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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.

Infection Risk During Chemotherapy

Strong chemotherapy described as myelosuppressive (my-eh-lo-suh-press-iv) can lower the number of infection-fighting white blood cells called neutrophils in your body. White blood cells are a key part of your immune system. At normal levels, white blood cells help protect your body against infection.1

A reduced neutrophil count is known as neutropenia (nu-tro-pee-nee-a).1 Neutropenia can put patients at risk for certain types of infection. Having neutropenia along with a fever—sometimes called a neutropenic fever or febrile neutropenia—may be a sign of a serious infection.2

Certain risk factors increase your chance of infection

According to national guidelines, if you are treated with strong chemotherapy, you may have a greater chance of developing low white blood cell counts or infections if any of the following conditions apply to you:3,4

  • You have been treated with strong chemotherapy or radiation before
  • You have other medical conditions (such as liver or kidney dysfunction, infections, or open wounds)
  • You developed low white blood cell counts before, while being treated with chemo
  • You already had a low white blood cell count before starting strong chemotherapy
  • Your cancer has spread to your bone marrow

Your doctor may recommend that you take a prescription medication that boosts the number of infection-fighting white blood cells called neutrophils.5

Learn More

What Can Happen to White Blood Cells During Strong Chemotherapy1

Before chemotherapy: White blood cells are a key part of your body’s fighting force (your immune system). At natural levels, white blood cells help protect your body against infection.

With strong chemotherapy: Strong chemotherapy can lower the number of infection-fighting white blood cells in your body, which may increase your risk for infection.

BOOST YOUR WHITE BLOOD CELL COUNT

Help reduce the risk of infection during strong chemo

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. National Cancer Institute. Dictionary of Cancer Terms: Febrile neutropenia. http://www.cancer.gov/dictionary?expand=F. Accessed May 7, 2014.
  3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myeloid Growth Factors V.2.2014. © National Comprehensive Cancer Network, Inc 2014. All rights reserved. Accessed May 29, 2014. To view the most recent and complete version of the guideline, go online to NCCN.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc.
  4. Lyman GH. J Natl Compr Canc Netw. 2005;3:557-571.
  5. Neulasta® (pegfilgrastim) Prescribing Information, Amgen.