Nuwiq (Simoctocog Alfa)
Recombinant Human Coagulation Factor VIII for Hemophilia A
Nuwiq is a recombinant human coagulation factor VIII (simoctocog alfa) used for the treatment and prevention of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency). Produced in a human cell line, Nuwiq closely resembles naturally occurring factor VIII and is suitable for patients of all ages, from newborns to adults.
Quick Facts
Key Takeaways
- Nuwiq is a recombinant factor VIII produced in human cells, used to treat and prevent bleeding in hemophilia A patients of all ages.
- It is administered by intravenous injection and can be self-administered at home after proper training.
- The most important risk is development of inhibitors (antibodies) that can reduce treatment effectiveness — regular monitoring is essential.
- Nuwiq must be reconstituted before use and injected slowly at no more than 4 ml per minute.
- Store refrigerated at 2–8°C; the powder can be kept at room temperature (max 25°C) for up to one month.
What Is Nuwiq and What Is It Used For?
Quick Answer: Nuwiq contains recombinant human coagulation factor VIII (simoctocog alfa), a protein essential for blood clotting. It is used to treat and prevent bleeding in patients with hemophilia A, a genetic condition where factor VIII is missing or does not function properly. Nuwiq is approved for all age groups.
Hemophilia A is an inherited bleeding disorder caused by a deficiency or absence of coagulation factor VIII, a critical protein in the blood clotting cascade. Without adequate levels of factor VIII, patients experience prolonged and sometimes spontaneous bleeding into joints, muscles, and other tissues. This condition affects approximately 1 in 5,000 male births worldwide, according to the World Federation of Hemophilia (WFH).
Nuwiq provides replacement factor VIII therapy by supplying a recombinant (genetically engineered) form of human factor VIII called simoctocog alfa. Unlike some other recombinant factor VIII products, Nuwiq is produced in a human embryonic kidney (HEK) 293F cell line. This means the protein undergoes human post-translational modifications, including glycosylation patterns that closely resemble naturally occurring factor VIII. The absence of non-human cell-derived proteins may offer advantages in terms of immunogenicity.
Nuwiq is indicated for two primary purposes. First, it is used for on-demand treatment of acute bleeding episodes, where it is administered to stop active bleeding as quickly as possible. Second, it is used for prophylaxis (prevention), where regular injections are given to maintain sufficient factor VIII levels and prevent spontaneous bleeding. Prophylactic treatment is the standard of care recommended by the WFH for patients with severe hemophilia A.
Nuwiq is also used to provide haemostatic cover during surgical procedures, where factor VIII levels must be carefully managed to prevent perioperative bleeding. The European Medicines Agency (EMA) approved Nuwiq for use across all age groups, making it suitable for newborns, children, adolescents, and adults with hemophilia A.
What Should You Know Before Taking Nuwiq?
Quick Answer: Do not use Nuwiq if you are allergic to simoctocog alfa or any of its excipients. Be aware of the risk of inhibitor development, allergic reactions including anaphylaxis, and potential cardiovascular complications. Always inform your healthcare provider about all medications you are taking.
Contraindications
Nuwiq must not be used if you have a known hypersensitivity (allergy) to the active substance simoctocog alfa or to any of the other ingredients in the product. These excipients include sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, and poloxamer 188. If you are uncertain whether you may be allergic to any of these components, consult your healthcare provider before starting treatment.
Warnings and Precautions
Several important warnings and precautions should be considered before and during treatment with Nuwiq:
In very rare cases, severe allergic reactions (anaphylaxis) can occur with Nuwiq. Early signs include skin rash, hives, itchy rash (urticaria) including generalised urticaria, swelling of the lips and tongue, shortness of breath, wheezing, chest tightness, vomiting, restlessness, low blood pressure, and dizziness. If any of these symptoms occur, stop the injection immediately and seek emergency medical attention. Anaphylaxis is a life-threatening emergency requiring immediate treatment with epinephrine.
