TGA approves first NOAC reversal agent


13 May 2016

The first reversal agent for a novel oral anticoagulant is now available in Australia.

Idarucizumab (Praxbind) manufactured by Boehringer Ingelheim is expected to be used in patients taking dabigatran who require reversal of anticoagulation for emergency surgery or who have life-threatening or uncontrolled bleeding.

Its registration is based on the results from the Phase III Reversal Effects of Idarucizumab on Active Dabigatran (REVERSE-AD) study published in the NEJM last year that showed idarucizumab completely reversed the anticoagulant effect of dabigatran within minutes.

“Management strategies for bleeding on NOACs have been based on supportive measures until now, but the availability of a specific reversal agent for dabigatran-associated bleeding should provide rapid and complete clearance of the anticoagulant effect,” said Professor Chris Ward who is a haematologist at the Royal North Shore Hospital in Sydney.

“While Praxbind can be given in these critical situations without waiting for the results of coagulation assays, we believe laboratory assays can aid in choosing which patients should be treated with Praxbind, and in confirming the reversal of drug effect.

Many laboratories can now test for dabigatran levels using assays such as the dilute thrombin time,” he said.

He added that restarting anticoagulation after idarucizumab (Praxbind) reversal for surgery or bleeding was important in patients with an ongoing risk of thrombosis.

“The timing and intensity of anticoagulation retreatment should be based on individual patient factors,” he advised.

Managing Director for Boehringer Ingelheim ANZ, Mr Wes Cook said while use of Praxbind is anticipated to be rare, was an important advancement in care for Australian patients with atrial fibrillation.

“We are working closely with specialists in emergency medicine, surgery and haematology to ensure the well-managed introduction of the reversal agent into clinical practice,” he said.

Idarucizumab (Praxbind) is a humanised monoclonal antibody fragment that binds specifically and exclusively to the direct thrombin inhibitor Pradaxa and is not suitable for use with other anticoagulants.

It comes as a ready-to-use solution that can be administered intravenously as two consecutive infusions over 5-10 minutes, or as an injection. It is not listed on the PBS

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