NovoEight
Recombinant Factor VIII for Hemophilia A Treatment and Bleeding Prevention
Quick Facts About NovoEight
Key Takeaways About NovoEight
- Replaces missing factor VIII: NovoEight provides the coagulation factor VIII that is deficient or absent in patients with hemophilia A, enabling normal blood clot formation
- Used for all ages: Approved for treatment and prevention of bleeding in hemophilia A patients from birth through adulthood, including perioperative management
- Inhibitor risk in new patients: Previously untreated patients have a higher risk (more than 1 in 10) of developing factor VIII inhibitors that can reduce treatment effectiveness
- Flexible storage: Can be stored at room temperature (up to 30°C) for up to 9 months, or up to 40°C for up to 3 months, once removed from refrigeration
- Self-administration possible: After proper training from healthcare professionals, patients or caregivers can learn to prepare and inject NovoEight at home
What Is NovoEight and What Is It Used For?
NovoEight contains turoctocog alfa, a recombinant human coagulation factor VIII produced using DNA technology. It is used to treat and prevent bleeding episodes in patients with hemophilia A, a hereditary condition in which the blood does not clot properly due to a deficiency of factor VIII.
Factor VIII is a naturally occurring protein in the blood that plays a critical role in the coagulation cascade – the complex series of chemical reactions that allows blood to form a clot and stop bleeding. In patients with hemophilia A, factor VIII is either absent, present in very low amounts, or does not function properly. Without adequate factor VIII, even minor injuries can lead to prolonged or uncontrolled bleeding, and spontaneous bleeding into joints and muscles can occur.
NovoEight works by replacing the missing or dysfunctional factor VIII. Once infused into the bloodstream, turoctocog alfa functions in the same way as the body's own factor VIII. It acts as a cofactor for activated factor IX (FIXa) in the intrinsic coagulation pathway, facilitating the conversion of factor X to activated factor X (FXa). This step is essential for generating thrombin, which converts fibrinogen to fibrin and ultimately forms a stable blood clot at the site of vascular injury.
NovoEight is manufactured by Novo Nordisk using recombinant DNA technology in Chinese hamster ovary (CHO) cells. The production process does not use any human or animal-derived materials in the cell culture medium, which minimises the theoretical risk of transmitting infectious agents. The final product is a highly purified, third-generation recombinant factor VIII concentrate that is reconstituted with a supplied solvent before intravenous injection.
NovoEight is indicated for the following uses in patients with hemophilia A:
- On-demand treatment: Treatment of acute bleeding episodes, including joint bleeds (haemarthrosis), muscle bleeds, and soft tissue haemorrhages
- Routine prophylaxis: Regular preventive treatment to reduce the frequency and severity of spontaneous bleeding episodes
- Perioperative management: Prevention and control of bleeding during and after surgical procedures, from minor dental extractions to major orthopaedic surgery
Hemophilia A affects approximately 1 in 5,000 male births worldwide. It is an X-linked recessive genetic disorder, meaning it predominantly affects males, while females are typically carriers. The World Federation of Hemophilia (WFH) estimates that over 400,000 people worldwide have hemophilia, though many cases remain undiagnosed, particularly in developing countries. Modern recombinant factor VIII products like NovoEight have significantly improved quality of life and life expectancy for people with hemophilia A.
What Should You Know Before Using NovoEight?
Do not use NovoEight if you are allergic to turoctocog alfa, any of its other ingredients, or hamster proteins. Before starting treatment, inform your doctor if you have previously developed factor VIII inhibitors, as this increases the risk of recurrence.
Contraindications
You should not use NovoEight if any of the following apply to you:
- Allergy to turoctocog alfa or any of the other ingredients in this medicine (listed in the ingredients section below) – symptoms may include rash, hives, itching, swelling, or difficulty breathing
- Allergy to hamster proteins – since NovoEight is produced in Chinese hamster ovary (CHO) cells, trace amounts of hamster-derived proteins may be present. If you have a known allergy to hamster proteins, you must not use this product
If you are unsure whether any of these conditions apply to you, consult your doctor before using NovoEight.
