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.
What is Neulasta® indicated for?
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.
Review the Neulasta® pivotal trial dataHow is Neulasta® dosed and administered?
There are two delivery methods for Neulasta® support: the Neulasta® Onpro® kit with the on-body injector for Neulasta®, and the prefilled syringe for manual injection.
- Both options deliver a single 6 mg fixed dose of Neulasta® with a half-life of 15–80 hours1
- Do not administer Neulasta® between 14 days before and 24 hours after administration of cytotoxic chemotherapy1
- The Neulasta® prefilled syringe for manual injection is not designed to allow for direct administration of doses less than 0.6 mL (6 mg), as the syringe does not bear graduation marks
- Direct administration to pediatric patients weighing less than 45 kg is not recommended due to the potential for dosing errors
- Use of the on-body injector for Neulasta® has not been studied in pediatric patients
For more information regarding dosing, please see the Neulasta® full Prescribing Information.
See the Neulasta® mechanism of actionWhat is the Neulasta® Onpro® kit?
The Neulasta® Onpro® kit is an innovative Neulasta® delivery method available for appropriate patients. It includes a single dose of Neulasta®, and a single-use on-body injector for Neulasta® that’s applied the same day as chemotherapy.1 The on-body injector is designed to deliver Neulasta® the next day, over 45 minutes approximately 27 hours after application, at home or other appropriate setting.1
Get more information about Neulasta® Onpro®Is there an additional cost for Neulasta® Onpro®?
The Neulasta® Onpro® kit is available at no additional cost beyond that of the prefilled syringe for manual injection. Neulasta® Onpro® has the same J-code (J2505) as the prefilled syringe for manual injection.*2
*Call 1‑844‑MYNEULASTA (1‑844‑696‑3852) to confirm payer-specific requirements.
Learn more about Neulasta® Onpro®Is financial assistance available for patients?
Through Amgen Assist 360™, patients have access to support options, regardless of their type of coverage. Options include Neulasta FIRST STEP® for eligible commercially-insured patients, The Safety Net Foundation for uninsured patients, and referral to independent co-pay foundations.
Eligibility for programs offered by independent co-pay foundations is based solely on the charity's criteria. Amgen has no control over independent, third-party programs and provides referrals as a courtesy only.
View access optionsWho should I contact if I have a question about Neulasta® or Neulasta® Onpro®?
If you have a clinical inquiry or would like to report an adverse event related to Neulasta®, connect online to medical information or call 1-800-77-AMGEN (1-800-772-6436).
If you have questions about Neulasta® Onpro®, 24/7 telephone support is available. Call 1‑844‑MYNEULASTA (1‑844‑696‑3852) for answers to your questions on Neulasta® Onpro®, reimbursement (including billing and coding), co-pay assistance, and the Product Replacement Program.
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, sickle cell crisis, in some cases fatal, can occur in patients receiving Neulasta®
- Discontinue Neulasta® if sickle cell crisis occurs
Glomerulonephritis
- Has occurred in patients receiving Neulasta®
- Diagnoses based on azotemia, hematuria, proteinuria, and renal biopsy
- Generally events resolved after dose reduction or discontinuation of Neulasta®
- If suspected, evaluate for cause and if cause is likely, consider dose‐reduction or interruption of Neulasta®
Leukocytosis
- Increased white blood cell counts of 100 x 109/L have been observed
- Monitoring CBCs is recommended
Capillary Leak Syndrome (CLS)
- CLS has been reported after G‐CSF administration, including Neulasta®
- Characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration
- Episodes vary in frequency, severity, and may be life‐threatening if treatment is delayed
- Patients with symptoms should be closely monitored and receive standard symptomatic treatment, which may include intensive care
Potential for Tumor Growth Stimulatory Effects on Malignant Cells
- G‐CSF receptor has been found on tumor cell lines
- The possibility that pegfilgrastim acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, cannot be excluded
Potential Device Failures
- Missed or partial doses have been reported in patients receiving pegfilgrastim via the on‐body injector (OBI) due to the device not performing as intended
- In the event of a missed or partial dose, patients may be at increased risk of events such as neutropenia, febrile neutropenia and/or infection than if the dose had been correctly delivered
- Instruct patients to notify their healthcare professional immediately in order to determine the need for a replacement dose if they suspect that the device may not have performed as intended
Aortitis
- Aortitis has been reported in patients receiving Neulasta®. It may occur as early as the first week after start of therapy
- Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c‑reactive protein and white blood cell count)
- Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue Neulasta® if aortitis is suspected
Nuclear Imaging
- Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results
Most common adverse reactions
- Bone pain
- Pain in extremity
Please see Neulasta® full Prescribing Information.
