ANDEXXA Coding Information

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INDICATION

ANDEXXA® (coagulation factor Xa [recombinant], inactivated-zhzo) is a recombinant modified human factor Xa (FXa) protein indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

This indication is approved under accelerated approval based on the change from baseline in anti-FXa activity in healthy volunteers. An improvement in hemostasis has not been established. Continued approval for this indication may be contingent upon the results of studies that demonstrate an improvement in hemostasis in patients.

Limitations of Use

ANDEXXA has not been shown to be effective for, and is not indicated for, the treatment of bleeding related to any FXa inhibitors other than apixaban or rivaroxaban.

IMPORTANT SAFETY INFORMATION FOR ANDEXXA® (coagulation factor Xa [recombinant], inactivated-zhzo)

WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS

Treatment with ANDEXXA has been associated with serious and life-threatening adverse events, including:

  • Arterial and venous thromboembolic events
  • Ischemic events, including myocardial infarction and ischemic stroke
  • Cardiac arrest
  • Sudden deaths

Monitor for thromboembolic events and initiate anticoagulation when medically appropriate. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed.

WARNINGS AND PRECAUTIONS

  • Arterial and venous thromboembolic events, ischemic events, and cardiac events, including sudden death, have occurred during treatment with ANDEXXA. To reduce thromboembolic risk, resume anticoagulant therapy as soon as medically appropriate following treatment with ANDEXXA. The safety of ANDEXXA has not been evaluated in subjects who experienced thromboembolic events or disseminated intravascular coagulation within two weeks prior to the life-threatening bleeding event requiring treatment with ANDEXXA. Safety of ANDEXXA also has not been evaluated in subjects who received prothrombin complex concentrates, recombinant factor VIIa, or whole blood products within seven days prior to the bleeding event.
  • Re-elevation or incomplete reversal of anticoagulant activity can occur.
  • ANDEXXA may interfere with the anticoagulant effect of heparin. If anticoagulation is needed, use an alternative anticoagulant to heparin.

ADVERSE REACTIONS

The most common adverse reactions (≥ 5%) in bleeding subjects receiving ANDEXXA were urinary tract infections and pneumonia. The most common adverse reactions (≥ 3%) in healthy volunteers treated with ANDEXXA were infusion-related reactions.

Please see full Prescribing Information, including Boxed WARNING.

INDICATION

ANDEXXA® (coagulation factor Xa [recombinant], inactivated-zhzo) is a recombinant modified human factor Xa (FXa) protein indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

This indication is approved under accelerated approval based on the change from baseline in anti-FXa activity in healthy volunteers. An improvement in hemostasis has not been established. Continued approval for this indication may be contingent upon the results of studies that demonstrate an improvement in hemostasis in patients.

Limitations of Use

ANDEXXA has not been shown to be effective for, and is not indicated for, the treatment of bleeding related to any FXa inhibitors other than apixaban or rivaroxaban.

IMPORTANT SAFETY INFORMATION FOR ANDEXXA® (coagulation factor Xa [recombinant], inactivated-zhzo)

WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS

Treatment with ANDEXXA has been associated with serious and life-threatening adverse events, including:

  • Arterial and venous thromboembolic events
  • Ischemic events, including myocardial infarction and ischemic stroke
  • Cardiac arrest
  • Sudden deaths

Monitor for thromboembolic events and initiate anticoagulation when medically appropriate. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed.

 

WARNINGS AND PRECAUTIONS

  • Arterial and venous thromboembolic events, ischemic events, and cardiac events, including sudden death, have occurred during treatment with ANDEXXA. To reduce thromboembolic risk, resume anticoagulant therapy as soon as medically appropriate following treatment with ANDEXXA. The safety of ANDEXXA has not been evaluated in subjects who experienced thromboembolic events or disseminated intravascular coagulation within two weeks prior to the life-threatening bleeding event requiring treatment with ANDEXXA. Safety of ANDEXXA also has not been evaluated in subjects who received prothrombin complex concentrates, recombinant factor VIIa, or whole blood products within seven days prior to the bleeding event.
  • Re-elevation or incomplete reversal of anticoagulant activity can occur.
  • ANDEXXA may interfere with the anticoagulant effect of heparin. If anticoagulation is needed, use an alternative anticoagulant to heparin.

ADVERSE REACTIONS

The most common adverse reactions (≥ 5%) in bleeding subjects receiving ANDEXXA were urinary tract infections and pneumonia. The most common adverse reactions (≥ 3%) in healthy volunteers treated with ANDEXXA were infusion-related reactions.

Please see full Prescribing Information, including Boxed WARNING.