: "I had no idea that the expiration time was any shorter than the customary 12 months. This is a very important piece of information that should be shared with each patient newly starting dabigatran."

And Dr Michael Ezekowitz (Lankenau Institute for Medical Research, Wynnewood, PA), co-principal investigator on the pivotal RE-LY trial—the basis for the approval of dabigatran—who recently answered questions on how to use dabigatran for heartwire readers, said he "had not heard of this" issue, either.

Packaging clearly indicates 30-day expiry for bottles of Pradaxa

Malin says that dabigatran comes as capsules with small pellets inside and that the latter are hydroscopic, so will draw in water and become unstable when exposed to humidity. But he stresses that the directions to use Pradaxa within 30 days of opening a bottle are found on the packaging for the bottle, on the side face of the box, and in the prescribing information, medication guide, and other materials, such as pharmacy "flashcards," which are being handed out to pharmacists.

"I would believe that this is being communicated clearly and openly and at every relevant touch point with healthcare providers and patients to avoid misunderstanding and consequent inappropriate use of the medication," he added.
I would believe that this is being communicated clearly and openly and at every relevant touch point with healthcare providers and patients.

And dabigatran "is still a drug that comes with a big benefit [in terms of] convenience, because when compared with the other therapy that can be used for this indication—mainly warfarin—you avoid INR measurements," Malin notes.

However, he acknowledges that this issue could cause problems if people have two bottles open at once—for example, at work and at home; "elderly people, in particular, might get confused if they don't have a space where they can note down the date it was opened." But he says that it would be fairly easy for people to "take a marker and write the date on when you opened the bottle; this is the preferred option for the patient."

Nevertheless, he says, "We should talk about this [expiry] issue openly. People have to know. The worst thing that could happen is that people take capsules from bottles beyond their shelf life, because by doing so, they risk not having the proper effect of the drug."


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PostSubject: Re: More on Pradaxa VERY IMPORTANT   Sat Feb 19, 2011 1:29 am

Dabigatran (brand name Pradaxa)
Special Storage and Stability Issues - Use the Blister Packs?

February, 2011
Henry I. Bussey, Pharm.D.

Dabigatran was recently approved for stroke prevention in atrial fibrillation in the U.S. The product is available in bottles of 60 capsules (a 30 day supply) or in blister packs which seal each capsule separately. The problem, apparently, is that the product deteriorates rather quickly when exposed to humidity. Capsules packaged in bottles are stable for only 30 days after the bottle is open and capsules should NOT be placed in any other container (such as weekly dosing containers as are often used to enhance adherence). I am told that the bottles contain a dessicant in the lid so that the product should remain stable for 30 days after initially opening the container as long as the lid is replaced tightly following each dose.

One solution to the stability problem, reportedly, is to use the blister pack packaging in which each dose is sealed separately. But care should be taken not to break the seal on a capsule before being ready to administer that dose. Whether blister packs pose an issue of "child resistant" packaging also should be considered.

For a more thorough discussion and further comment, see www.theheart.org/article/1181259.do?utm_campaign
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PostSubject: Re: More on Pradaxa VERY IMPORTANT   Thu Mar 31, 2011 2:55 pm

...and here we go, another update. Rolling Eyes

FDA says bottled dabigatran good for 60 days
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