Octanate
Plasma-Derived Human Coagulation Factor VIII for Haemophilia A
Quick Facts About Octanate
Key Takeaways About Octanate
- Essential replacement therapy: Octanate provides the missing coagulation factor VIII that patients with haemophilia A lack, enabling normal blood clot formation and bleeding control
- Dual-purpose use: It can be used both for on-demand treatment of active bleeding episodes and as regular prophylaxis to prevent bleeds in patients with severe haemophilia A
- Inhibitor risk: Development of neutralising antibodies (inhibitors) against factor VIII is a known complication, particularly in previously untreated patients – regular monitoring is essential
- Plasma-derived safety: While manufactured from screened human plasma with viral inactivation steps, a residual risk of pathogen transmission exists – hepatitis A and B vaccination is recommended
- Home treatment possible: After proper training at a haemophilia treatment centre, many patients can learn to reconstitute and self-administer Octanate at home
What Is Octanate and What Is It Used For?
Octanate is a plasma-derived human coagulation factor VIII concentrate used to treat and prevent bleeding in patients with haemophilia A. It belongs to the group of medicines known as coagulation factors and works by replacing the deficient or absent factor VIII protein that is essential for normal blood clotting.
Haemophilia A is an inherited bleeding disorder caused by a deficiency or absence of coagulation factor VIII in the blood. Factor VIII is a critical protein in the intrinsic coagulation cascade – it acts as a cofactor for activated factor IX (factor IXa), accelerating the conversion of factor X to its activated form (factor Xa). Without sufficient factor VIII activity, the blood clotting process is impaired, leading to prolonged or excessive bleeding following injury, surgery, or even spontaneously in severe cases.
Octanate provides exogenous factor VIII derived from pooled human plasma donated by carefully screened donors. When administered intravenously, it restores the plasma level of factor VIII, enabling the formation of stable fibrin clots and achieving haemostasis. The World Federation of Hemophilia (WFH) recognises plasma-derived factor VIII concentrates as an established and effective treatment option for haemophilia A, particularly in settings where recombinant products may not be available or affordable.
Octanate is indicated for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). This includes the management of spontaneous bleeds, trauma-related bleeds, and surgical bleeding, as well as routine prophylactic regimens designed to prevent bleeding episodes and protect joints from haemophilia-related damage (haemophilic arthropathy).
The importance of factor VIII replacement therapy in haemophilia A cannot be overstated. According to the WFH Guidelines for the Management of Hemophilia (2020), regular prophylaxis with factor VIII concentrates significantly reduces the frequency of spontaneous bleeding episodes, particularly into joints and muscles, and prevents the progressive joint destruction that is a hallmark of undertreated severe haemophilia A. Early initiation of prophylaxis, ideally before the onset of joint damage, is recommended as the standard of care for patients with severe haemophilia A (factor VIII activity <1%).
Octanate is manufactured by Octapharma, a global pharmaceutical company specialising in plasma-derived products. The manufacturing process includes solvent/detergent viral inactivation treatment to enhance safety. Octanate is available in three strengths: 250 IU, 500 IU, and 1000 IU per vial, all reconstituted to a concentration of 50 IU/ml (250 IU and 500 IU vials) or 100 IU/ml (1000 IU vial).
What Should You Know Before Using Octanate?
Before using Octanate, inform your doctor about any allergies, previous reactions to factor VIII products, and all other medications you are taking. It is strongly recommended that the product name and batch number are recorded each time you receive a dose of Octanate to maintain traceability.
Your doctor may recommend vaccination against hepatitis A and hepatitis B if you regularly receive treatment with plasma-derived factor VIII products. This is a precautionary measure because, although rigorous viral safety steps are applied during manufacturing, products derived from human plasma carry a theoretical residual risk of transmitting blood-borne infections.
Contraindications
You should not use Octanate if:
- You are allergic to human coagulation factor VIII or any of the other ingredients in the product (sodium citrate, sodium chloride, calcium chloride, glycine)
- You have experienced a previous severe allergic reaction (anaphylaxis) to any factor VIII concentrate
If you are unsure whether any of these conditions apply to you, consult your doctor or pharmacist before using Octanate.
