Explore resources just for you to help you on your treatment journey. Simultaneous determination of dabigatran, rivaroxaban, and. Choose pradaxa dabigatran etexilate for afib, dvt or pe. Pradaxa increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding. Management of dabigatran in adults dabigatran is an oral anticoagulant that acts as a direct thrombin inhibitor. Since frequent monitoring of degree of anticoagulation is unnecessary and food and drug interactions are minimal, dabigatran offers significant benefit and ease of use compared to warfarin. Pradaxa dosing guide starting patients on pradaxa assess renal function prior to initiating treatment with pradaxa. Pradaxa dabigatran side effects, dosage, interactions. Pradaxa dabigatran side effects, dosage, interactions drugs. Although it is thought that there are fewer drug interactions for noacs than for warfarin, clinical data suggest moderate to severe drug drug interactions when dabigatran is used in combination with verapamil, amiodarone, and dronedarone,14.
Information for the patient pradaxa 150 mg hard capsules. N24aminoiminomethylphenylaminomethyl1methyl1hbenzimidazol5ylcarbonyln2pyridinyl. Pradaxa is used to lower the risk of stroke caused by a blood clot in people with a heart rhythm disorder called atrial fibrillation. Drug information resources and literature retrieval. Please see additional important safety information about pradaxa on next page and full prescribing information, including boxed warning and medication guide. See 17 for patient counseling information and medication. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. After oral administration of radiolabeled dabigatran, 7% of radioactivity is recovered in urine and 86% in feces. Feb 19, 2020 how is this medicine dabigatran etexilate best taken.
Pradaxa dabigatran etexilate mesylate capsules boehringer. Pradaxa dabigatran etexilate mesylate capsules for oral use. Pradaxa s anticoagulant activity and halflife are increased in patients with renal impairment. To retrieve all information, including data published postapproval, use the all studies containing dabigatran query. Preventing these blood clots helps to reduce the risk of a stroke. Reduce the dose of pradaxa to 75 mg twice daily see warnings and precautions. Stability of repackaged dabigatran etexilate capsules in dose.
Pradaxa dabigatran etexilate mesylate capsules for oral. Usual adult dose for deep vein thrombosis prophylaxis. Dabigatran pradaxa dabigatran is not an inducer, inhibitor, or substrate of cyp450 enzymes but is a substrate of pgp. Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4. Apodabigatran should not be used with dronedarone see drug interactions. It is used as an alternative to warfarin and does not require monitoring by blood tests. Dabigatran etexilate mesylate food and drug administration. Warfarin drug interactions anticoagulation services. Peak milk levels occurred at about 7 hours after the dose in both patients. Therefore, clinicians should avoid or doseadjust concomitant administration of dabigatran with inducers or inhibitors of pgp enzymes based on the creatinine clearance crcl and induction or inhibition. Outcomes of dabigatran and warfarin for atrial fibrillation. Dailymed pradaxa dabigatran etexilate mesylate capsule. Dabigatran drugs and lactation database lactmed ncbi.
Specifically it is used to prevent blood clots following hip or knee replacement and in those with a history of prior clots. Dabigatran is a novel oral direct thrombin inhibitor recently approved by the fda for stroke prevention in patients with nonvalvular atrial fibrillation. Pradaxa dabigatran is an effective oral medicine for preventing and treating blood clots, but it can increase the risk of bleeding especially in older people and those with kidney problems. Risk factors for bleeding include the use of drugs that increase the risk of bleeding in general e. Medication guide pradaxa pra dax a dabigatran etexilate. Pradaxa dabigatran is not available in generic form so it can be expensive. Reduces the risk of stroke, and treats and prevents blood clots. Keep taking dabigatran etexilate as you have been told by your doctor or other health care provider, even if you feel well. Generally, the extent of anticoagulation does not need to be assessed with this drug. Instructions on starting patients on pradaxa, and dosing for multiple indications. Read the medication guide and, if available, the patient information leaflet provided by your pharmacist before you start taking dabigatran. Food and drug administration fda and australias therapeutic goods administration tga have issued safety alerts regarding the risk of moisture exposure and the effect on efficacy. Effect may last for several weeks after discontinuation of inducers of pglycoprotein andor cyp3a4 anticoagulants antithrombin agents e. Pradaxa dabigatran dosing, indications, interactions.