Warnings and Precautions
Talk to your doctor before using NovoEight. There are several important safety considerations to be aware of:
Anaphylaxis and allergic reactions: Although rare, there is a risk of severe, sudden allergic reactions (anaphylaxis) when using NovoEight. Early signs include skin rash, hives, generalised itching, swelling of the lips or tongue, difficulty breathing, wheezing, tightness in the chest, a general feeling of being unwell, and dizziness. If any of these symptoms occur, stop the injection immediately and contact your doctor. Severe allergic reactions may require emergency medical treatment.
Factor VIII inhibitors: Some patients using factor VIII replacement products develop antibodies (inhibitors) against factor VIII. These inhibitors can make NovoEight less effective at preventing or controlling bleeding. If you notice that your bleeding is not being adequately controlled with your usual dose, contact your doctor immediately. Do not increase the dose on your own without medical advice.
The risk of developing inhibitors is particularly high in previously untreated patients (PUPs), especially during the first 20 exposure days to any factor VIII product. In clinical studies, inhibitor development was classified as very common in PUPs (affecting more than 1 in 10 patients). In previously treated patients (PTPs) who have had more than 150 exposure days, the risk is uncommon (affecting fewer than 1 in 100 patients). Your doctor will monitor you or your child closely for inhibitor development through regular blood tests.
Previous inhibitor history: If you have previously been treated with factor VIII products and developed inhibitors, there is an increased risk of this happening again with NovoEight. Always inform your doctor about your complete treatment history with factor VIII products.
Other Medicines and NovoEight
Tell your doctor if you are taking, have recently taken, or might take any other medicines. No specific drug interactions with NovoEight have been reported in clinical studies. However, it is important that your healthcare team has a complete picture of all your medications, including over-the-counter products and supplements, to ensure safe and effective treatment.
Pregnancy and Breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. Hemophilia A is exceedingly rare in women because it is an X-linked recessive disorder. There is limited clinical experience with NovoEight use during pregnancy and breastfeeding, so treatment decisions should be made on an individual basis by your haematologist, carefully weighing the benefits against any potential risks.
Driving and Operating Machinery
NovoEight has no known effect on the ability to drive or use machines. There are no reported cognitive or psychomotor side effects that would impair these activities.
Sodium Content
This medicine contains 30.5 mg sodium (the main component of cooking/table salt) per reconstituted vial. This is equivalent to 1.5% of the recommended maximum daily dietary intake of sodium for an adult. If you are on a controlled sodium diet, inform your doctor, especially if you require multiple vials per infusion.
How Does NovoEight Interact with Other Drugs?
No specific drug interactions have been reported with NovoEight. However, it must not be mixed with other intravenous infusions or medications. Always inform your healthcare provider about all medicines you are using.
Unlike many small-molecule drugs that are metabolised by liver enzymes, NovoEight is a recombinant protein that is cleared from the body through the normal physiological pathways for protein catabolism. It does not interact with cytochrome P450 enzymes or other common drug-metabolising pathways. As a result, pharmacokinetic drug interactions in the traditional sense are not expected.
However, there are important practical considerations when administering NovoEight alongside other treatments:
| Consideration | Details | Recommendation |
|---|---|---|
| Do not mix with other IV solutions | NovoEight must not be mixed with other intravenous infusions or medications in the same syringe or infusion line | Use only the supplied 0.9% sodium chloride solvent for reconstitution |
| Antifibrinolytic agents | Tranexamic acid or aminocaproic acid may be used alongside NovoEight, particularly for dental procedures or mucosal bleeding | Commonly used in combination; follow your haematologist's dosing instructions |
| Central venous access devices | When using CVADs (ports or central lines), the line should be flushed with 0.9% sodium chloride solution before and after NovoEight injection | Use aseptic technique; do not mix with heparin in the same line |
| Emicizumab (Hemlibra) | Patients switching from emicizumab prophylaxis to NovoEight should be monitored carefully, as emicizumab can interfere with coagulation laboratory assays | Coordinate with your haemophilia treatment centre for monitoring during transitions |
| Bypassing agents | In patients with inhibitors, activated prothrombin complex concentrates (aPCC) or recombinant FVIIa may be needed instead of or alongside factor VIII | Use only under specialist supervision at a haemophilia treatment centre |
It is important to emphasise that NovoEight should only be reconstituted with the solvent provided in the package (0.9% sodium chloride solution). Do not use any other diluent. The reconstituted solution should not be further diluted or mixed with any other preparation prior to injection.
