Pegfilgrastim

Generic name: Pegfilgrastim, Pegfilgrastim-jmbd, Pegfilgrastim-pbbk, Pegfilgrastim-apgf, Pegfilgrastim-fpgk, Pegfilgrastim-cbqv, Pegfilgrastim-bmez
Dosage form: subcutaneous injection, autoinjector, on-body injector
Drug class: Colony stimulating factors

Usage of Pegfilgrastim

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 biosimilar versions of pegfilgrastim are given by suBCutaneous injection and available as a single-dose prefilled syringe. The Neulasta brand can also be given by subcutaneous injection using an on-body injector called Neulasta Onpro. The Udenyca brand is also available as a prefilled autoinjector and an on-body injector called Undenyca Onbody.

Pegfilgrastim side effects

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 medication 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 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 that 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 the FDA at 1-800-FDA-1088.

Before taking Pegfilgrastim

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if pegfilgrastim will harm your unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if pegfilgrastim passes into your breast milk.

Relate drugs

How to use Pegfilgrastim

Pegfilgrastim dosing information for patients with cancer receiving myelosuppressive chemotherapy

Pegfilgrastim 6 mg. Administer 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 and Udenyca brands) dosing information for patients acutely exposed to myelosuppressive doses of radiation

Administer two doses of pegfilgrastim 6 mg, 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.

Warnings

Important information for patients receiving pegfilgrastim using an on-body injection (Neulasta Onpro Kit or Udenyca Onbody).

See the Instructions for use for the on-body injector for detailed information.

Know the time that delivery of your dose is expected to start.

Avoid traveling, driving, or operating heavy machinery during hours 26 through hour 29 after the on-body injector is applied. Avoid activities and places that may interfere with monitoring during the 45 minutes (Neulasta Onpro) or 5 minutes (Udenyca Onbody) 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 the 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 a fever or infection.

Call your healthcare provider right away, as you may need a replacement dose if any of the following occur:

the on-body injector comes off before or during a dose delivery. Do not re-apply it.

the on-body injector is leaking.

the 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.

the on-body injector status light is flashing red.

What other drugs will affect Pegfilgrastim

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

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