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Novoeight (TUROCTOCOG ALFA)
Novoeight (TUROCTOCOG ALFA) is a recombinant DNA-derived antihemophilic factor VIII product developed by Novo Nordisk A/S. It is used to treat Hereditary factor VIII deficiency disease, also known as Hemophilia A. Novoeight works by replacing the deficient clotting factor VIII in the blood, allowing for proper blood clotting. It is a patented product with a commercial status, and its safety considerations include potential risks of hypersensitivity reactions, thromboembolic events, and the transmission of infectious agents. Novoeight is administered via intravenous injection.
At a glance
| Generic name | TUROCTOCOG ALFA |
|---|---|
| Sponsor | Novo Nordisk |
| Modality | Recombinant protein |
| Therapeutic area | Rare Disease |
| Phase | FDA-approved |
| First approval | 2013 |
Approved indications
- Hereditary factor VIII deficiency disease
Common side effects
- Inhibitors in Previously Untreated Patients (PUPs)
- High titer inhibitors (≥5 BU) in PUPs
- Injection site reaction
- Pyrexia
Key clinical trials
- Pharmacokinetic Comparison of Efanesoctocog Alfa vs Other EHL-rFVIII Products in Participants With Severe Haemophilia A (PHASE1)
- Study for Turoctocog Alfa Treatment Regimen in Iraqi Haemophilia A Patients
- Efficacy and Safety of Turoctocog Alfa Pegol (N8-GP) for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A (pathfinder10) (PHASE3)
- Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A (PHASE3)
- A Study Following Males With Haemophilia A on Prophylaxis With Esperoct®
- Adverse Event Data Collection From the EUHASS Registry on Turoctocog Alfa Pegol
- Post-Marketing Surveillance (Use-results Surveillance) With Esperoct®
- An Observational Research Study of the Health of Joints in People With Haemophilia Taking the Medicine Esperoct
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |