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.
Improving the Patient Experience
As part of our commitment to improving the Neulasta® (pegfilgrastim) Onpro® experience, an updated on-body injector (OBI) is now available.
Choose Neulasta® Onpro®
to give them back their day
Go directly to:
Choose Neulasta® Onpro® every cycle to help ensure next-day Neulasta® delivery1
patients reported feeling tired, fatigued, drained, and exhausted after receiving chemotherapy2,*
Traveling for injections the day after chemotherapy is time-consuming for patients and caregivers3,†
Nearly 2/3 of patients had a companion drive them to the clinic3
- Patients and their caregivers may need to make several arrangements for a next-day G-CSF treatment3
*Data from interviews with Neulasta® treatment–experienced oncology patients (N=227, PFS n=150, Neulasta® Onpro® n=77) conducted in November 2016. All patients in the study were asked to list one-word adjectives or short phrases that best described how they felt after receiving chemotherapy. 86% of patients recalled feeling tired, fatigued, drained, and exhausted after receiving chemotherapy.2
†Total time spent in the office, including wait time and time spent traveling for a return visit for G‑CSF injection, was reported by respondents in a prospective cohort study of 598 adult patients with ESBC. Patients included those treated with daily-dose filgrastim and those receiving once-per-cycle pegfilgrastim injections. On average, patients spent 1.72 hours per clinic visit for a G‑CSF injection.3
ESBC, early-stage breast cancer; G‑CSF, granulocyte colony-stimulating factor; PFS, prefilled syringe.
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend that pegfilgrastim be administered according to the FDA-approved dosing schedule (day after myelosuppressive chemotherapy)4,‡
of Neulasta® cycles were administered on days other than the day after chemotherapy5
The study included over 200,000 Neulasta® cycles from 2 patient databases. Over 90% of patients were ≤ 65 years of age. The vast majority of cycles (93%) were accompanied by the use of the Neulasta® prefilled syringe.5
increased risk of FN when Neulasta® was administered on days other than the day after chemotherapy5,§
Neulasta® Onpro® is designed to deliver 27 hours after application in accordance with labeling1
Do not administer Neulasta® between 14 days before and 24 hours after administration of chemotherapy1
‡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
FN rate for the day after chemotherapy vs all other days of Neulasta® administration was 2.53% and 3.04%, respectively.5
‡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
FN rate for the day after chemotherapy vs all other days of Neulasta® administration was 2.53% and 3.04%, respectively.5
§Retrospective cohort analysis based on health care claims from IMS PharMetrics Plus™ and Truven Health Analytics MarketScan® Commercial and Medicare Supplemental Databases. The collective data include health care claims from private US health plans, covering over 30 million persons annually. The data included all patients ≥ 18 years who, between July 1, 2010, and September 30, 2015, initiated ≥ 1 course of myelosuppressive chemotherapy for a primary solid tumor or non-Hodgkin's lymphoma. All patients who received a selected chemotherapy regimen with a risk of FN and pegfilgrastim prophylaxis in ≥ 1 cycles of chemotherapy were selected for inclusion in the study population. FN requiring inpatient care was identified based on an inpatient admission with a diagnosis (principal or secondary) of neutropenia, fever, or infection using ICD-9 and ICD-10 codes. FN requiring outpatient care was only ascertained based on an encounter in the outpatient setting with a diagnosis of neutropenia, fever, or infection, and—on the same date—code for IV administration of antimicrobial therapy.5
18% is the increase in relative risk comparing days other than the day after chemotherapy to the day after chemotherapy. Relative risk was estimated using GEE to account for correlation among repeated measures for the same subject, and adjusted using backward selection of patient, cancer, and treatment characteristics.5
||Do not administer Neulasta® the same day as chemotherapy.1
FN, febrile neutropenia; GEE, generalized estimating equations; ICD-9, International Classification of Diseases, 9th Revision; ICD-10, International Classification of Diseases, 10th Revision; IV, intravenous; NCCN, National Comprehensive Cancer Network.