In nvaf patients, a higher rate of clinical mi was reported in patients who received pradaxa 0. The absorption of the pro drug dabigatran etexilate is mediated by pglycoprotein pgp. Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4 may 2020, wolters kluwer updated. In actively controlled vte prevention trials 6,684 patients were treated with 150 mg or 220 mg. The halflife of dabigatran in healthy subjects is 12 to 17 hours. Monitoring anticoagulant therapy with new oral agents. This method included a hydrolysis step to account for the active acylglucuronide metabolites of dabigatran that demonstrate an equivalent anticoagulant. Dabigatran vs rivaroxaban for nonvalvular atrial fibrillation. Drug name active ingredients strength dosage formroute marketing status te code rld rs. It is approved as an alternative to warfarin for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The limited available data on pradaxa use in pregnant women are insufficient to determine drug associated risks for adverse. The original version pdf is appended to this article as a supplement background.
Pradaxa is the only noac with a specific reversal, available in all 50 states. This medicine is used when the atrial fibrillation is not caused by a heart valve problem. Jul 09, 2019 dabigatran spc pdf pradaxa safely and effectively. Dabigartin was first detectable in milk at 2 to 3 hours after the dose. Guidelines for management of bleeding with dabigatran or. Dr mariachiara dicesare, dr xinyi leng, dr ezequiel zaidel. Dabigatran is an anticoagulant that works by blocking the clotting protein thrombin. Indicated for treatment of deep vein thrombosis dvt and pulmonary embolus pe.
Many other drugs can increase your risk of bleeding when used with dabigatran. Renal clearance of dabigatran is 80% of total clearance after intravenous administration. When dabigatran is used to prevent a dvt or pe after hip replacement surgery it is usually taken 1 to 4 hours after surgery. Apr 06, 2017 recently, regulatory authorities such as the u. Pradaxa dabigatran etexilate mesylate us prescribing information. Anticoagulants are medicines that treat and prevent blood clots. Please refer to your new drug application nda originally submitted on december 15, 2009 and resubmitted and received on april 19, 2010 under section 505b1 of the federal food, drug, and cosmetic act fdca, for pradaxa dabigatran etexilate mesylate capsules. Drug drug drug drug pgp pgp ppgp p gp p gp pradaxa prescribing information. Pradaxa is the brand name of the drug dabigatran, which is used to treat and prevent blood clots. Pradax dabigatran etexilate mesilate canadian prescribing information. A major disadvantage is the absence of a reliable means of reversing its anticoagulant effect.
Dabigatran, sold under the brand name pradaxa among others, is an anticoagulant used to treat and prevent blood clots and to prevent stroke in people with atrial fibrillation. Use dabigatran etexilate as ordered by your doctor. Praxbind idarucizumab injection, for intravenous use initial u. Consider reducing the dose of pradaxa to 75 mg twice daily see drug. Dabigatran drug interaction potential anticoagulation. Dabigatran dabigatran pradaxa 75 mg capsule dabigatran pradaxa 150 mg capsule this patient information leaf let should be read with the.
Highlights of prescribing information these highlights do not include all the information needed to use pradaxa safely and effectively. Dabigatran was the subject of 3,781 serious adverse events reported to the fda in 2011, including 542 patient deaths, 2,367 hemorrhages, 291 acute renal failures and 644 strokes. Please see additional important safety information about pradaxa on next page and full prescribing information, including boxed warning and medication. Of note, in 2014, rivaroxaban was used 2 to 3 times more often than dabigatran in us patients with af, 41 perhaps partly because of prescriber misperceptions about bleeding risks with dabigatran, arising from us food and drug administration receipt of a large number of postmarketing case reports following its approval. The concurrent use of dabigatran with other anticoagulants, antiplatelet agents, and nonsteroidal antiinflammatory agents is expected to increase the risk of bleeding in comparison to use of dabigatran alone.
