Ryzneuta FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 23, 2023.

FDA Approved: Yes (First approved November 16, 2023)
Brand name: Ryzneuta
Generic name: efbemalenograstim alfa-vuxw
Dosage form: Injection
Company: Evive Biotech
Treatment for: Neutropenia Associated with Chemotherapy

Ryzneuta (efbemalenograstim alfa-vuxw) is a leukocyte growth factor to used to reduce the duration of febrile neutropenia in patients treated with chemotherapy for certain types of cancer.

• Ryzneuta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
• Febrile neutropenia refers to the occurrence of a fever during a period of significant neutropenia (reduced levels of neutrophils), and is a common and serious complication in patients undergoing anticancer treatments due to the increased risk of infection.
• Ryzneuta works as a colony-stimulating factor to help stimulate the growth of neutrophils.
• Ryzneuta is administered subcutaneously once per chemotherapy cycle, approximately 24 hours after cytotoxic chemotherapy.
• Warnings and precautions associated with Ryzneuta include fatal splenic rupture, acute respiratory distress syndrome, serious allergic reactions, sickle cell crises in patients with sickle cell disorders, glomerulonephritis, thrombocytopenia, capillary leak syndrome, and myelodysplastic syndrome and acute myeloid leukemia in patients with breast and lung cancer.
• Common adverse reactions include nausea, anemia, and thrombocytopenia.

Development timeline for Ryzneuta

Further information

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