Warnings and Precautions
Talk to your doctor, pharmacist, or nurse before using Octanate. Several important considerations apply to the safe use of this product:
Allergic and hypersensitivity reactions: Octanate contains trace amounts of other human proteins beyond factor VIII. All medicines containing proteins that are injected intravenously can potentially cause allergic reactions. Early signs of hypersensitivity include hives (urticaria), chest tightness, wheezing, low blood pressure, and generalised itching. In rare cases, these reactions may progress to severe anaphylaxis, which is a medical emergency requiring immediate treatment with adrenaline (epinephrine) and supportive care. If any symptoms of allergic reaction occur during infusion, stop the injection immediately and seek medical attention.
Inhibitor development: The development of inhibitors (neutralising antibodies against factor VIII) is a known and clinically significant complication of factor VIII replacement therapy. Inhibitors prevent the infused factor VIII from working properly, making it difficult or impossible to control bleeding with standard doses. You or your child will be monitored regularly for the development of inhibitors through blood tests. The risk is highest in previously untreated patients (PUPs), particularly during the first 20 exposure days, where inhibitor rates can exceed 30%. In previously treated patients (PTPs), the risk is considerably lower. If you or your child experiences a bleed that cannot be controlled with Octanate, inform your doctor immediately, as this may indicate inhibitor development.
Viral safety information: When medicines are manufactured from human blood or plasma, special measures are taken to prevent the transmission of infections to patients. These measures include careful selection of blood and plasma donors to exclude those at risk of carrying infections, testing of individual donations and plasma pools for viral markers, and the inclusion of virus inactivation and removal steps in the manufacturing process. Despite these precautions, the risk of transmitting infectious agents cannot be entirely eliminated.
The safety measures applied during Octanate manufacturing are considered effective against enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV). However, these measures may have limited effectiveness against non-enveloped viruses such as hepatitis A virus (HAV) and parvovirus B19. Parvovirus B19 infection can be particularly serious for pregnant women (risk of foetal infection) and for individuals with compromised immune systems or certain types of anaemia (such as sickle cell disease or haemolytic anaemia).
Pregnancy and Breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Haemophilia A almost exclusively affects males; however, female carriers can occasionally have reduced factor VIII levels and may require factor VIII replacement therapy during pregnancy, delivery, or surgical procedures. The decision to use Octanate during pregnancy or breastfeeding should be made on an individual basis by your treating physician, weighing the benefits against potential risks. There are no adequate and well-controlled studies of Octanate use specifically in pregnant or breastfeeding women, and animal reproduction studies have not been conducted with this product.
Driving and Operating Machinery
No effects on the ability to drive and use machines have been observed with Octanate. The intravenous route of administration and the nature of the active substance do not impair cognitive or motor function. However, if you feel unwell after receiving an infusion, you should wait until symptoms resolve before driving or operating machinery.
Sodium Content
The sodium content of Octanate varies depending on the vial strength:
- 250 IU vial: Contains less than 1 mmol sodium (23 mg) per vial, essentially sodium-free
- 500 IU and 1000 IU vials: Contain up to 40 mg sodium per vial, equivalent to approximately 2% of the WHO recommended maximum daily sodium intake for an adult
This information is relevant for patients on a controlled sodium diet.
How Does Octanate Interact with Other Drugs?
No known drug interactions have been reported between plasma-derived factor VIII products, including Octanate, and other medications. However, Octanate must not be mixed with other medicinal products during infusion. Always inform your doctor about all medicines you are using.
One of the pharmacological advantages of coagulation factor VIII replacement therapy is its very low potential for drug–drug interactions. Unlike small-molecule drugs that are metabolised by hepatic cytochrome P450 enzymes, factor VIII is a large glycoprotein that is cleared through physiological mechanisms distinct from conventional drug metabolism pathways. This means it does not compete with other medications for metabolic enzymes and does not induce or inhibit the metabolism of other drugs.
