Balfaxar FDA Approval History
Last updated by Judith Stewart, BPharm on July 26, 2023.
FDA Approved: Yes (First approved July 21, 2023)
Brand name: Balfaxar
Generic name: prothrombin complex concentrate, human-lans
Dosage form: Lyophilized Powder for Injection
Company: Octapharma USA, Inc.
Treatment for: Warfarin Reversal in Urgent Surgery & Invasive Procedures
Balfaxar (prothrombin complex concentrate, human-lans) is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for an urgent surgery/invasive procedure.
- Warfarin is a Vitamin K antagonist anticoagulant used to prevent blood clots from forming following a heart attack, heart valve surgery, stroke, deep vein thrombosis/pulmonary embolism, or for atrial fibrillation. The main side effect of warfarin is an increased risk of bleeding, particularly for patients undergoing urgent surgery or invasive procedures.
- Balfaxar is a non-activated four factor prothrombin complex concentrate (4F-PCC) containing vitamin K-dependent factors: Factor II (prothrombin), Factor VII, Factor IX and Factor X, as well as antithrombotic Proteins C and S. Balfaxar works to reverse the effects of warfarin by replenishing the levels of the deficient clotting factors to restore blood coagulation.
- FDA approval of Balfaxar was supported by the clinical trial LEX-209, which compared the efficacy and safety of Balfaxar head-to-head with a control 4F-PCC (Kcentra). Balfaxar met the primary endpoint of hemostatic efficacy and was determined to be non-inferior to Kcentra, with Balfaxar demonstrating effective hemostasis in 94.6% of patients versus 93.5% of patients for Kcentra. International Normalized Ratio (INR) reductions and vitamin K dependent coagulation factor increases supported the primary endpoint and PCC dosing and duration of infusion were also similar. The safety profile was similar between treatment arms and consistent with previous studies.
- Balfaxar is administered by intravenous infusion at a dose based on the patient’s baseline INR value, and body weight. Vitamin K should be administered concurrently to patients receiving Balfaxar to maintain factor levels once the effects of Balfaxar have diminished.
- The product label for Balfaxar carries a Boxed Warning for arterial and venous thromboembolic complications. Patients being treated with Vitamin K antagonist (VKA) therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the potential risks of thromboembolic events, especially in patients with the history of a thromboembolic event. Resumption of anticoagulation should be carefully considered as soon as the risk of thromboembolic events outweighs the risk of acute bleeding.
- Warnings and precautions associated with Balfaxar include anaphylactic-type reactions, and arterial and venous thromboembolic complications. As Balfaxar is made from human plasma, it may carry the risk of transmitting infectious agents including viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
- Common adverse reactions include procedural pain, wound complications, asthenia, anemia, dysuria, procedural vomiting and catheter site related reaction.
Development timeline for Balfaxar
| Date | Article |
|---|---|
| Jul 26, 2023 | Approval FDA Approves Balfaxar (prothrombin complex concentrate, human-lans) for Warfarin Reversal in Urgent Surgery & Invasive Procedures |
Further information
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