Neupogen

Neupogen is an injection used to reduce infection during chemotherapy, mobilize stem cells, treat chronic neutropenia, and improve survival after radiation.

Neupogen (filgrastim) is a granulocyte colony-stimulating factor (G-CSF) that works by binding to receptors on blood-forming cells in the bone marrow, prompting neutrophil progenitors to multiply and mature. It also enhances the infection-fighting function of mature neutrophils. G-CSF acts mainly on neutrophils, with minimal direct effect on other blood cells.

Neupogen received FDA approval on February 20, 1991. There are 5 biosimilars to Neupogen: Filkri, Nivestym, Nypozi, Releuko, and Zarxio.

Neupogen (filgrastim) is approved to:

• reduce the chance of infection due to a low white blood cell count, in people with certain types of cancer (nonmyeloid), who receive anti-cancer medicines (chemotherapy) that can cause fever and low blood cell count.
• reduce the time it takes for white blood cell counts to increase and fever to decrease after chemotherapy treatment in people with acute myeloid leukemia (AML).
• reduce the time it takes for low white blood cell counts to increase and fever to decrease in people with nonmyeloid cancers who receive chemotherapy followed by a bone marrow transplant.
• move your body's own blood stem cells from your bone marrow into your blood to be collected through a special filtering process.
• reduce the chance of getting and the length of fever, infections, and mouth sores in people who have severe low white blood cell counts that last a long time (chronic neutropenia) when they are born with this problem, it keeps coming back, or the cause is not known.
• increase survival in people with sudden exposure to high levels of radiation that damage the bone marrow so it cannot make enough blood cells (this is called hematopoietic syndrome of acute radiation syndrome [H-ARS]). The effectiveness of Neupogen for this use was only studied in animals, because it could not be studied in people.

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

Before you receive Neupogen, 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 allergic to latex. The needle cap on the Neupogen 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 Neupogen 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.

Serious side effects

Neupogen can cause serious side effects, including:

• Spleen rupture. Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Tell your healthcare provider right away if you develop pain in the left upper stomach (abdomen) area or your left shoulder.
• A serious lung problem called acute respiratory distress syndrome (ARDS). Tell your healthcare provider or get emergency medical help right away if you develop shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing.
• Serious allergic reactions. Allergic 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 develop any of these symptoms, stop using Neupogen and tell your healthcare provider or get emergency medical help right away.
• Sickle cell crises in people with sickle cell disorder. You may have a severe sickle cell crisis, which could lead to death. Tell your healthcare provider right away if you develop symptoms of sickle cell crisis such as pain or difficulty breathing.
• Kidney injury. Tell 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 (CLS). Neupogen can cause fluid to leak from blood vessels into your body's tissues. 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 alone, you may have an increased risk of developing a precancerous blood condition called MDS or a blood cancer called AML. Tell your healthcare provider if you develop any symptoms of MDS and AML, including tiredness, fever, or easy bruising or bleeding.
• Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with Neupogen. Tell your healthcare provider if you develop unusual bleeding or bruising during treatment with Neupogen.
• 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 arteries (arteritis). Serious inflammation of the large and medium blood vessels that carry blood from the heart to the body, including the aorta (the largest artery), can happen in people receiving Neupogen. Tell your healthcare provider right away if you develop fever, stomach (abdominal) pain, back pain, headache, neck pain, or generally feel unwell.

Common side effects

The most common side effects of Neupogen include, in people:

• with nonmyeloid cancers receiving chemotherapy: fever, pain, rash, cough, and shortness of breath
• with acute myeloid leukemia receiving chemotherapy: pain, nose bleed, and rash
• with nonmyeloid cancers receiving chemotherapy followed by bone marrow transplant: rash
• who are having their own blood cells collected: bone pain, fever, and headache
• with severe chronic neutropenia: pain, decreased red blood cells, nose bleed, diarrhea, reduced sensation, and hair loss

Your healthcare provider will check your blood cell counts regularly during treatment with Neupogen and will change your dose if needed. In patients treated for Acute Radiation Syndrome, more frequent blood tests, about every 3 days may be needed. Your healthcare provider may stop treatment with Neupogen if you develop severe side effects.

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.

• Neupogen injections can be given by a healthcare provider by intravenous (IV) infusion or under your skin (subcutaneous injection). If your healthcare provider decides that the subcutaneous injections can be given at home by you or your caregiver, follow the detailed "Instructions for Use" for information on how to prepare and inject a dose of Neupogen using a prefilled syringe or a vial.
• 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 your healthcare provider switches you between using the Neupogen prefilled syringe and the Neupogen vial, the amount of medicine (volume) you need to inject to receive your dose is different.
• If you are receiving Neupogen because you are also receiving chemotherapy, your dose of Neupogen should be injected at least 24 hours before or 24 hours after your dose of chemotherapy.
• If you miss a dose of Neupogen, talk to your healthcare provider about when you should give your next dose.
• If you inject too much Neupogen, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

How should I store Neupogen vial and prefilled syringe?

• Store Neupogen in the refrigerator between 36°F and 46°F (2°C and 8°C).
• Avoid freezing. If Neupogen is frozen 1 time, thaw in the refrigerator before using it. If it is frozen more than 1 time, throw it away and use a new vial or prefilled syringe.
• 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, 68°F and 77°F (20°C and 25°C), before preparing an injection.
• Throw away (dispose of) any Neupogen that has been left at room temperature for longer than 24 hours.

Keep Neupogen and all medicines out of the reach of children.

Active ingredient: filgrastim

Inactive ingredients: glacial acetic acid, polysorbate 80, sodium hydroxide, sorbitol, and water for Injection.

Neupogen is manufactured by Amgen Inc., One Amgen Center Drive, Thousand Oaks, California 91320-1799U.S. License No. 1080. For more information, go to www.NEUPOGEN.com or call 1-800-772-6436.

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Neupogen.

Neupogen (filgrastim) - Amgen Inc.

Neupogen biosimilar products

Biosimilar products can only be dispensed in place of the reference product if the healthcare provider specifically prescribes the biosimilar product by name.

Pharmacy laws for biosimilar prescribing may vary by state

Filkri (filgrastim-laha) - Accord BioPharma Inc.

View Filkri information in detail.

Nivestym (filgrastim-aafi) - Hospira Inc., a Pfizer Company

View Nivestym information in detail.

Nypozi (filgrastim-txid) - Tanvex BioPharma USA, Inc.

View Nypozi information in detail.

Releuko (filgrastim-ayow) - Kashiv BioSciences, LLC

View Releuko information in detail.

Zarxio (filgrastim-sndz) - Sandoz Inc.

View Zarxio information in detail.