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, sickle cell crisis, in some cases fatal, can occur in patients receiving Neulasta®
- Discontinue Neulasta® if sickle cell crisis occurs
Glomerulonephritis
- Has occurred in patients receiving Neulasta®
- Diagnoses based on azotemia, hematuria, proteinuria, and renal biopsy
- Generally events resolved after dose reduction or discontinuation of Neulasta®
- If suspected, evaluate for cause and if cause is likely, consider dose‐reduction or interruption of Neulasta®
Leukocytosis
- Increased white blood cell counts of 100 x 109/L have been observed
- Monitoring CBCs is recommended
Capillary Leak Syndrome (CLS)
- CLS has been reported after G‐CSF administration, including Neulasta®
- Characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration
- Episodes vary in frequency, severity, and may be life‐threatening if treatment is delayed
- Patients with symptoms should be closely monitored and receive standard symptomatic treatment, which may include intensive care
Potential for Tumor Growth Stimulatory Effects on Malignant Cells
- G‐CSF receptor has been found on tumor cell lines
- The possibility that pegfilgrastim acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, cannot be excluded
Potential Device Failures
- Missed or partial doses have been reported in patients receiving pegfilgrastim via the on‐body injector (OBI) due to the device not performing as intended
- In the event of a missed or partial dose, patients may be at increased risk of events such as neutropenia, febrile neutropenia and/or infection than if the dose had been correctly delivered
- Instruct patients to notify their healthcare professional immediately in order to determine the need for a replacement dose if they suspect that the device may not have performed as intended
Aortitis
- Aortitis has been reported in patients receiving Neulasta®. It may occur as early as the first week after start of therapy
- Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c‑reactive protein and white blood cell count)
- Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue Neulasta® if aortitis is suspected
Nuclear Imaging
- Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results
Most common adverse reactions
- Bone pain
- Pain in extremity
Please see Neulasta® full Prescribing Information.
Special Instructions for the On‐body Injector (OBI) for Neulasta®
A healthcare provider must fill the on‐body injector (OBI) with Neulasta® using the co‐packaged prefilled syringe and then apply the OBI to the patient’s skin (abdomen or back of arm). The back of the arm may only be used if there is a caregiver available to monitor the status of the OBI. Approximately 27 hours after the OBI is applied to the patient’s skin, Neulasta® will be delivered over approximately 45 minutes. A healthcare provider may initiate administration with the OBI on the same day as the administration of cytotoxic chemotherapy, as long as the OBI delivers Neulasta® no less than 24 hours after the administration of cytotoxic chemotherapy.
The prefilled syringe co‐packaged in the Neulasta® Onpro® kit contains additional solution to compensate for liquid loss during delivery through the OBI. If this syringe is used for manual subcutaneous injection, the patient will receive an overdose. If the prefilled syringe for manual use is used with the OBI, the patient may receive less than the recommended dose.
Do not use the OBI to deliver any other drug product except the Neulasta® prefilled syringe co‐packaged with the OBI. Use of the OBI has not been studied in pediatric patients.
The OBI should be applied to intact, non‐irritated skin on the arm or abdomen.
A missed dose could occur due to an OBI failure or leakage. Instruct patients using the OBI to notify their healthcare professional immediately in order to determine the need for a replacement dose of pegfilgrastim if they suspect that the device may not have performed as intended. If the patient misses a dose, a new dose should be administered by single prefilled syringe for manual use as soon as possible after detection.
Review the Patient Information and Patient Instructions for Use with the patient and provide the instructions to the patient.
Refer to the Healthcare Provider Instructions for Use for the OBI for full administration information.
For any OBI problems, call Amgen at 1‐800‐772‐6436 or 1‐844‐MYNEULASTA (1‐844‐696‐3852).
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INDICATION1
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.
Please see Important Safety Information below.
31%*
*p = 0.01
In a Real-World Study with nearly 11,000 patients
Delivering pegfilgrastim via PFS resulted in a significantly higher risk of FN† vs Onpro®1
Patients receiving Neulasta® via PFS experienced a 31% increased incidence of FN vs Neulasta® Onpro®1
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:
- Inpatient: Diagnosis of neutropenia AND (fever OR inpatient diagnosis of infection)
- Outpatient: Diagnosis of neutropenia AND (fever OR diagnosis of infection AND prescribed antimicrobials)
FN = temperature ≥ 38.2°C and absolute neutrophil count < 0.5 x 109/L.
PFS = prefilled syringe; FN = febrile neutropenia.
Real-World Study Design1
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).
- Patients were followed for 6 to 12 months following the start of the first chemotherapy cycle. The study period was 1/1/16-9/30/18
- Data Source: MarketScan® Commercial Claims and Encounters/Medicare Supplemental and Coordination of Benefits Databases
Real-World Study Limitations1
- Retrospective analysis that did not control for additional variables that may influence the incidence of FN
- Database was not sufficient to understand root causes for observed lower rate of FN for patients receiving Onpro®
Pivotal trial study design and results2
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.
