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NIVESTYM™ Highlights (filgrastim-aafi)

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 biosimilar1 to NEUPOGEN (filgrastim).

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). (1.3)
  • Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis. (1.4)
  • 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

  • Patients with cancer receiving myelosuppressive chemotherapy or induction and/or consolidation chemotherapy for AML.
    • 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.
    • 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.
    • 10 mcg/kg/day subcutaneous injection. (2.3)
    • Administer for at least 4 days before first leukapheresis procedure and continue until last leukapheresis. (2.3)
  • Patients with congenital neutropenia.
    • Recommended starting dose is 6 mcg/kg subcutaneous injection twice daily. (2.4)
  • Patients with cyclic or idiopathic neutropenia.
    • Recommended starting dose is 5 mcg/kg subcutaneous injection daily. (2.4)
  • 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

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

Prefilled Syringe

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

  • 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: Have occurred. (5.4)
  • Glomerulonephritis: Evaluate and consider dose-reduction or interruption of NIVESTYM if causality is likely. (5.5)

ADVERSE REACTIONS

Most common adverse reactions in patients:

  • With nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs (≥ 5% difference in incidence compared to placebo) are pyrexia, pain, rash, cough, and dyspnea. (6.1)
  • With AML (≥ 2% difference in incidence) are pain, epistaxis and rash. (6.1)
  • With nonmyeloid malignancies undergoing myeloablative chemotherapy followed by BMT (≥ 5% difference in incidence) is rash. (6.1)
  • 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.

Revised: 7/2018

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