Nevertheless, several important considerations should be noted when using Octanate in conjunction with other therapies:
| Therapy/Substance | Consideration | Recommendation |
|---|---|---|
| Other IV medications | Physical or chemical incompatibility may occur if mixed in the same infusion line | Do not mix Octanate with any other medicinal products during infusion |
| Antifibrinolytic agents (tranexamic acid, aminocaproic acid) | Often used concurrently in haemophilia to stabilise clots, especially for oral and mucosal bleeding | Can be used together; follow your haemophilia treatment centre’s protocol |
| Desmopressin (DDAVP) | Used to boost endogenous factor VIII in mild haemophilia A; combining with exogenous factor VIII is generally unnecessary | Discuss with your doctor; concurrent use is rarely indicated |
| Emicizumab (Hemlibra) | A bispecific antibody that mimics factor VIII function; factor VIII concentrates may still be needed for breakthrough bleeds or surgery | Used under specialist supervision; factor VIII monitoring is affected by emicizumab |
| Anticoagulants (warfarin, heparin, DOACs) | May counteract the haemostatic effect of factor VIII replacement | Use only when specifically indicated; specialist haematology guidance required |
| NSAIDs (ibuprofen, aspirin) | Can impair platelet function and increase bleeding risk in haemophilia patients | Avoid if possible; use paracetamol (acetaminophen) as a preferred analgesic |
It is critical that patients with haemophilia A avoid non-steroidal anti-inflammatory drugs (NSAIDs), particularly aspirin and ibuprofen, as these medications impair platelet function and can significantly increase the risk and severity of bleeding. Paracetamol (acetaminophen) is recommended as the preferred over-the-counter analgesic for patients with haemophilia. COX-2 selective inhibitors (e.g. celecoxib) may be considered under specialist guidance when anti-inflammatory treatment is specifically required.
Always tell your doctor or pharmacist about all medicines you are currently using, including prescription medications, over-the-counter products, vitamins, and herbal supplements. While Octanate itself has no known pharmacokinetic interactions, your overall treatment regimen for haemophilia A may include other agents that require careful coordination.
What Is the Correct Dosage of Octanate?
Octanate dosing is individualised based on body weight, the severity and location of the bleed, the desired factor VIII level, and the patient’s clinical response. For prophylaxis in severe haemophilia A, the typical dose is 20 to 40 IU per kg body weight every 2 to 3 days.
Octanate must be administered by intravenous injection after reconstitution with the provided solvent. Treatment should be initiated under the supervision of a physician experienced in the management of haemophilia. The dose and frequency of administration are always guided by clinical response, and factor VIII activity levels in the patient’s blood should be monitored during treatment to calculate the appropriate dose and infusion frequency.
Dose Calculation
Factor VIII activity is expressed either as a percentage of normal human plasma or in International Units (IU). One IU of factor VIII activity corresponds to the amount of factor VIII in one millilitre of normal human plasma. The calculation of the required dose is based on the principle that 1 IU of factor VIII per kg body weight raises plasma factor VIII activity by approximately 1.5% to 2% of normal activity.
Dose Calculation Formula
Required dose (IU) = Body weight (kg) × Desired factor VIII increase (%) × 0.5
For example, for a 70 kg patient who requires a factor VIII level increase to 50%: 70 × 50 × 0.5 = 1,750 IU
Treatment of Bleeding Episodes
The target factor VIII level and duration of treatment depend on the severity and type of bleeding. The following table provides guidance based on international haemophilia treatment guidelines:
| Bleed Type / Surgery | Target Factor VIII Level (%) | Dosing Frequency | Duration |
|---|---|---|---|
| Early joint bleed (haemarthrosis) | 20 – 40 | Every 12–24 hours | At least 1 day until pain resolves or healing is achieved |
| Extensive joint bleed or muscle bleed | 30 – 60 | Every 12–24 hours | 3–4 days or more until pain and functional impairment resolve |
| Life-threatening bleed (head, throat, abdomen) | 60 – 100 | Every 8–24 hours | Until the bleed is fully controlled |
| Minor surgery (including dental extraction) | 30 – 60 | Every 24 hours | At least 1 day until healing is achieved |
| Major surgery | 80 – 100 (pre- and post-operative) | Every 8–24 hours | Until adequate wound healing; then maintain 30–60% for at least 7 additional days |
Prophylaxis (Prevention of Bleeding)
Prophylactic Dosing for Severe Haemophilia A
Dose: 20 to 40 IU per kg body weight
Frequency: Every 2 to 3 days
The dose should be adjusted based on individual clinical response. In some cases, shorter dosing intervals or higher doses may be required, particularly in younger patients who may have faster factor VIII clearance rates. The goal of prophylaxis is to maintain a trough factor VIII level above 1% (or higher, depending on the patient’s bleeding phenotype and activity level).
