Neulasta 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. ? Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).
Pegfilgrastim, a Granulocyte Colony-Stimulating Factor (G-CSF) is a pegylated glycoprotein that regulates the production and release of functional neutrophils from bone marrow. Pegfilgrastim is a covalent conjugate of recombinant methionyl human G-CSF (Filgrastim) and monomethoxy polyethylene glycol. Filgrastim is a water soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD) and a 20 kD monomethoxy polyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of filgrastim. The average molecular weight of pegfilgrastim is approximately 39 kD.
Patients with cancer receiving myelosuppressive chemotherapy o 6 mg administered subcutaneously once per chemotherapy cycle. o Do not administer between 14 days before and 24 hours after administration of cytotoxic chemotherapy. o Use weight based dosing for pediatric patients weighing less than 45 kg; refer to Table 1. ? Patients acutely exposed to myelosuppressive doses of radiation o Two doses,6 mg each,administered subcutaneously one week apart. Administer the first dose as soon as possible after suspected or confirmed exposure to myelosuppressive doses of radiation,and a second dose one week after. o Use weight based dosing for pediatric patients weighing less than 45 kg; -
No formal drug interaction studies between Pegfilgrastim and other drugs have been performed. Increased hematopoietic activity of the bone marrow in response to growth factor therapy may result in transiently positive bone-imaging changes. Consider these findings when interpreting bone-imaging results. This medicinal product must not be mixed with other medicinal product, particularly sodium chloride solutions.
Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim. ? Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. ? Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever,lung infiltrates,or respiratory distress. Discontinue Neulasta in patients with ARDS. ? Serious allergic reactions,including anaphylaxis: Permanently discontinue Neulasta in patients with serious allergic reactions. ? The on-body injector for Neulasta uses acrylic adhesive. For patients who have reactions to acrylic adhesives,use of this product may result in a significant reaction. ? Fatal sickle cell crises: Have occurred. ? Glomerulonephritis: Evaluate and consider dose-reduction or interruption of Neulasta if causality is likely. ? Potential device failures: Instruct patients to notify their healthcare provider if they suspect the on-body injector may not have performed as intended.
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Pregnancy: Based on animal data,may cause fetal harm. Nursing Mothers: Caution should be exercised when administered to a nursing woman.
The maximum amount of Pegfilgrastim that can be safely administered in single or multiple doses has not been determined. Single subcutaneous doses of 300 mcg/kg have been administered to 8 healthy volunteers and 3 patients with non-small cell lung cancer without serious adverse effects. These patients experienced a mean maximum Absolute Neutrophil Count (ANC) of 55x109/L, with a corresponding mean maximum WBC of 67x109/L. The absolute maximum ANC observed was 96x109/L with a corresponding absolute maximum WBC observed of 120x109/L.
Pegfilgrastim should be stored in a refrigerator at 2-8°C. Do not freeze. Do not shake. Keep away from light
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