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.

Choose Neulasta® Onpro®

to give them back their day

Choose Neulasta® Onpro®
every cycle to help ensure
next-day
Neulasta® delivery1

patients reported feeling tired, fatigued, drained, and exhausted after receiving chemotherapy2-5,*


Traveling for injections the day after chemo is time-consuming for
patients and caregivers6,†

  • Patients and their caregivers may
    need to make several
    arrangements
    for a next-day
    G-CSF treatment

*Data from interviews with Neulasta®
treatment–experienced oncology patients
(N=227, PFS n=150, Neulasta® Onpro® n=77)
conducted in November 2016. Patients were asked
to list one-word adjectives or short phrases that best
described how they felt after receiving
chemotherapy. 86% of patients recalled feeling tired,
fatigued, drained, and exhausted.2

Total time spent in the office, including wait time and
time spent traveling for a return visit for G-CSF
injection, was reported by respondents in a
prospective cohort study of 598 adult patients
with ESBC. Patients included those treated with
daily-dose filgrastim and those receiving
once-per-cycle pegfilgrastim injections. On
average, patients spent 1.73 hours per clinic visit for
a G-CSF injection.6

ESBC, early-stage breast cancer; G-CSF,
granulocyte colony-stimulating factor; PFS, prefilled
syringe.


18% increased risk of FN when Neulasta® was administered on days other than the day after chemotherapy7,‡

Do not administer Neulasta®
between 14 days before and

24 hours after administration of
cytotoxic chemotherapy

Risk Graphic

FN rate for the day after chemotherapy vs all other days of Neulasta® administration was 2.53% and 3.04%, respectively.7

18% is the increase in the odds of FN comparing administration on day 1 (the day after the last day of chemotherapy; absolute risk 2.53%) to other days (including same day [the last day of chemo administration] and days 2–5 [after the last day of chemo administration]; absolute risk 3.04%). The 18% result was estimated using an adjusted analysis (using generalized estimating equations) to account for differences in patient, cancer, and treatment characteristics.

§Do not administer Neulasta® the same day as chemotherapy.

Retrospective cohort analysis based on health care claims from IMS PharmMetrics Plus and Truven Health Analytics MarketScan® Commercial and Medicare Supplemental Databases. The collective data include health care claims from private US health plans covering over 30 million people annually between July 1, 2010, and September 30, 2015.7

FN = temperature ≥ 38.2°C and ANC < 0.5 × 109/L.

ANC, absolute neutrophil count; FN, febrile neutropenia.

Neulasta® Onpro® is
patient-chosen protection**

95% of patients

of patients and nurses
would
choose
Neulasta® Onpro®

again8,9,††,‡‡

  • Not having to return to the doctor’s
    office
    the day after chemotherapy just
    for an injection was the most important
    factor for patients when choosing
    a G-CSF8,§§
  • Patients also valued how much
    experience
    their doctor has with the
    G-CSF they would receive and being
    informed
    by the doctor or nurse of all
    available ways to receive the G-CSF8


National Comprehensive Cancer Network® (NCCN®) recognizes the On-body Injector as an appropriate option for delivering the full dose of pegfilgrastim (Neulasta®) the day after chemotherapy10


**In a key study of 928 patients with breast cancer, when given once every chemotherapy cycle, 17% of patients got infections when not treated with Neulasta®—while only 1% of patients got infections when treated with Neulasta®.11

††2016 data from interviews with oncology patients who have had experience with Neulasta® (N=227, PFS n=150, Neulasta® Onpro® n=77). Patients who had received Neulasta® via Neulasta® Onpro® were asked to answer the question: Based on your personal experience getting your Neulasta® with Neulasta® Onpro®, if your doctor said you needed to use Neulasta® again in the future, would you request getting it with Neulasta® Onpro® again?8

‡‡Data from interviews with oncology nurses (N=250) conducted in October 2016. Respondents were asked if they agreed with this statement: Based on my Neulasta® Onpro® experience, when my patients are appropriate for Neulasta® (PFS or Neulasta® Onpro®), I would choose Neulasta® Onpro®.9

§§November 2016 data from interviews with oncology patients who have had experience with Neulasta® (N=227, PFS n=150, Neulasta® Onpro® n=77). Patients were asked a multiple-choice selection prompt: If your doctor felt you should receive a G-CSF medication, please select the 3 most important factors to you (other than safety and how well it works) when considering G-CSF care to boost your white blood cell count after chemotherapy. Patients then completed a follow-up prompt: Of the 3 most important factors you selected, we would like to know which is the most important. Please rank these from most important (1) to least important (3).8

Janine's Story

Janine, a breast cancer survivor, former New York City police officer, and mother of two, describes the burden of having to return to the clinic just for a shot.

