Neutropenia and Infections | ZIEXTENZO® (pegfilgrastim-bmez)

Chemotherapy works by killing cancer cells

Chemotherapy drugs can't tell the difference between cell types, so cells that can fight infection, such as neutrophils, may also be killed during chemotherapy treatments.

Normal blood cells compared to Neutropenia (low neutrophil count).

_{Adapted with permission from Patel K et al. JAMA Oncol. 2017;3(12):1751.}

When chemotherapy attacks healthy neutrophils (a type of white blood cell), the body is put at greater risk for infection because it has a weakened immune system. A low level of neutrophils is known as neutropenia. When combined with a fever, this condition is called febrile neutropenia.

Infections are a major risk for patients undergoing chemotherapy

Infection is a common complication of cancer treatment and can be life-threatening. An infection occurs when germs, such as bacteria or viruses, enter the body and multiply, which can cause illness, disease, or tissue damage. Alert your healthcare provider immediately if you think you may have an infection.

Protecting against the risk of infection

Protecting my body from infection

Protecting against the risk of infection

Neutropenia may occur in patients receiving chemotherapy, which can increase risk of serious infections. ZIEXTENZO helps protect against the risk of infection by boosting your white blood cell count.

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_{References: 1. US Centers for Disease Control and Prevention. What you need to know: Neutropenia and risk for infection. Accessed June 12, 2023. https://www.cdc.gov/cancer/preventinfections/pdf/neutropenia.pdf 2. Patel K, West H. Febrile Neutropenia. JAMA Oncol. 2017;3(12):1751. doi:10.1001/jamaoncol.2017.1114. 3. ZIEXTENZO Prescribing Information. Sandoz Inc. March 2021.}

Important Safety Information

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

Before you receive ZIEXTENZO, tell your healthcare provider about all of your healthcare conditions, including if you:

Have a sickle cell disorder
Have kidney problems
Are allergic to latex—The needle cap on the prefilled syringe contains dry natural rubber (made from latex).
Are pregnant or plan to become pregnant. It is not known if ZIEXTENZO will harm your unborn baby.
Are breastfeeding or plan to breastfeed. It is not known if ZIEXTENZO 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.

What are the possible serious side effects of ZIEXTENZO?

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 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. ZIEXTENZO 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 ZIEXTENZO 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 ZIEXTENZO. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.
Kidney injury (glomerulonephritis). ZIEXTENZO 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
- urinate less than usual
Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with ZIEXTENZO.
Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with ZIEXTENZO. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with ZIEXTENZO. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.
Capillary Leak Syndrome. ZIEXTENZO 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 ZIEXTENZO 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 may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop these symptoms during treatment with ZIEXTENZO.
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 effect of ZIEXTENZO is pain in your bones, arms, and legs.

These are not all the possible side effects of ZIEXTENZO. Call your healthcare provider for medical advice about side effects. To report negative side effects, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see ZIEXTENZO full Prescribing Information and Patient Information.

What is ZIEXTENZO?

ZIEXTENZO 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.