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NIVESTYM® (filgrastim-aafi) is an FDA-approved biosimilar to Neupogen® (filgrastim)1*

NIVESTYM offers the potential to help address treatment costs and was approved by the FDA based on the totality of evidence supporting high similarity to Neupogen1-3

46% of commercially insured patients have access to NIVESTYM nationwide, as of April 20222‖¶

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Download the National Coverage Brochure

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NIVESTYM is available in both prefilled syringes and single-dose vials1

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Review product information

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Approved for the eligible indications of Neupogen, with an identical dosing and administration schedule1

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Review dosing information

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NIVESTYM showed no clinically meaningful differences in efficacy vs Neupogen2

Studies in support of biosimilarity in healthy volunteers

Review efficacy data

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NIVESTYM showed a similar safety profile to Neupogen across adverse event categories2

Studies in support of biosimilarity in healthy volunteers

Review safety data

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Pfizer Oncology Together™ Co-Pay Savings Program for Injectables

Eligible,# commercially insured patients** may pay as little as $0 per NIVESTYM treatment.†† See full Terms and Conditions below.

  • This program covers up to $10,000 per calendar year ‡‡
  • There are no income requirements for patients to qualify
  • Patients enrolled in state- or federally funded prescription insurance programs are not eligible for this program
  • For information on enrollment, claims submissions, and reimbursement, visit PfizerOncologyTogether.com to download the Co-Pay Savings Program Brochure

FOR LIVE, PERSONALIZED SUPPORT

Call 1-877-744-5675 (Monday-Friday, 8 AM-8 PM ET)

Learn more about the program

   *Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar and the reference product.1

    †NIVESTYM does not have a designation of interchangeability with Neupogen.

    ‡WAC is a manufacturer’s undiscounted or list price to wholesalers/direct purchasers and, therefore, is not inclusive of discounts to payers, providers, distributors, and other purchasing organizations. Data as of May 2022.

    §Represents WAC for 480-mcg PFS only.

    ‖Percentage of commercial lives where NIVESTYM is covered at parity or at an advantage to Neupogen.

    ¶Medical policy data are current as of April 2022. Please verify individual patient benefits to confirm coverage.

   #Terms and Conditions: By using this program, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions below:

  • The Pfizer Oncology Together Co-Pay Savings Program for Injectables for NIVESTYM® is not valid for patients who are enrolled in a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veterans Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”).
  • Program offer is not valid for cash-paying patients.
  • With this program, eligible patients may pay as little as $0 co-pay per NIVESTYM treatment, subject to a maximum benefit of $10,000 per calendar year for out-of-pocket expenses for NIVESTYM including co-pays or coinsurances.
  • The amount of any benefit is the difference between your co-pay and $0.
  • After the maximum of $10,000 you will be responsible for the remaining monthly out-of-pocket costs.​​​​​​​
  • Patient must have private insurance with coverage of NIVESTYM.
  • This offer is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plans or other private health or pharmacy benefit programs.
  • You must deduct the value of this assistance from any reimbursement request submitted to your private insurance plan, either directly by you or on your behalf.
  • You are responsible for reporting use of the program to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the program, as may be required.
  • You should not use the program if your insurer or health plan prohibits use of manufacturer co-pay assistance programs.
  • This program is not valid where prohibited by law.
  • This program cannot be combined with any other savings, free trial or similar offer for the specified prescription.
  • Co-pay card will be accepted only at participating pharmacies.
  • This program is not health insurance.
  • This program is good only in the U.S. and Puerto Rico.
  • This program is limited to 1 per person during this offering period and is not transferable.
  • No other purchase is necessary.
  • Data related to your redemption of the program assistance may be collected, analyzed, and shared with Pfizer, for market research and other purposes related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified; it will be combined with data related to other assistance redemptions and will not identify you.
  • Pfizer reserves the right to rescind, revoke or amend this program without notice.
  • This program may not be available to patients in all states.
  • For more information about Pfizer, visit www.pfizer.com.
  • For more information about the Pfizer Oncology Together Co-Pay Savings Program for Injectables, visit pfizeroncologytogether.com, call 1-877-744-5675, or write to 
    Pfizer Oncology Together Co-Pay Savings Program for Injectables
    P.O. Box 220366
    ​​​​​​​Charlotte, NC 28222
  • Program terms and offer will expire at the end of each calendar year. Before the calendar year ends, you will receive information and eligibility requirements for continued participation.