Inhibitor Development: One of the most significant complications of factor VIII replacement therapy is the development of inhibitors — neutralising antibodies that the immune system produces against the infused factor VIII protein. When present at high levels, these inhibitors prevent the treatment from working effectively. Among previously untreated patients (PUPs), inhibitor development is very common, occurring in more than 1 in 10 patients. Among previously treated patients (PTPs) who have received more than 150 exposure days of factor VIII therapy, the risk is lower, affecting fewer than 1 in 100 patients. Your healthcare team will regularly monitor for inhibitor development through blood tests.
Cardiovascular Risk: In patients with existing cardiovascular risk factors, factor VIII replacement therapy may potentially increase cardiovascular risk. Discuss your cardiovascular history with your physician, especially if you have conditions such as hypertension, coronary artery disease, or a history of thromboembolic events.
Central Venous Access Devices (CVADs): Some patients, particularly young children, may require a central venous catheter for regular intravenous access. If a CVAD is used, the risk of catheter-related complications must be considered, including local infections at the insertion site, bacteraemia (bacteria in the bloodstream), and thrombosis (blood clot formation) at the catheter site.
It is important to record the batch (lot) number each time you use a new package of Nuwiq. Note the date and batch number found on the outer packaging and keep this information in a safe place. This allows traceability of the product in case of any adverse events or product recalls.
Pregnancy and Breastfeeding
Hemophilia A is an X-linked condition that primarily affects males. However, in rare cases, female carriers may have reduced factor VIII levels and experience bleeding symptoms. If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your healthcare provider before using Nuwiq. There are limited data on the use of Nuwiq during pregnancy and lactation, and your physician will assess the benefits and risks on an individual basis.
Driving and Using Machines
Nuwiq has no known effect on the ability to drive or operate machinery. Patients can generally continue their usual activities after administration.
Sodium Content
Each vial of Nuwiq contains 18.4 mg of sodium (a component of table salt), equivalent to approximately 0.92% of the WHO-recommended maximum daily sodium intake for adults. This should be considered by patients on a sodium-restricted diet.
How Does Nuwiq Interact with Other Drugs?
Quick Answer: No specific drug interactions with Nuwiq have been reported in clinical studies. However, you should always inform your physician or pharmacist about all medications you are currently taking, have recently taken, or plan to take, including over-the-counter medicines and supplements.
As a recombinant coagulation factor, Nuwiq operates within the body's natural clotting cascade and is not metabolised by the liver's cytochrome P450 enzyme system. This means that the typical drug-drug interactions seen with small-molecule drugs are generally not expected. Nevertheless, certain clinical considerations are important:
Clinical Considerations
Anticoagulant and antiplatelet medications: If a patient with hemophilia A is also receiving anticoagulants (such as warfarin, heparin, or direct oral anticoagulants) or antiplatelet agents (such as aspirin or clopidogrel) for other medical conditions, the haemostatic balance may be altered. Close coordination between the haemophilia treatment centre and the prescribing physician is essential to avoid both bleeding and thrombotic complications.
Other factor replacement products: Nuwiq should generally not be mixed with other medicinal products in the same syringe or infusion set. If a patient is transitioning between different factor VIII products or from factor VIII to an emicizumab-based prophylaxis, the transition should be managed under specialist supervision.
Fibrinolytic agents: In patients undergoing surgery, particularly oral surgery, antifibrinolytic agents such as tranexamic acid or aminocaproic acid may be used alongside factor VIII replacement to maintain clot stability. This combination is well-established in clinical practice but should be used under medical guidance.
| Drug Category | Examples | Consideration |
|---|---|---|
| Anticoagulants | Warfarin, heparin, DOACs | May alter haemostatic balance; close monitoring required |
| Antiplatelet agents | Aspirin, clopidogrel | May increase bleeding risk; coordinate with specialist |
| Antifibrinolytics | Tranexamic acid, aminocaproic acid | Often used adjunctively, especially in oral surgery |
| Other FVIII products | Advate, Kogenate, Elocta | Do not mix in same syringe; specialist-guided transition |
| Emicizumab | Hemlibra | Special protocols for breakthrough bleeding under emicizumab |
What Is the Correct Dosage of Nuwiq?
