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Balfaxar Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose vial—1 (w. diluent)
Manufacturer
Generic Availability
NO
Mechanism of Action
The administration of Balfaxar provides a rapid increase in plasma levels of the vitamin K-dependent coagulation factors (FII, FVII, FIX, FX) and antithrombotic proteins C and S. In combination they are referred to/known as the prothrombin complex. Balfaxar can temporarily correct the coagulation defect of patients with deficiency of one or several of these factors.
Balfaxar Indications
Indications
Urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA; eg, warfarin) therapy in adults with need for an urgent surgery/invasive procedure.
Balfaxar Dosage and Administration
Adult
See full labeling. Administer concomitant Vitamin K. Individualize dosing based on patient's baseline INR and weight. Potency (units) is defined by Factor IX content. Give by IV Infusion at a rate of 0.12mL/kg/min (~3 units/kg/min); max rate of 8.4mL/min (~210 units/min). ≤100kg: Pre-treatment INR: (2–<4): 25 units of Factor IX/kg; max 2500 units; (4–6): 35 units of Factor IX/kg; max 3500 units; (>6): 50 units of Factor IX/kg; max 5000 units. >100kg: do not exceed max dose. Repeat dosing: not recommended.
Children
Not established.
Balfaxar Contraindications
Contraindications
Known allergy to heparin. History of heparin-induced thrombocytopenia (HIT). IgA deficient patients with known antibodies against IgA.
Balfaxar Boxed Warnings
Boxed Warning
Arterial and venous thromboembolic complications.
Balfaxar Warnings/Precautions
Warnings/Precautions
Risk of arterial and venous thromboembolic complications (may be fatal). History of thromboembolic events within the previous 3 months (may not be suitable in these patients). Monitor for signs/symptoms of thromboembolic events during and after infusion. History of coronary heart disease, hepatic impairment, or at risk of thromboembolic events or disseminated intravascular coagulation; monitor. Discontinue immediately if hypersensitivity reactions occur. Measure INR before, during, and after each treatment. Contains human plasma; monitor for possible infection transmission. Pregnancy. Nursing mothers.
Balfaxar Pharmacokinetics
See Literature
Balfaxar Interactions
Not Applicable
Balfaxar Adverse Reactions
Adverse Reactions
Procedural pain, wound complications, asthenia, anemia, dysuria, procedural vomiting, catheter site related reaction; hypersensitivity, thromboembolic events (eg, stroke, PE, DVT).
Balfaxar Clinical Trials
See Literature
Balfaxar Note
Not Applicable
Balfaxar Patient Counseling
See Literature