  **For patients to be eligible for the Injectables Co-Pay Program for NIVESTYM, they must have commercial insurance that covers NIVESTYM and they cannot be enrolled in a state or federally funded insurance program. Whether a co-pay expense is eligible for the Injectables Co-Pay Program for NIVESTYM benefit will be determined at the time the benefit is paid. Co-pay expenses must be in connection with a separately paid claim for NIVESTYM administered in the outpatient setting.

  ††The Injectables Co-Pay Program for NIVESTYM will pay the co-pay for NIVESTYM up to the annual assistance limit of $10,000 per calendar year per patient.

  ‡‡The Injectables Co-Pay Program for NIVESTYM provides assistance for eligible, commercially insured patients prescribed NIVESTYM for co-pays or coinsurance incurred for NIVESTYM up to $10,000 per calendar year. It does not cover or provide support for supplies, services, procedures, or any other physician-related services associated with NIVESTYM treatment.


References:

  1. NIVESTYM [prescribing information]. New York, NY: Pfizer Inc.; November 2021.
  2. Data on file. Pfizer Inc.; New York, NY.
  3. US Food and Drug Administration. Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Silver Spring, MD: FDA, US Dept of Health and Human Services; April 2015. Accessed March 22, 2022. https://www.fda.gov/downloads/drugs/guidances/ucm291128.pdf.

NIVESTYM is a registered trademark of Pfizer Inc.
Neupogen is a registered trademark of Amgen Inc.

CONTRAINDICATIONS

NIVESTYM® is contraindicated in patients with a history of serious allergic reactions to human granulocyte-colony stimulating factors (G-CSF), such as filgrastim products or pegfilgrastim products.

WARNINGS AND PRECAUTIONS

Splenic Rupture

Splenic rupture, including fatal cases, has been reported following the administration of filgrastim products. Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.

Acute Respiratory Distress Syndrome

Acute respiratory distress syndrome (ARDS) has been reported in patients receiving filgrastim products. Evaluate patients who develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue NIVESTYM® in patients with ARDS.

Serious Allergic Reactions

Serious allergic reactions, including anaphylaxis, have been reported in patients receiving filgrastim products. The majority of reported events occurred upon initial exposure. Provide symptomatic treatment for allergic reactions. Allergic reactions, including anaphylaxis, in patients receiving filgrastim products can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue NIVESTYM® in patients with serious allergic reactions. NIVESTYM® is contraindicated in patients with a history of serious allergic reactions to human G-CSF such as filgrastim or pegfilgrastim.

Sickle Cell Disorders

Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim products. Discontinue NIVESTYM® if sickle cell crisis occurs.

Glomerulonephritis

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

Alveolar Hemorrhage and Hemoptysis

Alveolar hemorrhage manifesting as pulmonary infiltrates and hemoptysis requiring hospitalization has been reported in healthy donors treated with filgrastim products for peripheral blood progenitor cell (PBPC) mobilization. Hemoptysis resolved with discontinuation of filgrastim products. The use of NIVESTYM® for PBPC mobilization in healthy donors is not an approved indication.

Capillary Leak Syndrome

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

Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)

Patients With Severe Chronic Neutropenia (SCN)

Confirm the diagnosis of SCN before initiating NIVESTYM® therapy. MDS and AML have been reported to occur in the natural history of congenital neutropenia without cytokine therapy. Cytogenetic abnormalities, transformation to MDS, and AML have also been observed in patients treated with filgrastim products for SCN. Based on available data including a post-marketing surveillance study, the risk of developing MDS and AML appears to be confined to the subset of patients with congenital neutropenia. Abnormal cytogenetics and MDS have been associated with the eventual development of myeloid leukemia. The effect of filgrastim products on the development of abnormal cytogenetics and the effect of continued filgrastim product administration in patients with abnormal cytogenetics or MDS are unknown. Monitor patients for signs and symptoms of MDS/AML in these settings. If a patient with SCN develops abnormal cytogenetics or myelodysplasia‚ the risks and benefits of continuing NIVESTYM® should be carefully considered.

Patients with Breast and Lung Cancer

MDS and AML have been associated with the use of filgrastim products 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.

Thrombocytopenia

Thrombocytopenia has been reported in patients receiving filgrastim products. Monitor platelet counts.

Leukocytosis

Patients With Cancer Receiving Myelosuppressive Chemotherapy:

White blood cell counts of 100,000/mm3 or greater were observed in approximately 2% of patients who received filgrastim at dosages above 5 mcg/kg/day. In patients with cancer receiving NIVESTYM® as an adjunct to myelosuppressive chemotherapy, to avoid the potential risks of excessive leukocytosis, it is recommended that NIVESTYM® therapy be discontinued if the absolute neutrophil count (ANC) surpasses 10,000/mm3 after the chemotherapy-induced ANC nadir has occurred. Monitor CBCs at least twice weekly during therapy. Dosages of NIVESTYM® that increase the ANC beyond 10,000/mm3 may not result in any additional clinical benefit. In patients with cancer receiving myelosuppressive chemotherapy, discontinuation of filgrastim therapy usually resulted in a 50% decrease in circulating neutrophils within 1 to 2 days, with a return to pretreatment levels in 1 to 7 days.

