Indications & Uses
Coagulation Factor IX (Recombinant) is a human blood coagulation factor. Adults and children aged 12 years and above who have hemophilia B can use it for on-demand treatment and control of bleeding episodes, for perioperative management, and for routine prophylaxis to reduce the frequency of bleeding episodes. It is not indicated for induction of immune tolerance in patients with hemophilia B.
Pharmacology
Hemophilia B is a hereditary, sex-linked disorder of blood clotting. It happens because the body is short of factor IX. People with the condition can bleed into their joints, muscles or internal organs, sometimes without any obvious cause and sometimes after an accident or surgery. Coagulation Factor IX replaces the missing factor IX, so the deficiency is corrected for a time and the tendency to bleed is corrected with it.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Coagulation Factor IX is for intravenous use only, and only after it has been reconstituted.
It is used for on-demand treatment and control of bleeding episodes, and for managing bleeding around surgery. One international unit (IU) of coagulation factor IX per kg body weight raises the circulating factor IX activity by 0.98 IU/dL.
For the initial dose, the number of factor IX units needed (IU) is worked out as body weight (kg) x desired factor IX increase (% of normal or IU/dL) x the reciprocal of the observed recovery (IU/kg per IU/dL). The maintenance dose depends on the type of bleed or surgery, how serious the hemostatic challenge is, and how many days are needed until the wound has healed adequately.
Pediatric use: The safety and effectiveness of coagulation factor IX have not been established in children below 12 years of age.
Geriatric use: Clinical studies of coagulation factor IX did not include anyone aged 65 and over. It isn't known whether elderly patients respond differently from younger patients. The dose for elderly patients should be individualised.
Side Effects
Side-effect information is not available for this brand yet.
Cautions & Contraindications
Warnings & Precautions
Hypersensitivity reactions, including anaphylaxis, have occurred with Coagulation Factor IX. If symptoms appear, stop Coagulation Factor IX and give appropriate treatment. Some patients may also become hypersensitive to hamster (CHO) protein, which is present in trace amounts in the product. Neutralizing antibodies (inhibitors) to Coagulation Factor IX may develop. If the expected factor IX activity plasma levels are not reached, or if bleeding is not controlled with an appropriate dose, an assay that measures factor IX inhibitor concentration should be done. Nephrotic syndrome has been reported after immune tolerance induction with factor IX products in hemophilia B patients who have factor IX inhibitors. Thromboembolism has occurred with the use of Coagulation Factor IX.
Contraindications
Don't give Coagulation Factor IX to anyone who is known to be hypersensitive to it or to any of its excipients. This includes hamster protein.
Pregnancy & Breastfeeding
There are no data on the use of coagulation factor IX in pregnant women, so any risk linked to the medicine is unknown. Animal reproduction studies have not been done with coagulation factor IX either. In the U.S. general population, the estimated background risk of major birth defect is 2-4% and of miscarriage is 15-20% in clinically recognized pregnancies.
Nothing is known about whether coagulation factor IX passes into human milk, what effect it has on a breastfed infant, or whether it affects milk production. When deciding, weigh the developmental and health benefits of breastfeeding against the mother's clinical need for coagulation factor IX. Also consider any possible adverse effects on the breastfed infant, whether from the medicine or from the mother's underlying condition.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Common questions about Octanine F 500 IU
What is Octanine F 500 IU IV Infusion?
Octanine F 500 IU IV Infusion is a medicine that contains Coagulation Factor IX. It is made by City Overseas Ltd. It belongs to the Anti-fibrinolytic drugs group of medicines.
What is Octanine F used for?
Coagulation Factor IX (Recombinant) is a human blood coagulation factor. Adults and children aged 12 years and above who have hemophilia B can use it for on-demand treatment and control of bleeding episodes, for perioperative management, and for routine prophylaxis to reduce the frequency of bleeding episodes.
Can I take Octanine F during pregnancy or while breastfeeding?
There are no data on the use of coagulation factor IX in pregnant women, so any risk linked to the medicine is unknown. Animal reproduction studies have not been done with coagulation factor IX either. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Do I need a prescription for Octanine F?
Octanine F is a prescription (Rx) medicine. Take it as your doctor advises.