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... Read More

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

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Reducing the risk of febrile neutropenia (FN)

FN-related hospitalizations remain prevalent

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91,000+ hospitalizations among adult patients with cancer‑related neutropenia1,*

A retrospective cohort study (N = 91,560 patients) conducted with 2012 US hospital discharge data from the Agency for Healthcare Research and Quality Nationwide Inpatient Sample all-payer database. Hospitalizations may or may not have been caused by chemotherapy.1

*Subjects in these studies may or may not have received G-CSF support prior to FN hospitalization.

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

Evaluating FN risk

National guidelines recommend assessing risk of FN before every cycle2,3

According to the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®): Evaluate the risk of FN and administer primary CSF prophylaxis in first and subsequent cycles for patients at > 20% risk2,3

When assessing risk, evaluate both chemotherapy regimen and patient risk factors3

Chemotherapy regimen risk Plus Icon
Patient risk factors Plus Icon

Short-term COVID-19 guidelines Plus Icon

Next-day Neulasta® reduced the incidence of FN and FN-related hospitalization when used on time, every cycle4

Neulasta® reduced the risk of FN to 1%Neulasta® reduced the risk of FN to 1%

Phase 3, multicenter, multinational, double-blind, placebo-controlled trial of patients with breast cancer (Neulasta® [n = 463] or placebo [n = 465]) receiving 100 mg/m2 docetaxel Q3W for up to 4 cycles. Patients were randomized to receive a single subcutaneous injection of Neulasta® (6 mg) or placebo on day 2 of each chemotherapy cycle. The key endpoint was the percentage of patients who developed FN (Neulasta® 1% vs placebo 17%, P < 0.001). Also, secondary endpoints were lower for Neulasta®-treated patients as compared to placebo-treated patients (the incidence of hospitalization [1% vs 14%] and IV anti-infective use [2% vs 10%]).4

FN = febrile neutropenia; Q3W = once every 3 weeks; IV = intravenous.

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

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Download either the PDF version OR the Microsoft Word document (versions are identical in content)

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Populate 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.

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

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

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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 CBCs during Neulasta® therapy 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, diseases for which Neulasta® is not approved, 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.

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

References:

1. Tai E, et al. J Oncol Pract. 2017;13:e552-e561. doi:10.1200/JOP.2016.019588. 2. Smith TJ, et al. J Clin Oncol. 2015;33:3199-3212. 3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myeloid Growth Factors V.2.2020. National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed October 23, 2020. 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. Vogel CL, et al. J Clin Oncol. 2005;23:1178-1184. 5. Lyman GH, et al. Leuk Lymphoma. 2003;44:2069-2076. 6. Moreau M, et al. Ann Oncol. 2009;20:513-519. 7. Lyman GH, et al. J Clin Oncol. 2004;22:4302-4311. 8. Klastersky J, et al. J Clin Oncol. 2000;18:3038-3051. 9. Chao C, et al. Ann Oncol. 2014;25:1821-1829. 10. Takenaka Y, et al. Support Care Cancer. 2013;21:2861-2868. 11. Shayne M, et al. Cancer. 2007;110:1611-1620. 12. Intragumtornchai T, et al. Leuk Lymphoma. 2000;37:351-360. 13. Family L, et al. J Clin Oncol. 2016;34. Abstract 6559. 14. Pettengell R, et al. Br J Haematol. 2008;144:677-685. 15. NCCN. Short-term recommendations specific to issues with COVID-19 (SARS-CoV-2). Accessed October 23, 2020. https://www.nccn.org/covid-19/pdf/HGF_COVID-19.pdf.