Filgrastim-aafi
Generic Name: filgrastim-aafi
Brand Names:
Nivestym
11 DESCRIPTION Filgrastim-aafi is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. NIVESTYM is produced by Escherichia coli ( E coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. NIVESTYM has a molecular weight of 18‚799 daltons.
Overview
11 DESCRIPTION Filgrastim-aafi is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. NIVESTYM is produced by Escherichia coli ( E coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. NIVESTYM has a molecular weight of 18‚799 daltons.
Uses
1 INDICATIONS AND USAGE NIVESTYM 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).
Dosage
2 DOSAGE AND ADMINISTRATION • Patients with cancer receiving myelosuppressive chemotherapy or induction and/or consolidation chemotherapy for AML. o Recommended starting dose is 5 mcg/kg/day subcutaneous injection, short intravenous infusion (15 to 30 minutes), or continuous intravenous infusion. See Full Prescribing Information for recommended dosage adjustments and timing of administration. ( 2.1 ) • Patients with cancer undergoing bone marrow transplantation. o 10 mcg/kg/day given as an intravenous infusion no longer than 24 hours. See Full Prescribing Information for recommended dosage adjustments and timing of administration. ( 2.2 ) • Patients undergoing autologous peripheral blood progenitor cell collection and therapy. o 10 mcg/kg/day subcutaneous injection.
Side Effects
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 Warnings...
Warnings
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 NIVESTYM in patients with ARDS. ( 5.2 ) • Serious allergic reactions, including anaphylaxis: Permanently discontinue NIVESTYM in patients with serious allergic reactions. ( 5.3 ) • Fatal sickle cell crises: Discontinue NIVESTYM if sickle cell crisis occurs. ( 5.4 ) • Glomerulonephritis: Evaluate and consider dose-reduction or interruption of NIVESTYM if causality is likely. 4 CONTRAINDICATIONS NIVESTYM 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) ] .
Pregnancy
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 products 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).
Storage
Storage Store NIVESTYM in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not leave NIVESTYM in direct sunlight. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard NIVESTYM if frozen more than once. Avoid shaking. Transport via a pneumatic tube has not been studied.
Frequently Asked Questions
What is Filgrastim-aafi used for?▼
1 INDICATIONS AND USAGE NIVESTYM 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).
What are the side effects of Filgrastim-aafi?▼
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 Warnings...
Can I take Filgrastim-aafi during pregnancy?▼
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 products 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).
What are the important warnings for Filgrastim-aafi?▼
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 NIVESTYM in patients with ARDS. ( 5.2 ) • Serious allergic reactions, including anaphylaxis: Permanently discontinue NIVESTYM in patients with serious allergic reactions. ( 5.3 ) • Fatal sickle cell crises: Discontinue NIVESTYM if sickle cell crisis occurs. ( 5.4 ) • Glomerulonephritis: Evaluate and consider dose-reduction or interruption of NIVESTYM if causality is likely. 4 CONTRAINDICATIONS NIVESTYM 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) ] .
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.