Indication

Neulasta® is indicated to decrease the incidence.. Read more

Neulasta® 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 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.

Access and a commitment to patients

Most patients pay $0 out of pocket (OOP) per dose for Neulasta® Onpro®1

Chart 88%

of commercially insured patients pay $0 OOP costs per dose of Neulasta® Onpro®1,*

Broad national coverage:

100% of Medicare Part B lives2
and
99% of commercial benefit lives covered3

Neulasta® Onpro® is available at no extra cost beyond that of the Neulasta® PFS

*Data based on Decision Resources Group Remittance Database of 124,287 commercial, medical, and pharmacy claims identified between January 1, 2016, and December 31, 2016. Claims included in this analysis were categorized according to patient OOP costs for Neulasta® or Neulasta® Onpro®. Based on typical practices, 1 claim was assumed to represent a single dose of Neulasta® PFS or Neulasta® Onpro®.1

PFS, prefilled syringe.


Financial access resources for patients

Neulasta FIRST STEP™ Program

The Neulasta FIRST STEP™ Program can help your eligible commercially insured patients reduce out-of-pocket costs for Neulasta®.

To enroll your practice in the Neulasta FIRST STEP™ Program, please call 1-888-65-STEP1 (1-888-657-8371).

This program is not open to patients receiving prescription reimbursement under any federal, state, or government-funded healthcare program, such as Medicare, Medicare Advantage, Medicare Part D, Medicaid, Medigap, Veterans Affairs (VA), the Department of Defense (DoD), or TRICARE® or where otherwise prohibited by law.


Amgen Assist 360™:
Tools, information, and support for Amgen products

Benefit verification

  • Submit, store, and retrieve benefit verifications for all your patients currently on an Amgen product

Amgen reimbursement specialists

  • Connect with an Amgen Reimbursement Counselor or schedule a visit with a Field Reimbursement Specialist

Patient resource guide

  • Find co-pay and reimbursement resources for patients with different kinds of insurance or no insurance at all

Amgen Safety Net Foundation

  • Provides Neulasta® at no cost to qualifying patients with no or limited drug coverage who meet income eligibility requirements

Resources include referrals to independent nonprofit patient assistance programs. Eligibility for resources provided by independent nonprofit patient assistance programs is based on the nonprofits' criteria. Amgen has no control over these programs and provides referrals as a courtesy only.

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. 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.

or
Call 1‑888‑4ASSIST (1‑888‑427‑7478)
Monday to Friday 9:00 am to 8:00 pm ET

Amgen has an ongoing commitment to deliver reliable supply to our customers

Commitment

  • Zero supply shortages in the last decade 4
  • More than 250 quality checks to ensure consistency of product 5

Expertise

  • At the forefront of modern biotechnology for more than 35 years 5,6
  • State-of-the-art, next-generation manufacturing 7,8

Amgen makes significant investments in risk mitigation to ensure safety and supply.


Amgen:
Unwavering dedication to every patient, every time

Patients have benefited from 35 years of our G-CSF innovation, culminating in Neulasta® Onpro®:

February 1991

The first biologic approved to reduce the incidence of chemotherapy-induced FN

January 2002

Enabled patients to receive just 1 G-CSF injection instead of 10 to 119,10

December 2014

Redefined the patient experience by giving them an opportunity to not return to the office just for their Neulasta® shot the day after chemotherapy

November 2016

Designed to improve ease of use for healthcare providers


FN, febrile neutropenia; G-CSF, granulocyte colony-stimulating factor.


Comprehensive Support

  • Helping patients access Amgen medicines whenever possible
  • Best-in-class resources for patients 11
Next

See Febrile Neutropenia Risk.


Important Safety Information

Contraindication

  • Neulasta® 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, sickle cell crisis, in some cases fatal, 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 CBCs is recommended

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, cannot be excluded

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.

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 or 1‐844‐MYNEULASTA (1‐844‐696‐3852).

Important Safety Information

Contraindication

  • Neulasta® 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, sickle cell crisis, in some cases fatal, 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 CBCs is recommended

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, cannot be excluded

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.

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 or 1‐844‐MYNEULASTA (1‐844‐696‐3852).

See More Close

References: 1. Data on file, Amgen, May, 2018 [2]. 2. Data on file, Amgen, April, 2017. 3. Data on file, Amgen, 2017 [2]. 4. Data on file, Amgen, February, 2018. 5. Data on file, Amgen, October, 2014. 6. Amgen Fact Sheet 2018. Available at: www.amgen.com/~/media/amgen/full/www-amgen-com/downloads/fact-sheets/fact_sheet_amgen.ashx. Updated March 6, 2018. Accessed April 15, 2018. 7. Amgen. Amgen continues manufacturing expansion with additional $1 billion investment in Puerto Rico. Available at: www.amgen.com/media/newsreleases/2006/02/amgencontinuesmanufacturing-expansion-with-additional-$1-billion-investment-in-puerto-rico. Accessed August 25, 2017. 8. Amgen. Amgen to make significant investment in manufacturing, R&D and commercial operations expansion. www.amgen.com/media/news-releases/2006/01/amgen-to-make-significant-investment-in-manufacturingrd-and-commercial-operations-expansion. Accessed August 25, 2017. 9. Green MD, et al. Ann Oncol. 2003;14:29-35. 10. Henk et al. J Med Econ. 2013;16:160-168. 11. Data on file, Amgen, May, 2018 [3].

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Instructions for Use
Enhanced Neulasta® Onpro®Kit
Instructions for Use

Recent updates to Neulasta® Onpro® include approximately 35% smaller packaging,1 an updated fill symbol on the adhesive backing, and a co-packaged prefilled syringe without a needle guard.

1. Data on file, Amgen; 2016.