(filgrastim-aafi)

Prescribing Information
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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use NIVESTYM safely and effectively. See full prescribing information for NIVESTYM.

NIVESTYM™ (filgrastim-aafi) injection, for subcutaneous or intravenous use
Initial U.S. Approval: 2018
NIVESTYM (filgrastim-aafi) is biosimilar* to NEUPOGEN (filgrastim).

INDICATIONS AND USAGE

NIVESTYM is a leukocyte growth factor indicated to

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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)
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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)
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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)
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Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis. (1.4)
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Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia. (1.5)

DOSAGE AND ADMINISTRATION

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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)
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Patients with cancer undergoing bone marrow transplantation.
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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)
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Patients undergoing autologous peripheral blood progenitor cell collection and therapy.
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10 mcg/kg/day subcutaneous injection. (2.3)
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Administer for at least 4 days before first leukapheresis procedure and continue until last leukapheresis. (2.3)
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Patients with congenital neutropenia.
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Recommended starting dose is 6 mcg/kg subcutaneous injection twice daily. (2.4)
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Patients with cyclic or idiopathic neutropenia.
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Recommended starting dose is 5 mcg/kg subcutaneous injection daily. (2.4)
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Direct administration of less than 0.3 mL (180 mcg) using NIVESTYM prefilled syringe is not recommended due to potential for dosing errors. (2.5)

DOSAGE FORMS AND STRENGTHS

Vial

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Injection: 300 mcg/mL in a single-dose vial (3)
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Injection: 480 mcg/1.6 mL (300 mcg/mL) in a single-dose vial (3)

Prefilled Syringe

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Injection: 300 mcg/0.5 mL in a single-dose prefilled syringe (3)
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Injection: 480 mcg/0.8 mL in a single-dose prefilled syringe (3)

CONTRAINDICATIONS

Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products. (4)

WARNINGS AND PRECAUTIONS

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Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. (5.1)
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Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever and lung infiltrates or respiratory distress for ARDS.
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Discontinue NIVESTYM in patients with ARDS. (5.2)
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Serious allergic reactions, including anaphylaxis: Permanently discontinue NIVESTYM in patients with serious allergic reactions. (5.3)
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Fatal sickle cell crises: Discontinue NIVESTYM if sickle cell crisis occurs. (5.4)
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Glomerulonephritis: Evaluate and consider dose-reduction or interruption of NIVESTYM if causality is likely. (5.5)
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Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using NIVESTYM in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML. (5.8)
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Thrombocytopenia: Monitor platelet counts. (5.9)

ADVERSE REACTIONS

Most common adverse reactions in patients:

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With nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs (≥ 5% difference in incidence compared to placebo) are pyrexia, pain, rash, cough, and dyspnea. (6.1)
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With AML (≥ 2% difference in incidence) are pain, epistaxis and rash. (6.1)
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With nonmyeloid malignancies undergoing myeloablative chemotherapy followed by BMT (≥ 5% difference in incidence) is rash. (6.1)
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Undergoing peripheral blood progenitor cell mobilization and collection (≥ 5% incidence) are bone pain, pyrexia and headache. (6.1)
•
With severe chronic neutropenia (SCN) (≥ 5% difference in incidence) are pain, anemia, epistaxis, diarrhea, hypoesthesia and alopecia. (6.1)



To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.


*
Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product.
Biosimilarity of NIVESTYM has been demonstrated for the condition(s) of use (e.g. indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.

Revised: 2/2024

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