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Federal officials issued a complete response letter late Thursday, which me"...
Accidental overdose may lead to hemorrhagic complications. There is no reversal agent for dabigatran. In the event of hemorrhagic complications, initiate appropriate clinical support, discontinue treatment with PRADAXA, and investigate the source of bleeding. Dabigatran is primarily eliminated by the kidneys with a low plasma protein binding of approximately 35%. Hemodialysis can remove dabigatran; however, data supporting this approach are limited. Using a high-flux dialyzer, blood flow rate of 200 mL/min, and dialysate flow rate of 700 mL/min, approximately 49% of total dabigatran can be cleared from plasma over 4 hours. At the same dialysate flow rate, approximately 57% can be cleared using a dialyzer blood flow rate of 300 mL/min, with no appreciable increase in clearance observed at higher blood flow rates. Upon cessation of hemodialysis, a redistribution effect of approximately 7% to 15% is seen. The effect of dialysis on dabigatran's plasma concentration would be expected to vary based on patient specific characteristics. Measurement of aPTT or ECT may help guide therapy [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].
PRADAXA is contraindicated in patients with:
- Active pathological bleeding [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].
- History of a serious hypersensitivity reaction to PRADAXA (e.g., anaphylactic reaction or anaphylactic shock) [see ADVERSE REACTIONS].
- Mechanical prosthetic heart valve [see WARNINGS AND PRECAUTIONS]
Last reviewed on RxList: 8/27/2014
This monograph has been modified to include the generic and brand name in many instances.
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