Pegfilgrastim (Neulasta, Fulphila, Fylnetra, Nyvepria, Stimufend, Udenyca, Ziextenzo) is a man-made version of granulocyte colony-stimulating factor (G-CSF), which is a growth factor produced by your body. G-CSF stimulates your bone marrow to produce a type of white blood cell, called neutrophils. Neutrophils are important for fighting off infection.

Pegfilgrastim is used to reduce the risk of infection in some cancer patients and to increase your chances of surviving after exposure to high doses of radiation that affect your ability to make blood cells.

Pegfilgrastim is a leukocyte growth factor that works by binding to a receptor on immature cells called hematopoietic cells, which can develop into any type of blood cell. It makes them grow and turn into functioning neutrophils.

Pegfilgrastim is a pegylated or long-acting form of recombinant G-CSF, which means that it stays in your body for longer and doesn't need to be administered as often.

Pegfilgramstim is a type of biological drug. The original version of pegfilgrastim is called Neulasta and it was approved by the US Food and Drug Administration (FDA) in 2002.

Biosimilars of pegfilgrastim are also available. Biosimilar versions are highly similar to Neulasta and have the same effect on a person, but they are not identical. Biosimilars of pegfilgrastim include:

• Fulphila (pegfilgrastim-jmbd) approved in 2018
• Fylnetra (pegfilgrastim-pbbk) approved in 2022
• Nyvepria (pegfilgrastim-apgf) approved in 2020
• Stimufend (pegfilgrastim-fpgk) approved in 2022
• Udenyca (pegfilgrastim-cbqv) approved in 2018
• Ziextenzo (pegfilgrastim-bmez) approved in 2019

Neulasta and all of the biosimlar versions of pegfilgrastim are given by subcutaneous injection using a single-dose prefilled syringe. The Neulasta brand can also be given by subcutaneous injection using an on-body injector called Neulasta Onpro.

What is pegfilgrastim used for?

The Neulasta brand of pegfilgrastim is a prescription medication used to:

• Decrease the risk of infection, demonstrated by the presence of febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs that are likely to cause febrile neutropenia.
• Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). The effectiveness of Neulasta for this use has only been studied in animals, because it could not be studied in people.

Biosimilar versions of this medication including Fulphila, Fylnetra, Nyvepria, Stimufend, Udenyca and Ziextenzo, are only approved for decreasing the risk of infection in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs. They are not approved for use in people acutely exposed to myelosuppressive doses of radiation.

Pegfilgrastim is not approved for use for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Important information for patients receiving pegfilgrastim using the on-body injection (Neulasta Onpro kit).

• See the Instructions for use for the on-body injector for detailed information about the on-body injector for Neulasta and important information about your dose delivery that has been written by your healthcare provider.
  • Know the time that delivery of your dose is expected to start.
  • Avoid traveling, driving, or operating heavy machinery during hour 26 through hour 29 after the on-body injector for Neulasta is applied. Avoid activities and places that may interfere with monitoring during the 45-minute period that the medication is expected to be delivered by the on-body injector, and for 1 hour after delivery.
• A caregiver should be with you the first time that you receive this medication with the on-body injector.
• Before your next scheduled dose, avoid use of lotions, creams, or oils on your arms and stomach area (abdomen) to help keep the device on your skin.
• If placed on the back of the arm, a caregiver must be available to monitor the status of the on-body injector.
• If you have an allergic reaction during the delivery of the medication, remove the on-body injector by grabbing the edge of the adhesive pad and peeling off the on-body injector. Get emergency medical help right away.
• You should only receive a dose of the medication on the day your healthcare provider tells you.
• You should not receive your dose any sooner than 24 hours after you finish receiving your chemotherapy. The on-body injector is programmed to deliver your dose about 27 hours after your healthcare provider places the on-body injector on your skin.
• Do not expose the on-body injector to the following because it may be damaged and you could be injured:
  • Diagnostic imaging (e.g., CT Scan, MRI, Ultrasound, X-ray)
  • Radiation treatment
  • Oxygen rich environments, such as hyperbaric chambers
• Avoid airport X-ray scans. Request a manual pat down instead. Use care during a manual pat down to help prevent the on-body injector from being accidentally removed.
• Keep the on-body injector at least 4 inches away from electrical equipment such as cell phones, cordless telephones, microwaves and other common appliances. If the on-body injector is too close to electrical equipment, it may not work correctly and can lead to a missed or incomplete dose of your medication.
• The on-body injector is for adult patients only.
• If your on-body injector is not working properly, you may miss your dose or you may not receive your full dose. If you miss your dose or do not receive your full dose, you may have an increased risk of developing fever or infection.
• Call your healthcare provider right away, as you may need a replacement dose, if any of the following occur:
  • on-body injector comes off before or during a dose delivery. Do not re-apply it.
  • on-body injector is leaking.
  • adhesive on your on-body injector becomes noticeably wet (saturated) with fluid, or there is dripping. This may mean that the medication is leaking out of your on-body injector. If this happens you may only receive some of your dose, or you may not receive a dose at all.
  • on-body injector status light is flashing red.

