Nuwiq (Simoctocog alfa)

Information about Nuwiq (Simoctocog alfa)

Nuwiq (generic name: simoctocog alfa) is a recombinant human coagulation factor VIII used to treat and prevent bleeding episodes in individuals with hemophilia A (a genetic disorder where the blood does not clot properly due to a deficiency in factor VIII). Nuwiq is produced using advanced recombinant DNA technology and is designed to replace the missing or deficient factor VIII in patients with hemophilia A, thereby helping to control bleeding episodes and prevent excessive bleeding during surgery or injury.

Nuwiq is a clotting factor concentrate and is used as part of a comprehensive treatment plan for hemophilia A, which may include on-demand treatment for acute bleeds as well as prophylactic treatment to reduce the occurrence of bleeding episodes.

Product Highlights

• Nuwiq is indicated for the treatment and prevention of bleeding episodes in individuals with hemophilia A (congenital factor VIII deficiency). This includes both on-demand treatment of acute bleeds and preventive (prophylactic) therapy to reduce the frequency of bleeding episodes.
• Nuwiq is used to prevent bleeding during surgical procedures in hemophilia A patients, helping to manage bleeding risk during and after surgery.
• It is also indicated for the control of bleeding episodes in patients with hemophilia A during trauma or injury.

Key Ingredient

• Simoctocog Alfa 

Key Benefits

• Nuwiq helps control and prevent bleeding episodes in hemophilia A patients, providing fast and reliable clotting action.
• Regular prophylactic treatment with Nuwiq reduces the frequency of spontaneous bleeding episodes, allowing patients to lead more active and normal lives.
• Due to its long half-life, Nuwiq may offer more convenient dosing schedules, meaning fewer infusions may be required compared to other factor VIII products.
• Nuwiq is a recombinant product, which eliminates the risks associated with blood-borne infections found in plasma-derived clotting factors, such as HIV or hepatitis.

Direction of Use

• Nuwiq is administered by intravenous (IV) infusion. It is typically infused into a vein, with the rate and frequency of infusion determined by the patient's clinical condition.
• The dose and frequency of Nuwiq are individualized based on factors such as the severity of hemophilia A, the patient’s weight, and the nature of the bleeding episode or surgery. The typical starting dose is 10-20 IU/kg for acute bleeds, with prophylactic treatment often requiring 20-50 IU/kg every 3-4 days, depending on the patient’s needs.
• Nuwiq is supplied as a lyophilized powder that must be reconstituted with a sterile diluent (provided with the product) before infusion. It should be reconstituted and administered under sterile conditions to avoid contamination.

Safety Concerns

• Like other clotting factor concentrates, Nuwiq may cause allergic reactions, including anaphylaxis. Symptoms of an allergic reaction may include a rash, hives, swelling, or difficulty breathing. Patients should be monitored during the infusion, especially during the first few doses.
• Some patients, especially those who have been treated with factor VIII products for a long time, may develop inhibitors (antibodies that attack the factor VIII). The development of inhibitors can reduce the effectiveness of Nuwiq in controlling bleeding episodes.
• There is a risk of thromboembolic complications (e.g., deep vein thrombosis or pulmonary embolism) if too much factor VIII is infused, leading to excessive clotting. Proper dosing and careful monitoring are required.
• While Nuwiq is a recombinant product and carries a lower risk of viral transmission compared to plasma-derived factor VIII, there is still a minimal risk of viral infection. Patients should follow recommended safety precautions.
• Caution should be used when administering Nuwiq to patients with renal impairment, as the drug has not been well studied in this population.

Avoid Nuwiq (Simoctocog alfa) If:

• Nuwiq should not be used in patients with a known allergy or hypersensitivity to simoctocog alfa or any of the ingredients in the product, such as the diluent or stabilizers.
• Patients who have developed inhibitors to factor VIII should not use Nuwiq unless advised by a healthcare provider with expertise in managing inhibitor-related hemophilia A.
• Patients who have experienced severe allergic reactions (e.g., anaphylaxis) to any recombinant coagulation factor VIII products should avoid Nuwiq.
• Nuwiq should be used with caution in patients with conditions that predispose them to thromboembolic events, such as active or recent blood clotting disorders, unless closely monitored.

This product requires special packaging to maintain its integrity during the shipping process. DO NOT USE THIS MEDICATION if the attached temperature indicator shows that the medication was exposed to temperatures below 2 degrees or above 8 degrees Celsius, and contact the pharmacy immediately.