- High-purity plasma-derived human factor IX concentrate. - Double virus-inactivated (S/D and nanofiltration). - Proven safety and efficacy for prophylaxis and treatment of bleeding in Haemophilia B.
Presentation
Octanine F 500 IU (100 IU/ml) & 250 IU
Therapeutic indications
Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).
Dose
I-On demand treatment
Required units = body weight (kg) x desired factor IX rise (%) (IU/dl) x 0.8
The following can be used to guide dosing in bleeding episodes and surgery:
Hemorrhage
-Mild bleeding: 20-40 IU/Kg repeat infusion every 24 hours, at least for 1 day
-Moderate bleeding : 30-60 IU/Kg repeat infusion every 24 hours for 3-4 days
-Life threatening bleeding: 60-100 IU/Kg repeat infusion every 8-24 hours until threat is resolved
Surgery
-Minor surgery: 30-60 IU /KG repeat infusion every 24 hours at least for 1 day
-Major surgery: 80-100 IU/Kg pre-and postoperative, repeat infusion every 8-24 hours until adequate wound healing then therapy for at least another 7 days to maintain a factor IX activity of 30% to 60% (IU/dl).
II-Prophylaxis:
For long-term prophylaxis against bleedings in patients with severe haemophilia B, the usual doses are 20 to 40 IU of factor IX per kg body weight at intervals of 3 to 4 days. In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary.
III-Continuous infusion
There is not enough data available to recommend continuous infusion of OCTANINE F in surgical procedures.
IV-Paediatric population
In the study conducted in 25 children under 6 years of age, the median dose administered per exposure day was similar for prophylaxis and treatment of bleeding, i.e. 35 to 40 IU/kg BW.
Method of administration
Intravenous use.
The injection or infusion rate should not exceed 2-3 ml per minute.
Contraindications
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Known allergy related reduction of thrombocytes during heparin treatment (heparin – induced thrombocytopenia [HIT] type II).
Undesirable effects
hypersensitivity is RARE, anaphylactic shock, thromboembolic event, nephrotic syndrome, heparin induced thrombocytopenia, pyrexia and anti factor IX antibody are VERY RARE
Shelf life
2years
Biochemical and physical in-use stability has been demonstrated for 72 hours at 25°C. From a microbiological point of view, the reconstituted product should be used immediately. It would not be recommended for longer than 8 hours stored at room temperature (25°C).
Special precautions for storage
Do not store above 25°C.
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
Reference
Octanine® F - Summary of product characteristics