Octanine F IV Infusion

Hemophilia B or Christmas disease

Hemophilia B Management of bleeding Typical initial doses suggested below; usually two-thirds of initial dose given for maintenance Minor: Single dose of 25-35 IU/kg IV x 1 dose; may repeat dose after 24 hr Moderate: 40-55 IU/kg/day IV x 2 days or until adequate wound healing Major: 60-70 IU/kg/day IV x 2-3 days or until adequate wound healing Management of surgical procedures Minor: 50-60 IU/kg IV on day of surgery, decrease to 25-55 IU/kg/day during initial postop period (ie, 1st to 2nd week) Major: 70-95 IU/kg IV on day of surgery, decrease to 35-70 IU/kg/day during initial postop period (ie, 1st to 2nd week), THEN 25-35 IU/kg/day late postop period (ie, 3rd week onwards)

Safety and efficacy not established

Hypersensitivity to mouse or hamster protein.

Caution when used in patients at risk of thromboembolism or disseminated intravascular coagulation. May cause increased risk of intravascular coagulation and thrombosis in patients with hepatic impairment. Risk of viral infection transmission as factor IX complex is a plasma-derived product. Vaccination against hepatitis A and B are recommended in haemophilic patients. Safety and efficacy have not been demostrated in patients < 16 yr. Pregnancy. Lactation: Unknown if distributed in human breast milk

C Pregnancy Category: C Lactation: Unknown if distributed in human breast milk

>10% Headache (10.8%) 1-10% Dizziness (7.7%),Rash (1.6-7.7%),Injection site pain (6.2%),Nausea (6.2%),Urticaria (3.1-4.8%),Rhinitis (4.6%),Altered taste sense (4.6%),Dyspnea (3.2%),Fever (3.1%),Flushing (3.1%),Allergic reaction (1.5%) Frequency Not Defined Lethargy,Altered blood pressure (too rapid infusion),Thrombosis (large dose),Myocardial infarction (large dose),DIC (large dose),Chills,Tingling,Vomiting,Human-derived products: viral infection,Stinging at infusion site (large dose),Hives,Anaphylaxis

Factor IX is used as replacement therapy in patients with haemophilia B whereby there is a genetic deficiency of factor IX.

Octanine F 500 IU/vial IV Infusion manufactured by City Overseas. Its generic name is Factor IX Complex.