What Is the Correct Dosage of NovoEight?
The dose of NovoEight is individualised based on body weight, the severity of the bleeding episode, and the target factor VIII level. For routine prophylaxis, the usual dose is 20 to 50 IU per kilogram body weight, injected every 2 to 3 days. Treatment is initiated and supervised by a haematologist experienced in hemophilia care.
Always use NovoEight exactly as your doctor has told you. The dose is carefully calculated by your haematologist based on your weight, the type and location of bleeding, the severity of your hemophilia, and your individual pharmacokinetic response to factor VIII. Do not change your dose without consulting your doctor.
Routine Prophylaxis (Prevention of Bleeding)
Standard Prophylaxis Regimen
Dose: 20 to 50 IU per kilogram body weight
Frequency: Every 2 to 3 days (every 48–72 hours)
In some cases, particularly in younger patients, more frequent injections or higher doses may be necessary to maintain adequate factor VIII trough levels and prevent breakthrough bleeding. Your doctor will tailor the regimen based on your bleeding pattern and individual pharmacokinetic profile.
On-Demand Treatment of Bleeding Episodes
The dose for treating an acute bleeding episode depends on the severity and location of the bleed. The following table provides general guidance based on international haemophilia treatment guidelines:
| Type of Bleeding | Target FVIII Level | Dose (IU/kg) | Frequency |
|---|---|---|---|
| Early joint bleed (haemarthrosis) | 20–40 IU/dL | 10–20 IU/kg | Every 12–24 hours for 1–3 days |
| Muscle bleed or oral bleeding | 30–60 IU/dL | 15–30 IU/kg | Every 12–24 hours for 2–4 days |
| Major haemorrhage (e.g. head, throat, GI) | 60–100 IU/dL | 30–50 IU/kg | Every 8–24 hours until resolved |
| Minor surgery | 50–80 IU/dL | 25–40 IU/kg | Every 12–24 hours for 3–7 days |
| Major surgery | 80–100 IU/dL (pre-op and day 1–3) | 40–50 IU/kg | Every 8–12 hours initially, then reduce over 10–14 days |
Children and Adolescents
NovoEight can be used in patients of all ages, including neonates. Children under 12 years of age typically require higher doses or more frequent injections than adults because they have a faster clearance rate of factor VIII relative to body weight. This means the factor VIII level decreases more quickly in younger children, requiring more frequent top-up infusions to maintain adequate protection against bleeding.
Paediatric Dosing Considerations
Children under 12 years: Higher doses per kilogram or shorter dosing intervals may be needed. Your haematologist will adjust the regimen based on pharmacokinetic assessments and clinical response.
Adolescents 12 years and older: Can typically use the same dosing regimen as adults.
How NovoEight Is Given
NovoEight is given as an intravenous (IV) injection directly into a vein. The powder must first be reconstituted (dissolved) with the supplied solvent (0.9% sodium chloride solution). The injection should be given slowly over 2 to 5 minutes. Your healthcare team will teach you or your caregiver how to prepare and inject NovoEight so that you can self-administer at home.
Key points about administration:
- Only use the solvent provided in the package for reconstitution
- Gently swirl the vial – do not shake, as this causes foaming
- The reconstituted solution should be clear to slightly opalescent; do not use if it is cloudy or contains visible particles
- Use the reconstituted solution immediately, or within 4 hours at room temperature (up to 30°C), or within 24 hours if refrigerated (2–8°C)
- Do not freeze the reconstituted solution
Missed Dose
If you forget to take a prophylactic dose, contact your doctor for advice on how to compensate. Do not inject a double dose to make up for a missed one. Maintaining a regular injection schedule is important for effective prophylaxis. Consider setting reminders or using a treatment diary to help track your infusion schedule.
Overdose
If you inject more NovoEight than prescribed, contact your doctor immediately or go directly to the hospital. While no specific symptoms of overdose with recombinant factor VIII have been characterised, excessive dosing could theoretically increase the risk of thromboembolic events. Medical monitoring is recommended.
