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.