NovoSeven Recombinant Human Coagulation Factor Ⅶa for Injection

1. Indications and Usage
Hemophilia A or B with Inhibitors:
Treatment of bleeding episodes and perioperative management in patients with congenital Hemophilia A or B with inhibitors (>5 Bethesda Units) .
Acquired Hemophilia:
Treatment of bleeding episodes in patients with acquired hemophilia .
Congenital Factor VII Deficiency:
Treatment of bleeding episodes and perioperative management in patients with congenital Factor VII deficiency .
Glanzmann’s Thrombasthenia:
Treatment of bleeding episodes and perioperative management in patients with Glanzmann’s thrombasthenia with refractoriness to platelet transfusion .
2. Dosage and Administration
Route of Administration:
For Intravenous (IV) Injection ONLY.
Critical: Must be administered by slow intravenous push over 2 to 5 minutes. It is NOT for intravenous drip infusion.
Recommended Dosage:
Standard Dose: 90 µg/kg body weight .
Hemophilia A/B with Inhibitors: Administer every 2 to 3 hours until hemostasis is achieved.
Severe Bleeding: Dosing frequency may be increased (e.g., every 2 hours) initially, then extended to every 4, 6, 8, or 12 hours as clinical status improves.
Surgery/Procedures: Initial dose of 90 µg/kg immediately prior to surgery, repeated 2 hours later, then every 2 to 4 hours for 6–7 days (major surgery).
Critical Administration Instructions:
Reconstitution: Dissolve with the provided solvent (Sterile Water for Injection).
Shaking: Gently swirl the vial to dissolve; do not shake vigorously to avoid foaming.
Time Limit: Use immediately after reconstitution (typically within 3 hours).
3. Mechanism of Action
Extrinsic Pathway Activation:
Factor VIIa binds to Tissue Factor (TF) at the site of vascular injury, forming a complex that directly activates Factor X to Factor Xa.
Amplification of Thrombin Burst:
This complex triggers the conversion of prothrombin to thrombin. Thrombin then converts fibrinogen to fibrin, forming a stable clot.
Unique Feature: Unlike traditional factor concentrates, pharmacologic doses of rFVIIa can also directly activate Factor X on the surface of activated platelets independent of Tissue Factor, providing a “thrombin burst” primarily at the site of bleeding .
4. Safety and Warnings
Thromboembolic Events:
rFVIIa activates the coagulation cascade systemically. There is a risk of arterial and venous thrombosis (e.g., myocardial infarction, stroke, DVT, PE) .
High-Risk Groups: Patients with advanced atherosclerosis, crush injuries, sepsis, or DIC.
Disseminated Intravascular Coagulation (DIC):
Prolonged or excessive administration may lead to DIC, which should be monitored and treated.
Immunogenicity:
Development of neutralizing antibodies (inhibitors) to Factor VIIa is a theoretical risk, though rare.
5.Adverse Reactions and Clinical Research
Most Common Adverse Reactions:
Pyrexia (fever), rash, pruritus, and injection site pain.
Serious Adverse Events:
Thromboembolic events (incidence <0.4% in clinical trials, higher in elderly patients) .
Clinical Research Highlights:
Studies demonstrated that rFVIIa effectively controls bleeding in hemophilia patients with inhibitors without the risk of transmitting blood-borne viruses (as it is recombinant).
6.Drug Interactions
Activated Prothrombin Complex Concentrates (aPPC):
Concomitant use is not recommended due to the theoretical risk of severe thrombotic events.
Antifibrinolytics:
While sometimes used together (e.g., in oral surgery), the combination increases the risk of thrombosis and requires strict monitoring.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: Recombinant Human Coagulation Factor VIIa.
Appearance: Lyophilized powder (white to off-white) and solvent.
Packaging: Single-use vials (e.g., 1 mg, 2 mg, 5 mg).
Storage: Store at 2°C to 8°C.