Receiving pegfilgrastim using a single-dose prefilled syringe:

• Pegfilgrastim is given as an injection under your skin (subcutaneous injection) by a healthcare provider. 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" that comes with your medication for information on how to prepare and inject a dose.
• You and your caregiver will be shown how to prepare and inject this medication before you use it.
• You should not inject a dose of pegfilgrastim to children weighing less than 45 kg from a prefilled syringe. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the prefilled syringe.
• If you are receiving this medication because you are also receiving chemotherapy, the last dose of it should be injected at least 14 days before and 24 hours after your dose of chemotherapy.

Receiving pegfilgrastim using an on-body injector:

See the Instructions for use that come with your on-body injector for detailed information about how you will receive a dose of pegfilgrastim with the on-body injector, and how to remove and dispose of the on-body injector.

• See the section "Important information" above
• Pegfilgrastim is given as an injection under the skin (subcutaneous). Your healthcare provider will use a prefilled syringe with this medication in it to fill the on-body injector prior to applying it. The prefilled syringe with and the on-body injector are provided to your healthcare provider as part of Neulasta Onpro kit. The on-body injector will be applied to the stomach area (abdomen) or back of your arm by your healthcare provider. If the on-body injector was placed on the back of your arm, a caregiver must be available to monitor it.
• Your healthcare provider should place the on-body injector on an area of your skin that does not have swelling, redness, cuts, wounds, or abrasions. Tell your healthcare provider about any skin reactions that happen in the on-body injector application area after it has been applied.
• The on-body injector is programmed to deliver your dose about 27 hours after your healthcare provider places it on your skin.
• The dose of pegfilgrastim will be delivered over about 45 minutes. During dose delivery and for 1 hour after delivery, it is best to stay in a place where you or a caregiver can monitor the on-body injector to make sure you receive your full dose and watch for symptoms of an allergic reaction.
• Your healthcare provider will show you how to monitor the on-body injector to make sure delivery has been completed.
• Keep the on-body injector dry for about the last 3 hours before the dose delivery is expected to start. This will help you to better detect possible leaking from it.
• Only expose the on-body injector to temperatures between 41°F to 104°F (5°C to 40°C).

• Pegfilgrastim dosing information for patients with cancer receiving myelosuppressive chemotherapy
  • Pegfilgrastim 6 mg administered subcutaneously once per chemotherapy cycle.
  • Do not administer between 14 days before and 24 hours after administration of cytotoxic chemotherapy.
  • Use weight based dosing for pediatric patients weighing less than 45 kg.

    Body weight	Pegfilgrastim dose	Volume to administer
    Less than 10kg	See below*	See below*
    10-20kg	1.5mg	0.15ml
    21-30kg	2.5mg	0.25ml
    31-44kg	4mg	0.4ml

    *For pediatric patients weighing less than 10 kg, administer 0.1 mg/kg (0.01 mL/kg) of pegfilgrastim

• Pegfilgrastim (Neulasta brand only) dosing information for patients acutely exposed to myelosuppressive doses of radiation
  • Two doses, pegfilgrastim 6 mg each, administered subcutaneously one week apart. Administer the first dose as soon as possible after suspected or confirmed exposure to myelosuppressive doses of radiation, and a second dose one week after.
  • Use weight based dosing for pediatric patients weighing less than 45 kg; refer to the table above under pegfilgrastim dosing information for patients with cancer receiving myelosuppressive chemotherapy.

Do not take pegfilgrastim if you have had a serious allergic reaction to pegfilgrastim or filgrastim.

What should I tell my doctor before receiving pegfilgrastim?

Before you receive this medication, tell your healthcare provider about all of your medical conditions, including if you:

• have a sickle cell disorder.
• have kidney problems.
• are allergic to latex and are receiving the Neulasta, Stimufend or Ziextenzo brands of pegfilgrastim. The needle cap on the prefilled syringe for these brands contains dry natural rubber (derived from latex). You should not use these brands if you have a latex allergy.
  
  The needle cap on the prefilled syringes for Fulphila, Fylnetra, Nyvepria and Udenyca are not made with natural rubber latex.

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

If you are receiving pegfilgrastim using an on-body injector, while the on-body injector is in place you should avoid:

• traveling, driving or operating heavy machinery during hour 26 through hour 29 after the on-body injector is applied.
• sleeping on the on-body injector or applying pressure on it. It may not work properly.
• bumping the on-body injector or knocking it off your body.
• using other materials to hold the on-body injector in place. Using other materials could cover audio or visual indicators or press the on-body injector against your skin, and lead to a missed dose or incomplete dose.
• getting body lotion, creams, oils, and skin cleansing products near the on-body injector. These products may loosen the adhesive that holds the on-body injector onto your body.
• using bath tubs, hot tubs, whirlpools, or saunas, and direct sunlight. These may affect your medication.
• peeling off or disturbing the on-body injector adhesive before you receive your full dose.

Pegfilgrastim 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 area or your left shoulder.
• A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Call your healthcare provider or get emergency 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. This medication 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 this medicatoin 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 this medication. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.
• Kidney injury (glomerulonephritis). This medication 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
• Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment.
• Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment. Tell your healthcare provider if you have unusual bleeding or bruising during treatment. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.
• Capillary Leak Syndrome. Pegfilgrastim 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 and acute myeloid leukemia. If you have breast cancer or lung cancer, when Neulasta 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 myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop these symptoms during treatment.
• 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 pegfilgrastim. 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 pegfilgrastim are pain in the bones, arms, and legs.

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

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.