Indication

Neulasta® is indicated to decrease the incidence of infection, as... Read more

Neulasta® is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti‑cancer drugs associated with a clinically significant incidence of febrile neutropenia... Read more

Neulasta® is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti‑cancer drugs associated with a clinically significant incidence of febrile neutropenia.

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

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 data

How 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 action

What 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 options

Who 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.

References: 1. Neulasta® (pegfilgrastim) Prescribing Information, Amgen. 2. CMS. Alpha-Numeric HCPCS Drug Table for 2014. www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Downloads/DRUG2014.pdf. Accessed September 9, 2016.

Important Safety Information

Contraindication

Do not administer Neulasta® to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim.

Splenic Rupture

Splenic rupture, including fatal cases, can occur following the administration of Neulasta®. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Neulasta®.

Acute Respiratory Distress Syndrome

Acute respiratory distress syndrome (ARDS) can occur in patients receiving Neulasta®. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Neulasta® for ARDS. Discontinue Neulasta® in patients with ARDS.

Serious Allergic Reactions

Serious allergic reactions, including anaphylaxis, can occur in patients receiving Neulasta®. The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue Neulasta® in patients with serious allergic reactions.

Allergies to Acrylics

The On‑body Injector for Neulasta® uses acrylic adhesive. For patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction.

Use in Patients with Sickle Cell Disorders

Severe sickle cell crises can occur in patients with sickle cell disorders receiving Neulasta®. Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim, the parent compound of pegfilgrastim.

Glomerulonephritis

Glomerulonephritis has been reported in patients receiving Neulasta®. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after withdrawal of Neulasta®. If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of Neulasta®.

Leukocytosis

White blood cell counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim. Monitoring of CBCs during pegfilgrastim therapy is recommended.

Capillary Leak Syndrome

Capillary leak syndrome has been reported after granulocyte colony-stimulating factor (G-CSF) administration, including Neulasta®, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.

Potential for Tumor Growth Stimulatory Effects on Malignant Cells

The G-CSF receptor, through which pegfilgrastim and filgrastim act, 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 pegfilgrastim is not approved, cannot be excluded.

The most common adverse reactions (≥ 5% difference in incidence) in placebo-controlled clinical trials are bone pain and pain in extremity.

Please see full Prescribing Information.

Important Safety Information

Contraindication

Do not administer Neulasta® to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim.

Splenic Rupture

Splenic rupture, including fatal cases, can occur following the administration of Neulasta®. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Neulasta®.

Acute Respiratory Distress Syndrome

Acute respiratory distress syndrome (ARDS) can occur in patients receiving Neulasta®. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Neulasta® for ARDS. Discontinue Neulasta® in patients with ARDS.

Serious Allergic Reactions

Serious allergic reactions, including anaphylaxis, can occur in patients receiving Neulasta®. The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue Neulasta® in patients with serious allergic reactions.

Allergies to Acrylics

The On‑body Injector for Neulasta® uses acrylic adhesive. For patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction.

Use in Patients with Sickle Cell Disorders

Severe sickle cell crises can occur in patients with sickle cell disorders receiving Neulasta®. Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim, the parent compound of pegfilgrastim.

Glomerulonephritis

Glomerulonephritis has been reported in patients receiving Neulasta®. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after withdrawal of Neulasta®. If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of Neulasta®.

Leukocytosis

White blood cell counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim. Monitoring of CBCs during pegfilgrastim therapy is recommended.

Capillary Leak Syndrome

Capillary leak syndrome has been reported after granulocyte colony-stimulating factor (G-CSF) administration, including Neulasta®, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.

Potential for Tumor Growth Stimulatory Effects on Malignant Cells

The G-CSF receptor, through which pegfilgrastim and filgrastim act, 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 pegfilgrastim is not approved, cannot be excluded.

The most common adverse reactions (≥ 5% difference in incidence) in placebo-controlled clinical trials are bone pain and pain in extremity.

Please see full Prescribing Information.

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Instructions for Use
Enhanced Neulasta® Onpro®Kit
Instructions for Use

Recent updates to Neulasta® Onpro® include approximately 35% smaller packaging,1 an updated fill symbol on the adhesive backing, and a co-packaged prefilled syringe without a needle guard.

1. Data on file, Amgen; 2016.