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BLOOD AND BLOOD FORMING ORGANS › ANTIHEMORRHAGICS › VITAMIN K AND OTHER HEMOSTATICS › Blood coagulation factors
coagulation factor IX, II, VII and X in combination
B02BD01
Forms & Strengths
- Lyophilized powder for reconstitution with sterile water for injection
- Potency expressed in International Units (IU) of Factor IX per vial
- Commonly available strengths: 500 IU, 1000 IU, 1500 IU per vial (contains proportional amounts of Factors II, VII, and X)
Adult Dosing
- Reversal of Coumarin (vitamin K antagonist) anticoagulation: Dosing calculated based on baseline INR, target INR, and patient body weight (typically 25-50 IU Factor IX/kg)
- Bleeding episodes in hemophilia B or acquired factor deficiency: 20-100 IU/kg depending on severity of hemorrhage
- Perioperative management: Individualized based on target factor levels and type of surgery
Pediatric Dosing
- Safety and efficacy in pediatric patients (<18 years) not fully established for rapid warfarin reversal
- Hemophilia B bleeding episodes: Dosing follows adult mg/kg or IU/kg principles, adjusted for age and clinical response under pediatric hematology guidance
Indications
- Urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonists (e.g., warfarin) in patients with acute major bleeding or needing urgent surgery
- Prevention and control of bleeding episodes in patients with congenital factor IX deficiency (hemophilia B) when purified factor IX products are unavailable
Mechanism of Action
- Provides exogenous replacement of human vitamin K-dependent coagulation factors II, VII, IX, and X
- Restores the clotting cascade and thrombin generation capacity in patients with deficiencies or inhibition of these factors
Contraindications
- Known hypersensitivity to any component of the product or heparin (if used in manufacturing/diluent)
- History of disseminated intravascular coagulation (DIC)
- Active thrombosis or known severe active thromboembolic disease
Adverse Reactions
- Thromboembolic events (arterial and venous, including stroke, pulmonary embolism, deep vein thrombosis, myocardial infarction)
- Hypersensitivity reactions, anaphylaxis, urticaria, chills, flushing
- Fever, headache, nausea, tachycardia
- Transmission of blood-borne pathogens (theoretical risk)
Drug Interactions
- Vitamin K antagonists (e.g., warfarin): Pharmacodynamic antagonism; concurrent use counteracts the anticoagulant effect
- Antifibrinolytics (e.g., tranexamic acid, aminocaproic acid): May increase thrombotic risk when administered concomitantly
Curated Content: Needs Vetting Before Put to Clinical Use