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

Revised: 01/2021

What is NEUPOGEN?
NEUPOGEN 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.
Acute Radiation Syndrome: The effectiveness of NEUPOGEN for this use was only studied in animals, because it could not be studied in people.

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

Before you take NEUPOGEN, tell yourhealthcare providerabout all of your medical conditions, including if you:

• have a sickle cell disorder.

• have kidney problems.

• are receiving radiation therapy.

• are allergic to latex. The needle cap on the prefilled syringe contains dry natural rubber (derived from latex). You should not give NEUPOGEN using the prefilled syringe if you have latex allergies. Ask your healthcare provider about using the vial if you have latex allergies.

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

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

*NEUPOGEN 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 NEUPOGEN is given at home, see the detailed "Instructions for Use" that comes with your NEUPOGEN for information on how to prepare and inject a dose of NEUPOGEN.

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

• Your healthcare provider will tell you how much NEUPOGEN to inject and when to inject it. Do not change your dose or stop NEUPOGEN unless your healthcare provider tells you to.

• If you are receiving NEUPOGEN because you are also receiving chemotherapy, your dose of NEUPOGEN should be injectedat least 24 hours before or24 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 NEUPOGEN dose.

• If you are receiving NEUPOGEN because you have been suddenly (acutely) exposed to an amount of radiation that can affect your bone marrow (Acute Radiation Syndrome), you will need to have blood tests about every 3 days during treatment with NEUPOGEN to check your white blood cell count.

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

What are the possible side effects of NEUPOGEN?
NEUPOGEN 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. NEUPOGEN 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 NEUPOGEN 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 NEUPOGEN. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.

*Kidney injury (glomerulonephritis). NEUPOGEN 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. NEUPOGEN 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 *Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). * Neupogen 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). * If you have breast cancer or lung cancer, when NEUPOGEN is used with chemotherapy and radiation therapy, or with radiation therapy only, you may have an increased risk of developing MDS or AML. * Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding. * Call your healthcare provider if you develop any of these symptoms during treatment with NEUPOGEN. *Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with NEUPOGEN. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with NEUPOGEN. 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 NEUPOGEN.

*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 NEUPOGEN. 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 NEUPOGEN include:

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

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

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

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

• 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 NEUPOGEN. 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 NEUPOGEN?

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

*Do not freeze.

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

• Do not shake NEUPOGEN.

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

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

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

Keep NEUPOGEN out of the reach of children.

General information about the safe and effective use of NEUPOGEN.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use NEUPOGEN for a condition for which it was not prescribed. Do not give NEUPOGEN 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 NEUPOGEN that is written for healthcare professionals.

What are the ingredients in NEUPOGEN?
Active ingredient: filgrastim
Inactive ingredients: acetate, polysorbate 80, sodium, sorbitol, and water for Injection
Manufactured by:
Amgen Inc., One Amgen Center Drive, Thousand Oaks, California 91320-1799 U.S.A.
US License No. 1080
Patent: http://pat.amgen.com/neupogen/
© 1991-2021 Amgen Inc. All rights reserved.
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D

Take the cap off the vial. Clean the rubber stopper with one alcohol wipe.

E

Check the carton containing the syringe. If the carton has been opened or damaged, do not use that syringe. Dispose of (throw away) that syringe in the sharps disposal container.

F

Hold the syringe by the barrel with the needle cap pointing up. Carefully pull the needle cap straight off and away from your body.

Pull back on the plunger and draw air into the syringe that is the same amount (mL) as the dose of NEUPOGEN that your healthcare provider prescribed.

Important: Throw the needle cap into the sharps disposal container.

G

Keep the vial on the flat working surface and insert the needle straight down through the rubber stopper. Do not insert the needle through the rubber stopper more than 1 time.

H

Push the plunger down and inject all the air from the syringe into the vial of NEUPOGEN.

I

Keep the needle in the vial and turn the vial upside down. Make sure that the NEUPOGEN liquid is covering the tip of the needle.

J

Keep the vial upside down and slowly pull back on the plunger to fill the syringe barrel with NEUPOGEN to the correct marking amount (mL) of medicine that matches the dose your healthcare provider prescribed.

K

Keep the needle in the vial and check for air bubbles in the syringe. If there are air bubbles, gently tap the syringe barrel with your finger until the air bubbles rise to the top. Slowly push the plunger up to push the air bubbles out of the syringe.

L

Keep the tip of the needle in the liquid and again pull the plunger back to the number on the syringe barrel that matches your dose. Check again for air bubbles. The air in the syringe will not hurt you, but too large an air bubble can reduce your dose of NEUPOGEN. If there are still air bubbles, repeat the steps above to remove them.

M

Check again to make sure that you have the correct dose in the syringe. It is important that you use the exact dose prescribed by your healthcare provider. Do not remove the needle from the vial. Lay the vial down on its side with the needle still in the vial.

Step 3: Select and Prepare the Injection Site

N

Prepare and clean your injection site.