Study Results with Neulasta®
Neulasta® helps support your body's natural defenses
Neulasta® can help protect patients receiving strong chemotherapyChemotherapy—The use of drugs to destroy cancer cells. A person on chemotherapy may take one drug or a combination of drugs. Most often these drugs are given by vein using intravenous (IV) infusion. Some can be taken by mouth or given as a shot. against infectionInfection—An invasion of microorganisms such as bacteria or viruses that have the ability to multiply and cause disease. due to a low white blood cell countWhite blood cell (WBC)—A white blood cell is one of the three main types of blood cells. They are produced in the bone marrow and released into the blood. White blood cells are responsible for fighting infection. There are several kinds of white blood cells, including monocytes, lymphocytes, neutrophils, eosinophils, and basophils..1-3
In a key clinical study, Neulasta® reduced the number of people who got febrile neutropeniaNeutropenia—A lower-than-normal number of neutrophils (infection-fighting white blood cells) in the blood. It is a common side effect of some chemotherapy treatments. Doctors check the number of neutrophils when they measure the white blood cell count, to monitor the risk of infection. by 94% when compared to patients who did not receive Neulasta® at first.1,4 This study involved over 900 patients with breast cancer.1,4
In the study, the most common side effect experienced with Neulasta® was aching in the bones or muscles.
LEARN MORE ABOUT NEULASTA® AND NEUPOGEN® »
Neulasta® (pegfilgrastim) is a prescription medication used to reduce the risk of infection (initially marked by fever) in patients with some tumors receiving strong chemotherapy that decreases the number of infection-fighting white blood cells.
Important Safety Information
Who should not take Neulasta® (pegfilgrastim)?
Do not take Neulasta® (pegfilgrastim) if you have had an allergic reaction to Neulasta® (pegfilgrastim) or to NEUPOGEN® (Filgrastim).
What should I tell my health care provider before taking Neulasta® (pegfilgrastim)?
If you have a sickle cell disorder, make sure your doctor knows about it before using Neulasta® (pegfilgrastim).
- Spleen Rupture. Your spleen may become enlarged and can rupture while taking Neulasta® (pegfilgrastim). A ruptured spleen can cause death. The spleen is located in the upper left section of your stomach area. 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 doctor or seek emergency care right away if you have shortness of breath, trouble breathing, or a fast rate of breathing.
- Serious Allergic Reactions. Neulasta® (pegfilgrastim) can cause serious allergic reactions. These reactions can cause shortness of breath, wheezing, dizziness, swelling around the mouth or eyes, fast pulse, sweating, and hives. If you start to have any of these symptoms, call your doctor or seek emergency care right away. If you have an allergic reaction during the injection of Neulasta® (pegfilgrastim), stop the injection. Call your doctor right away.
- Sickle Cell Crises. You may have a serious sickle cell crisis if you have a sickle cell disorder and take Neulasta® (pegfilgrastim). Serious and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving Filgrastim, a medicine similar to Neulasta® (pegfilgrastim). Call your doctor right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.
What are the most common side effects of Neulasta® (pegfilgrastim)?
The most common side effect you may experience is aching in the bones and muscles. If this happens, it can usually be relieved with a nonaspirin pain reliever, such as acetaminophen.
- Occasionally pain and redness may occur at the injection site. If there is a lump, swelling, or bruising at the injection site that does not go away, talk to the doctor.
- Neulasta® (pegfilgrastim) should only be injected on the day the doctor has determined and should not be injected until approximately 24 hours after receiving chemotherapy.
- The needle cover on the single-use prefilled syringe contains dry natural rubber (latex), which should not be handled by persons sensitive to this substance.
If you have any questions about this information, be sure to discuss them with your doctor. 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.
- Neulasta® (pegfilgrastim) prescribing information, Amgen. V13, 2011.
- Green M, Koelbl H, Baselga J, et al. A randomized double-blind multicenter phase III study of fixed-dose single-administration
pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol. 2003;14:29-35.
- Holmes FA, O’Shaughnessy JA, Vukelja S, et al. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim
once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer.
J Clin Oncol. 2002;20:727-731.
- Vogel CL, Wojtukiewicz MZ, Carroll RR, et al. First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients
with breast cancer: a multicenter, double-blind, placebo-controlled phase III study. J Clin Oncol. 2005;23:1178-1184.