Stopping NovoEight
Do not stop using NovoEight without consulting your haematologist. If you discontinue prophylactic treatment, you will no longer be protected against spontaneous bleeding episodes. Any ongoing bleeding may not be adequately controlled. Your doctor will advise you on the appropriate duration of treatment and any necessary adjustments to your regimen.
What Are the Side Effects of NovoEight?
The most commonly reported side effects of NovoEight are injection site reactions and changes in liver function tests. The most clinically significant risk is the development of factor VIII inhibitors, which is very common in previously untreated patients (more than 1 in 10) and uncommon in previously treated patients (less than 1 in 100).
Like all medicines, NovoEight can cause side effects, although not everybody gets them. If you experience any serious side effects, contact your doctor immediately.
- Difficulty breathing, shortness of breath, or wheezing
- Tightness in the chest
- Swollen lips and tongue
- Skin rash, hives, or generalised itching
- Dizziness or loss of consciousness
- Low blood pressure (pale and cold skin, rapid heartbeat)
- Difficulty swallowing or red/swollen face or hands
These symptoms require immediate emergency treatment. Stop the injection and call emergency services.
Factor VIII Inhibitors
The development of inhibitory antibodies against factor VIII is a known complication of treatment with all factor VIII products. If inhibitors develop, the medicine may stop working properly and you or your child may experience persistent or uncontrolled bleeding. Contact your doctor immediately if this occurs.
Very Common (Previously Untreated Patients)
May affect more than 1 in 10 previously untreated patients
- Development of factor VIII inhibitors (neutralising antibodies)
Common
May affect up to 1 in 10 people
- Changes in liver function tests (elevated transaminases)
- Injection site reactions (redness and itching at the infusion site)
Common (Previously Untreated Patients Only)
May affect up to 1 in 10 previously untreated patients
- Skin redness (erythema)
- Inflammation of a vein (phlebitis)
- Bleeding into a joint (haemarthrosis)
- Bleeding into muscle tissue
- Cough
- Redness around catheter site
- Vomiting
Uncommon
May affect up to 1 in 100 people
- Fatigue
- Headache
- Dizziness
- Difficulty sleeping (insomnia)
- Rapid heart rate (tachycardia)
- Increased blood pressure
- Skin rash
- Fever
- Feeling of warmth
- Muscle stiffness and muscle pain
- Pain in arms and legs
- Swelling of legs and feet
- Joint disease
- Bruising
- Heart attack (myocardial infarction)
Very Rare
May affect up to 1 in 10,000 people
- Severe allergic reaction (anaphylaxis)
Side Effects in Children and Adolescents
The side effects observed in children and adolescents are the same as those seen in adults. No additional or unique adverse effects have been identified in the paediatric population in clinical studies. However, as noted above, the risk of inhibitor development is significantly higher in previously untreated children.
If you experience any side effects not listed here, or if any side effect becomes severe, contact your doctor or pharmacist. Reporting suspected side effects helps ensure ongoing monitoring of the medicine's benefit-risk balance.
How Should You Store NovoEight?
Store unopened NovoEight in a refrigerator at 2–8°C. Do not freeze. The powder can be stored at room temperature (up to 30°C) for a single period of up to 9 months, or at up to 40°C for up to 3 months. Once reconstituted, use immediately or within 4 hours at room temperature.
Proper storage of NovoEight is essential to maintain its effectiveness and safety. Keep this medicine out of the sight and reach of children. Do not use after the expiry date printed on the carton and vial label after “EXP”. The expiry date refers to the last day of the stated month.
Before Reconstitution (Powder Form)
- Primary storage: Refrigerate at 2–8°C. Do not freeze. Keep the vial in the outer carton to protect from light.
- Room temperature storage: The unreconstituted powder may be stored at room temperature (up to 30°C) for a single continuous period of up to 9 months.
- Higher temperature storage: Alternatively, it can be stored above room temperature (30°C up to 40°C) for a single continuous period of up to 3 months.
- Once removed from the refrigerator, do not return it to the refrigerator. Record the date of removal and storage temperature on the outer carton.
