Brand names: Andexxa
Route: Intravenous
FDA Black Box Warning
WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS Treatment with ANDEXXA has been associated with serious and life-threatening adverse events, including: ( 5.1 ) • 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. WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, and SUDDEN DEATHS See full prescribing information for complete boxed warning Treatment with ANDEXXA has been associated with serious and life-threatening adverse events, including: ( 5.1 ) • 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.
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of ANDEXXA in pregnant women to inform patients of associated risks. Animal reproductive and developmental studies have not been conducted with ANDEXXA. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Labor or Delivery The safety and effectiveness of ANDEXXA during labor and delivery have not been evaluated.
2 interactions on record
Unresponsiveness to unfractionated heparin following ANDEXANET ALFA administration, characterized by non-prolongation of activated clotting times and requirement for increased heparin dosing. Do not use unfractionated heparin following ANDEXANET ALFA administration.
Source: NLP:andexanet alfa
Andexanet binds to heparin-bound antithrombin III and may reduce heparin's anticoagulant effect, potentially leading to serious and life-threatening thrombotic events. Avoid heparin use after andexanet alfa for Factor Xa inhibitor reversal.
Source: NLP:heparin sodium