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Apixaban Reversal Agent

Apixaban Reversal Agent

About Apixaban Reversal Agent

The U.S. Food and Drug Administration (FDA) has approved Portola Pharmaceuticals' Andexxa, the first antidote indicated for patients treated with rivaroxaban (Xarelto) and apixaban (Eliquis), when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

What are the uses for apixaban?

Apixaban is used for reducing the risk of blood clots in the heart and strokes in patients with atrial fibrillation who have no problems with their heart valves (nonvalvular atrial fibrillation).

It also is used for treating and preventing deep venous thrombosis (DVT) and pulmonary embolism in patients who have undergone hip or knee replacement surgery.

INTRODUCTION

The use of any anticoagulant is associated with an increased risk of bleeding, and bleeding complications can be life-threatening. Bleeding is especially concerning with the direct oral anticoagulants (DOACs) because antidotes or specific reversal agents for some of the DOACs are lacking. Additionally, routine coagulation tests cannot be used to determine the degree of anticoagulation, making it more challenging to determine when the anticoagulant effect has resolved.

What is the dosage for apixaban?

The usual dose in nonvalvular atrial fibrillation is 5 mg by mouth twice daily. For individuals 80 years or older, weighing less than or equal to 60 kg, or with reduced kidney function, the usual dose is 2.5 mg twice daily.

The recommended dose for treating DVT or pulmonary embolism is 10 mg twice daily for the first 7 days and then 5 mg twice daily. After six months of treatment, the dose may be reduced to 2.5 mg daily for prevention of DVT or pulmonary embolism.

When apixaban is used to prevent the risk of DVT after hip or knee replacement surgery, the suggested dose is 2.5 mg daily beginning 12 to 24 hours after the surgery is completed.

RELATED DRUGS

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Discussion

Using the Naranjo method for estimating the probabilityof adverse drug reactions [6], the chances that our patient’sgastrointestinal bleed was related to her apixaban use was estimatedas ‘probable’ with a score of 6; a score > 9 is ‘definite’ and the rangefor ‘probable’ is 5–8. While it is not uncommon to have majorbleeding on anticoagulation, we believe that her ESRD contributedto an increased likelihood of bleeding and that current prescribingrecommendations make apixaban appear to be a safer option foranticoagulation than evidence actually suggests.

WARNINGS AND PRECAUTIONS

Increased Risk of Thrombotic Events after Premature Discontinuation: Premature discontinuation of any oral anticoagulant, including ELIQUIS, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from ELIQUIS to warfarin in clinical trials in atrial fibrillation patients. If ELIQUIS is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.

Side Effects

  • skin rash,
  • allergic reactions,
  • fainting, nausea, and
  • anemia.

Conclusion

To our knowledge, this is the second case report showing majorgastrointestinal bleeding when apixaban is used in patients withESRD on hemodialysis. Our patient’s risk of bleeding was furtherincreased by using apixaban with aspirin. This case highlights theneed for further investigation of apixaban in the setting of ESRD,with and without aspirin. While apixaban is a tempting option forpatients with DVT/PE, the potential for major bleeding in a patientwith ESRD is possibly increased. As a result, warfarin should remainthe preferred treatment option until more safety and efficacy data isobtained in patients with ESRD on apixaban. Moreover, care shouldbe taken when prescribing apixaban because the indication mayimpact the dosing recommendations in patients with poor renalfunction, according to the FDA-approved package insert.

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