Neulasta (pegfilgrastim)

Neulasta 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 your left upper stomach area or 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. 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 bygrabbing the edge of the adhesive pad and peeling off the on-body injector for Neulasta. 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. Call your healthcare provider right away if you develop symptoms of sickle cell crisis such as pain or difficulty breathing.
• 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
  • 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. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Common side effects of Neulasta include:

• bone pain,
• pain in your arms or legs, or
• injection site reactions (bruising, swelling, pain, redness, or a hard lump).

Get medical help right away if you have rare but very serious side effects of Neulasta including:

• breathing problems (e.g., trouble breathing, shortness of breath, fast breathing).

Patients With Cancer Receiving Myelosuppressive Chemotherapy

• The recommended dosage of Neulasta is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle.
• For dosing in pediatric patients weighing less than 45 kg, refer to Table 1.
• Do not administer Neulasta between 14 days before and 24 hours after administration of cytotoxic chemotherapy.

Patients With Hematopoietic Subsyndrome Of Acute Radiation Syndrome

• The recommended dose of Neulasta is two doses, 6 mg each, administered subcutaneously one week apart.
• For dosing in pediatric patients weighing less than 45 kg, refer to Table 1.
• Administer the first dose as soon as possible after suspected or confirmed exposure to radiation levels greater than 2 gray (Gy). Administer the second dose one week after the first dose.
• Obtain a baseline complete blood count (CBC). Do not delay administration of Neulasta if a CBC is not readily available.
• Estimate a patient's absorbed radiation dose (i.e., level of radiation exposure) based on information from public health authorities, biodosimetry if available, or clinical findings such as time to onset of vomiting or lymphocyte depletion kinetics.

• Although available data with Neulasta use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies in pregnant women exposed to filgrastim products.
• These studies have not established an association of filgrastim product use during pregnancy with major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• There are no data on the presence of pegfilgrastim in human milk, the effects on the breastfed child, or the effects on milk production.
• Other filgrastim products are secreted poorly into breast milk, and filgrastim products are not absorbed orally by neonates.
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Neulasta and any potential adverse effects on the breastfed child from Neulasta or from the underlying maternal condition.