Product Details

Therapeutic indications

- Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). 

- Octanate can be used for all age groups. 

- This preparation does not contain von Willebrand factor in pharmacologically effective quantities and is therefore not indicated in von Willebrand’s disease.

Key features of octanate®

Over 20 years of clinical experience:
Proven efficacy and safety profile in the treatment and prevention of bleeding in patients of all ages with hemophilia A1.

Efficacy and reassuring incidence of inhibitors in previously untreated patients (PUPs)

- 90% of PUPs inhibitor free;
- No inhibitors in patients with non-null F8 mutations;
- Haemostatic efficacy rated as “excellent” in 99.6% of infusions;
- Haemostatic efficacy rated as “excellent” in 100% of surgical procedures.

Effective inhibitor removal, even in patients with poor prognosis for ITI success

- Inhibitors eliminated in 79.2% of patients in median time of 3.9 months.
- Complete ITI success in 71% patients in a median time of 10.9 months.
- 86% reduction in mean monthly bleeding rate after inhibitor elimination.
In 48 patients in an interim analysis of the ObsITI study2

Dose

I- On-demand treatment 
Required units = body weight (kg) x desired factor VIII rise (%) (IU/dl) x 0.5 
The following can be used to guide dosing in bleeding episodes and surgery:

Hemorrhage
-Mild bleeding: 20-40 IU/Kg repeat infusion every 12-24 hours, at least for 1 day
-Moderate bleeding : 30-60 IU/Kg repeat infusion every 12-24 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 VIII activity of 30% to 60% (IU/dl).

II- Prophylaxis
For long-term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20 to 40 IU of factor VIII per kg body weight
at intervals of 2 to 3 days. In some cases, especially in younger patients, shorter dosage intervals or higher does may be necessary.

Method of administration

Intravenous use.
It is recommended not to administer more than 2–3 mL per minute.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Undesirable effects

Rare Hypersensitivity, anaphylactic shock, pyrexia.
Uncommon FVIII inhibitors in Previously treated patients (PTPs) but common in Previously Untreated Patients (PUPs).

Shelf life

2 years
The reconstituted solution must be used immediately and for single use only.

Special precautions for storage

Store in a refrigerator (2°C - 8°C).
Do not freeze.
Keep the vials in the outer carton in order to protect from light.

References

1. Octanate Summary of Product Characteristics.
2. Kreuz W et al. Haemophilia 2016; 22:87-95.
3. Klukowska A et al. Haemophilia 2018; 24:211-8.