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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.

What Is Neulasta®?

Strong chemotherapy can reduce your white blood cell count, weakening your immune system. A weakened immune system increases your risk of infection. Neulasta® is a prescription medication that can help reduce your risk of infection during strong chemotherapy. It does this by boosting the number of certain infection‑fighting white blood cells called neutrophils, which strengthens your immune system.1

How Neulasta® Works

Neulasta® works like a natural protein in your body to signal the growth of new white blood cells. Neulasta® helps reduce your risk of infection in a chemotherapy cycle with just one injection. It is a prescription medication given approximately 24 hours after you receive chemotherapy treatment to provide ongoing support through that cycle.3

Made by Amgen, Neulasta® is the #1 white blood cell booster prescribed by doctors to help reduce the risk of infection during strong chemotherapy.2

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How Neulasta® (pegfilgrastim) Works: Video Transcript

Cancer consists of cells that are different from normal cells—they can divide very quickly and grow out of control.

Chemotherapy is one of many options available to fight cancer. It works by stopping or slowing down the growth of cancer cells.

Unfortunately, while the chemotherapy is fighting cancer cells, it can also harm normal cells in the body that divide rapidly. Normal healthy cells that can be damaged by chemotherapy include cells that cause your hair to grow, cells that line your stomach and intestines, and white blood cells that help our bodies fight infections. So a person undergoing strong chemotherapy may be more susceptible to infection.

Neutrophils are a type of white blood cell that fight infections, so they’re particularly important for a person receiving certain types of chemo.

Our bodies make a natural protein that signals the body to make white blood cells. There are medicines that function in a way that is similar to your body’s proteins. Neulasta® (pegfilgrastim) is one of these medicines. It is called a white blood cell booster that help your body produce more white blood cells.

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.

Neulasta® works the same way as the protein that is made in the body. It acts on the cells in our bone marrow that would naturally develop to become white blood cells.

When Neulasta® is given, these cells start dividing rapidly, which means there’s a large increase in the number of new white blood cells that are formed.

The newly created white blood cells mature, they develop sacs that contain the substances needed to kill infection-causing bacteria.

Normally, it takes between 5 to 7 days for white blood cells to finish maturing. When a white-cell booster is given, however, white blood cells may finish maturing in less than one day and be released from the bone marrow into the blood.

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.

Neulasta® stays in the body for a long time, because the molecule is too large to be eliminated primarily by the kidney. As the number of white blood cells increases, Neulasta® is broken down by the white blood cells themselves and removed.

Because of this process, patients getting strong chemotherapy need only one injection of Neulasta® per chemotherapy cycle.

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.

What are the most common side effects of 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 and the Neulasta prescribing information by clicking the links for additional information.

©2015 Amgen. All rights reserved. 80607-R2-V1

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. Neulasta® (pegfilgrastim) Prescribing Information, Amgen.
  2. Amgen. Data on file.
  3. Neulasta® (pegfilgrastim) Patient Instructions For Use, Amgen.