IMPORTANT SAFETY INFORMATION
Contraindication
- Neulasta® is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim or filgrastim
- Reactions have included anaphylaxis
Splenic Rupture
- Splenic rupture, including fatal cases, can occur following the administration of Neulasta®
- Evaluate for an enlarged or ruptured spleen in patients who report left upper abdominal or shoulder pain
Acute Respiratory Distress Syndrome (ARDS)
- ARDS has occurred in patients receiving Neulasta®
- Evaluate patients who develop a fever and lung infiltrates or respiratory distress after receiving Neulasta®
- Discontinue Neulasta® in patients with ARDS
Serious Allergic Reactions
- Serious allergic reactions, including anaphylaxis can occur in patients receiving Neulasta®
- Majority of events occurred upon initial exposure and can recur within days after discontinuation of initial anti‐allergic treatment
- Permanently discontinue Neulasta® in patients with serious allergic reactions
Allergies to Acrylics
- On‐body injector (OBI) for Neulasta® uses acrylic adhesives
- Patients who are allergic to acrylic adhesives may have a significant reaction
Use in Patients With Sickle Cell Disorders
- In patients with sickle cell trait or disease, sickle cell crisis, in some cases fatal, can occur in patients receiving Neulasta®
- Discontinue Neulasta® if sickle cell crisis occurs
Glomerulonephritis
- Has occurred in patients receiving Neulasta®
- Diagnoses based on azotemia, hematuria, proteinuria, and renal biopsy
- Generally events resolved after dose reduction or discontinuation of Neulasta®
- If suspected, evaluate for cause and if cause is likely, consider dose‐reduction or interruption of Neulasta®
Leukocytosis
- Increased white blood cell counts of 100 x 109/L have been observed
- Monitoring CBCs is recommended
Capillary Leak Syndrome (CLS)
- CLS has been reported after G‐CSF administration, including Neulasta®
- Characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration
- Episodes vary in frequency, severity, and may be life‐threatening if treatment is delayed
- Patients with symptoms should be closely monitored and receive standard symptomatic treatment, which may include intensive care
Potential for Tumor Growth Stimulatory Effects on Malignant Cells
- G‐CSF receptor has been found on tumor cell lines
- The possibility that pegfilgrastim acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, cannot be excluded
Potential Device Failures
- Missed or partial doses have been reported in patients receiving pegfilgrastim via the on‐body injector (OBI) due to the device not performing as intended
- In the event of a missed or partial dose, patients may be at increased risk of events such as neutropenia, febrile neutropenia and/or infection than if the dose had been correctly delivered
- Instruct patients to notify their healthcare professional immediately in order to determine the need for a replacement dose if they suspect that the device may not have performed as intended
Aortitis
- Aortitis has been reported in patients receiving Neulasta®. It may occur as early as the first week after start of therapy
- Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c‑reactive protein and white blood cell count)
- Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue Neulasta® if aortitis is suspected
Nuclear Imaging
- Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results
Most common adverse reactions
- Bone pain
- Pain in extremity
Please see Neulasta® full Prescribing Information.
Special instructions for the on-body injector (OBI) for Neulasta®
A healthcare provider must fill the on-body injector (OBI) with Neulasta® using the co-packaged prefilled syringe and then apply the OBI to the patient's skin (abdomen or back of arm). The back of the arm may only be used if there is a caregiver available to monitor the status of the OBI. Approximately 27 hours after the OBI is applied to the patient's skin, Neulasta® will be delivered over approximately 45 minutes. A healthcare provider may initiate administration with the OBI on the same day as the administration of cytotoxic chemotherapy, as long as the OBI delivers Neulasta® no less than 24 hours after the administration of cytotoxic chemotherapy.
The prefilled syringe co-packaged in the Neulasta® Onpro® kit contains additional solution to compensate for liquid loss during delivery through the OBI. If this syringe is used for manual subcutaneous injection, the patient will receive an overdose. If the prefilled syringe for manual use is used with the OBI, the patient may receive less than the recommended dose.
Do not use the OBI to deliver any other drug product except the Neulasta® prefilled syringe co-packaged with the OBI. Use of the OBI has not been studied in pediatric patients.
The OBI should be applied to intact, non-irritated skin on the arm or abdomen.
A missed dose could occur due to an OBI failure or leakage. Instruct patients using the OBI to notify their healthcare professional immediately in order to determine the need for a replacement dose of pegfilgrastim if they suspect that the device may not have performed as intended. If the patient misses a dose, a new dose should be administered by single prefilled syringe for manual use as soon as possible after detection.
Review the Patient Information and Patient Instructions for Use with the patient and provide the instructions to the patient.
Refer to the Healthcare Provider Instructions for Use for the OBI for full administration information.
For any OBI problems, call Amgen at 1-800-772-6436 or 1-844-MYNEULASTA (1-844-696-3852).
References:
- Data on file, Amgen; 2019.
- Vogel CL, et al. J Clin Oncol. 2005;23(6):1178-1184.