Zarzio 30 MU/0.5 mL

RELEUKO 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). …

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

RELEUKO is a clear, colorless, preservative-free solution available as: Vial: Injection: 300 mcg/mL in a single-dose vial Injection: 480 mcg/1.6 mL (300 mcg/mL) in a single-dose vial Prefilled Syringe: Injection: 300 mcg/0.5 mL in a single-dose prefilled syringe Injection: 480 mcg/0.8 mL in a single-dose prefilled syringe Vial Injection: 300 mcg/mL in a single-dose vial ( 3 ) Injection: 480 mcg/1. …

• RELEUKO prefilled syringe with BD UltraSafe Plus™ Passive Needle Guard may not accurately measure volumes less than 0.3 mL due to the needle spring mechanism design
• Therefore, the direct administration of a volume less than 0.3 mL using RELEUKO prefilled syringe is not recommended due to the potential for dosing errors
• For direct administration of doses less than 0.3 mL (180 mcg) use RELEUKO single-dose vial. …

Among 855 subjects enrolled in 3 randomized, placebo-controlled trials of filgrastim-treated patients receiving myelosuppressive chemotherapy, there were 232 subjects age 65 or older, and 22 subjects age 75 or older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. …

• Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)
• Review the steps for direct patient administration with patients and caregivers
• Training by the healthcare provider should aim to ensure that patients and caregivers can successfully perform all of the steps in the Instructions for Use of RELEUKO vial and prefilled syringe, including showing the patient or caregiver how to measure the required dose, particularly if a patient is on a dose other than the entire prefilled syringe. …

• RELEUKO is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products [see Warnings and Precautions ]
• Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products

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 RELEUKO in patients with ARDS. ( 5.2 ) Serious allergic reactions, including anaphylaxis: Permanently discontinue RELEUKO in patients with serious allergic reactions. ( 5.3 ) Fatal sickle cell crises: Discontinue RELEUKO if sickle cell crisis occurs. ( 5.4 ) Glomerulonephritis: Evaluate and consider dose-reduction or interruption of RELEUKO if causality is likely. …

The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Splenic Rupture [see Warnings and Precautions ( 5.1 )] Acute Respiratory Distress Syndrome [see Warnings and Precautions ( 5.2 )] Serious Allergic Reactions [see Warnings and Precautions ( 5.3 )] Sickle Cell Disorders [see Warnings and Precautions ( 5.4 )] Glomerulonephritis [see Warnings and Precautions ( 5.5 )] Alveolar Hemorrhage and Hemoptysis [see Warnings and Precautious ( 5.6 )] Capillary Leak Syndrome [see Warnings and Precautions ( 5.7 )] Myelodysplastic Syndrome [see Warnings and Precautions ( 5.8 )] Acute Myeloid Leukemia [see Warnings and Precautions ( 5.8 )] Thrombocytopeni …

8.1 Pregnancy Risk Summary Available data from published studies, including several observational studies of pregnancy outcomes in women exposed to filgrastim products and those who were unexposed, have not established an association with filgrastim product use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes ( see Data ). …

The maximum tolerated dose of filgrastim products has not been determined. In filgrastim clinical trials of patients with cancer receiving myelosuppressive chemotherapy‚ WBC counts > 100‚000/mm 3 have been reported in less than 5% of patients‚ but were not associated with any reported adverse clinical effects. Patients in the BMT studies received up to 138 mcg/kg/day without toxic effects‚ although there was a flattening of the dose response curve above daily doses of greater than 10 mcg/kg/day.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.