NYVEPRIA Highlights

(pegfilgrastim-apgf)

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

NYVEPRIA™ (pegfilgrastim-apgf) injection, for subcutaneous use
Initial U.S. Approval: 2020

NYVEPRIA (pegfilgrastim-apgf) is biosimilar* to NEULASTA (pegfilgrastim) (1)

RECENT MAJOR CHANGES

Warnings and Precautions, Thrombocytopenia (5.7)

04/2021

Warnings and Precautions, Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) (5.10)

04/2021

INDICATIONS AND USAGE

NYVEPRIA 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)

Limitations of Use

NYVEPRIA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. (1)

DOSAGE AND ADMINISTRATION

Patients with cancer receiving myelosuppressive chemotherapy

•
6 mg administered subcutaneously once per chemotherapy cycle. (2.1)
•
Do not administer between 14 days before and 24 hours after administration of cytotoxic chemotherapy. (2.1)
•
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

•
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, lung infiltrates, or respiratory distress. Discontinue NYVEPRIA in patients with ARDS. (5.2)
•
Serious allergic reactions, including anaphylaxis: Permanently discontinue NYVEPRIA in patients with serious allergic reactions. (5.3)
•
Fatal sickle cell crises: Discontinue NYVEPRIA if sickle cell crisis occurs. (5.4)
•
Glomerulonephritis: Evaluate and consider dose-reduction or interruption of NYVEPRIA if causality is likely. (5.5)
•
Thrombocytopenia: Monitor platelet counts. (5.7)
•
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using NYVEPRIA in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML. (5.10)

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 Pfizer Inc. at 1-800-438-1985 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 NYVEPRIA 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: 3/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

NYVEPRIA™ (pegfilgrastim-apgf) injection, for subcutaneous use
Initial U.S. Approval: 2020

NYVEPRIA (pegfilgrastim-apgf) is biosimilar* to NEULASTA (pegfilgrastim) (1)

RECENT MAJOR CHANGES

Warnings and Precautions, Thrombocytopenia (5.7)

04/2021

Warnings and Precautions, Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) (5.10)

04/2021

INDICATIONS AND USAGE

NYVEPRIA 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)

Limitations of Use

NYVEPRIA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. (1)

DOSAGE AND ADMINISTRATION

Patients with cancer receiving myelosuppressive chemotherapy

•
6 mg administered subcutaneously once per chemotherapy cycle. (2.1)
•
Do not administer between 14 days before and 24 hours after administration of cytotoxic chemotherapy. (2.1)
•
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

•
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, lung infiltrates, or respiratory distress. Discontinue NYVEPRIA in patients with ARDS. (5.2)
•
Serious allergic reactions, including anaphylaxis: Permanently discontinue NYVEPRIA in patients with serious allergic reactions. (5.3)
•
Fatal sickle cell crises: Discontinue NYVEPRIA if sickle cell crisis occurs. (5.4)
•
Glomerulonephritis: Evaluate and consider dose-reduction or interruption of NYVEPRIA if causality is likely. (5.5)
•
Thrombocytopenia: Monitor platelet counts. (5.7)
•
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using NYVEPRIA in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML. (5.10)

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 Pfizer Inc. at 1-800-438-1985 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 NYVEPRIA 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: 3/2023
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