Andexanet alfa (EU: Ondexxya, U.S.: Andexxa) for the treatment of major bleeding

Introduction

Andexanet alfa (trade name EU: Ondexxya, U.S.: Andexxa) has been approved in Germany since April 2019 for stopping life-threatening or uncontrolled bleeding in adults who are taking the anti-clotting medications apixaban or rivaroxaban.

Anti-clotting medications (blood thinners) are used by people who have a higher risk of thrombosis or thromboembolism. The anti-clotting medications that can be taken in tablet form include medicines called direct oral anticoagulants (DOACs), such as apixaban and rivaroxaban. Apixaban and rivaroxaban work by inhibiting the clotting factor Xa. They are mainly used to treat atrial fibrillation, after the implantation of an artificial heart valve, an artificial knee joint or an artificial hip, or following pulmonary embolism. Their most common side effects include bleeding in various organs. Severe or life-threatening bleeding is very rare, though.

Andexanet alfa is an antidote to apixaban or rivaroxaban, meaning that it stops or counteracts their effects. If major bleeding occurs, andexanet alfa is supposed to stop the anti-clotting effect produced by the drug that inhibits clotting factor Xa (apixaban or rivaroxaban).

Application

Andexanet alfa is given as a brief intravenous drip (infusion): One milliliter of infusion solution contains 10 mg of andexanet alfa.

Two infusions need to be given in a row. The time between infusions and how long they last mostly depend on when apixaban or rivaroxaban was last used.

Other treatments

The standard treatments for life-threatening or uncontrolled bleeding in people who have used apixaban or rivaroxaban include things like blood products, prothrombin complex concentrates or giving enough fluids.

Assessment

In 2019, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) wanted to find out whether andexanet alfa has any advantages or disadvantages compared with the current standard treatments for major bleeding in patients who have used apixaban or rivaroxaban.

But the manufacturer didn’t provide any suitable data with which to do the assessment.

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the review and the hearings received, G-BA passed a resolution on the added benefit of andexanet alfa (Ondexxya, Andexxa).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Andexanet alfa (acute major bleeding) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A19-76. November 28, 2019. (IQWiG reports; Volume 849).

IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.

Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.

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Created on December 19, 2019
Next planned update: 2022

Authors/Publishers:

Institute for Quality and Efficiency in Health Care (IQWiG, Germany)

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