Children
Clinical studies have not demonstrated any specific dosing differences between children and adults. The dosage for children is calculated using the same formula as for adults, based on body weight and the desired factor VIII level increase. However, children – particularly those under 6 years of age – may have a shorter factor VIII half-life and higher clearance rates, which can necessitate more frequent dosing or higher doses to maintain adequate trough levels. Regular monitoring of factor VIII levels is essential in paediatric patients to ensure optimal prophylactic coverage.
Missed Dose
If you miss a scheduled dose of Octanate, administer it as soon as you remember. Do not take a double dose to compensate for the missed one. Continue with your next scheduled dose as directed by your doctor. If you are unsure about what to do, contact your haemophilia treatment centre for advice.
Overdose
No symptoms of overdose with human coagulation factor VIII have been reported. However, the recommended dose should not be exceeded. If you suspect you have administered more Octanate than prescribed, contact your doctor or haemophilia treatment centre for guidance.
Reconstitution and Administration
Octanate is supplied as a powder that must be reconstituted with the provided solvent before use. The reconstitution process should be performed using aseptic technique to prevent microbial contamination:
- Allow both the powder and solvent vials to reach room temperature before preparation. Do not use immediately after removing from the refrigerator.
- Remove the caps from both vials and clean the rubber stoppers with the provided alcohol swabs.
- Using the provided transfer device, connect the solvent vial to the powder vial according to the manufacturer’s instructions. The solvent will flow automatically into the powder vial.
- Gently swirl (do not shake) the powder vial until the powder is completely dissolved. This typically takes less than 10 minutes at room temperature.
- Inspect the reconstituted solution. It should be clear or slightly opalescent. Do not use if it appears cloudy or contains visible particles.
- Draw the solution into the provided syringe and administer by slow intravenous injection at a rate of no more than 2–3 ml per minute.
As a precautionary measure, monitor your pulse rate before and during injection. If you notice a significant increase in pulse rate, reduce the injection speed or temporarily stop the administration. Use the reconstituted solution immediately and only once (single use). Only use the injection equipment provided with the product. Discard any unused solution and all used materials according to local regulations.
What Are the Side Effects of Octanate?
Side effects of Octanate are generally uncommon. The most clinically significant adverse effects include hypersensitivity reactions (rare) and the development of inhibitory antibodies against factor VIII. In previously untreated patients, inhibitor development is very common (more than 1 in 10). Most other side effects are rare.
Like all medicines, Octanate can cause side effects, although not everybody experiences them. Because Octanate is a protein derived from human plasma, the main safety concerns relate to immune-mediated reactions and the theoretical risk of pathogen transmission. If you notice any side effects not listed below, or if any listed side effect becomes severe, tell your doctor immediately.
- Swelling of the face, lips, mouth, tongue, or throat causing difficulty swallowing or breathing (angioedema)
- Sudden wheezing, chest tightness, or difficulty breathing
- Severe drop in blood pressure with dizziness, fainting, or collapse (anaphylactic shock)
- Widespread hives or severe skin rash
- Uncontrolled bleeding despite adequate dosing (may indicate inhibitor development)
Very Common (Previously Untreated Patients Only)
May affect more than 1 in 10 previously untreated patients
- Development of inhibitory antibodies (inhibitors) against factor VIII – most significant in patients who have not previously received factor VIII treatment
Uncommon (Previously Treated Patients)
May affect up to 1 in 100 previously treated patients
- Development of inhibitory antibodies (inhibitors) in patients who have received more than 150 exposure days of factor VIII treatment
Rare
May affect up to 1 in 1,000 people
- Hypersensitivity or allergic reactions including: nausea, vomiting, burning and stinging at the infusion site, chest tightness, palpitations (tachycardia), chills, flushing, headache, hives (urticaria), low blood pressure (hypotension), skin rash, restlessness, drowsiness (lethargy), wheezing
- Fever
Very Rare
May affect up to 1 in 10,000 people
- Severe anaphylactic reaction (anaphylaxis), which may include shock and several of the symptoms described above – requires immediate emergency medical treatment
Understanding Inhibitor Development
Inhibitors are antibodies produced by the patient’s immune system that neutralise the activity of infused factor VIII. This is the most clinically significant complication of factor VIII replacement therapy. When inhibitors are present, Octanate may not work as effectively, and the patient may experience persistent or worsening bleeding despite treatment.