Quick Answer: Nuwiq dosage is individualised based on body weight, clinical situation (prevention vs. treatment of bleeding), and the target factor VIII level required. The usual prophylactic dose is 20–40 IU per kg body weight every 2–3 days. Treatment is typically lifelong. Only a physician experienced in hemophilia management should initiate and supervise therapy.
The dose of Nuwiq is calculated in International Units (IU) and is tailored to each patient based on their weight, the severity and location of bleeding, and the desired plasma factor VIII activity level. As a general rule, 1 IU of factor VIII per kg body weight raises the plasma factor VIII activity by approximately 2 IU/dL (2% of normal). Your physician will determine the optimal dose and frequency based on your individual response.
Prophylaxis (Prevention of Bleeding)
Standard Prophylactic Regimen
The usual prophylactic dose is 20 to 40 IU per kg body weight, administered every 2 to 3 days. In some cases, especially in younger patients, more frequent injections or higher doses may be necessary to maintain adequate trough levels and prevent breakthrough bleeding. Treatment for hemophilia A is typically lifelong.
On-Demand Treatment of Bleeding Episodes
When treating an active bleeding episode, the dose is determined by the type and severity of the bleed and the target factor VIII plasma level. The following table provides guidance based on international guidelines:
| Bleeding Type / Surgery | Required FVIII Level (%) | Dose Frequency / Duration |
|---|---|---|
| Early haemarthrosis, muscle bleed, or oral bleeding | 20–40% | Every 12–24 hours for at least 1 day until resolved |
| Extensive haemarthrosis, muscle bleed, or haematoma | 30–60% | Every 12–24 hours for 3–4 days or until pain and disability resolve |
| Life-threatening bleeding | 60–100% | Every 8–24 hours until critical state is overcome |
| Minor surgery (incl. dental extraction) | 30–60% | Every 24 hours for at least 1 day until healing |
| Major surgery | 80–100% (pre- and postoperative) | Every 8–24 hours until adequate wound healing; then maintain 30–60% for at least 7 more days |
Children and Adolescents
Nuwiq is administered to children and adolescents in the same way as to adults. The dose is calculated based on body weight. However, children often have a faster clearance of factor VIII and may require more frequent dosing or higher doses per kilogram compared to adults. In very young children who require frequent intravenous access, a central venous access device (CVAD) may be necessary. The paediatric haematologist will individualise the treatment regimen based on pharmacokinetic assessment and clinical response.
Missed Dose
If you miss a scheduled prophylactic dose of Nuwiq, administer it as soon as you remember. Do not take a double dose to make up for the missed one. Continue with your regular dosing schedule as advised by your physician. If you are unsure about what to do, contact your haemophilia treatment centre for guidance.
Overdose
No cases of overdose with Nuwiq have been reported in clinical studies. If you have accidentally administered more Nuwiq than prescribed, inform your healthcare provider. While no specific symptoms of overdose are known, supraphysiological levels of factor VIII could theoretically increase the risk of thromboembolic events, particularly in patients with cardiovascular risk factors.
Stopping Treatment
Do not stop using Nuwiq without consulting your physician. Stopping factor VIII replacement therapy can lead to uncontrolled bleeding, which can be dangerous, particularly for patients with severe hemophilia A. Treatment decisions should always be made in consultation with your haemophilia specialist.
What Are the Side Effects of Nuwiq?
Quick Answer: Like all medicines, Nuwiq can cause side effects, although not everyone experiences them. The most serious potential side effects include anaphylaxis (very rare) and inhibitor development. Common side effects include hypersensitivity reactions and fever. Most side effects are mild and manageable.
