Patient Resources | Nivestym® (filgrastim-aafi) Site | Safety Info

 

Patient Brochure

Learn about what NIVESTYM is indicated for, how it works similarly to Neupogen® (filgrastim), and why doctors can trust an FDA-approved biosimilar.

 


Making your support needs a priority. Together.

At Pfizer Oncology Together, we treat your individual needs as a priority. For eligible patients, we will help you find financial assistance options. We'll also connect you with a dedicated Care Champion who has social work experience and can provide resources that may help with some of your day-to-day challenges.

Learning about financial support. Together.

Pfizer Oncology Together can help you understand your insurance and identify what financial support may be available for your prescribed NIVESTYM.

The Pfizer Oncology Together Co-Pay Savings Program for Injectables for NIVESTYM

Provides eligible patients with support for out-of-pocket drug costs, including co-pays and coinsurance. See full terms and conditions below.*

For eligible, commercially insured patients

Eligible patients may pay as little as $0 for each NIVESTYM treatment.

Up to $10,000 per calendar year

The program covers up to $10,000 per calendar year.

No income requirements

There are no income requirements for patients to qualify.

Medicare/Government Insured

Help identifying resources for eligible patients with Medicare, Medicaid, and other government insurance plans:

  • Assistance with searching for support from independent charitable foundations. These foundations exist independently of Pfizer and have their own eligibility criteria and application processes. Availability of support from the foundations is determined solely by the foundations
  • Free medicine

If support from independent charitable foundations is not available, Pfizer Oncology Together will provide eligible patients with medication for free through the Pfizer Patient Assistance Program. The Pfizer Patient Assistance Program is a joint program of Pfizer Inc. and the Pfizer Patient Assistance Foundation. The Pfizer Patient Assistance Foundation is a separate legal entity from Pfizer Inc. with distinct legal restrictions.

Uninsured

Help identifying resources for eligible patients without any form of healthcare coverage:

  • Help finding coverage
  • Free medicine through the Pfizer Patient Assistance Program

Finding resources for your day-to-day. Together.

At Pfizer Oncology Together, our Care Champions, who have social work experience, can offer you resources that may help with some of your day-to-day challenges:

  • Connections to emotional support resources
  • Connections to an independent organization that helps eligible patients find rides and lodging for treatment-related appointments
  • Educational information on topics such as nutrition
  • Information to help you prepare for leaving or returning to work
  • Help identifying financial assistance resources

Some services are provided through third-party organizations that operate independently and are not controlled by Pfizer. Availability of services and eligibility requirements are determined solely by these organizations.

Terms and ConditionsBy 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 that are enrolled in a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veteran 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. 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, 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 will expire at the end of each calendar year. Before the calendar year ends, you will receive information and eligibility requirements for continued participation.

BACK

About Biosimilars

IMPORTANT SAFETY INFORMATION AND INDICATIONS

Do not take NIVESTYMTM if you have had a serious allergic reaction to human granulocyte colony-stimulating factors (G-CSFs) such as filgrastim products or pegfilgrastim products.

Before you take NIVESTYMTM, tell your healthcare provider about all of your medical conditions, including if you:

  • have a sickle cell disorder
  • have kidney problems
  • are receiving radiation therapy
  • are pregnant or plan to become pregnant. It is not known if NIVESTYMTM will harm your unborn baby
  • are breastfeeding or plan to breastfeed. It is not known if NIVESTYMTM passes into your breast milk

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive NIVESTYMTM?

  • NIVESTYMTM injections can be given by a healthcare provider by intravenous (IV) infusion or under your skin (subcutaneous injection). Your healthcare provider may decide that subcutaneous injections can be given at home by you or your caregiver. If NIVESTYMTM is given at home, see the detailed “Instructions for Use” that comes with your NIVESTYMTM prescription for information on how to prepare and inject a dose of NIVESTYMTM
  • Your healthcare provider should show you and your caregiver how to prepare and inject NIVESTYMTM before you use it
  • You should not try to inject a dose of NIVESTYMTM less than 0.3 mL (180 mcg) from a NIVESTYMTM prefilled syringe. A dose less than 0.3 mL cannot be accurately measured using the NIVESTYMTM prefilled syringe
  • Your healthcare provider will tell you how much NIVESTYMTM to inject and when to inject it. Do not change your dose or stop NIVESTYMTM unless your healthcare provider tells you
  • If you are receiving NIVESTYMTM because you are also receiving chemotherapy, your dose of NIVESTYMTM should be injected at least 24 hours before or 24 hours after your dose of chemotherapy
  • If you miss a dose of NIVESTYMTM, talk to your healthcare provider about when you should have your next dose

What are the possible side effects of NIVESTYMTM?

NIVESTYMTM may cause serious side effects, including:

  • Spleen rupture. Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in the left upper stomach (abdomen) area or your left shoulder
  • A serious lung problem called acute respiratory distress syndrome (ARDS). Call your healthcare provider or get emergency medical help right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing
  • Serious allergic reactions. NIVESTYMTM can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. If you have any of these symptoms, stop using NIVESTYMTM and call your healthcare provider or get emergency medical help right away
  • Sickle cell crises. You may have a serious sickle cell crisis if you have a sickle cell disorder and receive NIVESTYMTM. Serious sickle cell crises have happened in people with sickle cell disorders receiving filgrastim that have sometimes led to death. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing
  • Kidney injury (glomerulonephritis). NIVESTYMTM can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms:
    • swelling of your face or ankles
    • blood in your urine or dark-colored urine
    • you urinate less than usual
  • Capillary leak syndrome. NIVESTYMTM can cause fluid to leak from blood vessels into your body’s tissues. This condition is called “Capillary Leak Syndrome” (CLS). CLS can quickly cause you to have symptoms that may become life threatening. Get emergency medical help right away if you develop any of the following symptoms:
    • swelling or puffiness and are urinating less than usual
    • trouble breathing
    • swelling of your stomach area (abdomen) and feeling of fullness
    • dizziness or feeling faint
    • a general feeling of tiredness
  • Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with NIVESTYMTM. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with NIVESTYMTM. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot
  • Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with NIVESTYMTM
  • Inflammation of your blood vessels (cutaneous vasculitis). Tell your healthcare provider if you develop purple spots or redness of your skin
  • Inflammation of the aorta (aortitis). Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) may be caused by NIVESTYMTM. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms

