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BALFAXAR. Total Support.

Shield icon symbolizing Balfaxar's demonstrated efficacy and safety, comparable to Kcentra® in clinical trials.

BALFAXAR demonstrated similar efficacy and safety to Kcentra in a head-to-head clinical trial1,2

Clipboard icon with 'INR' and downward arrow, indicating Balfaxar's rapid and sustained INR reduction.

Rapid and sustained INR reduction was achieved with BALFAXAR1,2

Clock icon with '8 HR,' showing Balfaxar’s stability at room temperature for 8 hours after reconstitution.

BALFAXAR is stable at room temperature for 8 hours after reconstitution, 2x longer than Kcentra 1,3,a

Icon with two drops, indicating the preferred nextaro® transfer device for Balfaxar reconstitution.

Based on the results of a usability study, the nextaro® transfer device is preferred over the Mix2Vial by HCPs4,b

Globe icon symbolizing Balfaxar's 4F-PCC formulation approval in 88 countries outside the US.

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)4

Learn More About BALFAXAR

BALFAXAR vs Kcentra Head-to-Head Trial
Dosing

aBALFAXAR can be stored for up to 36 months at 2ºC to 25ºC (36ºF to 77ºF) from the date of manufacture.

bUser preference was determined from the responses of 16 healthcare providers using an 11-item questionnaire about the usability of the nextaro® and Mix2Vial transfer devices.

INR=international normalized ratio.

Nextaro is a registered trademark of sfm medical devices GmbH. Kcentra is a registered trademark of CSL Behring LLC.

References: 1. BALFAXAR, Prothrombin Complex Concentrate (Human) Full Prescribing Information. Paramus, NJ: Octapharma USA Inc. 2. Sarode R, Goldstein JN, Simonian G, Milling TJ Jr. A phase 3, prospective, randomized, double-blind, multicenter, non-inferiority study comparing two four-factor prothrombin complex concentrates for reversal of vitamin K antagonist-induced anticoagulation in patients needing urgent surgery with significant bleeding risk. Blood. 2022;140(Suppl 1):352-353. doi:10.1182/blood-2022-168890 3. Kcentra, Prothrombin Complex Concentrate (Human) Full Prescribing Information. King of Prussia, PA: CSL Behring LLC. 4. Data on File, Octapharma 2023.

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

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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.