In a prospective, noncontrolled, open label, multinational, multi-centre Phase III study (GENA-03) efficacy and safety of Nuwiq® were assessed in a pediatric study that enrolled 59 children aged 2 to 12 years. Fifty-seven (57) of these patients had at least 50 EDs. All patients had at least 50 previous EDs to a FVIII concentrate. The mean prophylactic dose was 38.9 IU/kg, administrated every other day or 3 times per week. A total of 45.8% of the patients did not experience any bleeding while receiving Nuwiq® prophylaxis. The annualized median (range) rate of all bleeding episodes (BEs) was 1.9 (0-20.7), with spontaneous BE rates of 0 (0-13.8) and traumatic BE rates of 1.57 (0-18.6). Prophylaxis with Nuwiq® was assessed to be excellent or good for spontaneous BEs in 96.6% of the patients, for traumatic in 98.3% and for all BEs 91.5% of the patients. Efficacy of Nuwiq® in the treatment of breakthrough bleeding was rated excellent or good for 82.4% of BEs. One or two infusions were sufficient to treat 81.3% of BEs and the median (range) number of infusions required to stop a BE was 1.0 (range 1–22). The mean dose for breakthrough bleeding treatment was 45.1 IU/kg.
PEDIATRIC STUDIES
Efficacy of Nuwiq® assessed in pediatric patients aged 2 to 12 years in the GENA-03 study
Design: Prospective, non-controlled, open-label, multinational, multi-centre, Phase III study
Dosing: PK and IVR: 50 IU/kg, in comparison to previously given FVIII product (in 50% of patients)
Prophylactic treatment: 30–40 IU FVIII/kg every other day or 3 times weekly. Two dose escalations of +5 IU/kg each allowed in case of an inadequate response (>2 spontaneous BEs during 1 month)
Treatment of BEs:
Minor BEs:
20–30 IU FVIII/kg every 12–24 h until BE resolution
Moderate to major BEs:
30–40 IU FVIII/kg every 12–24 h until BE resolution
Major to life threatening BEs:
Initial dose of 50–60 IU FVIII/kg and then a dose of 20–25 IU FVIII/kg every 8–12 h until BE resolution
Duration: >50 EDs and >6 months
Participants: 59 male PTPs with severe hemophilia A, age 6.1 years (mean), (range of 2-12)
safety information
Nuwiq® is indicated for the treatment and prophylaxis of bleeding in patients of all ages suffering with hemophilia A (congenital factor VIII deficiency).
Nuwiq® is also indicated for the peri-operative treatment of hemophilia A patients.
Pediatrics (< 12 years of age): Half-life (T1/2) and incremental in vivo recovery (IVR) are slightly lower in children than in adults and clearance is slightly higher. Efficacy in prophylaxis and the treatment of bleeds is comparable between children and adults. Data indicate that Nuwiq® is equally efficacious and safe in this population.
Nuwiq® is contraindicated for patients who are hypersensitive to the active substance or to any ingredient in the formulation or component of the container.
- It is essential to confirm the deficiency of FVIII before starting treatment with Nuwiq®.
- Nuwiq® powder should be reconstituted according to directions and using only the supplied solvent (2.5 mL water for injection) and the supplied injection set to ensure optimal effectiveness and safety.
- Transmission of infectious viruses can result from use of contaminated needles or accidental puncture with contaminated needles.
- Strongly recommended that every time Nuwiq® is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
- All patients treated with Nuwiq® should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests
Allergic-type hypersensitivity reactions are possible. - Risk of central venous access device (CVAD)-related complications.
- Do not use this medicine after the expiry date stated on the label or if signs of deterioration of the tamper-proof packaging, especially of the syringe and/or the vial, are visible.
- Pregnant and Nursing Women: animal reproduction studies have not been conducted with Nuwiq® and it has not been used in women. Nuwiq® should be used during pregnancy and lactation only if clearly indicated.
Please consult the product monograph at https://www.octapharma.ca/en/therapies/product-overview/ for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed on this site. The product monograph is also available by calling us at 1-888-438-0488 or by contacting us via email: medinfo@octapharma.ca
Health professionals may report adverse reactions to adr.canada@octapharma.com. You can also report any suspected Adverse Reactions directly to the Canada Vigilance Program (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html).
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