Composition: Human Coagulation Factor XI 500 IU
Availability: Dus, 1 vial serbuk injeksi @ 500 iu, 1 vial pelarut @ 5 ml + 1 disposable syringe + 1 double ended needle + 1 filter needle + 1 infusion set + 2 alcohol swabs
Pharmacology: Factor IX is a protein needed for blood coagulation process and maintain blood haemostasis derived from human plasma or recombinant. Working together with active factor VIII increases the conversion of factor X to activated factor X (Factor Xa). Factor Xa converts prothrombin to thrombin, converts fibrinogen to fibrin, is responsible for the process of blood clotting.
Indications: Treatment and prevention of bleeding in patients with hemophilia B (congenital factor IX deficiency)
Contraindications: Hypersensitivity to the active ingredients and/or additives in Octanine® preparations, heparin-induced thrombocytopenia (HIT Type II)
Dosage and How to use
The required dose is determined by the following formula:
Units required = body weight (Kg) x desired increase in factor IX activity (%) (IU/dl) x 0.8
For long-term prophylaxis against bleeding in patients with severe hemophilia B, the usual dose is 20 to 40 IU of factor IX per kg of body weight at intervals of 3 to 4 days.
Side Effects: The following side effects have been observed with preparations containing factor IX: Hypersensitivity or allergic reaction, rarely; severe anaphylaxis in association with formation of anti-factor IX antibodies. In rare cases, increase in body temperature, formation of inhibitors to factor IX.
Administration of low-purity factor IX preparations creates a potential risk of thromboembolic episodes (myocardial infarction, disseminated intravascular coagulation, venous thrombosis, pulmonary embolism). However, such side effects are extremely rare with highly purified factor IX preparations, such as Octanine®
There have been reports of the development of nephrotic syndrome when immune tolerance was attempted in hemophilia B patients with anti-factor IX antibodies and a history of allergic reactions. Because of the presence of heparin, heparin-induced thrombocytopenia (HIT type II) may occur although this is extremely rare, with platelet counts markedly below 100,000 per ul or rapid declines to less than 50% of baseline values.
In patients without prior heparin hypersensitivity, the onset of a decrease in the platelet count usually occurs within 6-14 days of starting treatment. In patients with heparin hypersensitivity, this decrease may occur within hours. In this case, the administration of Octanine® should be discontinued immediately. Patients should be advised not to use drugs containing heparin in the future.
Drug Interaction with other preparations: Not known
Incompatibility: Octanine® should not be mixed with other products
Storage Period and Method: 2 years. Store at 2⁰ - 25⁰ C. Do not freeze. Protect from light.