BALFAXAR Is a Globally Established VKA Reversal Agent1,2
BALFAXAR Is a Non-Activated, Human-Plasma Derived 4F-PCC1
The 4F-PCC formulation used in BALFAXAR is approved for use in 88 countries outside of the US (first licensed in Germany as Octaplex in 2003)2
BALFAXAR is approved for the urgent reversal of acquired coagulation factor deficiency induced by VKA (e.g., warfarin) therapy in adult patients with need for an urgent surgery or invasive procedure1
Clinical Practice Guideline Recommends 4F-PCC for Urgent Warfarin Reversal
American College of Cardiology (ACC)3
For patients requiring reversal of VKAs, administration of vitamin K must be accompanied by a repletion strategy such as 4F-PCC or plasma. 4F-PCC is preferred since it can be given in a much smaller volume and at a much faster infusion rate, compared with plasma.
Learn More About BALFAXAR
4F-PCC=4-factor prothrombin complex concentrate; INR=international normalized ratio; VKA=vitamin K antagonist.
References: 1. BALFAXAR, Prothrombin Complex Concentrate (Human) Full Prescribing Information. Paramus, NJ: Octapharma USA Inc. 2. Data on File, Octapharma 2023. 3. Tomaselli GF, Mahaffey KW, Cuker A, et al. 2017 ACC Expert consensus decision pathway on management of bleeding in patients on oral anticoagulants: a report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways. J Am Coll Cardiol. 2017;70(24):3042-3067.
Important Safety InformationView More +
WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS
Patients being treated with Vitamin K antagonists (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
Important Safety Information
WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS
Patients being treated with Vitamin K antagonists (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. Both fatal and non-fatal arterial and venous thromboembolic complications have been reported with BALFAXAR in clinical trials and post marketing surveillance. Monitor patients receiving BALFAXAR for signs and symptoms of thromboembolic events. BALFAXAR may not be suitable in patients with thromboembolic events in the prior 3 months.
BALFAXAR is contraindicated in patients with known anaphylactic or severe systemic reactions to BALFAXAR or any of its components. BALFAXAR is also contraindicated in patients with a known allergy to heparin, a history of heparin-induced thrombocytopenia (HIT), and IgA deficient patients with known antibodies against IgA.
In clinical trials, the most frequent (≥3%) adverse reactions observed in subjects receiving BALFAXAR were procedural pain, wound complications, asthenia, anemia, dysuria, procedural vomiting, and catheter-site-related reaction.
BALFAXAR is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.
Indications
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.
Please click here for Full Prescribing Information, including BOXED WARNING.
To report suspected adverse reactions, contact Octapharma USA, Inc. at 1-866-766-4860 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.