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Indication

Neulasta ® (pegfilgrastim) is indicated to decrease the incidence.. 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

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.

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

Learn more
Learn more

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 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.

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® (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 of complete blood count (CBC) during pegfilgrastim therapy is recommended

Thrombocytopenia

  • Thrombocytopenia has been reported in patients receiving pegfilgrastim. Monitor platelet counts

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

Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients With Breast and Lung Cancer

  • MDS and AML have been associated with the use of Neulasta® in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings

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).

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® (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 of complete blood count (CBC) during pegfilgrastim therapy is recommended

Thrombocytopenia

  • Thrombocytopenia has been reported in patients receiving pegfilgrastim. Monitor platelet counts.

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

Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer

  • MDS and AML have been associated with the use of Neulasta® in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings

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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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 febrile neutropenia.

Neulasta® is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Please see Important Safety Information below.

In the pivotal trial, next-day Neulasta® (pegfilgrastim) reduced the incidence of febrile neutropenia (FN) and FN-related hospitalization when used every cycle, at the right time.1,*

Pivotal trial study design and results1

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. The key endpoint was the percentage of patients who developed FN (Neulasta® 1% versus 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% versus 14%] and IV anti-infective use [2% versus 10%]).

*Do not administer Neulasta® between 14 days before and 24 hours after administration of cytotoxic chemotherapy.
Q3W = once every 3 weeks; IV = intravenous.

In a prospective observational study of ~2600 cancer patients,

Fewer patients experienced FN with Neulasta® Onpro® compared to other FN‑prophylaxis options2,3

This was an observational study and no formal statistical testing was performed. Descriptive statistics are available.

†Adjusted for baseline clinical and demographic differences between the groups, eg, degree of FN risk of chemotherapy regimen.

The primary endpoint was the overall incidence of FN over four cycles of chemotherapy, measured as ANC < 1,000 × 106/L and one of the following occurring within 24 hours of decreased ANC: Temperature > 38°C, use of specific oral antibiotics (eg, ciprofloxacin, levofloxacin, moxifloxacin, amoxicillin-clavulanate), or use of IV antibiotics.3

FN = temperature ≥ 38.2°C and ANC < 0.5 x 109/L. CI = confidence interval; FN = febrile neutropenia; ANC = absolute neutrophil count; IV = intravenous.

Prospective study design and results2,3

Prospective, observational US study to describe frequency of FN, adherence, and compliance among patients receiving myelosuppressive chemotherapy for breast, lung, prostate, or NHL malignancies.

  • The study enrolled patients from November 2018 to April 2020
  • The primary analysis included 2575 patients who completed up to four chemotherapy cycles
  • Investigators decided on the method of FN-prophylaxis. Patients were grouped into either the Neulasta® Onpro® group or other FN-prophylaxis group based on FN-prophylaxis method received in the first cycle. In both groups, physicians could change the type of G-CSF use in the following cycles (choice in first cycle was generally consistent across subsequent cycles)
    • Other FN-prophylaxis options included Neulasta® PFS or pegfilgrastim biosimilar PFS (61.7%), daily short-acting filgrastim or filgrastim biosimilar (7.3%), or no G-CSF (30.9%)
  • Secondary endpoints included: 1) Patients who received G-CSF support for all chemotherapy cycles regardless of timing of G-CSF administration (persistence) and 2) Patients who received pegfilgrastim on the day after chemotherapy in every cycle in which pegfilgrastim was administered (compliance)

G-CSF = granulocyte colony-stimulating factor; NHL = non-Hodgkin's lymphoma; PFS = prefilled syringe.

Prospective Study Limitations3

  • It was not possible to evaluate FN risk among patients lost to follow-up after study enrollment
  • Although the analysis of FN incidence controlled for known baseline differences between the groups, the lack of randomization means that the groups may have differed in ways that were not measured or recorded. The impact of such differences on the study findings is unknown
  • The study enrollment closed prematurely due to COVID-19 and did not achieve target sample sizes

Explore more study details here

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, 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 of complete blood count (CBC) during pegfilgrastim therapy is recommended

Thrombocytopenia

  • Thrombocytopenia has been reported in patients receiving pegfilgrastim. Monitor platelet counts

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

Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients With Breast and Lung Cancer

  • MDS and AML have been associated with the use of Neulasta® in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings

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. Vogel CL, et al. J Clin Oncol. 2005;23(6):1178-1184.
  2. Data on file, Amgen; 2020.
  3. Mahtani RL, et al. A multicenter, prospective, observational study to determine the incidence of febrile neutropenia (FN), persistence and G-CSF utilization among cancer patients at high risk for FN receiving pegfilgrastim by an on-body injector (OBI) versus other FN-prophylaxis strategies. Poster presented at: San Antonio Breast Cancer Symposium®, Virtual.