Neulasta® Onpro® is patient- and nurse-chosen protection¶
of patients and nurses would choose Neulasta® Onpro® again6,7,#,**
- Not having to return to the doctor’s
office the day after chemotherapy just for an injection was the most important factor for patients when choosing a G‑CSF6, ††
- Patients also valued how much experience their doctor has with the G‑CSF they would receive and being informed by the doctor or nurse of all available ways to receive the G‑CSF6
The National Comprehensive Cancer Network® (NCCN®) recognizes the on-body injector as an appropriate option for delivering the full dose of pegfilgrastim (Neulasta®) the day after chemotherapy4
¶In a key study of 928 patients with breast cancer, when given once every chemotherapy cycle, 17% of patients got infections when not treated with Neulasta®—while only 1% of patients got infections when treated with Neulasta®.8
#2016 data from interviews with oncology patients who have had experience with Neulasta® (N=227, PFS n=150, Neulasta® Onpro® n=77). Patients who had received Neulasta® via Neulasta® Onpro® were asked to answer the question: Based on your personal experience getting your Neulasta® with Neulasta® Onpro®, if your doctor said you needed to use Neulasta® again in the future, would you request getting it with Neulasta® Onpro® again?6
**Data from interviews with oncology nurses (N=250) conducted in October 2016. Respondents were asked if they agreed with this statement: Based on my Neulasta® Onpro® experience, when my patients are appropriate for Neulasta® PFS or Neulasta® Onpro®, I would choose Neulasta® Onpro®.7
††November 2016 data from interviews with oncology patients who have had experience with Neulasta® (N=227, PFS n=150, Neulasta® Onpro® n=77). Patients were asked a multiple-choice selection prompt: If your doctor felt you should receive a G‑CSF medication, please select the 3 most important factors to you (other than safety and how well it works) when considering G‑CSF care to boost your white blood cell count after chemotherapy. Patients then completed a follow-up prompt: Of the 3 most important factors you selected, we would like to know which is the most important. Please rank these from most important (1) to least important (3).6
Consider what Neulasta® Onpro® can offer patients and practices
| Neulasta® Onpro® | |
|---|---|
| 9 of 10 patients report feeling fatigued the day after chemo. Provides option to automatically deliver G‑CSF at home1,2,‡‡,§§ |  |
| May eliminate the time patients and caregivers spend traveling for G‑CSF appointments3 | |
| Fewer next-day injection appointments3 | |
| Designed for automatic next-day delivery of pegfilgrastim (Neulasta®) in accordance with guidelines and labeling1,‡‡,§§ | |
| Would be chosen again by 95% of patients if they needed Neulasta® again6,|||| | |
| Is the product of 3 decades of innovation and commitment to enhancing patient experience9-11,¶¶ | |
| May provide G‑CSF support through the nadir12 | |
‡‡ Incomplete doses have been reported with Neulasta® Onpro® due to the device not performing as intended. This may increase risk of neutropenia, febrile neutropenia and/or infection.1
§§ Data from interviews with Neulasta® treatment–experienced oncology patients (N=227, PFS n=150, Neulasta® Onpro® n=77) conducted in November 2016. All patients in the study were asked to list one-word adjectives or short phrases that best described how they felt after receiving chemotherapy. 86% of patients surveyed recalled feeling tired, fatigued, drained, and exhausted after receiving chemotherapy.2
|||| 2016 data from interviews with oncology patients who have had experience with Neulasta® (N=227, PFS n=150, Neulasta® Onpro® n=77). Patients who had received Neulasta® via Neulasta® Onpro® were asked to answer the question: Based on your personal experience getting your Neulasta® with Neulasta® Onpro®, if your doctor said you needed to use Neulasta® again in the future, would you request getting it with Neulasta® Onpro® again?6
¶¶ NEUPOGEN® was approved in 1991; Neulasta® Onpro® was approved in 2014.11,13
4 steps to apply
1.
Prepare the application site
2.
Fill the on‑body injector
3.
Confirm on‑body injector status
4.
