Truxima Approval History
Reviewed by J.Stewart BPharm. Last updated on Nov 28, 2018.
Truxima (rituximab-abbs) is a CD20-directed cytolytic antibody biosimilar to Rituxan indicated for the treatment of adult patients with non-Hodgkin’s lymphoma.
- The product label for Truxima contains a Boxed Warning to alert health care professionals and patients about the increased risk of fatal infusion reactions, severe skin and mouth reactions, Hepatitis B virus reactivation and Progressive Multifocal Leukoencephalopathy.
- The FDA approval of Truxima is based on clinical data that demonstrates Truxima is biosimilar to Rituxan.
- Truxima is administered as an intravenous infusion by a healthcare professional with appropriate medical support to manage severe infusion reactions that may occur.
- Most common side effects reported in clinical trials were infusion reactions, fever, lymphopenia, chills, infection and asthenia.
Development History and FDA Approval Process for Truxima
|Nov 28, 2018||FDA Approves Truxima (rituximab-abbs), a Biosimilar to Rituxan for Non-Hodgkin’s Lymphoma|
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