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.

According to the American Society of Clinical Oncology (ASCO) and the 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% risk1,2

When assessing risk, evaluate both chemotherapy regimen and patient risk factors2

Select chemotherapy regimens associated with a
High Risk of FN
Breast cancer
  • TAC (docetaxel + doxorubicin + cyclophosphamide) Q3W2,3,*
  • TC (docetaxel + cyclophosphamide) Q3W2,4,*
  • TCH*± P (docetaxel + carboplatin + trastuzumab with or without pertuzumab)2,5,6
Non-Hodgkin's lymphoma
  • BR (bendamustine + rituximab)7,†
  • CHOP*,‡ ± R (cyclophosphamide + doxorubicin + vincristine + prednisolone with or without rituximab) Q3W2,8,9
Non-small cell lung cancer
  • Carboplatin + paclitaxel Q3W10,‡
Small cell lung cancer
  • Topotecan2,*
Select chemotherapy regimens associated with an
Intermediate Risk of FN
Breast cancer
  • AC (doxorubicin + cyclophosphamide) + sequential docetaxel11, †
Non-small cell lung cancer
  • Cisplatin + etoposide2,*
  • Cisplatin + docetaxel2,12,*
  • Carboplatin + docetaxel13,†
Prostate cancer
  • Cabazitaxel2,*
  • Docetaxel + prednisone14,†
Small cell lung cancer
  • Carboplatin + etoposide2,*

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. Do not administer Neulasta® between 14 days before and 24 hours after administration of chemotherapy. The recommended dosage of Neulasta® is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle.

*Select regimens listed from NCCN Guidelines® and scientific publications. Please see references for source information.

Select regimens not listed by the NCCN.

Select regimens listed by the NCCN as intermediate risk. Regimens listed as high risk based on published literature showing risk of FN of 17% or greater.15

CSF, colony-stimulating factor; FN, febrile neutropenia; NCCN, National Comprehensive Cancer Network; Q3W, once every 3 weeks.


See how neutrophil nadirs can be unpredictable

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Neutrophil nadirs can be unpredictable and vary by chemotherapy agent

*Select regimens listed from NCCN Guidelines® and scientific publications. Please see references for source information.

Select regimens not listed by the NCCN.

Rituximab has been associated with late-onset neutropenia (defined as occurring at least 60 days after the last treatment). In a retrospective evaluation of patients with diffuse large B-cell lymphoma receiving CHOP-R, the median time to neutrophil nadir (ANC=0.66 x 109/L) was 129 days. Late-onset neutropenia occurred 76 to 192 days after the completion of rituximab and the duration of neutropenia ranged from 8 to 16 days.10

§ Select regimens listed by NCCN as intermediate risk. Regimens listed as high risk based on published literature showing risk of FN of 17% or greater.22

**Not an antineoplastic agent.3

ANC, absolute neutrophil count; CHOP-R, cyclophosphamide + doxorubicin + vincristine + prednisone + rituximab; FN, febrile neutropenia; NCCN, National Comprehensive Cancer Network; Q3W, once every 3 weeks.

References:

1. Smith TJ, et al. J Clin Oncol. 2015;33:3199-3212. 2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myeloid Growth Factors V.2.2018. ©National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed August 3, 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. 3. McEvoy GK, ed in chief, Snow ED, ed. AHFS: Drug Information 2017. Bethesda, MD: American Society of Health-System Pharmacists; 2017. 4. Doxorubicin Hydrochloride for Injection Prescribing Information, Pfizer. 5. Younis T, et al. Support Care Cancer. 2012;20:2523-2530. 6. Perjeta (pertuzumab) Prescribing Information, Genentech, Inc. 7. Schneeweiss A, et al. Ann Oncol. 2013;24:2278-2284. 8. Cerchione C, et al. Support Care Cancer. 2017;25:839-845. 9. Treanda® (bendamustine hydrochloride) Prescribing Information, Teva. 10. Dunleavy K, et al. Semin Hematol. 2010;47:180-186. 11. Ösby E, et al. Blood. 2003;101:3840-3848. 12. Delarue R, et al. Lancet Oncol. 2013;14:525-533. 13. Barton-Burke M, et al, eds. Cancer Chemotherapy: A Nursing Process Approach. 3rd ed. Sudbury, MA: Jones and Bartlett Publishers; 2001:chap 4. 14. Ohe Y, et al. Ann Oncol. 2007;18:317-323. 15. Swain SM, et al. N Engl J Med. 2010;362:2053-2065. 16. Platinol (cisplatin for injection, USP) Prescribing Information, Bristol-Myers Squibb. 17. Toposar (etoposide injection USP) Prescribing Information, Teva. 18. Schiller JH, et al. N Engl J Med. 2002;346:92-98. 19. Yoshimura N, et al. J Thorac Oncol. 2009;4:371-375. 20. Diéras V, et al. Eur J Cancer. 2013;49:25-34. 21. Kongsted P, et al. Urol Oncol. 2015;33:494.e15-494.e20. doi:10.1016/j.urolonc.2015.06.022. 22. Vogel CL, et al. J Clin Oncol. 2005;23:1178-1184.


