Patents
NUWIQ® is made under U.S. Patents:
US8329871B2
US8871439B2
US9115381B2
US9120873B2
US9273325B2
US9296799B2
US9388402B2
US9512457B2
US10626431B2
US10822393B2
Last update 11.07.2024
US8329871B2
US8871439B2
US9115381B2
US9120873B2
US9273325B2
US9296799B2
US9388402B2
US9512457B2
US10626431B2
US10822393B2
Last update 11.07.2024
Please see NUWIQ full Prescribing Information. Instructions For Use
Please see NUWIQ full Prescribing Information. Instructions For Use
Indications and Use
NUWIQ® is a recombinant antihemophilic factor [coagulation factor VIII (Factor VIII)] 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. NUWIQ® is not indicated for the treatment of von Willebrand Disease.
Contraindications
NUWIQ is contraindicated in patients who have manifested life-threatening hypersensitivity reactions, including anaphylaxis, to the product or its components.
Warnings and Precautions
Hypersensitivity reactions, including anaphylaxis, are possible with NUWIQ. Early signs of hypersensitivity reactions that can progress to anaphylaxis may include angioedema, chest tightness, dyspnea, wheezing, urticaria, or pruritus. Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur.
The formation of neutralizing antibodies (inhibitors) to Factor VIII can occur following the administration of NUWIQ. Monitor all patients for the development of Factor VIII inhibitors by appropriate clinical observations and laboratory tests. If the plasma Factor VIII level fails to increase as expected, or if bleeding is not controlled after NUWIQ administration, suspect the presence of an inhibitor (neutralizing antibody).
Adverse Reactions
The most frequently occurring adverse reactions (>5%) in clinical trials were upper respiratory tract infection, headache, fever, cough, lower respiratory tract infection, rhinitis, chills, abdominal pain, arthralgia, anemia, and pharyngitis.
Please See NUWIQ full Prescribing Information. Instructions For Use