Dabigatran is metabolized to four different acyl glucuronides and both the glucuronides and dabigatran have similar pharmacological activity. Read the medication guide and, if available, the patient information leaflet provided by your pharmacist before you start taking dabigatran and each. Fdaapproved reversal treatment available in all 50 states. For patients currently receiving a parenteral anticoagulant, start pradaxa 0 to 2 hours before the time that the next dose of the parenteral drug was to have been administered or at the time of discontinuation of a continuously administered parenteral drug e. The effect of dabigatran on the activated partial thromboplastin time and thrombin time as determined by the hemoclot thrombin inhibitor assay in patient plasma samples. Dabigatran is used to prevent blood clots from forming because of a certain irregular heart rhythm atrial fibrillation. Patient information sheet dabigatran also known as. Dabigatran is an oral direct thrombin inhibitor widely used to prevent and treat various thromboembolic complications. See how pradaxa compares to warfarin, and find dosing and coverage information. According to data compiled by quarterwatch, in 2011, the fda received more safety reports about dabigatran than any other drug. Dabigatran drug interaction potential anticoagulation services.
Watch videos, access surveys, and download tools and brochures. Cmsms method for the simultaneous determination of three direct oral anticoagulants dabigatran, rivaroxaban, and apixaban in human plasma that is suitable for pharmacokinetic studies and routine tdm in busy hospital laboratories. Table 1 below and drug interactions, drug drug interactions, table 14. Pradaxa is an anticoagulant thrombin inhibitor that helps prevent the formation of blood clots. Its also used to reduce the risk of stroke in people with a heart rhythm disorder known as atrial. Please see important safety information and full prescribing information, including boxed warning. Multums drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients andor to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. An advantage of this agent over other anticoagulants is that routine laboratory monitoring and related dose adjustments are considered unnecessary. Potential noac drug interactions dabigatran apixaban46 and rivaroxaban79 contraindicated note. A specific reversal agent idarucizumab for dabigatran is available when reversal of the anticoagulant effect of dabigatran is needed. Pradaxa fda prescribing information, side effects and uses. The ester is then hydrolyzed, forming dabigatran, the active moiety. You can ask your pharmacist or doctor for information about pradaxa that is written for health professionals. Should severe bleeding occur, treatment with pradaxa must be discontinued and the source of bleeding investigated promptly.
Anticoagulant about this pubmed health uses uses of this medicine. Direct oral anticoagulants doacs guide direct factor xa inhibitors direct thrombin factor iia inhibitor apixaban eliquis edoxaban savaysa rivaroxaban xarelto dabigatran pradaxa fda approved indications and dosages nvaf 5 mg po bid crcl 30 mlmin. Pradaxa, inndabigatran etexilate european medicines agency. It does not establish any rights for any person and is not binding on fda or the public. The effects may cause deterioration in a patients clinical status. Interactions linked to dabigatran etexilate and dabigatran metabolic profile. Moderate renal impairment 30 50 mlmin ecrcl comedication with pglycoprotein inhibitors, including. For more information about pradaxa, including current prescribing information and medication guide, go to. Guidelines for management of bleeding with dabigatran or rivaroxaban 2 reversal of dabigatran idarucizumab is a monoclonal antibody fragment that completely reverses the effect of dabigatran within minutes. In preliminary results from a study on dabigatran in breastmilk, two patients received oral dabigatran etexilate 220 mg 2. Dabigatran 150 mg twice daily has been associated with lower rates of stroke than warfarin in trials of atrial fibrillation, but largescale evaluations in clinical practice are limited.
Similarly, some other drugs commonly known as cyp inhibitors such as ketoconazole, itraconazole, macrolides, human. Learn how pradaxa can help reduce the risk of stroke in afib not caused by a heart valve problem. For situations of lifethreatening or uncontrolled bleeding, when rapid reversal of the anticoagulation effects of dabigatran is required, the specific reversal agent, praxbind. C 25 h 25 n 7 o 3 c 34 h 41 n 7 o 5 c 34 h 41 n 7 o 5 ch 4 o 3 s cas number. Additional treatment, hospitalization, or an extended hospital stay may be necessary. When dabigatran is used to treat or prevent dvt or pe or to prevent strokes or serious blood clots in people who have atrial fibrillation, it is usually taken twice a day. Jan 23, 2020 dabigatran etexilate mesylate is absorbed as the dabigatran etexilate ester.