Indication

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.

Access and resources for you and your Onpro® patients

Access and resources for you and your Onpro® patients

Broad national coverage with opportunities to save1,2

Most Neulasta® doses had a $5 or less out-of-pocket prescription cost for patients

Medicare Fee for Service

61% of prescriptions for Neulasta® for patients with Medicare Part B insurance cost $5 or less per dose

The remaining 38% of prescriptions cost patients an average of $561 per dose.*,†

Additional financial support may be available depending upon patient eligibility.

*These data are based on paid claims data from national data providers for the period 1/1/2021-12/31/2021. 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. 98% of prescriptions for Neulasta® for patients with Medicare coverage and supplemental insurance (such as Medigap) pay $0 per dose of Neulasta®, while the remaining 2% of prescriptions cost patients an average of $628 per dose.

Medicare Advantage

61% of prescriptions for Neulasta® for patients with Medicare Advantage insurance cost $5 or less per dose

The remaining 39% of prescriptions cost patients an average of $533 per dose.*

Additional financial support may be available depending upon patient eligibility.

*These data are based on paid claims data from national data providers for the period 1/1/2021-12/31/2021. Actual cost may vary depending on dose, insurance coverage, and eligibility for support programs.

Commercial Insurance

86% of prescriptions for Neulasta® for patients with commercial insurance cost $5 or less per dose

The remaining 14% of prescriptions cost an average of $709 per dose.*

Additional financial support may be available to commercially insured patients through use of a co-pay card assistance program depending upon patient eligibility.

*These data are based on paid claims data from national data providers for the period 1/1/2021-12/31/2021. Actual cost may vary depending on dose, insurance coverage, and eligibility for support programs.

As of 4/14/2022, 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.

Personalized support you and your patients can count on

Amgen Assist 360™ offers resources that can support a variety of your team's needs, including payer policies, reimbursement, financial assistance for your patients, and more.

Connect with us live:

Call 1-866-AMG-ASST (1-866-264-2778)

Monday through Friday — 9:00 AM to 8:00 PM ET

For eligible commercially insured patients

Pay as little as $0 for Neulasta®

The Amgen FIRST STEP™ Co-Pay Program is here to help eligible commercially insured patients pay for their out-of-pocket prescription costs.

  • Pay as little as $0 out-of-pocket for each dose or cycle
  • Can be applied to deductible, co-insurance, and co-payment
  • No income eligibility requirement

Terms, conditions, and program maximums apply. Other restrictions may apply. See the Amgen FIRST STEP™ Co-Pay Program Terms and Conditions for details. 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 patients with government insurance such as Medicare

Amgen Assist 360™ can refer them to independent nonprofit patient assistance programs that may be able to help them afford the co-pay costs for their prescribed medicine.§

§Amgen Assist 360™ can refer patients to independent nonprofit patient assistance programs that may be able to help them afford the co-pay costs for their prescribed medicine.

For uninsured patients

Amgen® Safety Net foundation is a nonprofit patient assistance program sponsored by Amgen that helps qualifying patients access Amgen medicines at no cost.

Contact Amgen Assist 360™ to see if your patient is eligible and learn how Amgen® Safety Net Foundation can help them afford Neulasta®/Neulasta® Onpro®.

Amgen Assist 360™ resources for your office

BENEFIT VERIFICATION SUPPORT

Experience more tools with fewer clicks at the Amgen Assist 360™ Customer Portal, where benefits management meets streamlined efficiency, allowing for intuitive site navigation.

CODING AND BILLING GUIDES

Find the information you need when using Neulasta®/Neulasta® Onpro® in your office.

AMGEN REIMBURSEMENT TEAM

Amgen Reimbursement Counselors are available by phone to support your benefit verification needs. Or schedule a remote or live visit with a Field Reimbursement Specialist. Just call (866) AMG-ASST (1-866-264-2778).

Downloadable Resources

Visit AmgenAssist360.com to find more tools designed specifically for Neulasta®/Neulasta® Onpro®, including coding and billing guides, and example letters of appeal or medical necessity.

Amgen Assist 360™ resources for your patients

We know every patient you see has unique needs. And we’re here to help you find answers and support for them.

We know every patient you see has unique needs. And we’re here to help you find answers and support for them.

Amgen Nurse Navigators CAN HELP

A dedicated Amgen Nurse Navigator* can offer support and direct your patients to resources to help them manage treatment depending on their unique needs.