The risk of inhibitor development is highest during the first 50 exposure days, with most inhibitors appearing within the first 20 exposure days. Risk factors for inhibitor development include the severity of the underlying factor VIII gene mutation, family history of inhibitors, ethnicity, treatment intensity (particularly high-dose treatment during immune system challenges such as surgery or infection), and whether the patient has been previously treated. According to published data, approximately 25–35% of previously untreated patients with severe haemophilia A develop inhibitors, while the incidence in previously treated patients is approximately 2–5%.
Regular monitoring for inhibitors is essential and is typically performed using the Bethesda assay or the Nijmegen modification of the Bethesda assay. If inhibitors are detected, your haemophilia treatment specialist will discuss alternative treatment strategies, which may include immune tolerance induction (ITI) therapy, bypassing agents (such as activated prothrombin complex concentrates or recombinant activated factor VII), or emicizumab.
Reporting Side Effects
If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this information. You can also report side effects directly to your national pharmacovigilance authority. By reporting side effects, you can help provide more information on the safety of this medicine.
How Should You Store Octanate?
Store Octanate in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Keep the product in its original packaging to protect from light. Once reconstituted, use the solution immediately.
Proper storage of Octanate is essential to maintain the stability and potency of the factor VIII protein. The following storage guidelines should be strictly followed:
- Refrigerated storage: Store at 2°C to 8°C (36°F to 46°F). Do not freeze the product, as freezing can damage the protein and compromise its effectiveness.
- Light protection: Keep Octanate in the original carton to protect the powder from light exposure, which can degrade the active ingredient.
- Expiry date: Do not use Octanate after the expiry date printed on the label. The expiry date refers to the last day of the stated month.
- After reconstitution: The reconstituted solution should be used immediately. It is intended for single use only. Do not store reconstituted solution for later use.
- Visual inspection: Do not use if the reconstituted solution appears cloudy or contains visible particles that have not dissolved.
- Disposal: Dispose of unused medicine and all used injection materials in accordance with local regulations. Do not dispose of medicines via household waste or wastewater.
Keep all medicines out of the sight and reach of children. If you are travelling with Octanate, use an insulated cooling bag to maintain the required temperature range. Avoid exposing the product to extreme temperatures during transport.
What Does Octanate Contain?
The active substance in Octanate is human coagulation factor VIII derived from pooled human plasma. It is available in three strengths: 250 IU, 500 IU, and 1000 IU per vial, supplied as a powder with accompanying solvent for reconstitution.
Octanate is supplied as a white or slightly yellow powder (which may appear as a friable solid) together with a clear, colourless solvent (water for injections). The product is available in the following presentations:
| Vial Strength | Solvent Volume | Reconstituted Concentration |
|---|---|---|
| 250 IU | 5 ml | 50 IU/ml |
| 500 IU | 10 ml | 50 IU/ml |
| 1000 IU | 10 ml | 100 IU/ml |
Other Ingredients
In addition to the active substance, the powder contains the following excipients:
- Sodium citrate – acts as a stabiliser and buffer
- Sodium chloride – adjusts the tonicity (salt concentration) of the solution
- Calcium chloride – provides calcium ions necessary for the coagulation process
- Glycine – an amino acid used as a stabiliser to protect the factor VIII protein
The solvent is water for injections, a highly purified, sterile water used to dissolve the powder before administration.
Packaging Contents
Each Octanate pack contains:
- 1 vial of Octanate powder
- 1 vial of solvent (water for injections)
- 1 injection equipment set (transfer device, infusion set, disposable syringe)
- 2 alcohol swabs for disinfection
Not all pack sizes may be marketed in all countries. The marketing authorisation holder is Octapharma, and the product is manufactured at Octapharma facilities in Austria, France, and Sweden.
Frequently Asked Questions About Octanate
Plasma-derived factor VIII products like Octanate are manufactured from pooled human plasma collected from screened blood donors. Recombinant factor VIII products are produced using genetically engineered cell lines (typically Chinese hamster ovary or baby hamster kidney cells) and do not contain human plasma. Both types are effective in treating haemophilia A. Plasma-derived products undergo rigorous viral inactivation and removal steps, while recombinant products have a theoretically lower risk of pathogen transmission. The World Federation of Hemophilia considers both plasma-derived and recombinant products acceptable treatment options, and no consistent differences in inhibitor development rates have been demonstrated between the two types in large prospective studies.
