Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The most common adverse reactions (≥ 5%) in bleeding patients receiving ANDEXXA were urinary tract infections and pneumonia.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The most common adverse reactions (≥ 5%) in bleeding patients receiving ANDEXXA were urinary tract infections and pneumonia.
In Study 3 (ANNEXA-4), four hundred and seventy-seven patients with acute major bleeding were enrolled and received ANDEXXA.
Of these 477 patients, 419 patients were treated with apixaban (245/419;
58.5%) or rivaroxaban (174/419;
Most patients had received apixaban or rivaroxaban as anticoagulation treatment for atrial fibrillation (348/419;
83%) or venous thromboembolism (65/419;
In the majority of patients, ANDEXXA was used to reverse anticoagulant therapy following either an intracranial hemorrhage (289/419;
5 WARNINGS AND PRECAUTIONS • Arterial and venous thromboembolic events, ischemic events, and cardiac events, including sudden death, have occurred during treatment with ANDEXXA.
Resume anticoagulant therapy as soon as medically appropriate following treatment with ANDEXXA .
( 5.1 ) • Unresponsiveness to unfractionated heparin has been reported following ANDEXXA administration.
( 5.2 ) • Re-elevation or incomplete reversal of anticoagulant activity can occur.
( 5.3 ) 5.1 Thromboembolic and Ischemic Risks The thromboembolic and ischemic risks were assessed in 419 bleeding -patients in the ANNEXA-4 study who received ANDEXXA and were treated with apixaban or rivaroxaban.
Like all medications, Andexxa can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: