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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 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.

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IMPORTANT SAFETY INFORMATION

What is STIMUFEND^® (pegfilgrastim-fpgk)?

Site Map

Are You a US Healthcare Professional?

You are now leaving STIMUFEND.com.

IMPORTANT SAFETY INFORMATION

What is STIMUFEND® (pegfilgrastim-fpgk)?

What is STIMUFEND^® (pegfilgrastim-fpgk)?