Watch video

Consider what Neulasta® Onpro® can offer patients and practices

Neulasta® Onpro®
9 of 10 patients report feeling fatigued the day after chemo. Provides option to automatically deliver G-CSF at home1,2,*** Check Mark Yes
May eliminate the time patients and caregivers spend traveling for G-CSF appointments6 Check Mark Yes
Fewer next-day injection appointments6 Check Mark Yes
Designed for automatic next-day delivery of pegfilgrastim (Neulasta®) in accordance with guidelines and labeling1,*** Check Mark Yes
Would be chosen again by 95% of patients if they needed Neulasta® again8,††† Check Mark Yes
Is the product of 3 decades of innovation and commitment to enhancing patient experience12-14,‡‡‡ Check Mark Yes
G-CSF support through the nadir15 Check Mark Yes

***Incomplete doses have been reported with Neulasta® Onpro® due to the device not performing as intended. This may increase risk of neutropenia, febrile neutropenia and/or infection.1

†††2016 data from interviews with oncology patients who have had experience with Neulasta® (N=227, PFS n=150, Neulasta® Onpro® n=77). Patients who had received Neulasta® via Neulasta® Onpro® were asked to answer a survey.8

‡‡‡NEUPOGEN® was approved in 1991; Neulasta® Onpro® was approved in 2014.1,14

4 steps to apply
Neulasta® Onpro®16

1.
Prepare the application site
1) Prepare the application site.
2.
Fill the On‑body Injector
2) Fill the On‑body Injector.
3.
Confirm On‑body Injector status
3) Confirm On‑body Injector activation.
4.
Apply the On‑body Injector
4) Apply the On‑body injector.

The information provided does not replace the Healthcare Provider Instructions for Use. Prior to use, please review the Instructions for Use.


Explore
Neulasta® Onpro®

See a 3-D video featuring a 360°
view of the On-body Injector
and tips on how to prepare and
apply it.

If your Neulasta® Onpro® kit contains a needle guard, this video will demonstrate the application.

This video does not replace the Instructions for Use. Please consult the Instructions for Use when using the Neulasta® Onpro® kit.

If your Neulasta® Onpro® kit contains a needle guard, this video will demonstrate the application.

This video does not replace the Instructions for Use. Please consult the Instructions for Use when using the Neulasta® Onpro® kit.

Neulasta® Onpro® in practice

Hear two of your colleagues
on prescribing Neulasta®
Onpro® and incorporating it
into their practices.

Dr. Kashif Ali Photo Dr. Kashif Ali Photo Dr Kashif Ali Dr. Dana Thompson Photo Dr. Dana Thompson Photo Dr Dana Thompson

Help guide the
patient experience

Patient educational video

Patient Education Video Watch Now

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.

Patient brochure

Helps patients understand infection risk, how Neulasta® may help, and how Neulasta® Onpro® works. Download now.

Sharps container program

Sharps Container Program

Patients can order a FREE sharps container for On-body Injector disposal by completing an enrollment form or calling 1‑844‑MYNEULASTA (1-844-696-3852) any day to receive their container in 7 to 10 business days.

24/7 telephone support

Patients get 24/7 telephone support for questions about Neulasta® Onpro®.

Next

See dosing information.

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. Neulasta® (pegfilgrastim) Prescribing Information, Amgen. 2. Data on file, Amgen, February, 2017 [2]. 3. Cyclophosphamide Prescribing Information, Baxter. 4. Doxil® (doxorubicin hydrochloride liposome injection) Prescribing Information, Janssen. 5. Taxotere® (docetaxel) Prescribing Information, Sanofi-Aventis. 6. Stephens JM, et al. J Med Econ. 2016;19:537-547. 7. Data on file, Amgen, June, 2017. 8. Data on file, Amgen, February, 2017 [1]. 9. Data on file, Amgen, November, 2016. 10. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myeloid Growth Factors V.1.2018. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed March 15, 2018. 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. 11. Vogel CL, et al. J Clin Oncol. 2005;23:1178-1184. 12. Data on file, Amgen, October, 2014. 13. Amgen Fact Sheet 2018. Available at: http://www.amgen.com/~/media/amgen/full/www-amgen-com/downloads/fact-sheets/fact_sheet_amgen.ashx. Updated March 6, 2018. Accessed April 15, 2018. 14. NEUPOGEN® (filgrastim) Prescribing Information, Amgen. 15. Green MD, et al. Ann Oncol. 2003;14:29-35. 16. Neulasta® (pegfilgrastim) Onpro® kit Healthcare Provider Instructions for Use, Amgen.

Back to top
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.