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.
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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
†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 Guidelines state that based on clinical trial data, pegfilgrastim should be administered the day after chemotherapy (category 1 recommendation)4
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
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
FN rate for the day after chemotherapy vs all other days of Neulasta® administration was 2.53% and 3.04%, respectively.5
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.
of patients and nurses would choose Neulasta® Onpro® again6,7,‡‡,§§
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
Neulasta® Onpro® | |
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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
The information provided does not replace the Healthcare Provider Instructions for Use. Prior to use, please review the Instructions for Use.
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.
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®.
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.
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.
Patients get 24/7 telephone support for questions about Neulasta® Onpro®.
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.
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).
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).
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.
Please see Neulasta® full Prescribing Information.
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 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. 5. Data on file, Amgen; 2018. 6. Data on file, Amgen; [2]; 2017. 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.
Neulasta® (pegfilgrastim) is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with non-myeloid 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.
31%*
*p = 0.01
Across all cycles of chemotherapy, the incidence of FN associated with PFS was 1.7% (n = 455) vs 1.3% (n = 126) for Neulasta® Onpro®1
†FN was defined as:
FN = temperature ≥ 38.2°C and absolute neutrophil count < 0.5 x 109/L.
PFS = prefilled syringe; FN = febrile neutropenia.
A retrospective study designed to compare the incidence of FN associated with Neulasta® Onpro® vs Neulasta® PFS among patients receiving myelosuppressive chemotherapy. The study included 35,856 cycles of chemotherapy in which Neulasta® was administered (9395 Neulasta® Onpro® and 26,461 PFS administrations).
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%]).
Q3W = once every 3 weeks; IV = intravenous.
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).