Learn more about
BALFAXAR reconstitution
and administration
- BALFAXAR is stable for up to 36 months refrigerated and at room temperature (2°C to 25°C; 36°F to 77°F) from the date of manufacture.
- Store the vial in the original package to protect it from light.
- Do not freeze.
- Do not use beyond the expiration date on the vial label and carton.
- Any unused product or waste material should be disposed of immediately in accordance with local requirements.
Do not freeze.
aUser 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.3
References: 1. BALFAXAR, Prothrombin Complex Concentrate (Human) Full Prescribing Information. Paramus, NJ: Octapharma USA Inc. 2. US Food and Drug Administration. 510K Summary: K183187. March 2019. Accessed October 31, 2023. https://www.accessdata.fda.gov/cdrh_docs/pdf18/K183187.pdf 3. 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
Important Safety InformationView Less —
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.