Peripheral Blood Progenitor Cell Collection and Therapy:

During the period of administration of NIVESTYM® for PBPC mobilization in patients with cancer, discontinue NIVESTYM® if the leukocyte count rises to >100,000/mm3.

Cutaneous Vasculitis

Cutaneous vasculitis has been reported in patients treated with filgrastim products. In most cases, the severity of cutaneous vasculitis was moderate or severe. Most of the reports involved patients with SCN receiving long-term filgrastim therapy. Hold NIVESTYM® therapy in patients with cutaneous vasculitis. NIVESTYM® may be started at a reduced dose when the symptoms resolve and the ANC has decreased.

Potential Effect on Malignant Cells

NIVESTYM® is a leukocyte growth factor that primarily stimulates neutrophils. The G-CSF receptor through which NIVESTYM® acts has also been found on tumor cell lines. The possibility that NIVESTYM® acts as a growth factor for any tumor type cannot be excluded. The safety of filgrastim products in chronic myeloid leukemia (CML) and myelodysplasia has not been established.

When NIVESTYM® is used to mobilize PBPC, tumor cells may be released from the marrow and subsequently collected in the leukapheresis product. The effect of reinfusion of tumor cells has not been well studied, and the limited data available are inconclusive.

Simultaneous Use With Chemotherapy and Radiation Not Recommended

The safety and efficacy of NIVESTYM® given simultaneously with cytotoxic chemotherapy have not been established. Because of the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy, do not use NIVESTYM® in the period of 24 hours before through 24 hours after the administration of cytotoxic chemotherapy.

The safety and efficacy of NIVESTYM® have not been evaluated in patients receiving concurrent radiation therapy. Avoid the simultaneous use of NIVESTYM® with chemotherapy and radiation therapy.

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.

Aortitis

Aortitis has been reported in patients receiving filgrastim products. 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 (eg, c‑reactive protein and white blood cell count). Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue NIVESTYM® if aortitis is suspected.

ADVERSE REACTIONS

The most common adverse reactions in patients:

  • with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs (≥5% difference in incidence compared to placebo) are anemia, constipation, diarrhea, oral pain, vomiting, asthenia, malaise, peripheral edema, decreased hemoglobin, decreased appetite, oropharyngeal pain, and alopecia
  • with AML (≥2% difference in incidence) are epistaxis, back pain, pain in extremity, erythema, maculopapular rash, diarrhea, constipation, and transfusion reaction
  • with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) (≥5% difference in incidence) are rash, hypersensitivity, thrombocytopenia, anemia, hypertension, sepsis, bronchitis, and insomnia
  • undergoing peripheral blood progenitor cell mobilization and collection (≥5% incidence) are bone pain, pyrexia, increased blood alkaline phosphatase, and headache
  • with severe chronic neutropenia (≥5% difference in incidence) are arthralgia, bone pain, back pain, muscle spasms, musculoskeletal pain, pain in extremity, splenomegaly, anemia, upper respiratory tract infection, urinary tract infection, epistaxis, chest pain, diarrhea, hypoesthesia, and alopecia

This product’s labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

Patients With Cancer Receiving Myelosuppressive Chemotherapy

  • NIVESTYM® 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 significant incidence of severe neutropenia with fever​​​​​​​​​​​​​​

Patients With Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy

  • NIVESTYM® is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML)

Patients With Cancer Undergoing Bone Marrow Transplantation

  • NIVESTYM® is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ eg, febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by BMT

Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy

  • NIVESTYM® is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis

Patients With Severe Chronic Neutropenia

  • NIVESTYM® is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (eg‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia​​​​​​​
Please see full Prescribing Information and Patient Information for NIVESTYM.

INDICATIONS

Patients With Cancer Receiving Myelosuppressive Chemotherapy

  • NIVESTYM® 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 significant incidence of severe neutropenia with fever

Patients With Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy

  • NIVESTYM® is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML)

Patients With Cancer Undergoing Bone Marrow Transplantation

  • NIVESTYM® is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ eg, febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by BMT

Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy

  • NIVESTYM® is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis

Patients With Severe Chronic Neutropenia

  • NIVESTYM® is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (eg‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia

Please see full Prescribing Information.

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