After Reconstitution (Solution Form)
- The reconstituted solution should be used immediately for best results.
- If immediate use is not possible: up to 24 hours at 2–8°C, or up to 4 hours at room temperature (up to 30°C or up to 40°C, depending on prior storage conditions).
- Store the reconstituted solution in the vial. If not used immediately, it may lose its sterility and could cause infections.
- Do not freeze the reconstituted solution and do not store it in injection syringes.
Appearance and Disposal
The powder in the vial is white or slightly yellowish. Do not use if the colour has changed. The reconstituted solution should appear clear to slightly opalescent. Do not use the solution if it is cloudy or contains visible particles.
Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment.
What Does NovoEight Contain?
The active substance is turoctocog alfa (human coagulation factor VIII, rDNA). Each vial contains nominally 250, 500, 1000, 1500, 2000, or 3000 IU. The solvent is 0.9% sodium chloride solution for injection.
Active Ingredient
The active substance is turoctocog alfa (human coagulation factor VIII produced by recombinant DNA technology). Each vial of NovoEight contains a nominal amount of turoctocog alfa as follows:
- 250 IU – reconstituted to 62.5 IU/mL
- 500 IU – reconstituted to 125 IU/mL
- 1000 IU – reconstituted to 250 IU/mL
- 1500 IU – reconstituted to 375 IU/mL
- 2000 IU – reconstituted to 500 IU/mL
- 3000 IU – reconstituted to 750 IU/mL
Inactive Ingredients (Excipients)
The other ingredients in the powder are: L-histidine, sucrose, polysorbate 80, sodium chloride, L-methionine, calcium chloride dihydrate, sodium hydroxide, and hydrochloric acid. These excipients help stabilise the factor VIII protein and maintain the appropriate pH and osmolality of the reconstituted solution.
The solvent (diluent) contains: sodium chloride (9 mg/mL, i.e. 0.9%) and water for injections.
Package Contents
Each NovoEight package contains:
- 1 vial with white or slightly yellowish powder
- 1 pre-filled syringe with 4 mL clear, colourless solvent
- 1 plunger rod
- 1 vial adapter
You will also need an infusion set (tubing with butterfly needle), sterile alcohol swabs, gauze pads, and adhesive bandage, which are not included in the NovoEight package.
Marketing Authorisation Holder and Manufacturer
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark. NovoEight is authorised in the European Union by the European Medicines Agency (EMA) and is available in numerous countries worldwide.
How Do You Prepare and Inject NovoEight?
NovoEight must be reconstituted with the supplied solvent before intravenous injection. The preparation involves attaching the vial adapter, connecting the pre-filled syringe, dissolving the powder, and then injecting the solution slowly into a vein over 2 to 5 minutes. Always use aseptic (sterile) technique.
Do not attempt to prepare or inject NovoEight until a doctor or nurse has shown you how to do it properly. Always follow the step-by-step instructions provided with the product. The following is a summary of the key preparation steps:
Step 1: Preparation
- Wash your hands thoroughly and dry them with a clean towel or let them air-dry
- Remove the vial, adapter, and pre-filled syringe from the carton; leave the plunger rod in the carton
- Allow the vial and syringe to reach room temperature (hold them in your hands)
- Remove the plastic cap from the vial and wipe the rubber stopper with a sterile alcohol swab
Step 2: Attach the Adapter and Syringe
- Remove the protective paper from the adapter without touching the adapter spike
- Place the vial on a flat surface and snap the adapter onto the vial
- Attach the plunger rod to the pre-filled syringe by screwing it clockwise
- Remove the syringe cap and screw the syringe onto the adapter
Step 3: Reconstitute
- Push the plunger rod to inject all solvent into the vial
- Gently swirl the vial until all powder is dissolved – do not shake
- Check the solution: it should be clear to slightly opalescent with no particles or discolouration
Step 4: Draw Up and Inject
- Turn the vial upside down with the syringe still attached
- Pull the plunger back to draw the solution into the syringe
- Remove any air bubbles by tapping the syringe and pushing the air back into the vial
- Disconnect the syringe from the adapter
- Attach the infusion set and inject slowly into a vein over 2 to 5 minutes
All equipment is for single use only. Do not reuse any component. Dispose of all used materials safely according to your pharmacist's instructions. Do not mix NovoEight with other intravenous infusions or medications. If multiple vials are needed for a full dose, repeat the reconstitution process with additional vials.
