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.

The impact of febrile neutropenia (FN) may be greater than you think

Consequences of FN

FN and its consequences can be debilitating for your patients

More than 80% of patients with FN required hospitalization in the United States 1

Study design: Data are from a retrospective cohort study conducted using 2007–2010 data from the Humedica database. The total study population was 2,131 patients, including 401 patients who experienced 458 episodes of FN. An episode of FN was identified based on any of the following criteria: an absolute neutrophil count (ANC) < 1.0 x 109/L, and evidence of infection or fever; inpatient diagnosis of neutropenia, fever, or infection; outpatient diagnosis of neutropenia, and non-prophylactic oral or intravenous antimicrobial use; or mention of FN in the physician’s notes. Primary endpoints were to examine the incidence, treatment, and consequences of chemotherapy-induced FN across inpatient and outpatient care settings. 1

See how FN could impact a patient

View case study
Case Study—Renee*

What could happen if Renee* misses her next Neulasta® dose?

Neulasta® Hypothetical patient profile picture: Renee

Meet Renee*:
prescribed Neulasta® to help reduce the risk of FN2, 3

  • Age 53
  • Breast cancer
  • Prescribed TC (Q3W)
  • Working mom
  • Leads a choir group
  • Cares for her elderly father

If Renee* misses her Neulasta® dose, she could increase her risk of developing FN

Cycle 1
Chemotherapy Next-day Neulasta®
Day
01
Administered TC
Day
02
Patient recieved Neulasta® dose
Cycle 2
Chemotherapy Missed next-day Neulasta®
Day
01
Administered TC
Day
02
Patient missed Neulasta dose. G-CSF support not administered
Day
07
Patient presented to ER with fever, neutropenia.
Patient hospitalized for 5 days and administered IV antibiotics
Day
12
Patient discharged

Find out how Neulasta® reduced the risk of FN every cycle, for patients like Renee*

See the data

What could happen if a patient misses an ANC-monitoring appointment?

View another case study

*Hypothetical patient.

Case Study—George*

What could happen if George* misses his ANC-monitoring appointment?

Neulasta® Hypothetical patient profile picture: George

Meet George*:
placed on a wait-and-see treatment plan to manage his FN risk2, 4

  • Age 65
  • Non-Hodgkin’s lymphoma (NHL)
  • Prescribed CHOP + R (Q3W)
  • Part-time museum guide
  • Volunteers at a food bank
  • Enjoys traveling with his wife

If George* misses his ANC-monitoring appointment, he could be at risk of developing FN

Cycle 1
Chemotherapy ANC monitoring
Day
01
CHOP + R administered. ANC at low end of normal. Additional monitoring ordered
Day
06
Patient missed ANC-monitoring appointment and rescheduled for the following week
Day
10
Patient presented to ER with fever, neutropenia.
Patient hospitalized for 9 days and administered IV antibiotics
Day
19
Patient discharged
Day
22
Next chemotherapy cycle scheduled to begin

For patients like George,* Neulasta® EVERY cycle significantly reduced the risk of FN.

Find out how

*Hypothetical patient.

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

  • Download either the PDF version OR the Microsoft Word document (versions are identical in content)
  • Populate checklist, including the appropriate ICD-10 codes (code descriptions are on page 2 of the checklist)
  • Saving the completed checklist to your patient's file can help facilitate prior authorization discussions with Payors
Download PDF Checklist Download Word Checklist

Consider patient risk factors

Patient risk factors for FN (in addition to chemotherapy regimen and cancer type) 5
  • Age ≥ 65 years
  • Advanced disease
  • Preexisting neutropenia or bone marrow involvement with tumor
  • Infection
  • Open wounds or recent surgery
  • Poor performance status or poor nutritional status
  • Cardiovascular disease
  • Poor renal function
  • Liver dysfunction, most notably elevated bilirubin
  • Multiple comordid conditions
  • HIV infection
Patient risk factors for poor clinical outcomes resulting from FN or infection 5
  • Sepsis syndrome
  • Age > 65 years
  • Profound neutropenia (ANC < 0.1 x 109/L)
  • Neutropenia expected to last > 10 days
  • Pneumonia
  • Invasive fungal infection
  • Other clinically documented infections
  • Hospitalization at time of fever
  • Prior episode of FN

