Pradaxa in Bottles Must Be Used Within 30 Days

Disclosures

February 07, 2011

February 4, 2011 (Ingelheim, Germany) — Healthcare professionals saythat 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.

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 that can be affected by humidity. But he stresses that the directions to use Pradaxa within 30 days of opening a bottle are found on thepackaging for the bottle, on the side face of the box, andin the prescribinginformation, 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." 

Pradaxa Approved in Japan; Now Cleared for Marketing in 75 Countries

Meanwhile, dabigatran has recently been approved in Japan [1], under the brand name Prazaxa for the prevention of ischemic stroke and systemic embolism in patients with nonvalvular AF, "marking the first approval of a novel oral anticoagulant in the Asia-Pacific region and specifically Japan in nearly 50 years," the company notes. This takes the number of countries in which dabigatran is approved to 75, it adds.

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