NUWIQ now available!
Leigh Carpenter, RPh, Director of Pharmacy
Last September, the FDA approved NUWIQ, manufactured by Octapharma for treatment of Hemophilia A. NUWIQ is pronounced as “Nu-veek”. It is the first and only recombinant factor VIII derived from a human cell line without chemical modification or protein fusion. NUWIQ is indicated in adults and children with Hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. It is not indicated for the treatment of von Willebrand Disease.
The product became available on January 4th. According to Octapharma, it is the first B-domain deleted recombinant factor VIII produced in a culture without using additives of human or animal origin. In global studies, NUWIQ showed a mean half-life of 17.1 hours in adults, 11.9 hours for children ages 2-5, and 13.1 hours for children ages 6-12. The product is also approved in many countries, including the United Kingdom, Australia, Canada, Germany, Italy, Sweden and Argentina. The dose and duration of therapy depends on the severity of the Factor VIII deficiency, the location and extent of the bleeding, and the patient’s clinical condition.
The package insert states that the dose for routine prophylaxis in adolescents and adults is 30-40 IU/kg every other day or three times weekly. For children ages 2-11, the dose for routine prophylaxis is 30-50 IU/kg every other day or three times weekly.
NUWIQ will be available in 250, 500, 1000 and 2000 IU vial sizes. Each kit contains a pre-filled, easy-to-use 2.5ml syringe for reconstitution and includes a needleless Mix-2-Vial adaptor. It may be stored at refrigerated temperature (35-46 degrees Fahrenheit) up until the expiration date or at room temperature up to 77 degrees for a single period not exceeding three months. After storage at room temperature, do not return to the refrigerator. If you are interested in trying NUWIQ, please contact your Hemophilia Treatment Center physician.