Yes, many patients with haemophilia A learn to self-administer their factor VIII concentrates at home after receiving comprehensive training from their haemophilia treatment centre. Home treatment allows for faster treatment of bleeding episodes and is essential for maintaining an effective prophylactic regimen. Training covers proper reconstitution technique, aseptic preparation, venipuncture, intravenous injection, recognition of adverse reactions, and proper disposal of materials. Some patients, particularly younger children, may require a caregiver to administer the product. Your haemophilia treatment team will assess your readiness for home treatment and provide ongoing support.
The most common clinical sign of inhibitor development is that your factor VIII treatment becomes less effective – you may notice that bleeding episodes do not respond as well to your usual dose, or that you need increasingly higher doses to achieve haemostasis. Your haemophilia treatment centre will regularly test for inhibitors through blood tests (Bethesda assay). If you experience bleeding that is difficult to control with your normal dose of Octanate, report this to your doctor immediately. Early detection and management of inhibitors is critical for maintaining effective treatment.
Yes, Octanate is approved for use in patients of all ages, including children. The dosing is the same for children and adults, calculated based on body weight and the desired factor VIII level. However, younger children may have a shorter factor VIII half-life, requiring more frequent dosing. Children, particularly those who are previously untreated, should be monitored carefully for inhibitor development. Early initiation of prophylaxis in children with severe haemophilia A is strongly recommended by the World Federation of Hemophilia to prevent joint damage and improve long-term outcomes.
If you experience any signs of an allergic reaction during infusion – such as hives, chest tightness, wheezing, flushing, dizziness, or swelling of the face or throat – stop the infusion immediately. For mild reactions, your doctor may recommend antihistamines or corticosteroids before future infusions. For severe reactions (anaphylaxis), call your local emergency services immediately. Always have your emergency action plan available and ensure that family members or caregivers know what to do in case of a severe reaction. Report all allergic reactions to your haemophilia treatment centre.
Yes, you can travel with Octanate, but proper planning is essential. Store the product in an insulated cooling bag during transport to maintain the required temperature of 2–8°C. Carry a letter from your haemophilia treatment centre explaining your condition and the need to carry medical supplies, including needles and syringes. This is particularly important for air travel and when crossing international borders. Ensure you carry sufficient supplies for the duration of your trip plus extra in case of delays. Know the location of haemophilia treatment centres at your destination. The World Federation of Hemophilia maintains a directory of treatment centres worldwide.
References
- Srivastava A, Santagostino E, Dougall A, et al. WFH Guidelines for the Management of Hemophilia, 3rd edition. Haemophilia. 2020;26 Suppl 6:1-158. doi:10.1111/hae.14046
- European Medicines Agency (EMA). Octanate – Summary of Product Characteristics. Available from EMA product database.
- Iorio A, Stonebraker JS, Chambost H, et al. Establishing the prevalence and prevalence at birth of hemophilia in males: a meta-analytic approach using national registries. Ann Intern Med. 2019;171(8):540-546. doi:10.7326/M19-1208
- Peyvandi F, Mannucci PM, Garagiola I, et al. A randomized trial of factor VIII and neutralizing antibodies in hemophilia A. N Engl J Med. 2016;374(21):2054-2064. doi:10.1056/NEJMoa1516437
- Manco-Johnson MJ, Abshire TC, Shapiro AD, et al. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia A. N Engl J Med. 2007;357(6):535-544. doi:10.1056/NEJMoa067659
- World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd List (2023). Geneva: World Health Organization.
- International Society on Thrombosis and Haemostasis (ISTH). Guidelines on factor VIII and factor IX inhibitor testing. J Thromb Haemost. 2020.
- Octapharma AG. Octanate Prescribing Information and Patient Information Leaflet. Current approved version.
- Fischer K, Steen Carlsson K, Petrini P, et al. Intermediate-dose versus high-dose prophylaxis for severe hemophilia: comparing outcome and costs since the 1970s. Blood. 2013;122(7):1129-1136. doi:10.1182/blood-2012-12-470898
- Blanchette VS, Key NS, Ljung LR, et al. Definitions in hemophilia: communication from the SSC of the ISTH. J Thromb Haemost. 2014;12(11):1935-1939. doi:10.1111/jth.12672
About Our Medical Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, which includes board-certified specialists in haematology, clinical pharmacology, and internal medicine. Our editorial process follows the GRADE evidence framework and adheres to international guidelines from the World Federation of Hemophilia (WFH), the International Society on Thrombosis and Haemostasis (ISTH), and the European Medicines Agency (EMA).
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