When is pradaxa available

At Boehringer Ingelheim, the health of our patients is our first priority and we work diligently to ensure our medications are accessible and affordable for all patients. We are in active discussions with various insurance companies about formulary coverage and anticipate PRADAXA will be reimbursed at a co-pay level similar to other preferred branded products. PRADAXA mg taken twice daily has been shown to significantly reduce stroke and systemic embolism by 35 percent beyond the reduction achieved with warfarin, 1 the current standard of care for patients with non-valvular atrial fibrillation.

PRADAXA mg taken twice daily has been shown to significantly reduce both ischemic strokes caused by blood clots and hemorrhagic strokes caused by bleeding compared to warfarin. About Atrial Fibrillation and Stroke Atrial fibrillation AFib , characterized by an irregular heartbeat, 2 can cause blood clots to form in the heart that can travel to the brain and cause a stroke.

Lapses in therapy should be avoided, and if PRADAXA must be temporarily discontinued for any reason, therapy should be restarted as soon as possible. P-gp inhibitors ketoconazole, verapamil, amiodarone, quinidine, and clarithromycin, do not require dose adjustments.

These results should not be extrapolated to other P-gp inhibitors. These were commonly dyspepsia including abdominal pain, upper abdominal pain, abdominal discomfort, and epigastric discomfort and gastritis-like symptoms including GERD, esophagitis, gastritis, and GI ulcer.

The effect of Pradaxa in preventing blood clots in adults who have undergone a hip or knee replacement is comparable to that of enoxaparin. Blood clots occur rarely in children and treatment has involved injection of anticoagulant medicines. Pradaxa, which is taken by mouth, is more convenient for adults and children. Pradaxa compared well with warfarin in reducing the risk of strokes in adults with atrial fibrillation without increasing the risk of major bleeding.

Since certain patients who take Pradaxa are at increased risk of bleeding, a number of precautions were included in the prescribing information.

In addition, the overall benefit of Pradaxa in the treatment and prevention of DVT and PE is comparable to that of warfarin. However, the number of bleeding events was lower for Pradaxa than for warfarin. Although the studies showed a small higher risk of heart problems with Pradaxa than with warfarin, the benefits of Pradaxa were still considered to outweigh its risks.

The company that makes Pradaxa will provide an educational pack for all doctors who are expected to prescribe the medicine, to increase awareness of the risk of bleeding and provide guidance on how to manage it. Patients will also receive an alert card summarising key safety information on the medicine.

The company will also provide a training video and technical support by phone for the preparation and dosing of the solution. Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pradaxa have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Pradaxa are continuously monitored. Side effects reported with Pradaxa are carefully evaluated and any necessary action taken to protect patients. Pradaxa received a marketing authorisation valid throughout the EU on 18 March More detail is available in the summary of product characteristics.

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Pradaxa RSS. Table of contents Overview Authorisation details Product information Assessment history. Patient safety. Patient safety information. Expand section Collapse section. Prevention of blood clots after hip or knee replacement Pradaxa or mg a day was as effective as enoxaparin an anticoagulant given by injection in preventing formation of blood clots or death in patients who had undergone hip or knee replacement in two main studies. Prevention of blood clots or stroke in patients at risk of stroke Pradaxa mg or mg twice a day was as effective as warfarin another anticoagulant given by mouth in preventing stroke or a blood clot blocking blood vessels in other parts of the body in a study of patients with non-valvular atrial fibrillation who were considered to be at risk of stroke.

Authorisation details. Product details Name Pradaxa. D Ingelheim am Rhein Germany. There are twenty-six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dabigatran etexilate mesylate profile page. Free Forever Trial. Subscribe to access the full database , or Free Forever Trial. Serving leading biopharmaceutical companies globally:.

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