What is Nuwiq used for?

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Nuwiq can be used for all age groups.

What is the active ingredient in Nuwiq?

Simoctocogum alfa. Czynnik VIII krzepnięcia krwi ludzki, rekombinowany (Simoctocogum alfa)

What pharmaceutical form is Nuwiq available in?

Nuwiq: Proszek i rozpuszczalnik do sporządzania roztworu do wstrzykiwań 250 j.m. (dożylna)

Is Nuwiq OTC or prescription only?

Nuwiq requires a doctor's prescription.

What are the side effects of Nuwiq?

Summary of the safety profile Hypersensitivity or allergic reactions (which may include angiooedema, burning and stinging at the infusion site, chills, flushing, headache, hives, hypotension, lethargy, nausea, rash, restlessness, tachycardia, tightness of the chest, tingling, urticaria, including generalised urticaria, vomiting, wheezing) have rarely been observed with FVIII preparations and may in some cases progress to severe anaphylaxis (including shock). Development of neutralising antibodie

Who should NOT take Nuwiq?

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Does Nuwiq interact with other medications?

No interaction studies have been performed with Nuwiq.

Can Nuwiq be used during pregnancy?

Animal reproduction studies have not been conducted with factor VIII. Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breast feeding is not available. Therefore, factor VIII should be used during pregnancy and breast-feeding only if clearly indicated. There are no fertility data available.

What ATC class does Nuwiq belong to?

Nuwiq: ATC B02BD02. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Nuwiq

This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.

Nuwiq — Description, Dosage, Side Effects | PillsCard

Pharmacotherapeutic group: Antihaemorrhagics, blood coagulation factor VIII, ATC code: B02BD02. The factor VIII/von Willebrand factor complex consists of two molecules (factor VIII and von Willebrand factor) with different physiological functions. When infused into a haemophiliac patient, factor VIII binds to von Willebrand factor in the patient's circulation. Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X converts prothrombin into thrombin. Thrombin then converts fibrinogen into fibrin and a clot can be formed. Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as results of accidental or surgical trauma. By replacement therapy the plasma levels of factor VIII are increased, thereby temporarily enabling a correction of the factor VIII deficiency and correction of the bleeding tendencies. Adult and adolescent population 12 - 65 years of age Prophylaxis: In a clinical study in 32 adult patients with severe haemophilia A, the median consumption of Nuwiq for prophylaxis was 468.7 IU/kg/month. Treatment of bleeding: The median dose to treat break-through bleeding episodes was 33.0 IU/kg in these patients who were on prophylaxis. In another clinical study, 22 adult patients were treated on demand. In total 986 bleeding episodes were treated with a median dose of 30.9 IU/kg. In general, minor bleeds required slightly lower, and more severe bleeds required up to three-fold higher median doses. Individualised prophylaxis: Individualised PK-based prophylaxis was evaluated in 66 adult PTPs with severe haemophilia A. Following a 1-3 month standard prophylaxis phase (every other day or 3 times weekly dosing), 44 (67%) patients were switched to a dosing regimen based on their PK assessment, and 40 completed the 6 months of prophylaxis according to the assigned dosing and treatment scheme. Of these patients, 34 (85%) were treated twice weekly or less. 33 (82.5%) patients did not experience any bleeds and 36 (90.0%) patients had no spontaneous bleeds. The mean ± SD annualised bleeding rate was 1.2 ± 3.9 and the mean ± SD dose were 52.2 ± 12.2 IU/kg per injection and 99.7 ± 25.6 IU/kg per week. Of note, annualised bleeding rate (ABR) is not comparable between different factor concentrates and between different clinical studies. Paediatric population Data were obtained in 29 previously treated children between 2 and 5 years of age, 31 children between 6 and 12 years of age and one adolescent of 14 years. The median dose per prophylactic infusion was 37.8 IU/kg. Twenty patients used median doses of more than 45 IU/kg. The median consumption of Nuwiq for prophylaxis per month was 521.9 IU/kg. A higher median dose of Nuwiq was required to treat bleedings in children (43.9 IU/kg) than in adults (33.0 IU/kg), and a higher median dose was required to treat moderate to major than minor bleedings (78.2 IU/kg vs. 41.7 IU/kg). Younger children in general required higher median doses (6-12 years: 43.9 IU/kg; 2-5 years: 52.6 IU/kg). These data were corroborated by a long-term follow-up of 49 of these children who were treated for an additional median period of approximately 30 months (range from 9.5 to 52 months); during this period 45% of children had no spontaneous bleeds. Data from 108 previously untreated patients with severe haemophilia A (<1% FVIII:C) were obtained in a prospective open-label clinical study. In the majority of patients prophylactic treatment was initiated after the occurrence of the first bleeding episode requiring treatment.