Stop using Nuwiq and seek emergency medical attention immediately if you notice signs of a severe allergic reaction: skin rash, hives, generalised itching, swelling of the lips or tongue, difficulty breathing, wheezing, chest tightness, vomiting, restlessness, low blood pressure, or dizziness. Also contact your doctor immediately if bleeding does not stop or recurs frequently despite treatment, as this may indicate inhibitor development.
Very Common (previously untreated patients)
May affect more than 1 in 10 patients
- Development of inhibitory antibodies (in previously untreated patients)
Common
May affect up to 1 in 10 patients
- Hypersensitivity reactions
- Fever (pyrexia)
Uncommon
May affect up to 1 in 100 patients
- Tingling or numbness (paraesthesia)
- Headache
- Vertigo (spinning sensation)
- Dizziness
- Shortness of breath (dyspnoea)
- Dry mouth
- Back pain
- Injection site inflammation
- Injection site pain
- General feeling of being unwell (malaise)
- Bleeding anaemia
- Anaemia
- Chest pain
- Positive non-neutralising antibody (in previously treated patients)
Very Rare
May affect up to 1 in 10,000 patients
- Anaphylactic shock (severe, life-threatening allergic reaction)
Inhibitor development in previously treated patients: For patients who have previously been treated with factor VIII products (more than 150 exposure days), the risk of developing inhibitors is uncommon, affecting fewer than 1 in 100 patients. If you or your child notice that bleeding episodes are not adequately controlled by Nuwiq, or that the medication seems less effective than before, contact your doctor immediately for inhibitor testing.
If you experience any side effects, including those not listed above, tell your doctor or pharmacist. You can also report side effects to your national pharmacovigilance authority. By reporting side effects, you help provide more information on the safety of this medicine.
How Should You Store Nuwiq?
Quick Answer: Store Nuwiq in a refrigerator at 2–8°C. Do not freeze. The powder can be stored at room temperature (up to 25°C) for a single period of up to 1 month. Use the reconstituted solution immediately. Keep the medicine out of sight and reach of children.
Proper storage of Nuwiq is essential to maintain the stability and effectiveness of the factor VIII protein. Follow these storage guidelines carefully:
- Refrigerated storage: Store the unopened vial in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze the product, as freezing can damage the protein structure.
- Light protection: Keep the vial in the original outer carton to protect from light, as simoctocog alfa is light-sensitive.
- Room temperature storage: Before reconstitution, the powder may be stored at room temperature (not above 25°C / 77°F) for a single continuous period of up to 1 month. Record the date you remove the product from the refrigerator on the outer carton. Once stored at room temperature, do not return it to the refrigerator.
- After reconstitution: The reconstituted solution should be used immediately. Do not store the prepared solution for later use.
- Expiry date: Do not use Nuwiq after the expiry date printed on the carton and vial label after "EXP". The expiry date refers to the last day of that month.
- Visual inspection: Before use, inspect the reconstituted solution. It should be clear, colourless, and free from visible particles. Do not use if the solution appears cloudy or contains particles.
- Tamper evidence: Do not use the product if you notice any signs of tampering with the packaging, particularly with the syringe and/or vial.
Unused medicine or waste material should be disposed of according to local pharmacy guidelines. Do not dispose of medicines via household waste or down the drain. These measures help to protect the environment.
What Does Nuwiq Contain?
Quick Answer: Nuwiq powder contains simoctocog alfa as the active substance, along with excipients including sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, and poloxamer 188. The solvent is water for injections.
Active Substance
The active substance is recombinant human coagulation factor VIII (simoctocog alfa). Each vial of powder contains a specified number of International Units (IU): 250, 500, 1000, 1500, 2000, 2500, 3000, or 4000 IU of simoctocog alfa. After reconstitution with 2.5 ml of water for injections, each ml of the resulting solution contains approximately 100, 200, 400, 600, 800, 1000, 1200, or 1600 IU/ml of simoctocog alfa respectively.
