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Clinical Results for Neulasta®

In clinical trials, the most common side effect of Neulasta is pain in the bones and in your arms and legs.

Key study results

Neulasta® was shown to help reduce the risk of infection with fever (sometimes called febrile neutropenia or neutropenic fever) through strong chemo treatment.1-4


In a key study of 928 breast cancer patients who received up to 4 cycles of strong chemotherapy, one group of patients received Neulasta® (the study group), while the other group did not receive Neulasta® (the placebo group).1,4


The study results showed a1,4:

  • 94% reduction in the cases of febrile neutropenia (low white blood cell count with fever, a sign of infection) in the group of patients receiving Neulasta®
    • 17% of patients not treated with Neulasta® got an infection vs 1% of Neulasta® patients
  • 93% reduction in the number of patients hospitalized for febrile neutropenia and associated infections
    • 14% of patients not treated with Neulasta® were hospitalized vs 1% of Neulasta®
  • 80% reduction in intravenous (IV) anti-infective medication use
    • 10% of patients not treated with Neulasta® needed IV anti-infective medication vs 2% of Neulasta® patients1
  • The most common side effect experienced with Neulasta® was aching in the bones or muscles

Neulasta® reduced infection risk by 94% in patients taking strong chemotherapy when used every cycle1,4

 

TALK WITH YOUR DOCTOR BEFORE STARTING STRONG CHEMO

Ask your doctor if you may be at risk for infection


PATIENT STORIES

Real patients with cancer share their stories




References

  1. Neulasta® (pegfilgrastim) Prescribing Information, Amgen.
  2. Green M, Koelbl H, Baselga J, et al. Ann Oncol. 2003;14:29-35.
  3. Holmes FA, O’Shaughnessy JA, Vukelja S, et al. J Clin Oncol. 2002;20:727-731.
  4. Vogel CL, Wojtukiewicz MZ, Carroll RR, et al. J Clin Oncol. 2005;23:1178-1184.

Important Safety Information

Who should not take Neulasta®?

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

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 problems with your kidneys
  • Have any other medical 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 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 healthcare 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. 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®.
  • Kidney injury (glomerulonephritis). Kidney injury has been seen in patients who received Neulasta®. You should notify your healthcare provider right away if you experience puffiness in your face or ankles, blood in your urine or brown colored urine or you notice you urinate less than usual.
  • Increased white blood cell count (leukocytosis). Your doctor will check your blood during treatment with Neulasta®.
  • 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 often
    • trouble breathing
    • swelling of your stomach-area (abdomen) and feeling of fullness
    • dizziness or feeling faint
    • a general feeling of tiredness

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 are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).


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 Neulasta® Patient Information.

Indication

Neulasta® 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.




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 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.

Important Safety Information & Indication

Important Safety Information

Who should not take Neulasta®?

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

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 problems with your kidneys
  • Have any other medical 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 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 healthcare 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. 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®.
  • Kidney injury (glomerulonephritis). Kidney injury has been seen in patients who received Neulasta®. You should notify your healthcare provider right away if you experience puffiness in your face or ankles, blood in your urine or brown colored urine or you notice you urinate less than usual.
  • Increased white blood cell count (leukocytosis). Your doctor will check your blood during treatment with Neulasta®.
  • 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 often
    • trouble breathing
    • swelling of your stomach-area (abdomen) and feeling of fullness
    • dizziness or feeling faint
    • a general feeling of tiredness

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 are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).


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 Neulasta® Patient Information.

Indication

Neulasta® 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.