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Important Safety Information

Who should not take Neulasta®?

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

What should I tell my health care provider before taking Neulasta®? Tell your healthcare provider if you:

  • Have sickle cell trait or sickle cell disease
  • Have had severe skin reactions to acrylic adhesives
  • Are allergic to latex
  • Have any other medical problems
  • Are pregnant or plan to become pregnant
  • Are breastfeeding or plan to breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are 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 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.
  • A serious lung problem called acute respiratory distress syndrome (ARDS). Call your health care provider or get emergency medical help right away if you get any of these symptoms of ARDS: fever, shortness of breath, trouble breathing, or a fast rate of breathing.
  • Serious Allergic Reactions. Get emergency medical help right away if you get any of these symptoms of a serious allergic reaction with Neulasta: shortness of breath, wheezing, dizziness, swelling around the mouth or eyes, fast pulse, sweating, and hives. 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 for Neulasta. Get emergency medical help right away.
  • Sickle Cell Crises. Severe sickle cell crises, and sometimes death, can happen in people with sickle cell trait or disease who receive filgrastim, a medicine similar to Neulasta.

The most common side effect of Neulasta is pain in the bones and in your arms and legs.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Neulasta. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For more information about Neulasta, talk with your healthcare provider or pharmacist; go to www.neulasta.com, or call 1-844-696-3852 (1-844-MYNEULASTA).

Please see the Neulasta Patient Information for additional information.

Indication

Neulasta® (pegfilgrastim) is a prescription medication used to help reduce the chance of infection due to a low white blood cell count, in people with certain types of cancer (non-myeloid), who receive anti-cancer medicines (chemotherapy) that can cause fever and low blood cell count.

It is not known if Neulasta is safe and effective in children.

Help Reduce Infection Risk
During Chemotherapy

Strong chemotherapy can cause a range of side effects. One side effect that concerns oncologists (doctors who specialize in the treatment of cancer) is when patients develop a low white blood cell count with a fever, sometimes called febrile neutropenia or neutropenic fever. This condition can be a sign of an infection, with potentially serious consequences.1

Patients can develop a neutropenic fever during any chemo cycle. Studies have found that the risk is highest with the first cycle of chemo, but it may also happen in later cycles.2 Talk with your doctor to learn if you may be at risk for an infection.

Understanding Your Blood Counts

Your doctor may routinely use a test called a Complete Blood Count (CBC) before and during your chemotherapy treatment. Understanding your blood counts may help you take a more active role in your treatment. The CBC test reports your blood counts—the number of white blood cells, red blood cells, and platelets in your blood—and compares your counts to normal ranges.3 Below is a sample chart of normal ranges to help you track your own blood counts. Your doctor will keep an eye on your blood counts to see whether chemotherapy is lowering any of them.

Sample chart of Normal Blood Count Ranges4*
Normal Ranges: MaleNormal Ranges: Female
  • White Blood Cells (WBCs)
5.0-10.0 x 109/L5.0–10.0 x 109/L
  • Neutrophils
2.5-8.0 x 109/L2.5-8.0 x 109/L
  • Red Blood Cells (RBCs)
4.7-6.1 x 1012/L4.2-5.4 x 1012/L
  • Hemoglobin (Hb or Hgb)
14-18 g/dL12-16 g/dL
  • Hematocrit (Hct)
0.42-0.520.37-0.47
  • Platelets (Pls)
150-400 x 109/L150-400 x 109/L

L = liter

g/dL = grams per deciliter

* A CBC may include additional blood cell counts not included in this table. Normal ranges may vary
by lab, race, and age.

Neutrophils—a specific type of white blood cell

White blood cells protect your body against foreign invaders such as bacteria. There are several types of white blood cells in the body, each with a different function. Neutrophils are a specific type of white blood cell that are critical to defend against certain types of infection.5 When looking at the results of a CBC test, your doctor will check your total white blood cell count and the absolute neutrophil count (ANC). The ANC is the number of neutrophils present in the blood, which is one way your doctor can tell how well your body can fight infection.5 If your ANC falls below normal, you will have a condition called neutropenia.5 Neutropenia can increase your risk of infection and is a common side effect of strong chemotherapy treatments.5

The importance of monitoring white blood cell counts

It's important for your doctor to monitor your white blood cell count throughout your chemotherapy treatment. Having a low white blood cell count increases your risk of developing certain types of infection.1 Your doctor may routinely use a test called a complete blood count (CBC) before and during your chemotherapy treatment.5 A CBC can help tell if a patient is at increased risk of or has an infection.3

Using medications to help boost your white blood cell count

It's important for your doctor to monitor all your blood counts throughout your chemotherapy treatment. If any fall below your normal range, your doctor may recommend certain prescription medicines.

Neulasta® is a once-per-cycle white blood cell booster

Medications which may be called white blood cell boosters help your body produce more infection-fighting white blood cells during strong chemotherapy. These medications are man-made forms of a substance called granulocyte (gran-yoo-loh-site) colony-stimulating factor (G-CSF) that is naturally produced by the body. They stimulate the growth of a type of white blood cell called neutrophils, which are important in the body's fight against infection.

HELP REDUCE YOUR INFECTION RISK DURING STRONG CHEMO

Neulasta® was proven to help reduce the risk of infection

TALK WITH YOUR DOCTOR BEFORE STARTING STRONG CHEMO

Ask your doctor if you may be at risk for infection

References

  1. Wujcik D. Infection. In: Groenwald SL, Goodman M, Frogge MH, Yarbro CH, eds. Cancer Symptom Management. Boston, Mass: Jones & Bartlett Publishers; 1996:289-304.
  2. Vogel CL, Wojtukiewicz MZ, Carroll RR, et al. J Clin Oncol. 2005;23:1178-1184.
  3. Chemotherapy and you. National Cancer Institute website. Update May 2007. NIH Publication No. 11-7156. Available at: http://www.cancer.gov/cancertopics/chemotherapy-and-you.pdf. Accessed May 15, 2014.
  4. Pagana KD, Pagana TJ. Mosby's Manual of Diagnostic and Laboratory Tests. St Louis, MO: Mosby; 1998.
  5. Infections in people with cancer. American Cancer Society website. Updated November 6, 2013. http://www.cancer.org/
    treatment/treatmentsandsideeffects/physicalsideeffects/infectionsinpeoplewithcancer/infectionsinpeoplewithcancer/
    infections-in-people-with-cancer-precautions-to-take. Accessed April 2, 2014.
  6. Neulasta® (pegfilgrastim) Patient Product Information, Amgen.
  7. NEUPOGEN® (filgrastim) Patient Product Information, Amgen.