iately and seek emergency care. Promptly eva luate any signs or symptoms of blood loss and consider the need for blood replacement. Discontinue BEVYXXA in patients with active pathological bleeding.
There is no established way to reverse the anticoagulant effect of BEVYXXA, which can be expected to persist for at least 72 hours after the last dose. It is unknown whether hemodialysis removes BEVYXXA. Protamine sulfate, vitamin K, and tranexamic acid are not expected to reverse the anticoagulant activity of BEVYXXA.
5.2 Spinal/Epidural Anesthesia or Puncture
When neuraxial anesthesia (spinal/epidural anesthesia) or spinal/epidural puncture is employed, patients treated with antithrombotic agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis.
Do not remove an epidural catheter earlier than 72 hours after the last administration of BEVYXXA. Do not administer the next BEVYXXA dose earlier than 5 hours after the removal of the catheter. If traumatic puncture occurs, delay the administration of BEVYXXA for 72 hours.
Monitor patients frequently for signs and symptoms of neurological impairment (e.g., numbness or weakness of the legs, bowel or bladder dysfunction). If neurological compromise is noted, urgent diagnosis and treatment is necessary. Prior to neuraxial intervention, consider the potential benefit versus the risk in anticoagulated patients or in patients to be anticoagulated for thromboprophylaxis.
5.3 Use in Patients with Severe Renal Impairment
Patients with severe renal impairment (CrCl ≥ 15 to < 30 mL/min computed by Cockcroft-Gault using actual body weight) taking BEVYXXA may have an increased risk of bleeding events. Reduce dose of BEVYXXA, monitor patients closely, and promptly eva luate any signs or symptoms of blood loss in these patients [see DOSAGE AND ADMINISTRATION (2.2), WARNINGS AND PRECAUTIONS (5.1), ADVERSE REACTIONS (6.1), USE IN SPECIFIC POPULATIONS (8.6), CLINICAL PHARMACOLOGY (12.3)].
5.4 Use in Patients on Concomitant P-gp Inhibitors
Patients on concomitant P-gp inhibitors with BEVYXXA may have an increased risk of bleeding. Reduce dose of BEVYXXA in patients receiving or starting P-gp inhibitors. Monitor patients closely and promptly eva luate any signs or symptoms of blood loss in these patients [see DOSAGE AND ADMINISTRATION (2.3), WARNINGS AND PRECAUTIONS (5.1), ADVERSE REACTIONS (6.1), DRUG INTERACTIONS (7.1), CLINICAL PHARMACOLOGY (12.3)].
Avoid use of BEVYXXA in patients with severe renal impairment receiving concomitant P-gp inhibitors [see WARNINGS AND PRECAUTIONS (5.3)].
6 ADVERSE REACTIONS
The following serious adverse reactions are described elsewhere in the labeling:
Risk of Bleeding [see WARNINGS AND PRECAUTIONS (5.1, 5.3, 5.4)].
Spinal/Epidural Anesthesia or Puncture [see BOXED WARNING and WARNINGS AND PRECAUTIONS (5.2)].
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 practice.
The safety of BEVYXXA was eva luated in the Acute Medically Ill Prevention with Extended Duration Betrixaban (APEX) Study [see CLINICAL STUDIES (14)], including 3,716 patients treated with BEVYXXA for a median of 36 days compared to 3,716 patients trea |
