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NIVESTYM™ Medication Guide (filgrastim-aafi)

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Review the steps for direct patient administration with patients and caregivers. Training by the healthcare provider should aim to ensure that patients and caregivers can successfully perform all of the steps in the Instructions for Use of NIVESTYM vial and prefilled syringe, including showing the patient or caregiver how to measure the required dose, particularly if a patient is on a dose other than the entire prefilled syringe. If a patient or caregiver is not able to demonstrate that they can measure the dose and administer the product successfully, you should consider whether the patient is an appropriate candidate for self-administration of NIVESTYM or whether the patient would benefit from a different NIVESTYM presentation. Advise patients of the following risks and potential risks with NIVESTYM:

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Rupture or enlargement of the spleen may occur. Symptoms include left upper quadrant abdominal pain or left shoulder pain. Advise patients to report pain in these areas to their physician immediately [see Warnings and Precautions (5.1)].
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Dyspnea, with or without fever, progressing to Acute Respiratory Distress Syndrome, may occur.
Advise patients to report dyspnea to their physician immediately [see Warnings and Precautions (5.2)].
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Serious allergic reactions may occur, which may be signaled by rash‚ facial edema‚ wheezing‚ dyspnea‚ hypotension‚ or tachycardia. Advise patients to seek immediate medical attention if signs or symptoms of hypersensitivity reaction occur [see Warnings and Precautions (5.3)].
•
In patients with sickle cell disease, sickle cell crisis and death have occurred. Discuss potential risks and benefits for patients with sickle cell disease prior to the administration of human granulocyte colony-stimulating factors [see Warnings and Precautions (5.4)].
•
Glomerulonephritis may occur. Symptoms include swelling of the face or ankles, dark colored urine or blood in the urine, or a decrease in urine production. Advise patients to report signs or symptoms of glomerulonephritis to their physician immediately [see Warnings and Precautions (5.5)].
•
There may be an increased risk of Myelodysplastic Syndrome and/or Acute Myeloid Leukemia in patients with congenital neutropenia who receive filgrastim products and in patients with breast and lung cancer who receive filgrastim products in conjunction with chemotherapy and/or radiation therapy. Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding. Advise patients to report to their physician signs and symptoms of MDS/AML [see Warnings and Precautions (5.8)].
•
Cutaneous vasculitis may occur, which may be signaled by purpura or erythema. Advise patients to report signs or symptoms of vasculitis to their physician immediately [see Warnings and Precautions (5.11)].
•
Aortitis may occur. Symptoms may include fever, abdominal pain, malaise, back pain, and increased inflammatory markers. Advise patients to report signs and symptoms of aortitis to their physician immediately [see Warnings and Precautions (5.15)].

Instruct patients who self-administer NIVESTYM using the prefilled syringe or single-dose vial of the:

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Importance of following the applicable Instructions for Use.
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Dangers of reusing needles, syringes, or unused portions of single-dose vials.
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Importance of following local requirements for proper disposal of used syringes, needles, and unused vials.
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Importance of informing the healthcare provider if difficulty occurs when measuring or administering partial contents of the NIVESTYM prefilled syringe. If difficulty occurs, use of the NIVESTYM vial may be considered.
•
Difference in product concentration of the NIVESTYM prefilled syringe in comparison to the NIVESTYM vial. When switching patients from the NIVESTYM prefilled syringe to the NIVESTYM vial, or vice versa, ensure that patients understand the correct volume to be administered since the concentration of NIVESTYM differs between the prefilled syringe and the vial.

This Patient Information has been approved by the U.S. Food and Drug Administration

Revised: March 2023

Patient Information
NIVESTYM (Neye-ves-tim)
(filgrastim-aafi)
injection

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:

•
have a sickle cell disorder.
•
have kidney problems.
•
are receiving radiation therapy.
•
are pregnant or plan to become pregnant. It is not known if NIVESTYM will harm your unborn baby.
•
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?

•
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.
•
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.
•
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. 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.
•
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.
•
Kidney injury (glomerulonephritis). NIVESTYM can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms:
o
swelling of your face or ankles
o
blood in your urine or dark colored urine
o
you urinate less than usual
•
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:
o
swelling or puffiness and are urinating less than usual
o
trouble breathing
o
swelling of your stomach area (abdomen) and feeling of fullness
o
dizziness or feeling faint
o
a general feeling of tiredness
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Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML).
o
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).
o
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.
o
Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding.
o
Call your healthcare provider if you develop any of these symptoms during treatment with NIVESTYM.
•
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.
•
Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with NIVESTYM.
•
Inflammation of your blood vessels (cutaneous vasculitis). Tell your healthcare provider right away 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) 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.
•
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

Manufactured by Hospira, Inc., a Pfizer Company, Lake Forest, IL 60045 USA
US License No. 1974

Distributed by Pfizer Labs, division of Pfizer Inc., New York, NY 10001 USA

LAB-0935-5.0
For more information go to www.pfizer.com or call 1-800-438-1985.

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