In addition to the chemotherapy regimen, consider patient-related risk factors

NCCN Guidelines®: If your patient is on an intermediate-risk regimen and has
1 or more risk factors, consider pegfilgrastim (Neulasta® or Neulasta® Onpro®)2

Even one of these select risk factors can increase risk:2,§

  • Baseline cytopenias16,17
  • Poor performance status (ECOG ≥ 2)18
  • Age ≥ 65 years17
  • COPD19,**
  • Chronic immunosuppression in the post-transplant setting, including organ transplant16
  • Liver disease20
  • Renal disease17
  • Cardiovascular disease17,**
  • Diabetes21,**
  • Prior chemotherapy22
  • Prior radiotherapy16
  • Poor nutritional status23,**
  • Decreased serum albumin23,**
  • Open wounds/recent surgery24
  • Active infections25,**
  • HIV20
  • Metastatic18,**
  • Elevated lactate dehydrogenase23,**

§The patient risk factors included here have been identified through published literature and clinical guidelines. This list is not exhaustive. There may be other risk factors that apply based on available research and the clinical judgment of the treating physicians. These risk factors in addition to high or intermediate risk chemotherapy regimens can increase the risk of infection.

**Risk factors not listed by the NCCN.

COPD, chronic obstructive pulmonary disease; ECOG, Eastern Cooperative Oncology Group; HIV, human immunodeficiency virus.

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

ICD-10, International Statistical Classification of Diseases and Related Health Problems, 10th Revision.

Evaluate the risk of febrile neutropenia in patients like these to reduce its impact

  • Meet Safiya
  • Meet Shelley

Meet Safiya, a patient with breast cancer who was not prescribed Neulasta® in every cycle

  • Aged 39; single mother of children aged 15 and 9
  • Diagnosed with invasive ductal carcinoma
  • Stage IIIB cancer considered locally advanced disease, a risk factor for FN
  • Prescribed docetaxel, plus pertuzumab and trastuzumab

Safiya was not prescribed Neulasta® in her first cycle of chemotherapy, developed FN, and was hospitalized

  • Locally advanced disease and docetaxel treatment put Safiya at risk, and she developed FN in her first cycle of chemotherapy

Meet Shelley, a metastatic patient and the first to receive Neulasta® Onpro®

  • Aged 51; new grandmother living alone
  • Diagnosed with stage IV, HER2+ breast cancer
  • Bone and liver metastases discovered
  • Prescribed docetaxel plus pertuzumab and trastuzumab Q3W
  • Overall treatment plan goals were to extend life and prevent progression

Shelley’s FN risk was associated with chemotherapy regimen-, patient-, and treatment-related risk factors

HER2, human epidermal growth factor receptor 2.

Meet Safiya

Meet Safiya, a patient with breast cancer who was not prescribed Neulasta® in every cycle

Meet more patients
  • Aged 39; single mother of children aged 15 and 9
  • Diagnosed with invasive ductal carcinoma
  • Stage IIIB cancer considered locally advanced disease, a risk factor for FN
  • Prescribed docetaxel, plus pertuzumab and trastuzumab

Safiya was not prescribed Neulasta® in her first cycle of chemotherapy, developed FN, and was hospitalized

  • Locally advanced disease and docetaxel treatment put Safiya at risk, and she developed FN in her first cycle of chemotherapy
Meet Shelley

Meet Shelley, a metastatic patient and the first to receive Neulasta® Onpro®

  • Aged 51; new grandmother living alone
  • Diagnosed with stage IV, HER2+ breast cancer
  • Bone and liver metastases discovered
  • Prescribed docetaxel plus pertuzumab and trastuzumab Q3W
  • Overall treatment plan goals were to extend life and prevent progression

Shelley’s FN risk was associated with chemotherapy regimen-, patient-, and treatment-related risk factors

HER2, human epidermal growth factor receptor 2.

Choose Neulasta® Onpro® every cycle

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.

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 MoreClose

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.

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).

References:

1. Smith TJ, et al. J Clin Oncol. 2015;33:3199-3212. 2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myeloid Growth Factors V.2.2018. ©National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed August 3, 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. 3. Martin M, et al. N Engl J Med. 2005;352:2302-2313. 4. Younis T, et al. Support Care Cancer. 2012;20:2523-2530. 5. Perjeta (pertuzumab) Prescribing Information, Genentech, Inc. 6. Schneeweiss A, et al. Ann Oncol. 2013;24:2278-2284. 7. Cerchione C, et al. Support Care Cancer. 2017;25:839-845. 8. Ösby E, et al. Blood. 2003;101:3840-3848. 9. Delarue R, et al. Lancet Oncol. 2013;14:525-533. 10. Ohe Y, et al. Ann Oncol. 2007;18:317-323. 11. Swain SM, et al. N Engl J Med. 2010;362:2053-2065. 12. Schiller JH, et al. N Engl J Med. 2002;346:92-98. 13. Yoshimura N, et al. J Thorac Oncol. 2009;4:371-375. 14. Kongsted P, et al. Urol Oncol. 2015;33:494.e15-494.e20. doi:10.1016/j.urolonc.2015.06.022. 15. Vogel CL, et al. J Clin Oncol. 2005;23:1178-1184. 16. Moreau M, et al. Ann Oncol. 2009;20:513-519. 17. Lyman GH, et al. Leuk Lymphoma. 2003;44:2069-2076. 18. Lyman GH, et al. J Clin Oncol. 2004;22:4302-4311. 19. Klastersky J, et al. J Clin Oncol. 2000;18:3038-3051. 20. Chao C, et al. Ann Oncol. 2014;25:1821-1829. 21. Takenaka Y, et al. Support Care Cancer. 2013;21:2861-2868. 22. Shayne M, et al. Cancer. 2007;110:1611-1620. 23. Intragumtornchai T, et al. Leuk Lymphoma. 2000;37:351-360. 24. Family L, et al. J Clin Oncol. 2016;34. Abstract 6559. 25. Pettengell R, et al. Br J Haematol. 2008;144:677-685.

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