They can also:

  • Answer questions about Amgen medication
  • Help your patient navigate and understand how to get Amgen medications
  • Refer and direct your patient to community resources as well as offer tools that support stress management and emotional wellness

Enroll your patient today and connect them with their dedicated Amgen Nurse Navigator.

Financial Support

Amgen Assist 360™ can help your patients access Neulasta®, regardless of the type of insurance they have.

*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.

Additional resources for your office

In addition to the resources available through Amgen Assist 360™, you can also order resources to help you administer Neulasta®, guide conversations with patients, or learn more about prescribing Neulasta® for your patients.

Explore amgenhcpmaterials.com

Eligibility for returns of damaged on-body injector for Neulasta®

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. Our return policy allows customers to obtain replacement if product is mishandled or improperly stored, patient no-show or refusal, and similar situations.

Call 1-866-AMG-ASST (1-866-264-2778)
Monday to Friday 9:00 am to 8:00 pm ET
Image of Neulasta® Onpro® on-body injector

Assess your patients' risk of febrile neutropenia (FN) every cycle

Risk assessment tool icon

Download a risk assessment checklist (as PDF or Word document) (versions are identical in content).

 


Checklist icon

Complete the 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.


File folder icon

Save the completed checklist to your patient's file to help facilitate prior authorization discussions with payers.

Important Safety Information

Contraindication

  • Neulasta® (pegfilgrastim) is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim or filgrastim
  • Reactions have included anaphylaxis

Splenic Rupture

  • Splenic rupture, including fatal cases, can occur following the administration of Neulasta®
  • Evaluate for an enlarged or ruptured spleen in patients who report left upper abdominal or shoulder pain

Acute Respiratory Distress Syndrome (ARDS)

  • ARDS has occurred in patients receiving Neulasta®
  • Evaluate patients who develop a fever and lung infiltrates or respiratory distress after receiving Neulasta®
  • Discontinue Neulasta® in patients with ARDS

Serious Allergic Reactions

  • Serious allergic reactions, including anaphylaxis can occur in patients receiving Neulasta®
  • Majority of events occurred upon initial exposure and can recur within days after discontinuation of initial anti-allergic treatment
  • Permanently discontinue Neulasta® in patients with serious allergic reactions

Allergies to Acrylics

  • On-body injector (OBI) for Neulasta® uses acrylic adhesives
  • Patients who are allergic to acrylic adhesives may have a significant reaction

Use in Patients With Sickle Cell Disorders

  • In patients with sickle cell trait or disease, severe and sometimes fatal sickle cell crises can occur in patients receiving Neulasta®
  • Discontinue Neulasta® if sickle cell crisis occurs

Glomerulonephritis

  • Has occurred in patients receiving Neulasta®
  • Diagnoses based on azotemia, hematuria, proteinuria, and renal biopsy
  • Generally events resolved after dose reduction or discontinuation of Neulasta®
  • If suspected, evaluate for cause and if cause is likely, consider dose-reduction or interruption of Neulasta®

Leukocytosis

  • Increased white blood cell counts of 100 x 109/L have been observed
  • Monitoring of complete blood count (CBC) during pegfilgrastim therapy is recommended

Thrombocytopenia

  • Thrombocytopenia has been reported in patients receiving pegfilgrastim. Monitor platelet counts

Capillary Leak Syndrome (CLS)

  • CLS has been reported after G-CSF administration, including Neulasta®
  • Characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration
  • Episodes vary in frequency, severity, and may be life-threatening if treatment is delayed
  • Patients with symptoms should be closely monitored and receive standard symptomatic treatment, which may include intensive care

Potential for Tumor Growth Stimulatory Effects on Malignant Cells

  • G-CSF receptor has been found on tumor cell lines
  • The possibility that pegfilgrastim acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which Neulasta® is not approved, cannot be excluded

Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients With Breast and Lung Cancer

  • MDS and AML have been associated with the use of Neulasta® in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings

Potential Device Failures

  • Missed or partial doses have been reported in patients receiving pegfilgrastim via the on-body injector (OBI) due to the device not performing as intended
  • In the event of a missed or partial dose, patients may be at increased risk of events such as neutropenia, febrile neutropenia and/or infection than if the dose had been correctly delivered
  • Instruct patients to notify their healthcare professional immediately in order to determine the need for a replacement dose if they suspect that the device may not have performed as intended

Aortitis

  • Aortitis has been reported in patients receiving Neulasta®. It may occur as early as the first week after start of therapy
  • Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count)
  • Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue Neulasta® if aortitis is suspected

Nuclear Imaging

  • Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results

Most common adverse reactions

  • Bone pain
  • Pain in extremity

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; 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. 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. 6. Neulasta® (pegfilgrastim) Prescribing Information, Amgen.

