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BLOOD AND BLOOD FORMING ORGANS › ANTIHEMORRHAGICS › VITAMIN K AND OTHER HEMOSTATICS › Blood coagulation factors
coagulation factor IX
B02BD04
Forms & Strengths
- Lyophilized powder for reconstitution: 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU vial strengths
- Single-use vials supplied with sterile water for injection and administration set
Adult Dosing
- Hemophilia B prophylaxis: 40-75 IU/kg once weekly (recombinant) or 1-2 times weekly based on product
- On-demand treatment for bleeding episodes: Individualized based on target factor IX levels (each IU/kg raises FIX level by approximately 0.5-1% normal)
- Minor surgery/hemorrhage: Target 30-60% rise; repeat every 24 hours as needed
- Major surgery/life-threatening bleed: Target 60-100% rise; repeat every 12-24 hours
Pediatric Dosing
- Safety and efficacy profile similar to adults; pharmacokinetic differences may require higher or more frequent dosing in children under 12 years
- Prophylaxis: 40-80 IU/kg weekly or divided twice weekly depending on specific product pharmacokinetics
Indications
- Control and prevention of bleeding episodes in patients with hemophilia B (congenital factor IX deficiency / Christmas disease)
- Perioperative management of bleeding in patients with hemophilia B
- Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in hemophilia B
Mechanism of Action
- Replaces missing coagulation factor IX, a vitamin K-dependent plasma protein synthesized in the liver
- Activated factor IX (FIXa), in combination with activated factor VIII, activates factor X to factor Xa
- Factor Xa converts prothrombin to thrombin, leading to the formation of a fibrin clot and hemostasis
Contraindications
- Known life-threatening hypersensitivity to coagulation factor IX products or hamster proteins (for certain recombinant products)
- History of anaphylactic or severe systemic hypersensitivity reactions to the specific product or its components
Adverse Reactions
- Hypersensitivity reactions including anaphylaxis, urticaria, chest tightness, hypotension
- Development of neutralizing antibodies (inhibitors)
- Thromboembolic complications, particularly with high doses or impure plasma-derived concentrates
- Injection site reactions, headache, dizziness, nausea, altered taste
Drug Interactions
- Antifibrinolytic agents (e.g., tranexamic acid, aminocaproic acid): Potential increased risk of thrombosis when used concomitantly with plasma-derived products
- Emtricitabine/Tenofovir or other nephrotoxic agents: No direct pharmacokinetic interaction, but caution advised in underlying comorbidities
Curated Content: Needs Vetting Before Put to Clinical Use