Filgrastim-sndz

1 INDICATIONS AND USAGE ZARXIO is a leukocyte growth factor indicated to • Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti‑cancer drugs associated with a significant incidence of severe neutropenia with fever ( 1.1 ) • Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) ( 1.2 ) • Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) ( 1.3 ) • Mobilize autologous hematopoietic progenitor cells into the...

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: • Splenic Rupture [see Warnings and Precautions ( 5.1 )] • Acute Respiratory Distress Syndrome [see Warnings and Precautions ( 5.2 )] • Serious Allergic Reactions [see Warnings and Precautions ( 5.3 )] • Sickle Cell Disorders [see Warnings and Precautions ( 5.4 )] • Glomerulonephritis [see Warnings and Precautions ( 5.5 )] • Alveolar Hemorrhage and Hemoptysis [see Warnings and Precautions ( 5.6 )] • Capillary Leak Syndrome [see Warnings and Precautions ( 5.7 )] • Myelodysplastic Syndrome [see Warnings and Precautions ( 5.8 )] • Acute Myeloid Leukemia [see Warnings and Precautions ( 5.8 )] • Thrombocytopenia [see Warnings and Precautions ( 5.9 )] • Leukocytosis [see...

8.1 Pregnancy Risk Summary Available data from published studies, including several observational studies of pregnancy outcomes in women exposed to filgrastim products and those who were unexposed, have not established an association with filgrastim product use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). Reports in the scientific literature have described transplacental passage of filgrastim in pregnant women when administered ≤ 30 hours prior to preterm delivery (≤ 30 weeks gestation).

5 WARNINGS AND PRECAUTIONS • Fatal splenic rupture : Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. ( 5.1 ) • Acute respiratory distress syndrome (ARDS) : Evaluate patients who develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue ZARXIO in patients with ARDS. ( 5.2 ) • Serious allergic reactions, including anaphylaxis : Permanently discontinue ZARXIO in patients with serious allergic reactions. ( 5.3 ) • Fatal sickle cell crises : Discontinue ZARXIO if sickle cell crisis occurs. ( 5.4 ) • Glomerulonephritis : Evaluate and consider dose-reduction or interruption of ZARXIO if causality is likely. 4 CONTRAINDICATIONS ZARXIO is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products [see Warnings and Precautions ( 5.3 )] .