Apply the on‑body injector
The information provided does not replace the Healthcare Provider Instructions for Use. Prior to use, please review the Instructions for Use.
Neulasta® Onpro® application tips from an oncology nurse
Hear from Tina Pryor, RN, about applying the Neulasta® Onpro®.
This video does not replace the Instructions for Use. Please consult the Instructions for Use when using the Neulasta® Onpro® kit.
Tap into a different way to learn
Get to know Neulasta® Onpro® through an engaging, interactive learning experience.
Designed for oncology nurses, the tool offers hands-on digital simulations. It does not replace the Healthcare Provider Instructions for Use. Always refer to the Instructions for Use when using Neulasta® Onpro®.
Neulasta® Onpro® in practice
Hear two of your colleagues
on prescribing Neulasta®
Onpro® and incorporating it
into their practices.
Dr Kashif Ali
Dr Dana Thompson
Help guide the
patient experience
Patient educational video
Gives patients an overview of Neulasta® and how the on-body injector for Neulasta® works.
This video does not replace the Instructions for Use. Please consult the Instructions for Use when using the Neulasta® Onpro® kit.
Sharps container program
Patients can order a FREE sharps container for on-body injector disposal by completing an enrollment form or calling 1-844-MYNEULASTA (1-844-696-3852) to receive their container in 7 to 10 business days.
24/7 telephone support
Patients get 24/7 telephone support for questions about Neulasta® Onpro®.
Next
See dosing information.
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. Neulasta® (pegfilgrastim) Prescribing Information, Amgen. 2. Data on file, Amgen; [1]; 2017. 3. Stephens JM, et al. J Med Econ. 2016;19:537-547. 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hematopoietic Growth Factors V.1.2021. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed March 26, 2021. To view the most recent and complete version of the guideline, go online to NCCN.org. 5. Data on file, Amgen; 2018. 6. Data on file, Amgen; [2]; 2020. 7. Data on file, Amgen; 2016. 8. Vogel CL, et al. J Clin Oncol. 2005;23:1178-1184. 9. Data on file, Amgen; 2014. 10. Amgen Fact Sheet 2018. Available at: http://www.amgen.com/~/media/amgen/full/www-amgen-com/downloads/fact-sheets/fact_sheet_amgen.ashx. Updated March 6, 2018. Accessed April 15, 2018. 11. NEUPOGEN® (filgrastim) Prescribing Information, Amgen. 12. Green MD, et al. Ann Oncol. 2003;14:29-35. 13. Food and Drug Administration. Supplement approval. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125031Orig1s175ltr.pdf. Published December 23, 2014. Accessed August 10, 2018. 14. Neulasta® (pegfilgrastim) Onpro® kit Healthcare Provider Instructions for Use, Amgen.
×
Onpro® Kit HCP Instructions for Use:
Which version of the HCP Instructions for Use came with your patient's on-body injector?
×
On-body Injector Patient Instructions for Use:
Which version of the Instructions for Use did your doctor's office give you?
If you don’t recognize the images above or if you prefer a physical copy, contact your doctor.
×
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. See More.
Please see Important Safety Information below.
In the pivotal trial, next-day Neulasta® reduced the incidence of febrile neutropenia (FN) and FN-related hospitalization when used every cycle, at the right time.* Please see pivotal trial study design and results below.1
*Do not administer Neulasta® between 14 days before and 24 hours after administration of cytotoxic chemotherapy.
In a prospective observational study of ~2600 cancer patients,
Fewer patients experienced FN with Neulasta® Onpro® vs 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
CI = confidence interval; FN = febrile neutropenia; ANC = absolute neutrophil count; IV = intravenous.
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%]).
Prospective study design2,3
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)
Prospective study design (cont)2,3
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
G-CSF = granulocyte colony-stimulating factor; IV = intravenous; NHL = non-Hodgkin's lymphoma; PFS = prefilled syringe; Q3W = once every 3 weeks.
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).
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References:
- Vogel CL, et al. J Clin Oncol. 2005;23(6):1178-1184.
- Data on file, Amgen; 2020.
- 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.