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

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Paying for Neulasta Onpro

Across all insurance types, a majority of patients pay $5 or less per dose* for Neulasta Onpro.

*These data are based on paid claims data from national data providers for the period from 01/01/23 through 12/31/23. Your actual cost may vary depending on your dose, insurance coverage, and eligibility for support programs. Talk to your insurance provider for specific information about your prescription coverage.


Insurance Coverage for Neulasta Onpro

Regardless of the type of insurance you have, a majority of commercial and Medicare insurance plans have coverage for Neulasta Onpro.

These data are based on insurance claims from national data providers through June 4, 2024. Talk to your insurance provider for specific information about your prescription coverage.

Personalized support you and your patients can count on

Connect with us live:

Call 866 264-2778

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

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Amgen® SupportPlus Co-Pay Program
Amgen® SupportPlus Co-Pay Program

The Amgen SupportPlus Co-Pay Program may help eligible patients with private or commercial insurance lower their out-of-pocket costs.

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

Encourage your patients with private or commercial insurance to check eligibility and enroll.

*Eligibility criteria and program maximums apply. See AmgenSupportPlus.com/Copay for full Terms and Conditions.

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Financial Support
Financial Support

We know every patient has unique needs. And we’re here to provide financial support information and resources, regardless of their current financial situation or what type of insurance they have.

Learn more about how Amgen SupportPlus can help your patients access their prescribed medication. Visit AmgenSupportPlus.com to learn more.

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HCP Support Center
HCP Support Center

Our Amgen® SupportPlus Representatives can assist with issues around patient coverage, prior authorizations, co-pay programs, and more.

Benefits Verification

  • Verify patient’s insurance plan coverage details

Prior Authorization Requirements

  • Provide payer-specific prior authorization forms

Amgen SupportPlus Customer Portal

  • A tool for managing patient benefits verifications and more
  • Submit, store, and retrieve benefit verifications electronically

Visit myAmgenPortal.com to register and submit forms online

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Amgen® Access Specialists
Amgen® Access Specialists

An Access Specialist can provide live or virtual coverage and access resources to support your patients.

Contact your Access Specialist for live or virtual support that includes:

  • Help with navigating prior authorization, appeals, and fulfillment processes
  • Educating on payer requirements and necessary documentation for individual patient support
  • Guidance on general reimbursement questions, including product coding and billing information
  • Answers to general questions about Amgen SupportPlus programs and other available resources
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Amgen® Nurse Partners
Amgen® Nurse Partners

Dedicated Amgen Nurse Partners* can offer supplemental support and provide information about resources to help patients access their prescribed medication.

Amgen Nurse Partners can provide supplemental support, including:

  • Guidance on resources that may help lower out-of-pocket medication costs
  • Assistance to help your patients stay on track with their medication
  • Answers to questions about Amgen SupportPlus

Patients can connect with a dedicated Amgen Nurse Partner by enrolling in Amgen SupportPlus in two ways:

  • Download and complete the Amgen SupportPlus Enrollment Form found on AmgenSupportPlus.com and give it to your office to complete and fax to 1-888-407-9787
  • Call 866-264-2778 to enroll by phone

*Amgen Nurse Partners are only available to patients that are prescribed certain Amgen products. They are not part of your patient’s treatment team and do not provide medical advice, nursing, or case management services. Amgen Nurse Partners will not inject patients with Amgen medications. 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 SupportPlus, 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 Amgen SupportPlus at (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; [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. 3. Data on file, Amgen; [3]; 2024.

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.

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).