Excipients (Inactive Ingredients)
The powder contains the following excipients:
- Sucrose — a sugar used as a stabiliser to protect the protein during freeze-drying
- Sodium chloride — maintains isotonicity of the reconstituted solution
- Calcium chloride dihydrate — required for factor VIII stability and activity
- Arginine hydrochloride — an amino acid that enhances protein stability
- Sodium citrate dihydrate — a buffering agent to maintain appropriate pH
- Poloxamer 188 — a surfactant that prevents protein aggregation
The solvent is sterile water for injections, supplied in a pre-filled glass syringe containing 2.5 ml.
Appearance and Packaging
The powder is a white to off-white friable powder supplied in a glass vial. After reconstitution, the solution should be clear, colourless, and essentially free from visible particles. Each package contains: 1 vial of powder, 1 pre-filled syringe with 2.5 ml water for injections, 1 vial adapter, 1 butterfly needle, and 2 alcohol swabs.
How Do You Prepare and Administer Nuwiq?
Quick Answer: Nuwiq must be reconstituted with the provided solvent before intravenous injection. Allow components to reach room temperature, dissolve the powder gently without shaking, and inject slowly at no more than 4 ml per minute. Patients can learn to self-administer after proper training.
Proper reconstitution and administration technique are essential for safe and effective treatment. Treatment should initially be supervised by a physician experienced in the management of hemophilia A. After adequate training, patients or their caregivers may administer Nuwiq at home.
Step-by-Step Reconstitution
- Warm to room temperature: Allow the pre-filled syringe with solvent and the sealed powder vial to reach room temperature by holding them in your hands. Do not use any other heating method. Maintain room temperature throughout the preparation.
- Prepare the vial: Remove the plastic snap-off cap from the powder vial to expose the centre of the rubber stopper. Do not remove the grey stopper or the metal ring around the top of the vial.
- Clean the vial top: Wipe the top of the vial with one of the provided alcohol swabs and allow it to dry.
- Attach the adapter: Peel off the paper backing from the adapter package. Without removing the adapter from its package, place it over the centre of the rubber stopper and press down firmly until the adapter spike pierces through. The adapter will click into place around the vial.
- Prepare the syringe: Attach the plunger rod to the syringe by screwing it clockwise into the syringe plunger until you feel slight resistance. Break off the tamper-proof plastic tip from the syringe.
- Remove adapter packaging: Remove and discard the adapter package, leaving the adapter attached to the vial.
- Connect syringe to vial: Attach the solvent syringe to the vial adapter by turning clockwise until firmly connected.
- Dissolve the powder: Slowly push the plunger rod to inject all the solvent into the powder vial. Without removing the syringe, gently swirl or rotate the vial to dissolve the powder. Do not shake. Wait until the powder is completely dissolved.
- Inspect the solution: Check the final solution visually. It should be clear, colourless, and free from particles. Do not use cloudy solutions or those containing precipitates.
- Draw up the solution: Turn the vial (with attached syringe) upside down and slowly draw the entire reconstituted solution into the syringe.
- Disconnect: Unscrew the filled syringe from the adapter by turning counter-clockwise. Discard the empty vial with adapter.
Intravenous Injection
- Clean the selected injection site with the second alcohol swab.
- Attach the provided butterfly (infusion) needle set to the syringe.
- Insert the needle into the chosen vein. If a tourniquet was used to make the vein more visible, release it before starting the injection.
- Inject the solution slowly into the vein at a rate not exceeding 4 ml per minute.
- Blood must not enter the syringe, as there is a risk of fibrin clot formation.
If your prescribed dose requires more than one vial of powder, you may use the same butterfly needle for the sequential injections. The vial adapter and syringe are single-use only and must be discarded after each vial.
Frequently Asked Questions About Nuwiq
Nuwiq is used for the treatment and prevention of bleeding in patients with hemophilia A (congenital factor VIII deficiency). It contains recombinant human coagulation factor VIII (simoctocog alfa) which replaces the missing clotting factor. Nuwiq is suitable for all age groups including newborns, children, adolescents, and adults. It is used both for on-demand treatment of bleeding episodes and for routine prophylaxis to prevent bleeding.
