What is NIVESTYM?

NIVESTYM is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body's fight against infection.

Do not take NIVESTYM if you have had a serious allergic reaction to human G-CSFs such as filgrastim products or pegfilgrastim products.

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

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have a sickle cell disorder.

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have kidney problems.

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are receiving radiation therapy.

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are pregnant or plan to become pregnant. It is not known if NIVESTYM will harm your unborn baby.

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are breastfeeding or plan to breastfeed. It is not known if NIVESTYM 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 NIVESTYM?

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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 for information on how to prepare and inject a dose of NIVESTYM.

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You and your caregiver should be shown how to prepare and inject NIVESTYM before you use it, by your healthcare provider.

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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.

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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 your healthcare provider tells you to.

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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. Your healthcare provider will do blood tests to monitor your white blood cell count, and if necessary, adjust your NIVESTYM dose.

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If you miss a dose of NIVESTYM, talk to your healthcare provider about when you should give your next dose.

What are the possible side effects of NIVESTYM?

NIVESTYM may cause serious side effects, including:

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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.

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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.

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Serious allergic reactions. NIVESTYM 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 NIVESTYM and call your healthcare provider or get emergency medical help right away.

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Sickle cell crises. You may have a serious sickle cell crisis, which could lead to death, if you have a sickle cell disorder and receive NIVESTYM. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.

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Kidney injury (glomerulonephritis). NIVESTYM can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms:

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swelling of your face or ankles

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blood in your urine or dark colored urine

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you urinate less than usual

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Capillary leak syndrome. NIVESTYM 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:

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swelling or puffiness and are urinating less than usual

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trouble breathing

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swelling of your stomach area (abdomen) and feeling of fullness

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dizziness or feeling faint

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a general feeling of tiredness

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Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML).

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NIVESTYM may increase the risk of developing a precancerous condition called MDS or a type of blood cancer called AML in people who were born with low white blood cell counts (congenital neutropenia).

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If you have breast cancer or lung cancer, when NIVESTYM is used with chemotherapy and radiation therapy, or with radiation therapy only, you may have an increased risk of developing MDS or AML.

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Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding.

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Call your healthcare provider if you develop any of these symptoms during treatment with NIVESTYM.

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Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with NIVESTYM. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with NIVESTYM. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.

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Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with NIVESTYM.

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Inflammation of your blood vessels (cutaneous vasculitis). Tell your healthcare provider right away if you develop purple spots or redness of your skin.

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Inflammation of the aorta (aortitis). Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported in patients who received NIVESTYM. 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 experienced in patients receiving NIVESTYM include:

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Patients with cancer receiving chemotherapy: fever, pain, rash, cough, and shortness of breath

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Patients with acute myeloid leukemia receiving chemotherapy: pain, nose bleed, and rash

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Patients with cancer receiving chemotherapy followed by bone marrow transplant: rash

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Patients who are having their own blood cells collected: bone pain, fever, and headache

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Patients with severe chronic neutropenia: pain, decreased red blood cells, nose bleed, diarrhea, reduced sensation, and hair loss

These are not all the possible side effects of NIVESTYM. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store NIVESTYM?

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Store NIVESTYM in the refrigerator between 36°F to 46°F (2°C to 8°C).

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Do not freeze.

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Keep NIVESTYM in the original carton to protect from light or physical damage. Do not leave NIVESTYM in direct sunlight.

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Do not shake NIVESTYM.

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Take NIVESTYM out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.

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Throw away (dispose of) any NIVESTYM that has been left at room temperature for longer than 24 hours.

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After you inject your dose, throw away (dispose of) any unused NIVESTYM left in the vials or prefilled syringes. Do not save unused NIVESTYM in the vials or prefilled syringes for later use.

Keep NIVESTYM out of the reach of children.

General information about the safe and effective use of NIVESTYM.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use NIVESTYM for a condition for which it was not prescribed. Do not give NIVESTYM to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about NIVESTYM that is written for healthcare professionals.

What are the ingredients in NIVESTYM?

Active ingredient: (filgrastim-aafi)

Inactive ingredients: acetate, polysorbate 80, sodium, sorbitol, and water for Injection