Neulasta® (pegfilgrastim) is 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 clinically significant incidence of febrile neutropenia. Neulasta® is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. See More.
Please see Important Safety Information below.
In the pivotal trial, next-day Neulasta® reduced the incidence of febrile neutropenia (FN) and FN-related hospitalization when used every cycle, at the right time.* Please see pivotal trial study design and results below.1
*Do not administer Neulasta® between 14 days before and 24 hours after administration of cytotoxic chemotherapy.
This was an observational study and no formal statistical testing was performed. Descriptive statistics are available.
†Adjusted for baseline clinical and demographic differences between the groups, eg, degree of FN risk of chemotherapy regimen.
The primary endpoint was the overall incidence of FN over four cycles of chemotherapy, measured as ANC < 1,000 × 106/L and one of the following occurring within 24 hours of decreased ANC: Temperature > 38°C, use of specific oral antibiotics (eg, ciprofloxacin, levofloxacin, moxifloxacin, amoxicillin-clavulanate), or use of IV antibiotics.3
CI = confidence interval; FN = febrile neutropenia; ANC = absolute neutrophil count; IV = intravenous.
Phase 3, multicenter, multinational, double-blind, placebo-controlled trial of patients with breast cancer (Neulasta® [n = 463] or placebo [n = 465]) receiving 100 mg/m2 docetaxel Q3W for up to 4 cycles. The key endpoint was the percentage of patients who developed FN (Neulasta® 1% versus placebo 17%, P < 0.001). Also, secondary endpoints were lower for Neulasta®-treated patients as compared to placebo-treated patients (the incidence of hospitalization [1% versus 14%] and IV anti-infective use [2% versus 10%]).
Prospective, observational, US study to describe frequency of FN, adherence, and compliance among patients receiving myelosuppressive chemotherapy for breast, lung, prostate, or NHL malignancies.
G-CSF = granulocyte colony-stimulating factor; IV = intravenous; NHL = non-Hodgkin's lymphoma; PFS = prefilled syringe; Q3W = once every 3 weeks.
Neulasta® Injection: 6 mg/0.6 mL in a single-dose prefilled syringe for manual use only.
Neulasta® Injection: 6 mg/0.6 mL in a single-dose prefilled syringe co-packaged with the on-body injector (OBI) for Neulasta® (Neulasta® Onpro® kit).
A healthcare provider must fill the on-body injector (OBI) with Neulasta® using the co-packaged prefilled syringe and then apply the OBI to the patient’s skin (abdomen or back of arm). The back of the arm may only be used if there is a caregiver available to monitor the status of the OBI. Approximately 27 hours after the OBI is applied to the patient’s skin, Neulasta® will be delivered over approximately 45 minutes. A healthcare provider may initiate administration with the OBI on the same day as the administration of cytotoxic chemotherapy, as long as the OBI delivers Neulasta® no less than 24 hours after the administration of cytotoxic chemotherapy.
The prefilled syringe co-packaged in the Neulasta® Onpro® kit contains additional solution to compensate for liquid loss during delivery through the OBI. If this syringe is used for manual subcutaneous injection, the patient will receive an overdose. If the prefilled syringe for manual use is used with the OBI, the patient may receive less than the recommended dose.
Do not use the OBI to deliver any other drug product except the Neulasta® prefilled syringe co-packaged with the OBI. Use of the OBI has not been studied in pediatric patients.
The OBI should be applied to intact, non-irritated skin on the arm or abdomen.
A missed dose could occur due to an OBI failure or leakage. Instruct patients using the OBI to notify their healthcare professional immediately in order to determine the need for a replacement dose of pegfilgrastim if they suspect that the device may not have performed as intended. If the patient misses a dose, a new dose should be administered by single prefilled syringe for manual use as soon as possible after detection.
Review the Patient Information and Patient Instructions for Use with the patient and provide the instructions to the patient.
Refer to the Healthcare Provider Instructions for Use for the OBI for full administration information.
For any OBI problems, call Amgen at 1-800-772-6436 or 1-844-MYNEULASTA (1-844-696-3852).
Please rotate your tablet to use the Neulasta® Onpro®
Interactive Learning Tool.
Please switch to a tablet or computer to use the Neulasta® Onpro® Interactive Learning Tool.