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.

Patient Access Resources

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.* 1

*Call 1‑844‑MYNEULASTA (1‑844‑696‑3852) for more information.


Coding and coverage policies change periodically and often without warning. The healthcare provider is solely responsible for determining coverage and reimbursement parameters and appropriate coding for his/her own patients and procedures. This information is not a guarantee of coverage or reimbursement.

83% of commercial patients pay $0 out-of-pocket (OOP) per dose for Neulasta® and Neulasta Onpro®.

Data based on Decision Resources Group Remittance Database of 38,333 commercial medical and pharmacy claims identified between January 1, 2016 and December 31, 2016 based on the J-code (J2505) and national drug code (NDC) numbers for Neulasta® (55513-0190-01) and Neulasta® Onpro® (55513-0192-01). Claims included in this analysis were categorized according to patient OOP cost for Neulasta® or Neulasta® Onpro®.

Amgen First Step™ Program.

Amgen FIRST STEP™ Program

The Neulasta FIRST STEP® Program may help reduce OOP drug costs for your eligible commercially insured patients

  • No out-of-pocket cost for the first dose
  • No income eligibility requirement
  • For subsequent doses, Amgen will pay the out-of-pocket amount in excess of $25 per dose, up to $10,000 in assistance per calendar year
Support for your eligible commercially insured patients regardless of their income.

Here's what a patient needs to qualify:

  • Must be prescribed Neulasta®
  • Must have private commercial health insurance that covers medication costs for Neulasta®
  • Must not be a participant in any federal-, state-, or government-funded healthcare program such as Medicare, Medicare Advantage, Medicare Part D, Medicaid, Medigap, Veterans Affairs (VA), the Department of Defense (DoD), or TRICARE®
  • May not seek reimbursement for value received from the Amgen FIRST STEP program from any third-party payers, including flexible spending accounts or healthcare savings accounts. If at any time patients begin receiving coverage under any federal-, state-, or government-funded healthcare program, patients will no longer be eligible to participate in the Amgen FIRST STEP Program and must call 1-888-65-STEP1 (1-888-657-8371) Monday through Friday, 9 am-8 pm EST, to stop participation. Restrictions may apply. Amgen reserves the right to revise or terminate this program, in whole or in part, without notice at any time. This is not health insurance. Program invalid where otherwise prohibited by law.

Coverage limits:

  • Program covers out-of-pocket medication costs for the Amgen product only. Program does not cover any other costs related to office visit or administration of Amgen product.
  • No out-of-pocket for first dose; $25 out-of-pocket cost for subsequent dose or cycle; maximum benefit of $10,000 per patient per calendar year. Patient is responsible for costs above these amounts.
  • Ongoing activation of the Amgen FIRST STEP card is contingent on the submission of the required Explanation of Benefits (EOB) form by the healthcare provider’s office within 45 days of use of the Amgen FIRST STEP card. Patients will be responsible for reimbursing the program for all amounts paid out if the EOB for the date of service is not received within 45 days.

For additional program details, please visit www.AmgenFIRSTSTEP.com or call 1‑888‑65STEP1 (1‑888‑657‑8371).

Other restrictions apply. Not valid where prohibited by law. Amgen reserves the right to revise or terminate this program, in whole or in part, without notice at any time.

Amgen Assist 360™

Find co-pay and reimbursement resources§ for patients with different kinds of insurance, or no insurance at all.

Amgen Assist 360™.
For more information, please contact Amgen Assist 360™ at 1‑888‑4ASSIST or visit AmgenAssist360.com.

§Resources include referrals to independent nonprofit patient assistance programs. Eligibility for resources provided by independent nonprofit patient assistance programs is based on the nonprofits' criteria. Amgen has no control over these programs and provides referrals as a courtesy only.

The Safety Net Foundation

The Safety Net Foundation provides Neulasta® at no cost to qualifying patients with no or limited drug coverage who meet income eligibility requirements.

Amgen Safety Net Foundation.

Amgen Safety Net Foundation is a nonprofit patient assistance program sponsored by Amgen that helps qualifying patients access certain Amgen medicines at no cost.

To discuss enrollment or to learn more, please call 1‑888‑SN‑AMGEN (1‑888‑762‑6436) or visit www.amgensafetynetfoundation.com.

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.