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Taking NIVESTYM

How will I receive NIVESTYM?1

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

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 and Patient Information for NIVESTYMTM.

References:

1. NIVESTYM [prescribing information]. New York, NY: Pfizer Inc, July 2018. 2. US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry. April 2015. 3. Data on file. Pfizer Inc, New York, NY. 4. Casadevall N, Edwards IR, Felix T, et al. Pharmacovigilance and biosimilars: considerations, needs and challenges. Expert Opin Biol Ther. 2013;13(7):1039-1047. 5. Australia Department of Health. How have biosimilar medicines been used around the world? www.health.gov.au/internet/main/publishing.nsf/Content/biosimilar-how-have-biosimilar-medicines-been-used-around-the-world. Accessed January 12, 2018. 6. Generic and Biosimilars Initiative. Biosimilars approved in Canada. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Canada. Accessed January 12, 2018.

NIVESTYM is a trademark of Pfizer Inc.

Neupogen® is a registered trademark of Amgen, Inc.