ghing less than 45 kg, dosing of Neulasta is weight based and is provided in Table 1 [see Dosage and Administration (2.3)]. This dosing regimen is based on population modeling and simulation analyses. The exposure associated with this dosing regimen is expected to provide sufficient pharmacodynamic activity to treat humans exposed to myelosuppressive doses of radiation [see Clinical Pharmacology (12.3)]. The safety of Neulasta at a dose of 6 mg has been assessed on the basis of clinical experience in patients with cancer receiving myelosuppressive chemotherapy.
The efficacy of Neulasta for the acute radiation syndrome setting was studied in a randomized, placebo-controlled non-human primate model of radiation injury. Rhesus macaques were randomized to either a control (n=23) or treated (n=23) cohort. On study day 0, animals (n = 6 to 8 per irradiation day) were exposed to total body irradiation (TBI) of 7.50 ± 0.15 Gy delivered at 0.8 ± 0.03 Gy/min, representing a dose that would be lethal in 50% of animals by 60 days of follow-up (LD50/60). Animals were administered subcutaneous injections of a blinded treatment (control article [5% dextrose in water] or pegfilgrastim [300-319 mcg/kg/day]) on study day 1 and on study day 8. The primary endpoint was survival. Animals received medical management consisting of intravenous fluids, antibiotics, blood transfusions, and other support as required.
Pegfilgrastim significantly (at 0.0014 level of significance) increased 60-day survival in irradiated non-human primates: 91% survival (21/23) in the pegfilgrastim group compared to 48% survival (11/23) in the control group.
16 HOW SUPPLIED/STORAGE AND HANDLING
Neulasta single-use prefilled syringe for manual use
Neulasta is supplied in a prefilled single-use syringe for manual use containing 6 mg pegfilgrastim, supplied with a 27-gauge, 1/2-inch needle with an UltraSafe® Needle Guard.
The needle cap of the prefilled syringe contains dry natural rubber (a derivative of latex).
Neulasta is provided in a dispensing pack containing one sterile 6mg/0.6 mL prefilled syringe (NDC 55513-190-01).
Neulasta prefilled syringe does not bear graduation marks and is intended only to deliver the entire contents of the syringe (6 mg/0.6 mL) for direct administration. Use of the prefilled syringe is not recommended for direct administration for pediatric patients weighing less than 45 kg who require doses that are less than the full contents of the syringe.
Store refrigerated between 36° to 46°F (2° to 8°C) in the carton to protect from light. Do not shake. Discard syringes stored at room temperature for more than 48 hours. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard syringe if frozen more than once.
Neulasta OnproTM kit
Neulasta Onpro kit is provided in a carton containing one sterile prefilled syringe and one sterile On-body Injector for Neulasta (NDC 55513-192-01).
The single-use prefilled syringe contains 0.64 mL of solution that delivers 6 mg/0.6 mL of pegfilgrastim when used with the On-body Injector for Neulasta. The prefilled syringe is supplied with a 27-gauge, 1/2-inch needle with an UltraSafe® Needle Guard. The syringe does not bear graduation marks and is only to be used with the On-body Injector for Neulasta.
The needle cap of the prefilled syringe contains dry natural
