What is UDENYCA®?
UDENYCA® 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.
IMPORTANT SAFETY INFORMATION
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:
- 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 whne interpreting bone imaging results.
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 for UDENYCA®, and discuss it with your doctor. The physician Prescribing Information is also available.
