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
More
Neulasta® is not
indicated for the mobilization of peripheral blood
progenitor cells for hematopoietic stem cell transplantation.
The information provided in this section is intended expressly for health care professionals in the United States. Click "Yes, I am" to enter if you are a U.S. health care professional.
Which version of the Instructions for Use did your doctors's office give you?
If you don’t recognize the images above or if you prefer a physical copy, contact your doctor.
Which version of the HCP Instructions for Use came with your patient's on-body injector?
*Based on a retrospective database analysis analyzing inpatient hospitalization discharges from 2016 to 2018. The primary objective was to estimate the total number of FN-related hospitalizations among adult patients in the United States during the years 2016, 2017, and 2018 using hospitalization discharge data from the National Inpatient Sample (NIS). The NIS is the largest publicly available all-payer inpatient healthcare database designed to produce US regional and national estimates of inpatient utilization, access, charges, quality, and outcomes. Unweighted, it contains data from more than 7 million hospital stays each year. Weighted, it estimates more than 35 million hospitalizations nationally. FN was defined as a hospitalized patient discharge record with: a cancer diagnosis code and a neutropenia diagnosis code and a (fever or infection) diagnosis code.1
†Total costs of $46,793 per FN event per patient were calculated using estimates that included the proportion of patients that survived, died, were readmitted for any cause, were readmitted with FN and survived, and were readmitted with FN and died. Cost of an average FN hospitalization stay based on multiple data sources. It was assumed that a patient not discharged to a skilled nursing facility (SNF) incurred outpatient management costs. A factor of 1.31806 was used to estimate post-discharge non-SNF outpatient neutropenia healthcare costs. The proportion of patients who died or were readmitted was estimated using Dulisse et al, 2013. Inflation adjustment from annual 2012 to Q1 2020 for the index hospitalization, annual 2016 to Q1 2020 for the SNF stay, and annual 2010 to Q1 2020 for all-cause readmission and mortality cost used medical care consumer price indices from the Bureau of Labor Statistics.2
According to the American Society of Clinical Oncology (ASCO®) and the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): Evaluate the risk of FN and administer primary G-CSF prophylaxis in first and subsequent cycles for patients at high or intermediate FN risk.3,4
Select chemotherapy regimens associated with a
Breast cancer
Non-Hodgkin's lymphoma
Non-small cell lung cancer
Small cell lung cancer
Select chemotherapy regimens associated with an
Breast cancer
Non-small cell lung cancer
Prostate cancer
Small cell lung cancer
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. Do not administer Neulasta® between 14 days before and 24 hours after administration of chemotherapy. The recommended dosage of Neulasta® is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle.
*Select regimens listed from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and scientific publications. Please see references for source information.
†Select regimens not listed by the NCCN.
‡Select regimens listed by the NCCN as intermediate risk. Regimens listed as high risk based on published literature showing risk of FN of 17% or greater.17
CSF = colony-stimulating factor; FN = febrile neutropenia; NCCN = National Comprehensive Cancer Network; Q3W = once every 3 weeks.
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): If your patient is on an intermediate-risk regimen and has 1 or more risk factors, consider pegfilgrastim (Neulasta® or Neulasta® Onpro®)3
Baseline cytopenias18,19
Poor performance status (ECOG ≥ 2)20
Age ≥ 65 years19
COPD21,†
Chronic immunosuppression in the post-transplant
setting, including organ transplant18
Liver disease22
Renal disease19
Cardiovascular disease19,†
Diabetes23,†
Prior chemotherapy24
Prior radiotherapy18
Poor nutritional status25,†
Decreased serum albumin25,†
Open wounds/recent surgery26
Active infections27,†
HIV22
Metastatic20,†
Elevated lactate dehydrogenase25,†
*The patient risk factors included here have been identified through published literature and clinical guidelines. This list is not exhaustive. There may be other risk factors that apply based on available research and the clinical judgment of the treating physicians. These risk factors in addition to high or intermediate risk chemotherapy regimens can increase the risk of infection.
†Risk factors not listed by the NCCN.
NCCN = National Comprehensive Cancer Network; ECOG = Eastern Cooperative Oncology Group; COPD = chronic obstructive pulmonary disease; HIV = human immunodeficiency virus.
Phase 3, multicenter, multinational, double-blind, placebo-controlled trial of patients with breast cancer (Neulasta® [n = 463] or placebo [n = 465]) receiving 100mg/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%]).17
FN = temperature ≥ 38.2°C and absolute neutrophil count < 0.5 x 109/L.
