FDA approved Neulasta (pegfilgrastim) for Febrile Neutropenia and Acute Radiation SyndromeFDA approved Neulasta to help prevent infections from chemotherapy and radiation.

Neulasta is a leukocyte growth factor. The label does not provide a detailed mechanism of action.

Neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adults and pediatric patients aged newborn and older with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. It is also indicated to increase survival in adults and pediatric patients aged newborn and older acutely exposed to myelosuppressive doses of radiation. Limitations: Not indicated for mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

For cancer patients receiving myelosuppressive chemotherapy: Adults of any weight and pediatric patients weighing 45 kg and greater: 6 mg subcutaneously once per chemotherapy cycle. Pediatric patients weighing less than 45 kg: weight-based dosing per Table 1 (e.g., <10 kg: 0.1 mg/kg; 10-20 kg: 1.5 mg; 21-30 kg: 2.5 mg; 31-44 kg: 4 mg). Do not administer between 14 days before and 24 hours after chemotherapy. For acute radiation syndrome: Adults and pediatric patients weighing 45 kg and greater: two doses of 6 mg subcutaneously one week apart, with the first dose as soon as possible after suspected or confirmed exposure to radiation >2 Gy. Pediatric patients weighing less than 45 kg: weight-based dosing per Table 1. Administer first dose as soon as possible; do not delay if CBC not available. Estimate radiation dose from public health authorities, biodosimetry, or clinical findings. Preparation: Allow to reach room temperature for at least 30 minutes; do not warm otherwise. Discard if left at room temperature >48 hours. Inspect for particulate matter or discoloration; do not use if present. Prefilled syringe for manual use is for single 6 mg/0.6 mL dose only; needle cap contains latex.

Trial data not available in label.

No specific contraindications listed in the label. The label notes that the prefilled syringe needle cap contains dry natural rubber (latex), so persons with latex allergies should not administer this product.

Neulasta is indicated to reduce febrile neutropenia in patients receiving myelosuppressive chemotherapy and to increase survival after acute radiation exposure. It is not indicated for stem cell mobilization. Clinicians should follow dosing guidelines and consider weight-based dosing in pediatric patients.