⚠️ Warnings

The powder should only be reconstituted with the supplied solvent (2.5 mL water for injections) using the supplied injection set. The vial should be gently rotated until all powder is dissolved. After reconstitution, the solution should be drawn back into the syringe. The reconstituted medicinal product should be inspected visually for particulate matter and discoloration prior to administration. The reconstituted medicinal product is a clear, colourless solution, free from foreign particles and has a pH of 6.5 to 7.5. Do not use solutions that are cloudy or have deposits. Instructions for preparation and administration 1. Allow the solvent syringe (water for injections) and the powder in the closed vial to reach room temperature. You can do this by holding them in your hands until they feel as warm as your hands. Do not use any other way to heat the vial and pre-filled syringe. This temperature should be maintained during reconstitution. 2. Remove the plastic flip-off cap from the powder vial to expose the central portions of the rubber stopper. Do not remove the gray stopper or metal ring around the top of the vial. 3. Wipe the top of the vial with an alcohol swab. Allow the alcohol to dry. 4. Peel back the paper cover from the vial adapter package. Do not remove the adapter from the package. 5. Place the powder vial on an even surface and hold it. Take the adapter package and place the vial adapter over the centre of the rubber stopper of the powder vial. Press down firmly the adapter package until the adapter spike penetrates the rubber stopper. The adapter snaps to the vial when done. 6. Peel back the paper cover from the pre-filled syringe package. Hold the plunger rod at the end and do not touch the shaft. Attach the threaded end of the plunger rod to the solvent syringe plunger. Turn the plunger rod clockwise until a slight resistance is felt. 7. Break off the tamper-proof plastic tip from the solvent syringe by snapping the perforation of the cap. Do not touch the inside of the cap or the syringe tip. In case the solution is not used immediately close the filled syringe with the tamper-proof plastic tip for storage. 8. Remove the adapter packaging and discard. 9. Firmly connect the solvent syringe to the vial adapter by turning clockwise until resistance is felt. 10. Slowly inject all solvent into the powder vial by pressing down the plunger rod. 11. Without removing the syringe, gently move or swirl the vial in circles a few times to dissolve the powder. Do not shake. Wait until all the powder dissolves completely. 12. Visually inspect the final solution for particles before administration. The solution should be clear and colourless, practically free from visible particles. Do not use solutions that are cloudy or have deposits. 13. Turn the vial attached to the syringe upside down, and slowly draw the final solution into the syringe. Make sure that the entire content of the vial is transferred to the syringe. 14. Detach the filled syringe from the vial adapter by turning counter clockwise and discard the empty vial. 15. The solution is now prepared for immediate use. Do not refrigerate. 16. Clean the chosen injection site with one of the provided alcohol swabs. 17. Attach the provided infusion set to the syringe. Insert the needle of the infusion set into the chosen vein. If you have used a tourniquet to make the vein easier to see, this tourniquet should be released before you start injecting the solution. No blood must flow into the syringe due to the risk of formation of fibrin clots. 18. Inject the solution into the vein at a slow speed, not faster than 4 mL per minute. If you use more than one vial of powder for one treatment, you may use the same injection needle again. The vial adapter and the syringe are for single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Nuwiq

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