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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.
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.
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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