Nuwiq is produced in a human cell line (HEK 293F cells), unlike many other recombinant factor VIII products that are manufactured in hamster cell lines (CHO or BHK cells). This means Nuwiq undergoes human-type post-translational modifications, particularly glycosylation. The absence of non-human cell-derived proteins may potentially offer advantages in terms of reduced immunogenicity, though direct comparative clinical data are limited.
Yes, you can travel with Nuwiq. The powder can be stored at room temperature (up to 25°C) for up to 1 month, making it convenient for travel. Use an insulated bag if temperatures may exceed 25°C. Carry a letter from your physician explaining your condition and need for injectable medication. Keep the product in its original packaging and never freeze it. Once removed from the refrigerator for room temperature storage, note the date and do not return it to the refrigerator.
Factor VIII inhibitors are antibodies produced by the immune system that can neutralise infused factor VIII, making it less effective or ineffective at stopping bleeding. Inhibitor development is more common in patients who have never been treated with factor VIII before (more than 1 in 10) and less common in previously treated patients (fewer than 1 in 100). Signs that inhibitors may have developed include bleeding that does not stop or recurs frequently despite treatment. Regular monitoring through blood tests is essential, and you should notify your doctor immediately if your treatment seems less effective.
Yes, Nuwiq is approved for patients of all ages, including newborns, infants, children, and adolescents. Children and younger patients may require more frequent dosing because they tend to clear factor VIII more quickly than adults. In very young children, a central venous access device (CVAD) may be needed for regular intravenous access. The dosage is always individualised based on body weight, pharmacokinetic response, and clinical outcome, under the supervision of a paediatric haematologist.
If you notice any signs of an allergic reaction during the injection — such as skin rash, hives, swelling, difficulty breathing, wheezing, chest tightness, dizziness, or low blood pressure — stop the injection immediately and seek emergency medical attention. Severe allergic reactions (anaphylaxis) are very rare but require immediate treatment. Always have emergency contact information readily available during self-administration at home.
References
This article is based on the following peer-reviewed sources, international guidelines, and regulatory documents:
- European Medicines Agency (EMA). Nuwiq – Summary of Product Characteristics (SmPC). EMA/671791/2014. Last updated 2023.
- 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
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List, 2023. Geneva: WHO; 2023.
- Mahlangu J, Kuliczkowski K, Engelen ET, et al. Efficacy and safety of rVIII-SingleChain (simoctocog alfa): results of a phase 1/3 multicenter clinical trial in previously treated patients with severe hemophilia A. Thromb Haemost. 2016;116(3):521–529.
- Lissitchkov T, Hampton K, von Drygalski A, et al. Novel, human cell line-derived recombinant factor VIII (simoctocog alfa, Nuwiq) in adults with severe hemophilia A: efficacy and safety. Haemophilia. 2016;22(2):225–231.
- Klukowska A, Szczepanski T, Vrabel A, et al. Simoctocog alfa (Nuwiq) in previously untreated patients with severe hemophilia A: final results of the NuProtect study. Thromb Haemost. 2018;118(4):679–686.
- British National Formulary (BNF). Simoctocog alfa. National Institute for Health and Care Excellence (NICE). Accessed January 2026.
- 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.
Medical Editorial Team
This article has been written and reviewed by our medical editorial team, comprising licensed physicians specialising in haematology and clinical pharmacology. All medical information is evidence-based and follows international guidelines from the WFH, WHO, and EMA. Our editorial process adheres to the GRADE evidence framework to ensure the highest quality of medical content.
Our team includes board-certified specialists with expertise in haematology, coagulation disorders, and clinical pharmacology. All content undergoes a rigorous multi-step review process including medical accuracy verification, evidence grading, and readability assessment. We maintain complete independence from pharmaceutical companies and receive no commercial funding.
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