Frequently Asked Questions About NovoEight
NovoEight is used to treat and prevent bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency). It can be used for on-demand treatment of acute bleeds, routine prophylaxis to reduce bleeding frequency, and perioperative management during surgeries. It is approved for all age groups, from neonates to adults.
NovoEight is given as an intravenous injection directly into a vein. The powder must be reconstituted with the supplied 0.9% sodium chloride solvent. The injection should be given slowly over 2 to 5 minutes. After training from your healthcare team, you or a caregiver can learn to prepare and inject NovoEight at home, which is common practice for people with hemophilia.
Factor VIII inhibitors are antibodies produced by the immune system that target and neutralise factor VIII. When inhibitors develop, factor VIII replacement therapy becomes less effective, meaning bleeding episodes may not be adequately controlled. This is the most serious complication of factor VIII treatment. The risk is highest in previously untreated patients (affecting more than 1 in 10). Regular monitoring with blood tests is essential to detect inhibitors early.
Yes, NovoEight is approved for use in patients of all ages, including newborns. Children under 12 years may need higher doses or more frequent injections because they tend to clear factor VIII from their bodies more quickly than adults. Adolescents aged 12 and older can generally use the same dose as adults. Your haematologist will determine the best dosing regimen for your child.
Unopened NovoEight vials should be stored in a refrigerator at 2–8°C (do not freeze). The powder can be taken out of the fridge and stored at room temperature (up to 30°C) for a single period of up to 9 months, or at up to 40°C for up to 3 months. Once removed from the fridge, it must not be returned. After reconstitution, use the solution immediately or within 4 hours at room temperature (24 hours if refrigerated).
Hemophilia A is extremely rare in women as it is an X-linked recessive disorder. There is limited clinical data on the use of NovoEight during pregnancy and breastfeeding. If you are pregnant, breastfeeding, or planning a pregnancy, discuss the risks and benefits with your haematologist, who will advise you on the most appropriate treatment approach.
References
This article is based on the following international medical guidelines and peer-reviewed sources. All medical claims have evidence level 1A, the highest quality of evidence based on systematic reviews of randomised controlled trials.
- 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). NovoEight – Summary of Product Characteristics. EMA product information database. Last updated October 2020. Accessed January 2026.
- Lentz SR, Misgav M, Gomperts E, et al. Results from a large multinational clinical trial (guardian™1) using prophylactic treatment with turoctocog alfa in adolescent and adult patients with severe haemophilia A: safety and efficacy. Haemophilia. 2013;19(5):691–697.
- Kulkarni R, Karim FA, Engell CT, et al. Results from the large multinational clinical trial (guardian™3) using prophylactic treatment with turoctocog alfa in paediatric patients with severe haemophilia A: safety, efficacy and pharmacokinetics. Haemophilia. 2013;19(5):698–705.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd list. Geneva: WHO; 2023.
- World Federation of Hemophilia (WFH). Annual Global Survey 2022. Montreal: WFH; 2023.
- Peyvandi F, Mannucci PM, Garagiola I, et al. A Randomized Trial of Factor VIII and Neutralizing Antibodies in Hemophilia A. New England Journal of Medicine. 2016;374(21):2054–2064.
- Novo Nordisk A/S. NovoEight Patient Information Leaflet. Last revised October 2020.
Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, a group of licensed specialist physicians with expertise in haematology, clinical pharmacology, and internal medicine.
Medical Writers
Board-certified physicians specialising in haematology and clinical pharmacology with documented academic and clinical experience in coagulation disorders.
Medical Reviewers
Independent review board ensuring clinical accuracy, adherence to international guidelines (WFH, EMA, WHO), and evidence level 1A standards.
All content follows the GRADE evidence framework and is reviewed against current international guidelines. We have no commercial funding or pharmaceutical sponsorship. For more information, see our editorial standards and medical team pages.