Get to know STIMUFEND® (pegfilgrastim-fpgk)
STIMUFEND is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body. STIMUFEND is a biosimilar of the original product, Neulasta® (pegfilgrastim).
STIMUFEND was approved to:
Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).
You will receive STIMUFEND at least 24 hours after your chemotherapy treatment.
- STIMUFEND needs to be injected only once during each chemotherapy cycle
- STIMUFEND is administered as an injection under the skin (subcutaneous injection) by your healthcare provider
Ask your healthcare provider about being able to administer STIMUFEND at home, by yourself, or with the help of your caregiver.
At home, store STIMUFEND in its original carton in the refrigerator between 36°F and 46°F (2°C to 8°C).
Take STIMUFEND out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.
Administration sites
Do not try to inject STIMUFEND unless you or your caregiver has received training from your healthcare provider.
If you have a fever of 100.4°F or higher, call your healthcare provider or 911 immediately. Having a fever could be a sign of febrile neutropenia (fever with low white blood cell count).
In addition, let your healthcare provider know about any new skin rashes or if you have bleeding that does not stop.
Look out for other signs of infections
- Sore throat
- Chills
- Shortness of breath
- Rapid heartbeat
- Pus or yellowish discharge
- Abdominal (belly) pain
- Burning or pain when urinating
- Sores or white patches in the mouth
While this information is intended as a guide, always follow the instructions provided by your healthcare provider.
If you have a fever of 100.4°F or higher, call your healthcare provider or 911 immediately. Having a fever could be a sign of febrile neutropenia (fever with low white blood cell count).
In addition, let your healthcare provider know about any new skin rashes or if you have bleeding that does not stop.
Look out for other signs of infections
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While this information is intended as a guide, always follow the instructions provided by your healthcare provider.
A biosimilar is a medicine that is highly similar to the original product (also called "reference product") with no clinically meaningful differences in safety, purity, or effectiveness.
How does a biosimilar compare with the original product?
- Both made from living cells
- Work in the body in the same way
- Equally safe and effective
Why are biosimilars important?
- Help reduce costs for patients and healthcare systems
- Increase availability to more patients in need
- Encourage innovation in health care
"FDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards. That means patients and health care professionals will be able to rely upon the safety and effectiveness of the biosimilar or interchangeable product, just as they would the reference [original] product."
—US Food and Drug Administration
- Filename
- KabiCare-Biosimilars-Patient-Brochure-3285.pdf
- Size
- 1 MB
- Format
KabiCare Patient Support Program
Fresenius Kabi provides you access to KabiCare, a comprehensive patient support program
Our experts work closely with you to help simplify your treatment journey, including enrolling in KabiCare, navigating insurance coverage and financial assistance, securing access to medication, offering disease education, injection training, refill reminders, and more.
Once enrolled, you’ll have access to a wide range of materials, including:
Enrollment support
Financial support*
Insurance support
Clinical support
Important Safety Information
Do not take STIMUFEND if you have had a serious allergic reaction to pegfilgrastim or filgrastim.
Before you receive Stimufend, tell your healthcare provider about all of your healthcare conditions, including if you:
- Have a sickle cell disorder
- Are allergic to latex – The needle cap on the prefilled syringe contains dry natural rubber (derived from latex).
- Have kidney problems
- Are pregnant or plan to become pregnant. It is not known if Stimufend may harm your unborn baby.
- Are breastfeeding or plan to breastfeed. It is not known if Stimufend 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.
Warnings and Precautions
- Spleen Rupture. Your spleen may become enlarged and can rupture while taking Stimufend. 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. Stimufend 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. Call your healthcare provider or get emergency medical help right away if you have any of these symptoms.
- 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 Stimufend. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.
- Kidney injury (glomerulonephritis). Stimufend 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, or you urinate less than usual.
- Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with Stimufend.
- Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with Stimufend. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with Stimufend. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.
- Capillary Leak Syndrome. Stimufend 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 Stimufend 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 Stimufend.
- 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 Stimufend. 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 Stimufend is pain in your bones and in your arms and legs.
These are not all the possible side effects of Stimufend. Call your healthcare provider for medical advice about side effects. You may report negative side effects to the FDA at 1-800-FDA-1088.
Indication and Usage
Stimufend is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Stimufend is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).
Limitations of Use
Stimufend is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
Please see STIMUFEND Patient Information.
STIMUFEND Injection: 6 mg/0.6 mL in a single-dose prefilled syringe for manual use only.
Indications
Stimufend is indicated to:
- Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia
- Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome)
Limitations of Use
Stimufend is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.