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.
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?
Neulasta® HCPCS code effective 1/1/2022: J2506—Injection, pegfilgrastim, 0.5 mg
The remaining 13% of prescriptions cost an average of $793 per dose*
*These data are based on paid claims data from national data providers for the period 1/1/2020-12/31/2020. Actual cost may vary depending on dose, insurance coverage, and eligibility for support programs.
The remaining 38% of prescriptions cost patients an average of $808 per dose*,†
*These data are based on paid claims data from national data providers for the period 1/1/2020-12/31/2020. Actual cost may vary depending on dose, insurance coverage and eligibility for support programs.
†Patients with traditional Medicare (Part B) may also carry supplemental insurance, such as Medigap. 97% of prescriptions for Neulasta® for patients with Medicare coverage and supplemental insurance (such as Medigap) pay $0 per dose of Neulasta®, while the remaining 3% of prescriptions cost patients an average of $577 per dose.
The remaining 39% of prescriptions cost patients an average of $730 per dose*
*These data are based on paid claims data from national data providers for the period 1/1/2020-12/31/2020. Actual cost may vary depending on dose, insurance coverage, and eligibility for support programs.
The remaining 4% of prescriptions cost patients an average of $732 per dose*
*These data are based on paid claims data from national data providers for the period 1/1/2020–12/31/2020. Actual cost may vary depending on dose, insurance coverage, and eligibility for support programs.
As of 08/18/2021 the list price for Neulasta® is $6,417.99† per dose. Neulasta® is a single dose administered once per chemotherapy cycle. Most patients do not pay the list price. Actual cost will vary.
†List price is also referred to as wholesale acquisition cost or WAC. WAC is the price at which Amgen sells its products to wholesalers.
Amgen Assist 360™ is a single place for patients, caregivers, and healthcare professionals to go to find the support, tools, and resources most important to them.
Monday through Friday — 9:00 AM to 8:00 PM ET
BENEFIT VERIFICATION Submit, store, and retrieve benefit verifications for all patients currently on Amgen medications electronically with ease from our secure Amgen Assist 360™ Provider Portal.
REIMBURSEMENT COUNSELORS Call an Amgen Reimbursement Counselor directly for your benefit verification needs.
FIELD REIMBURSEMENT SPECIALISTS Schedule a remote or live appointment with a Field Reimbursement Specialist who can assist with:
AMGEN NURSE NAVIGATOR† is a single point of contact for Amgen Assist 360™ services, designed to help your patients find the resources‡ that are most important to them. We’re here to assist patients with the following:
FINANCIAL AND CO-PAY ASSISTANCE
For eligible‡ commercially insured patients, the Amgen FIRST STEP™ co-pay program can help.
*Resources include referrals to independent nonprofit patient assistance programs. Eligibility for resources provided by independent nonprofit patient assistance programs is based on the nonprofit’s criteria. Amgen has no control over these programs and provides referrals as a courtesy only.
†Amgen Nurse Navigators are only available to patients that are prescribed certain products. Nurse Navigators are there to support, not replace, your treatment plan and do not provide medical advice or case management services. Patients should always consult their healthcare provider regarding medical decisions or treatment concerns.
‡Terms, conditions, and program maximums apply. This program is not open to patients receiving prescription reimbursement under any federal-, state-, or government-funded healthcare program. Not valid where prohibited by law.
For eligible§ commercially insured patients
Amgen FIRST STEP™ can help your eligible commercially insured patients cover their out-of-pocket prescription costs, including deductible, co-insurance, and co-payment.
§Terms, conditions, and program maximums apply. This program is not open to patients receiving prescription reimbursement under any federal, state, or government-funded healthcare program. Not valid where prohibited by law.
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The Neulasta® Onpro® kit, purchased directly from Amgen or an authorized distributor, is eligible for return and credit or a replacement shipment due to malfunction or failure of an on-body injector for Neulasta®, including situations where it did not perform as described in the Instructions for Use. New return policy effective October 1, 2017, allows Customer to obtain replacement if product is mishandled or improperly stored, patient no-show or refusal, and similar situations.
The patient educational video gives patients an overview of Neulasta® and how the on-body injector for Neulasta® works.
This video does not replace the Instructions for Use. Please consult the
Instructions
for Use when using the Neulasta®
Onpro® kit.
Order resources to help you administer Neulasta®, guide
conversations with
patients, or learn more about prescribing Neulasta® for your patients.
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).