References:
1. Data on file, Amgen; 2021. 2. Rifkin RM, et al. Support Care Cancer. 2022;1-10. doi: 10.1007/s00520-022-07226-9. 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.

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; [3]; 2020.

References:
1. Data on file, Amgen; [1]; 2020. 2. Data on file, Amgen; [2]; 2020. 3. Vogel CL, et al. J Clin Oncol. 2005;23(6):1178-1184. 4. Data on file, Amgen; 2021. 5. Rifkin RM, et al. Support Care Cancer. 2022;1-10. doi: 10.1007/s00520-022-07226-9. 6. Data on file, Amgen; 2022.

Important Safety Information

Contraindication

  • Neulasta® (pegfilgrastim) is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim or filgrastim
  • Reactions have included anaphylaxis

Splenic Rupture

  • Splenic rupture, including fatal cases, can occur following the administration of Neulasta®
  • Evaluate for an enlarged or ruptured spleen in patients who report left upper abdominal or shoulder pain

Acute Respiratory Distress Syndrome (ARDS)

  • ARDS has occurred in patients receiving Neulasta®
  • Evaluate patients who develop a fever and lung infiltrates or respiratory distress after receiving Neulasta®
  • Discontinue Neulasta® in patients with ARDS

Serious Allergic Reactions

  • Serious allergic reactions, including anaphylaxis can occur in patients receiving Neulasta®
  • Majority of events occurred upon initial exposure and can recur within days after discontinuation of initial anti-allergic treatment
  • Permanently discontinue Neulasta® in patients with serious allergic reactions

Allergies to Acrylics

  • On-body injector (OBI) for Neulasta® uses acrylic adhesives
  • Patients who are allergic to acrylic adhesives may have a significant reaction

Use in Patients With Sickle Cell Disorders

  • In patients with sickle cell trait or disease, severe and sometimes fatal sickle cell crises can occur in patients receiving Neulasta®
  • Discontinue Neulasta® if sickle cell crisis occurs

Glomerulonephritis

  • Has occurred in patients receiving Neulasta®
  • Diagnoses based on azotemia, hematuria, proteinuria, and renal biopsy
  • Generally events resolved after dose reduction or discontinuation of Neulasta®
  • If suspected, evaluate for cause and if cause is likely, consider dose-reduction or interruption of Neulasta®

Leukocytosis

  • Increased white blood cell counts of 100 x 109/L have been observed
  • Monitoring of complete blood count (CBC) during pegfilgrastim therapy is recommended

Thrombocytopenia

  • Thrombocytopenia has been reported in patients receiving pegfilgrastim. Monitor platelet counts

Capillary Leak Syndrome (CLS)

  • CLS has been reported after G-CSF administration, including Neulasta®
  • Characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration
  • Episodes vary in frequency, severity, and may be life-threatening if treatment is delayed
  • Patients with symptoms should be closely monitored and receive standard symptomatic treatment, which may include intensive care

Potential for Tumor Growth Stimulatory Effects on Malignant Cells

  • G-CSF receptor has been found on tumor cell lines
  • The possibility that pegfilgrastim acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which Neulasta® is not approved, cannot be excluded

Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients With Breast and Lung Cancer

  • MDS and AML have been associated with the use of Neulasta® in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings

Potential Device Failures

  • Missed or partial doses have been reported in patients receiving pegfilgrastim via the on-body injector (OBI) due to the device not performing as intended
  • In the event of a missed or partial dose, patients may be at increased risk of events such as neutropenia, febrile neutropenia and/or infection than if the dose had been correctly delivered
  • Instruct patients to notify their healthcare professional immediately in order to determine the need for a replacement dose if they suspect that the device may not have performed as intended

Aortitis

  • Aortitis has been reported in patients receiving Neulasta®. It may occur as early as the first week after start of therapy
  • Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count)
  • Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue Neulasta® if aortitis is suspected

Nuclear Imaging

  • Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results

Most common adverse reactions

  • Bone pain
  • Pain in extremity

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).