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.
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?
In a prospective observational study of ~2600 cancer patients
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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.
†Regardless of option received in subsequent cycles.
The primary endpoint was the overall incidence of FN over four cycles of chemotherapy, measured as absolute neutrophil count (ANC) < 1,000 x 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-clavulante), or use of IV antibiotics.2
ANC = absolute neutrophil count; FN = febrile neutropenia; G-CSF = granulocyte colony-stimulating factor; CI = confidence interval; IV = intravenous.
This was an observational study and no formal statistical testing was performed. Descriptive statistics are available.
The primary endpoint was the overall incidence of FN over four cycles of chemotherapy, measured as ANC < 1,000 x 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-clavulante), or use of IV antibiotics.2
Investigators decided on the method of FN prophylaxis. Patients were grouped into either the Neulasta® Onpro® group or other FN-prophylaxis group based on FN-prophylaxis method received in the first cycle
*Approximately 31% of patients received no FN prophylaxis in cycle 1, and 24% received no FN prophylaxis in every cycle.
FN = febrile neutropenia; G-CSF = granulocyte colony-stimulating factor; ANC = absolute neutrophil count; PFS = prefilled syringe.
In the same prospective observational study of ~2600 cancer patients
*Percent of patients receiving pegfilgrastim PFS on the day after chemotherapy, for all cycles in which pegfilgrastim PFS was administered.
Note: For any given patient, physicians generally chose the same FN-prevention therapy over time. However, a small percentage of patients received different therapies in different cycles. To facilitate comparison, the Onpro® group was comprised of patients who received Onpro® in every cycle. The comparator group was comprised of patients in the other physician-choice group who received pegfilgrastim PFS at least once, and measured patient compliance for only those cycles in which pegfilgrastim PFS was administered.
Study Design1,2
Prospective observational US study to describe frequency of FN, adherence, and compliance among patients receiving myelosuppressive chemotherapy for breast, lung or prostate cancer or NHL.
Study Limitations2
PFS = prefilled syringe; NHL = non-Hodgkin’s lymphoma.
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend that pegfilgrastim be administered according to the FDA-approved dosing schedule (day after myelosuppresive chemotherapy)3,*
*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.
Dose intensity is defined as the delivered dose of chemotherapy per unit of time. RDI is expressed as a percentage, calculated as the delivered dose intensity divided by the standard dose intensity. A higher RDI is indicative of fewer dose reductions and delays. Patients with RDI ≥ 85% were considered to have maintained their dose. The 85% cut point is commonly reported in the literature.5
It was not possible to determine from the data whether Neulasta® patients received Onpro® or the prefilled syringe. However, of the 379 patients from these healthcare systems who received Neulasta® in the first cycle, 97% (n = 368) received it on the day following chemotherapy, as recommended in the Neulasta® Prescribing Information. The Neulasta® group in this analysis was limited to next-day patients.
Study Design: Retrospective cohort study conducted at Geisinger Health System (Danville, PA), Henry Ford Health System (Detroit, MI), Kaiser Permanente Northwest (Portland, OR), and Reliant Medical Group (Worcester, MA), January 2009-December 2017 (for all sites except Geisinger, 2009-2014). Analysis included patients with breast cancer, colorectal cancer, lung cancer, or non-Hodgkin’s lymphoma, receiving chemotherapy regimens with high or intermediate risk of FN. Multivariable regression models were employed to estimate the relationship between the use of Neulasta® and RDI.
*RDI ≥ 85%.
†Course-level analysis. All cycles included. The analysis categorized patients as next-day Neulasta® users vs non-users of G-CSF based on the first cycle of chemotherapy only. However, for patients who received next-day Neulasta® in cycle 1, subsequent Neulasta® use was: 87% in cycle 2, 86% in cycle 3, and 78% in cycle 4. For patients who did not receive any G-CSF in cycle 1, no G-CSF use was 81% in cycle 2, 79% in cycle 3, and 79% in cycle 4.
‡Adjusted odds ratio controlling for clinical and demographic characteristics, including but not limited to age, metastasis (yes/no), and FN risk of chemotherapy regimen.
*Incomplete doses have been reported with Neulasta® Onpro® due to device not performing as intended. This may increase risk of neutropenia, febrile neutropenia, and/or infection.
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).