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What is ZARXIO?

ZARXIO is a man-made form of granulocyte colony-stimulating factor (G-CSF) called filgrastim. G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell that is important in the body's fight against infection.

Some cancer treatments decrease white blood cell counts, which may increase the risk of infection. A low level of neutrophils is known as neutropenia.

Learn more about ZARXIO

 

What is a biosimilar?

ZARXIO is the first biosimilar approved in the US.

A biosimilar is a medication that has been approved by the FDA as being highly similar to a previously approved biologic medication. Biosimilars may be available at a lower cost than the referenced biologic medication.

What is ZARXIO approved to treat?

ZARXIO is a prescription medicine used to help reduce the chance of infection due to a low white blood cell count in patients with certain types of cancer (nonmyeloid) who are receiving chemotherapy that can cause fever and a low blood cell count.

How is ZARXIO administered?

ZARXIO injections can be given by a healthcare provider by subcutaneous (under the skin) injection or by intravenous (IV) infusion. Your healthcare provider may decide subcutaneous injections can be given at home by you or your caregiver. If ZARXIO is given at home, see the detailed Instructions for Use that come with your prescription for information on how to prepare and inject a dose of ZARXIO.

You and your caregiver will be shown how to prepare and inject ZARXIO before you use it.

Watch the administration video

How do I administer a ZARXIO injection?

Your healthcare provider will provide you with training on how to inject ZARXIO. They will explain what dose you should administer and how frequently it should be injected. You should not attempt to give yourself a subcutaneous injection until you have received the appropriate training from your healthcare provider.

Watch the administration video

How do I prepare for a ZARXIO injection?

In addition to the prefilled syringe that is included in your pack, you will need:

  • 1 alcohol wipe
  • 1 cotton ball or gauze
  • Sharps disposal container
  • 1 adhesive bandage

You should not inject a dose of ZARXIO less than 0.3 mL (180 mcg) from a ZARXIO prefilled syringe. A dose less than 0.3 mL cannot be accurately measured using the ZARXIO prefilled syringe.

Learn more about administration

How should I store ZARXIO?

  • Store ZARXIO in the refrigerator between 36°F to 46°F (2°C to 8°C)
  • Protect from freezing ZARXIO. If frozen, thaw in the refrigerator before use. Throw away (dispose of) ZARXIO if it has been frozen more than 1 time
  • Store ZARXIO in the original pack to protect it from light
  • Avoid shaking ZARXIO
  • Take ZARXIO out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection
  • ZARXIO may be allowed to reach room temperature for up to 4 days. Throw away (dispose of) any ZARXIO that has been left at room temperature for longer than 4 days
  • After you inject your dose, throw away (dispose of) any unused ZARXIO left in the prefilled syringe. Do not save unused ZARXIO in the prefilled syringe for later use

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

How do I throw away (dispose of) used ZARXIO prefilled syringes?

After you inject your dose, throw away (dispose of) any unused ZARXIO left in the prefilled syringe. Do not save unused ZARXIO in the prefilled syringe for later use.

Put your used prefilled syringes in an FDA-cleared sharps disposal container (see Figure A) right away after use. Do not throw away (dispose of) ZARXIO prefilled syringes in your household trash.

sharps container

If you do not have an FDA-cleared sharps disposal container, you may use a household container that:

  • Is made of a heavy-duty plastic
  • Can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
  • Is upright and stable during use
  • Is leak-resistant
  • Is properly labeled to warn of hazardous waste inside the container

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles, syringes, and prefilled syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at http://www.fda.gov/safesharpsdisposal.

Important: Always keep the sharps disposal container out of the reach of children.

Reference: ZARXIO Prescribing Information. Sandoz Inc. September 2022.

IMPORTANT SAFETY INFORMATION

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

Before you take ZARXIO, tell your doctor about all of your medical conditions, including if you:

  • have a sickle cell disorder.
  • have a problem with your kidneys, as you may need more frequent urine tests.
  • are receiving radiation therapy.
  • are allergic to latex. The needle cap on the prefilled syringe contains natural rubber (derived from latex). Do not handle the prefilled syringe if you are allergic to latex.
  • are pregnant or plan to become pregnant. It is not known if ZARXIO will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if ZARXIO passes into your breast milk.

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

What are the possible side effects of ZARXIO? 
ZARXIO may cause serious side effects, including:

  • Spleen rupture. Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your doctor 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 doctor 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. ZARXIO 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 ZARXIO, and call your doctor or get emergency help right away.
  • Sickle cell crises. You may have a serious sickle cell crisis if you have a sickle cell disorder and take ZARXIO. Serious sickle cell crisis has happened in people with sickle cell disorders receiving filgrastim that has sometimes led to death. Call your doctor right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.
  • Kidney injury (glomerulonephritis). Kidney injury has been seen in patients who received filgrastim products. Call your doctor right away if you experience puffiness in your face or ankles, blood in your urine or brown-colored urine or you notice you urinate less than usual.
  • Capillary leak syndrome. ZARXIO 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 often.
    • 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).
    • ZARXIO 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 ZARXIO 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 ZARXIO.
  • Decreased platelet count (thrombocytopenia). Your doctor will check your blood during treatment with ZARXIO. Tell your doctor if you have unusual bleeding or bruising while taking ZARXIO. This could mean a decrease of platelets, which reduces the ability of blood to clot.
  • Increased white blood cell count (leukocytosis). Your doctor will check your blood during treatment with ZARXIO.
  • Inflammation of your blood vessels (cutaneous vasculitis). Tell your doctor 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 filgrastim products. 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 ZARXIO include aching in the bones and muscles.

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

Please see full Prescribing Information for ZARXIO.

What is ZARXIO?

ZARXIO is a man-made form of granulocyte colony-stimulating factor (GCSF). 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.

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ZARXIO, Ziextenzo, and the Sandoz One Source logo are registered trademarks of Novartis AG.
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255147-1 06/2023