1.2 Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome Neulasta is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see Dosage and Administration (2.2) and Clinical Studies (14.2)].

2       DOSAGE AND ADMINISTRATION

2.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy The recommended dosage of Neulasta is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle. For dosing in pediatric patients weighing less than 45 kg, refer to Table 1.  Do not administer Neulasta between 14 days before and 24 hours after administration of cytotoxic chemotherapy.

2.2 Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome The recommended dose of Neulasta is two doses, 6 mg each, administered subcutaneously one week apart. For dosing in pediatric patients weighing less than 45 kg, refer to Table 1. Administer the first dose as soon as possible after suspected or confirmed exposure to radiation levels greater than 2 gray (Gy). Administer the second dose one week after the first dose.

Obtain a baseline complete blood count (CBC). Do not delay administration of Neulasta if a CBC is not readily available. Estimate a patient’s absorbed radiation dose (i.e., level of radiation exposure) based on information from public health authorities, biodosimetry if available, or clinical findings such as time to onset of vomiting or lymphocyte depletion kinetics.  

2.3 Administration Neulasta is administered subcutaneously via a single prefilled syringe for manual use or for use with the On-body Injector for Neulasta which is co-packaged with a single prefilled syringe.  Use of the On-body Injector for Neulasta has not been studied in pediatric patients. 

Pediatric Patients weighing less than 45 kg

The Neulasta prefilled syringe is not designed to allow for direct administration of doses less than 0.6 mL (6 mg). The syringe does not bear graduation marks which are necessary to accurately measure doses of Neulasta less than 0.6 mL (6 mg) for direct administration to patients. Thus, the direct administration to patients requiring dosing of less than 0.6 mL (6 mg) is not recommended due to the potential for dosing errors. Refer to Table 1.

Table 1.  Dosing of Neulasta for pediatric patients weighing less than 45 kg  Body Weight Neulasta Dose Volume to Administer
Less than 10 kg* See below* See below*
10 - 20 kg 1.5 mg 0.15 mL
21 - 30 kg 2.5 mg 0.25 mL
31 - 44 kg 4 mg 0.40 mL
*For pediatric patients weighing less than 10 kg, administer 0.1 mg/kg (0.01 mL/kg) of Neulasta.
Visually inspect parenteral drug products (prefilled syringe) for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer Neulasta if discoloration or particulates are observed.

The needle cap on the prefilled syringes contains dry natural rubber (derived from latex); persons with latex allergies should not administer these products.

2.4 Special Healthcare Provider Instructions for the On-body Injector for Neulasta A healthcare provider must fill the On-body Injector with Neulasta using the prefilled syringe and then apply the On-body Injector for Neulasta to the patient’s skin (abdomen or back of arm). The back of the arm may only be used if ther