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INDICATIONS
NYPOZI® 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.
• reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML).
• 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.
• mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis.
• 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.
• increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome).
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
• NYPOZI is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors (G-CSFs), such as filgrastim or pegfilgrastim.
WARNINGS AND PRECAUTIONS
Fatal Splenic Rupture
• Splenic rupture, including fatal cases, can occur following the administration of NYPOZI.
• Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
Acute Respiratory Distress Syndrome (ARDS)
• ARDS has been reported in patients receiving NYPOZI.
• Evaluate patients who develop fever and lung infiltrates or respiratory distress for ARDS.
• Discontinue NYPOZI in patients with ARDS.
Serious Allergic Reactions, including Anaphylaxis
• Serious allergic reactions, including anaphylaxis, have been reported in patients receiving NYPOZI.
• Majority of reported events occurred upon initial exposure.
• Provide symptomatic treatment for allergic reactions.
• Allergic reactions, including anaphylaxis, in patients receiving NYPOZI can recur within days after the discontinuation of initial anti-allergic treatment.
• Permanently discontinue NYPOZI in patients with serious allergic reactions.
Fatal Sickle Cell Disorders
• Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim products.
• Discontinue NYPOZI if sickle cell crisis occurs.
Glomerulonephritis
• Has occurred in patients receiving NYPOZI.
• Diagnoses were based on azotemia, hematuria, proteinuria, and renal biopsy.
• Generally, events resolved after dose reduction or discontinuation of NYPOZI.
• If causality is likely, consider dose-reduction or interruption of NYPOZI.
Myelodysplastic Syndrome and Acute Myeloid Leukemia (AML)
Patients with Severe Chronic Neutropenia
• Confirm the diagnosis of SCN before initiating NYPOZI therapy.
• MDS and AML have been reported to occur in the natural history of congenital neutropenia without cytokine therapy.
• Cytogenetic abnormalities, transformation to MDS, and AML have also been observed in patients treated with NYPOZI for SCN.
• Based on available data including a postmarketing surveillance study, the risk of developing MDS and AML appears to be confined to the subset of patients with congenital neutropenia.
• Abnormal cytogenetics and MDS have been associated with the eventual development of myeloid leukemia.
• The effect of NYPOZI on the development of abnormal cytogenetics and the effect of continued NYPOZI administration in patients with abnormal cytogenetics or MDS are unknown. Monitor patients for signs and symptoms of MDS/AML in these settings.
• If a patient with SCN develops abnormal cytogenetics or myelodysplasia, the risks and benefits of continuing NYPOZI should be carefully considered.
Patients with Breast and Lung Cancer
• MDS and AML have been associated with the use of NYPOZI in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings.
Thrombocytopenia
• Thrombocytopenia has been reported in patients receiving NYPOZI.
• Monitor platelet counts.
ADVERSE REACTIONS
The most common adverse reactions in patients:
• with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs are anemia, constipation, diarrhea, oral pain, vomiting, asthenia, malaise, edema peripheral, hemoglobin decreased, decreased appetite, oropharyngeal pain, and alopecia.
• with AML are epistaxis, back pain, pain in extremity, erythema, rash maculo-papular, diarrhea, constipation, and transfusion reaction.
• with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by BMT are rash, hypersensitivity, thrombocytopenia, anemia, hypertension, sepsis, bronchitis, and insomnia.
• undergoing peripheral blood progenitor cell mobilization and collection are bone pain, pyrexia, increased blood alkaline phosphatase, and headache.
• with severe chronic neutropenia are arthralgia, bone pain, back pain, muscle spasms, musculoskeletal pain, pain in extremity, splenomegaly, anemia, upper respiratory tract infection, urinary tract infection, epistaxis, chest pain, diarrhea, hypoesthesia, and alopecia. | 
