Rx Item-ZIEXTENZO SY 6MG/0.6ML 0.6ML PF pegfilgrastim-bmez injection by SANDOZ U

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

ZIEXTENZO� (pegfilgrastim-bmez) injection, for subcutaneous use
ZIEXTENZO (pegfilgrastim-bmez) is biosimilar* to NEULASTA� (pegfilgrastim).
Initial U.S. Approval: 2019
INDICATIONS AND USAGE

ZIEXTENZO is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. (1.1)

Limitations of Use

ZIEXTENZO is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
DOSAGE AND ADMINISTRATION

Patients with cancer receiving myelosuppressive chemotherapy

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6 mg administered subcutaneously once per chemotherapy cycle. (2.1)
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Do not administer between 14 days before and 24 hours after administration of cytotoxic chemotherapy. (2.1)
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Use weight based dosing for pediatric patients weighing less than 45 kg; refer to Table 1. (2.2)

DOSAGE FORMS AND STRENGTHS

Injection: 6 mg/0.6 mL solution in a single-dose prefilled syringe for manual use only. (3)
CONTRAINDICATIONS

Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as pegfilgrastim products or filgrastim 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, lung infiltrates, or respiratory distress. Discontinue ZIEXTENZO in patients with ARDS. (5.2)
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Serious allergic reactions, including anaphylaxis: Permanently discontinue ZIEXTENZO in patients with serious allergic reactions. (5.3)
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Fatal sickle cell crises: Have occurred. (5.4)
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Glomerulonephritis: Evaluate and consider dose-reduction or interruption of ZIEXTENZO if causality is likely. (5.5)

ADVERSE REACTIONS

Most common adverse reactions (? 5% difference in incidence compared to placebo) are bone pain and pain in extremity. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

*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 ZIEXTENZO 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.

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

Revised: 11/2019

Rx Item-ZIEXTENZO SY 6MG/0.6ML 0.6ML PF
RX57841-115-02

Rx Item-ZIEXTENZO SY 6MG/0.6ML 0.6ML PF
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