Pradaxa storage/handling requires attention.Darren Triller | February 7, 2011
Those caring for patients with cardiovascular disease or risk factors for thromboembolism have long awaited safer, more predictable alternatives to warfarin. However, it is quickly becoming clear that the “perfect” warfarin substitute is not yet available.
Prescribing information for Pradaxa (dabigatran), the newly available direct thrombin inhibitor, details several storage and handling requirements that may affect the safety and utility of the agent in certain patient populations and settings.
1. Capsules cannot be crushed: Opening or otherwise altering the intact capsule can result in increased exposure to the drug, and possibly put patients at increased risk of bleeding. This factor is of particular importance to hospitals and long term care facilities, where patients are unable to swallow or they ingest nutrition and medications through feeding tubes. Policies and procedures should be developed and enforced to avoid inappropriate administration of oral Pradaxa.
2. Capsules dispensed in bottles are only stable for 30 days: Exposure of the hygroscopic drug to ambient humidity upon opening results in accelerated degradation of the medication, and administration of such an exposed product may produce insufficient or unpredictable levels of anticoagulation. Because the product is available as both bottles AND blister packed, unit dose packages, it may be wise for prescribers and dispensing pharmacies to utilize the blister packs in all possible cases. Patients utilizing bottles of Pradaxa need to be counseled on the proper storage and administration of the drug.
Pradaxa may be an excellent alternative to warfarin in many cases, but needs to be stored and administered appropriately to gain the greatest benefits and avoid unnecessary exposure to risk. Full prescribing information is available at: www.pradaxa.com