G-CSF = granulocyte colony-stimulating factor; Q3W = once every 3 weeks; IV = intravenous.
No caregiver* and can't get back to the healthcare facility
Immunosuppressed patients may want to stay away from those with a viral infection28
Family or work conflicts
Chemo a day before holiday closings
Such as a blizzard, could make driving hazardous
And the clinic is closed on Saturday
Chemo two days in a row and the patient doesn't want to come back a third day every cycle
Missed prefilled syringe appointment last cycle and/or didn't receive injection next day
Total time spent includes more than just driving time
*For patients with Onpro® applied on the abdomen. The back of the arm may only be used if there is a caregiver available to monitor the status of the on-body injector for Neulasta®.
†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.
Download a risk assessment tool (as PDF or Word document) (versions are identical in content).
Populate checklist, including the appropriate ICD-10 codes (code descriptions are on page 2 of the checklist).
ICD-10 = International Statistical Classification of Diseases and Related Health Problems, 10th Revision.
Saving the completed checklist to your patient's file can help facilitate prior authorization discussions with payers.
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. Neulasta® (pegfilgrastim) Prescribing Information, Amgen. 3.
Kirshner JJ, et al. Support Care Cancer. 2018;26:1323-1334. 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; 2020. 3. Referenced
with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN
Guidelines®) for Myeloid Growth Factors V.1.2021. ©National Comprehensive
Cancer Network, Inc. 2021. All rights reserved. Accessed April 25, 2021. 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. 4. Smith TJ, et al. J Clin
Oncol. 2015;33:3199-3212. 5. Martin M, et al. N Engl J Med.
2005;352:2302-2313. 6. Younis T, et al. Support Care Cancer.
2012;20:2523-2530. 7. Perjeta (pertuzumab) Prescribing Information, Genentech, Inc.
8. Schneeweiss A, et al. Ann Oncol. 2013;24:2278-2284. 9.
Cerchione C, et al. Support Care Cancer. 2017;25:839-845. 10. Ösby
E, et al. Blood. 2003;101:3840-3848. 11. Delarue R, et al. Lancet Oncol. 2013;14:525-533. 12. Ohe Y, et al. Ann Oncol. 2007;18:317-323. 13. Swain SM, et al. N Engl J Med. 2010;362:2053-2065. 14. Schiller JH, et al. N Engl J Med. 2002;346:92-98. 15. Yoshimura N, et al. J Thorac Oncol. 2009;4:371-375. 16. Kongsted P, et al. Urol Oncol. 2015;33:494.e15-494.e20. doi:10.1016/j.urolonc.2015.06.022.
17. Vogel CL, et al. J Clin Oncol. 2005;23:1178-1184. 18.
Moreau M, et al. Ann Oncol. 2009;20:513-519. 19. Lyman GH, et al.
Leuk Lymphoma. 2003;44:2069-2076. 20. Lyman GH, et al. J Clin Oncol. 2004;22:4302-4311. 21. Klastersky J, et al. J Clin Oncol. 2000;18:3038-3051. 22. Chao C, et al. Ann Oncol. 2014;25:1821-1829. 23. Takenaka Y, et al. Support Care Cancer. 2013;21:2861-2868. 24. Shayne M, et al. Cancer. 2007;110:1611-1620. 25. Intragumtornchai T, et al. Leuk Lymphoma. 2000;37:351-360. 26. Family L, et al. J Clin Oncol. 2016;34. Abstract 6559. 27. Pettengell R, et al. Br J Haematol. 2008;144:677-685. 28. 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 December 20, 2021. 29. Neulasta® (pegfilgrastim) Prescribing
Information, Amgen.
References:
1. Data on file, Amgen; 2021. 2. Mahtani RL, et al. A multicenter,
prospective, observational study to determine the incidence of febrile neutropenia (FN),
persistence and G-CSF utilization among cancer patients at high risk for FN receiving
pegfilgrastim by an on-body injector (OBI) versus other FN-prophylaxis strategies.
Poster presented at: San Antonio Breast Cancer Symposium®, Virtual.
3. Referenced with permission from the NCCN Clinical Practice Guidelines in
Oncology (NCCN Guidelines®) for Myeloid Growth Factors V.1.2021.
©National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed April
5, 2021. 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.
4. Data on file, Amgen; 2020. 5. Lyman GH. J Natl Comr
Canc Netw. 2009;7:2612-2615.
Reference:
1. Data on file, Amgen; 2021.
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.
Reference:
1. Vogel CL, et al. J Clin Oncol. 2005;23(6):1178-1184.
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).
