Eflapegrastim

Rolvedon 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 clinically significant incidence of febrile neutropenia. Limitations of Use Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. Rolvedon 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 clinically significant incidence of febrile neutropenia.

Eflapegrastim-xnst is a recombinant human granulocyte growth factor that binds to G-CSF receptors on myeloid progenitor cells and neutrophils, triggering signaling pathways that control cell differentiation, proliferation, migration and survival.

• Recommended Dose: 13.2 mg administered subcutaneously once per chemotherapy cycle. • Administer approximately 24 hours after cytotoxic chemotherapy. Do not administer within the period from 14 days before to 24 hours after administration of cytotoxic chemotherapy.

Rolvedon is contraindicated in patients with a history of serious allergic reactions to eflapegrastim, pegfilgrastim, or filgrastim products. Reactions may include anaphylaxis. Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as eflapegrastim, pegfilgrastim or filgrastim products.

• 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 Rolvedon in patients with ARDS. • Serious allergic reactions, including anaphylaxis: Permanently discontinue Rolvedon in patients with serious allergic reactions. • Sickle Cell Crisis in Patients with Sickle Cell Disorders: Discontinue Rolvedon if sickle cell crisis occurs. • Glomerulonephritis: Evaluate and consider dose-reduction or interruption of Rolvedon if causality is likely. • Leukocytosis: Monitor complete blood count (CBC) during Rolvedon therapy. • Thrombocytopenia: Monitor platelet counts.

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 • Nuclear Imaging The most common adverse reactions (≥20%) are fatigue, nausea, diarrhea, bone pain, headache, pyrexia, anemia, rash, myalgia, arthralgia, and back pain.

Store refrigerated at 36°F to 46°F (2°C to 8°C) in the carton to protect from light. Discard any prefilled syringe left at room temperature for greater than 72 hours. Do not freeze, discard syringe if frozen. Do not shake.