Efbemalenograstim alfa

1. INDICATIONS AND USAGE 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. Limitations of Use RYZNEUTA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. RYZNEUTA is a leukocyte growth factor 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.

Efbemalenograstim alfa-vuxw is a colony-stimulating factor that acts on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.

2. DOSAGE AND ADMINISTRATION Recommended Dose: 20 mg administered subcutaneously once per chemotherapy cycle. Administer approximately 24 hours after cytotoxic chemotherapy. Do not administer between 14 days before and 24 hours after administration of cytotoxic chemotherapy.

4. CONTRAINDICATIONS RYZNEUTA is contraindicated in patients with a history of serious allergic reactions to granulocyte stimulating factors such as efbemalenograstim alfa-vuxw, pegfilgrastim, or filgrastim products. Patients with a history of serious allergic reactions to granulocyte stimulating factors such as efbemalenograstim alfa-vuxw, pegfilgrastim, or filgrastim products.

5. WARNINGS AND PRECAUTIONS Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue RYZNEUTA in patients with ARDS. Serious allergic reactions, including anaphylaxis: Permanently discontinue RYZNEUTA in patients with serious allergic reactions. Sickle cell crises in Patients with Sickle Cell Disorders: Discontinue RYZNEUTA if sickle cell crisis occurs. Glomerulonephritis: Evaluate and consider dose-reduction or interruption of RYZNEUTA if causality is likely. Thrombocytopenia: Monitor platelet counts. Capillary Leak Syndrome: Monitor patients with symptoms, consider intensive care.

6. ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Splenic Rupture Acute Respiratory Distress Syndrome Serious Allergic Reactions Sickle Cell Crisis in Patients with Sickle Cell Disorders Glomerulonephritis Leukocytosis Thrombocytopenia Capillary Leak Syndrome Potential for Tumor Growth Stimulatory Effects on Malignant Cells Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer Aortitis Most common adverse reactions (≥10%) were nausea, anemia, and thrombocytopenia.

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the carton to protect from light. Discard syringes stored at room temperature for more than 48 hours. Do not freeze. Do not shake.