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UDENYCA is a prescription medicine used to help reduce the chance of infection due to a low white blood cell count, in people with certain types of cancer (non-myeloid), who receive anti-cancer medicines (chemotherapy) that can cause fever and low blood cell count.

DO NOT TAKE UDENYCA if you have had a serious allergic reaction to pegfilgrastim or filgrastim products.

What are possible side effects of UDENYCA?

UDENYCA may cause serious side effects, including:

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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 care right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing.
Serious allergic reactions: UDENYCA 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 UDENYCA and call your healthcare provider or get emergency medical help right away.
Sickle cell crises: You may have a serious sickle cell crisis if you have a sickle cell disorder and receive UDENYCA. Serious sickle cell crises have happened in people with sickle cell disorders receiving pegfilgrastim that has sometimes led to death. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.
Kidney injury (glomerulonephritis): UDENYCA 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 with UDENYCA.
Decreased platelet count (thrombocytopenia): Your healthcare provider will check your blood during treatment with UDENYCA. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with UDENYCA. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.
Capillary Leak Syndrome: UDENYCA 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 UDENYCA 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 with UDENYCA.
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.
Bone Imaging (Nuclear Imaging): The formation of certain blood cells may increase and can be associated with short term changes in bone imaging. Your doctor should consider this when interpreting bone imaging results.
Allergies to Acrylics (UDENYCA ONBODY only): The on-body injector (OBI) for UDENYCA uses acrylic adhesive. If you have had reactions to acrylic adhesives, use of this product may result in a significant reaction.

The most common side effects of UDENYCA are pain in the bones, arms, and legs.

These are not all the possible side effects of UDENYCA. Call your healthcare provider for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences at 1-800-4-UDENYCA (1-800-483-3692) or notify the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please read the Patient Information and the Prescribing Information for UDENYCA.