The most common side effects of NIVESTYMTM include aching in the bones and muscles. These are not all the possible side effects of NIVESTYMTM. Call your healthcare provider for medical advice about side effects.

You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit http://www.fda.gov/MedWatch or call 1-800-FDA-1088.

INDICATIONS

Patients with Cancer Receiving Myelosuppressive Chemotherapy

  • NIVESTYMTM 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

  • NIVESTYMTM 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

  • NIVESTYMTM 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 bone marrow transplantation

Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy

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

Patients with Severe Chronic Neutropenia

  • NIVESTYMTM 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, including Patient Information, for NIVESTYMTM.

NIVESTYM is a registered trademark of Pfizer Inc.

Neupogen is a trademark of Amgen, Inc.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

Do not take NIVESTYMTM if you have had a serious allergic reaction to human granulocyte colony-stimulating factors (G-CSFs) such as filgrastim products or pegfilgrastim products.

Before you take NIVESTYMTM, tell your healthcare provider about all of your medical conditions, including if you:

  • have a sickle cell disorder
  • have kidney problems
  • are receiving radiation therapy
  • are pregnant or plan to become pregnant. It is not known if NIVESTYMTM will harm your unborn baby
  • are breastfeeding or plan to breastfeed. It is not known if NIVESTYMTM passes into your breast milk

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive NIVESTYMTM?

  • NIVESTYMTM injections can be given by a healthcare provider by intravenous (IV) infusion or under your skin (subcutaneous injection). Your healthcare provider may decide that subcutaneous injections can be given at home by you or your caregiver. If NIVESTYMTM is given at home, see the detailed “Instructions for Use” that comes with your NIVESTYMTM prescription for information on how to prepare and inject a dose of NIVESTYMTM
  • Your healthcare provider should show you and your caregiver how to prepare and inject NIVESTYMTM before you use it
  • You should not try to inject a dose of NIVESTYMTM less than 0.3 mL (180 mcg) from a NIVESTYMTM prefilled syringe. A dose less than 0.3 mL cannot be accurately measured using the NIVESTYMTM prefilled syringe
  • Your healthcare provider will tell you how much NIVESTYMTM to inject and when to inject it. Do not change your dose or stop NIVESTYMTM unless your healthcare provider tells you
  • If you are receiving NIVESTYMTM because you are also receiving chemotherapy, your dose of NIVESTYMTM should be injected at least 24 hours before or 24 hours after your dose of chemotherapy
  • If you miss a dose of NIVESTYMTM, talk to your healthcare provider about when you should have your next dose

What are the possible side effects of NIVESTYMTM?

NIVESTYMTM may cause serious side effects, including:

  • Spleen rupture. Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in the left upper stomach (abdomen) area or your left shoulder
  • A serious lung problem called acute respiratory distress syndrome (ARDS). Call your healthcare provider or get emergency medical help right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing
  • Serious allergic reactions. NIVESTYMTM can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. If you have any of these symptoms, stop using NIVESTYMTM and call your healthcare provider or get emergency medical help right away
  • Sickle cell crises. You may have a serious sickle cell crisis if you have a sickle cell disorder and receive NIVESTYMTM. Serious sickle cell crises have happened in people with sickle cell disorders receiving filgrastim that have sometimes led to death. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing
  • Kidney injury (glomerulonephritis). NIVESTYMTM can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms:
    • swelling of your face or ankles
    • blood in your urine or dark-colored urine
    • you urinate less than usual
  • Capillary leak syndrome. NIVESTYMTM can cause fluid to leak from blood vessels into your body’s tissues. This condition is called “Capillary Leak Syndrome” (CLS). CLS can quickly cause you to have symptoms that may become life threatening. Get emergency medical help right away if you develop any of the following symptoms:
    • swelling or puffiness and are urinating less than usual
    • trouble breathing
    • swelling of your stomach area (abdomen) and feeling of fullness
    • dizziness or feeling faint
    • a general feeling of tiredness
  • Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with NIVESTYMTM. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with NIVESTYMTM. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot
  • Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with NIVESTYMTM
  • Inflammation of your blood vessels (cutaneous vasculitis). Tell your healthcare provider if you develop purple spots or redness of your skin
  • Inflammation of the aorta (aortitis). Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) may be caused by NIVESTYMTM. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms

The most common side effects of NIVESTYMTM include aching in the bones and muscles. These are not all the possible side effects of NIVESTYMTM. Call your healthcare provider for medical advice about side effects.

You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit http://www.fda.gov/MedWatch or call 1-800-FDA-1088.

INDICATIONS

Patients with Cancer Receiving Myelosuppressive Chemotherapy

  • NIVESTYMTM 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

  • NIVESTYMTM 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

  • NIVESTYMTM 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 bone marrow transplantation

Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy

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

Patients with Severe Chronic Neutropenia

  • NIVESTYMTM 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, including Patient Information, for NIVESTYMTM.

NIVESTYM is a registered trademark of Pfizer Inc.

Neupogen is a trademark of Amgen, Inc.