Important Safety Information

Do not take Neulasta^® if you have had a serious allergic reaction to pegfilgrastim or filgrastim.

Before you receive Neulasta^®, tell your healthcare provider about all of your healthcare conditions, including if you:

• Have a sickle cell disorder
• Have had severe skin reactions to acrylic adhesives
• 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 Neulasta^® may harm your unborn baby.
• Are breastfeeding or plan to breastfeed. It is not known if Neulasta^® 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.

What are the possible serious side effects of Neulasta^®?

• Spleen Rupture. Your spleen may become enlarged and can rupture while taking Neulasta^®. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in the left upper stomach area or left shoulder tip area.
• 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. Neulasta^® 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 an allergic reaction during the delivery of Neulasta^®, remove the on-body injector for Neulasta^® by grabbing the edge of the adhesive pad and peeling off the on-body injector. Get emergency medical help right away.

• 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 Neulasta^®.
• Kidney injury (glomerulonephritis). Neulasta^® 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 Neulasta^®.
• Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with Neulasta^®. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with Neulasta^®. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.
• Capillary Leak Syndrome. Neulasta^® 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 Neulasta^® 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 may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop these symptoms during treatment with Neulasta^®.
• 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 Neulasta^®. 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 Neulasta^® is pain in your bones and in your arms and legs.

These are not all the possible side effects of Neulasta^®. Call your healthcare provider for medical advice about side effects. You may report negative side effects to the FDA at 1-800-FDA-1088.

Please see Neulasta^® Patient Information.

Neulasta^® Injection: 6 mg/0.6 mL in a single-dose prefilled syringe for manual use only.

Neulasta^® Injection: 6 mg/0.6 mL in a single-dose prefilled syringe co-packaged with the on-body injector (OBI) for Neulasta^® (Neulasta^® Onpro^® kit).