ASCO and the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend:

Evaluating first- and subsequent-cycle CSF use for myelosuppressive chemotherapy regimens with an approximate ≥ 20% risk of FN.5,6

"Primary prophylaxis with a CSF starting in the first cycle and continuing through subsequent cycles of chemotherapy is recommended in patients who have an approximately 20% or higher risk for febrile neutropenia on the basis of patient-, disease-, and treatment-related factors." 5

— Excerpted from 2015 ASCO guidelines

ASCO, American Society of Clinical Oncology; CSF, colony-stimulating factor; NCCN, National Comprehensive Cancer Network® (NCCN®).

Help protect your patients at risk of FN

About neutrophil nadirs

Myelosuppressive chemotherapy decreases ANC, resulting in neutropenia and a neutrophil nadir

Duration and depth of chemotherapy-induced neutropenia has an associated nadir7

Neutrophil nadir chart.

Study design: Phase 3, multicenter, randomized, double-blind, placebo-controlled trial in patients (N = 210) with small-cell lung cancer receiving up to 6 cycles of chemotherapy with cyclophosphamide, doxorubicin, and etoposide. Patients were randomized to receive either placebo (n = 104) or NEUPOGEN® (filgrastim) (n = 95) 24 hours post-chemotherapy (beginning on day 4 and continuing through day 12 and up to day 17 of a 21-day cycle unless the postnadir neutrophil count after day 12 exceeded 10.0 × 109/L, in which case growth factor support was discontinued for the remainder of the cycle). Primary endpoint was the incidence of fever (≥ 38°C) associated with an ANC < 1.0 x 109/L. 7

†Severe neutropenia (Grade 4) = ANC < 0.5 × 109/L.

Risk associated with severe neutropenia

A longer duration of severe neutropenia is directly related to an increased risk of FN

Incidence of FN by duration of severe neutropenia in cycle 1 in patients with cancer receiving granulocyte colony-stimulating factor (G-CSF) support 8

Incidence of FN by duration of severe neutropenia in cycle 1 in patients with cancer receiving G-CSF support.

Study design: Retrospective analysis combining 2 randomized phase 3 clinical trials comparing Neulasta® to NEUPOGEN® (filgrastim). Patients received myelosuppressive chemotherapy (docetaxel 75 mg/m2 and doxorubicin 60 mg/m2) on day 1; on day 2, patients received either once-per-cycle Neulasta® or once-daily NEUPOGEN®. Data are from cycle 1. Primary endpoint of this retrospective analysis was to characterize the relationship between the duration of severe neutropenia and FN. 8

‡Severe neutropenia = ANC < 0.5 x 109/L.

Next See Neulasta® efficacy in patients with breast cancer or NHL

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. Weycker D, et al. J Oncol Pharm Pract. 2014;20:190‑198. 2. Neulasta® (pegfilgrastim) Prescribing Information, Amgen. 3. Kosaka Y, et al. Support Care Cancer. 2015;23:1137‑1143. 4. Pettengell R, et al. Support Care Cancer. 2012;20:647‑652. 5. Smith TJ, et al. J Clin Oncol. 2015;33:3199‑3212. 6. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myeloid Growth Factors V.2.2016. National Comprehensive Cancer Network, Inc. 2016. All rights reserved. Accessed September 9, 2016. To view the most recent and complete version of the guideline, go online to www.nccn.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc. 7. Crawford J, et al. N Engl J Med. 1991;325:164‑170. 8. Meza L, et al. Proc Am Soc Clin Oncol. 2002;21:Abstract 2840.

NEUPOGEN® is administered by subcutaneous injection, short intravenous infusion (15 to 30 minutes), or continuous intravenous infusion.

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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.