You have been prescribed Nuwiq® for the treatment and management of your congenital haemophilia A. Haemophilia A is caused by a genetic mutation that prevents the body from making enough factor VIII. Factor VIII is important to help prevent, and or control bleeding.
Nuwiq® is a clotting factor concentrate made using recombinant technology, and contains the active ingredient human coagulation factor VIII.
We have provided some basic information for you about Nuwiq®, recombinant FVIII therapy. If you have a question that is not answered here or in your package leaflet information, please contact your doctor, pharmacist or nurse.
What is Nuwiq®?
Nuwiq® is an injectable medicine that contains human recombinant coagulation factor VIII (simoctocog alfa). Factor VIII is necessary for blood to form clots and to prevent or treat bleeds. In patients with haemophilia A, factor VIII is missing or is not working properly. Nuwiq® replaces the missing factor VIII.
Who can use Nuwiq®?
Nuwiq® is for people with haemophilia A. It may be used by adults and children of all age groups.
How is Nuwiq® produced?
Nuwiq® is produced by recombinant DNA technology in human embryonic kidney (HEK) cells. No animal or human-derived materials are added during the manufacturing process or to the final medicinal product. A film showing the manufacturing process of Nuwiq® is available here.
Why have I been given Nuwiq®?
You have been given Nuwiq® as you have congenital haemophilia A. Nuwiq® is licensed for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Nuwiq® can be used for all age groups.
What can you tell me about inhibitors with Nuwiq®?
The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. Octapharma are currently running a trial in patients that have never had a FVIII product before. The development of inhibitors in these patients will be assessed in this trial.
What are some possible side effects of Nuwiq®?
Like all medicines, this medicine can cause side effects, although not everybody gets them. You should be aware of the early signs of allergic reactions. If severe, sudden allergic reactions (anaphylactic) occur (very rare, up to 1 in 10,000), the injection must be stopped immediately. You must contact your doctor immediately if you notice any of the following symptoms:
- rash, hives, wheals, generalised itching
- swelling of lips and tongue
- difficulty in breathing, wheezing, tightness in the chest
- general feeling of being unwell
- dizziness and loss of consciousness
These symptoms can be early symptoms of an anaphylactic shock. If any of these symptoms occur, stop the injection immediately and contact your doctor. Severe symptoms require prompt emergency treatment.
Uncommon side effects may affect up to 1 in 100 people. These may include tingling or numbness (paraesthesia), headache, injection site inflammation, injection site pain, back pain, vertigo or dry mouth.
What vial sizes does Nuwiq® come in, and what is the reconstituted volume?
Nuwiq® is supplied in packs containing single-use vials of 250, 500, 1000 or 2000 International Units (IU). Packs can be distinguished by colour-coded printing on the label and the box. The reconstituted volume is 2.5 ml for all vial sizes.
What is the correct dose for Nuwiq®?
The correct dose depends on several factors including the extent of the bleeding, the site of bleeding, and whether you are using Nuwiq® to prevent bleeding (known as 'prophlyaxis') or to treat a bleed ('on-demand'). The amount to be administered, and how often to administer it, should be determined by your response to treatment. Your doctor will calculate the dose for you.
How should Nuwiq® be stored?
Nuwiq® should be stored in a refrigerator between 2°C – 8°C, and should not be allowed to freeze. You should keep the vial in the outer carton to protect it from light. Before reconstitution, Nuwiq® may be kept at room temperature (up to 25°C) for a single period not exceeding 1 month. Once Nuwiq® has been taken out of the refrigerator it must not be returned to the refrigerator. Please record the beginning of storage at room temperature on the product carton.
Use the reconstituted solution immediately after reconstitution. The Nuwiq® reconstitution video guide can be found here.
- The efficacy and safety of Nuwiq® was assessed in three pivotal multicentre, multinational studies (GENA-01, GENA-03, and GENA-08).
- GENA-01 - efficacy of on demand treatment and surgical prophylaxis in previously treated patients (PTPs).
- GENA-03 - efficacy and safety in previously treated children.
- GENA-08 - efficacy and safety of prophylactic treatment in PTPs.