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... Read
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Neulasta® is not
indicated for the mobilization of peripheral blood
progenitor cells for hematopoietic stem cell transplantation.
Onpro® has broad national coverage and financial support options for any insurance type4
G-CSF = granulocyte colony-stimulating factor; FN = febrile neutropenia; OBI = on-body injector.
Pivotal trial study design and results3
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% vs 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% vs 14%] and IV anti-infective use [2% vs 10%]).
FN defined as temperature ≥ 38.2°C and absolute neutrophil count < 0.5 x 109/L; Q3W = once every 3 weeks; IV = intravenous.
Onpro® is designed to automatically deliver pegfilgrastim ~27 hours after application.‡
‡Incomplete doses have been reported with Neulasta® Onpro® due to device not performing as intended. This may increase risk of neutropenia, FN, and/or infection.
Listen to expert perspective on keeping patients' treatment plans on track
Contraindication
Splenic Rupture
Acute Respiratory Distress Syndrome (ARDS)
Serious Allergic Reactions
Allergies to Acrylics
Use in Patients With Sickle Cell Disorders
Glomerulonephritis
Leukocytosis
Thrombocytopenia
Capillary Leak Syndrome (CLS)
Potential for Tumor Growth Stimulatory Effects on Malignant Cells
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients With Breast and Lung Cancer
Potential Device Failures
Aortitis
Nuclear Imaging
Most common adverse reactions
Please see Neulasta® full Prescribing Information.
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).
Special Instructions for the On-body Injector (OBI) for Neulasta®
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 1-800-772-6436 or 1-844-MYNEULASTA (1-844-696-3852). 1-844-MYNEULASTA (1-844-696-3852).
References:
1. Yang BB, et al. Cancer Chemother Pharmacol. 2015;75:1199-1206.
2. Kirshner JJ, et al. Support Care Cancer. 2018;26:1323-1334. 3.
Neulasta® (pegfilgrastim) Prescribing Information, Amgen. 4.
Yang BB, et al. Clin Pharmacokinet. 2011;50:295-306. 5. Haegerstam GA. Acta Orthop Scand. 2001;72:308-317. 6. Schweizerhof M, et al. Nat Med. 2009;15:802-807.
References:
1. Data on file, Amgen; 2021. 2. Data on file, Amgen; [1]; 2020. 3. Weycker D, et al. J Oncol Pharm Pract. 2014;20:190-198. 4. Vogel CL, et al. J Clin Oncol. 2005;23:1178-1184. 5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myeloid Growth Factors V.2.2023. ©National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed September 21, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 6. American Cancer Society. Watching for and Preventing Infections. https://www.cancer.org/treatment/treatments-and-side-effects/physical-side-effects/low-blood-counts/infections/preventing-infections-in-people-with-cancer.html. Accessed August 15, 2022. 7. Neulasta® (pegfilgrastim) Prescribing Information, Amgen. 8. Data on file, Amgen; [2]; 2020.
References:
1. Data on file, Amgen; 2020. 2. Lyman GH. J Natl Comr Canc Netw. 2009;7:2612-2615.
References:
1. Data on file, Amgen; [1]; 2022. 2. Data on file, Amgen; [2]; 2022.
References:
1. Data on file, Amgen; [1]; 2020. 2. Data on file, Amgen; [2]; 2020. 3.
Data on file, Amgen; [3]; 2020. 4. Data on file, Amgen; 2016.
5. Vogel CL, et al.
J Clin Oncol. 2005;23(6):1178-1184.
References:
1. Data on file, Amgen; 2021. 2. NEUPOGEN® (filgrastim) Prescribing Information, Amgen. 3. Neulasta® (pegfilgrastim) Prescribing Information, Amgen.
4. Data on file, Amgen; [1];
2020. 5. Data on file, Amgen; [2]; 2020. 6. Data on file, Amgen; 2016. 7. Vogel CL, et al. J Clin Oncol. 2005;23(6):1178-1184. 8. Data on file, Amgen; 2023.
References:
1. Data on file, Amgen; [1]; 2022. 2. Data on file, Amgen; [2]; 2022.
References:
1. Data on file, Amgen; 2023.
2. Data on file, Amgen; 2020.
3. Vogel CL, et al. J Clin Oncol. 2005;23(6):1178-1184.
4. Data on file, Amgen; 2022.
Contraindication
Splenic Rupture
Acute Respiratory Distress Syndrome (ARDS)
Serious Allergic Reactions
Allergies to Acrylics
Use in Patients With Sickle Cell Disorders
Glomerulonephritis
Leukocytosis
Thrombocytopenia
Capillary Leak Syndrome (CLS)
Potential for Tumor Growth Stimulatory Effects on Malignant Cells
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients With Breast and Lung Cancer
Potential Device Failures
Aortitis
Nuclear Imaging
Most common adverse reactions
Please see Neulasta® full Prescribing Information.
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).
Special Instructions for the On-body Injector (OBI) for Neulasta®
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 1-800-772-6436 or 1-844-MYNEULASTA (1-844-696-3852). 1-844-MYNEULASTA (1-844-696-3852).
