Important Safety Information
What should I know before I take NYVEPRIA?
Do not use NYVEPRIA if you are allergic to pegfilgrastim, filgrastim, any of the ingredients of NYVEPRIA, or to other products made using the bacteria Escherichia coli. Talk to your doctor if you have any questions about this information.
Before you take NYVEPRIA, tell your healthcare provider about all your medical conditions, including if:
- There is a lump, swelling, or bruising at the injection site that does not go away, talk to your doctor. Occasionally, a problem may develop at the injection site.
- You have sickle cell trait or sickle cell disease, tell your doctor prior to treatment. If you develop left upper abdominal pain or pain at the tip of your shoulder, tell your doctor or nurse immediately.
- You are pregnant, plan to become pregnant, think you may be pregnant, or are breastfeeding, you should consult your doctor before using NYVEPRIA.
Tell your healthcare provider about all the medicines you take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.
What are the possible side effects of NYVEPRIA?
The most common side effect that you may experience is aching in the bones and muscles. If this occurs, it can usually be relieved with a non-acetylsalicylic acid over-the-counter pain reliever. Ask your doctor which is the most suitable one for you.
NYVEPRIA may also cause other side effects, including:
Spleen rupture. Your spleen may become enlarged and can rupture while taking NYVEPRIA. A ruptured spleen can cause death. The spleen is located in the upper left section of your stomach area. Call your doctor right away if you have pain in the left upper-stomach area or left shoulder-tip area. This pain could mean your spleen is enlarged or ruptured.
Serious allergic reactions can also happen. These reactions may cause a rash over the whole body, shortness of breath, wheezing, a drop in blood pressure (usually causing dizziness or light-headedness), swelling around the mouth or eyes, fast pulse, or sweating. If you experience an allergic reaction during the injection of NYVEPRIA, the injection should be stopped immediately. If at any time a serious allergic reaction occurs, immediately call a doctor or emergency services (for example, call 911).
Low platelet counts (thrombocytopenia).
This presents as easy bruising and increased bleeding.
A serious lung problem called acute respiratory distress syndrome (ARDS). Call your doctor or seek emergency care right away if you have shortness of breath, trouble breathing, or a fast rate of breathing.
Kidney injury (glomerulonephritis) has been seen in patients who received NYVEPRIA. Call your doctor immediately if you experience puffiness in your face or ankles, blood in your urine or brown-coloured urine, or if you notice that you urinate less often than usual.
Cutaneous vasculitis. This presents as a rash in the skin surface that looks like purple or red spots or bumps, clusters of small dots, splotches, or hives. Your skin may also be itchy. Talk to your healthcare provider if you experience these symptoms.
Capillary leak syndrome. This can present as swelling or puffiness, and may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness. Talk to your healthcare provider if you experience these symptoms.
Severe sickle cell crisis has been associated with the use of pegfilgrastim in patients with sickle cell trait or sickle cell disease. Severe sickle cell crises, in some cases resulting in death, have also been associated with filgrastim, the parent compound of pegfilgrastim. If you have a sickle cell trait or sickle cell disease, make sure that you tell your doctor before you start taking NYVEPRIA so that the potential risks and benefits can be discussed.
Abnormal number of immature bone marrow cells (myelodysplastic syndrome), which could lead to a type of cancer (acute myeloid leukemia), presents as fever, bone pain, bruising, difficulty breathing, bleeding, and a general feeling of tiredness.*
Redness, swelling, or itching at the site of injection. This may be an allergy to the ingredients in NYVEPRIA, or it may be a local reaction. If you notice any of these signs or symptoms, call your doctor.
These are not all the possible side effects you may feel when taking NYVEPRIA. If you experience any side effects not listed here, call your healthcare professional.
* Adverse event in breast and lung cancer patients receiving chemotherapy and/or radiotherapy