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Important Safety Information

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Indication and Important Safety Information

Neulasta® (pegfilgrastim) is prescribed 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
Ruptured spleen (including fatal cases) and a serious lung problem called acute respiratory distress syndrome have been reported. Call your doctor or seek emergency care right away if you have abdominal or shoulder tip pain, shortness of breath, trouble breathing, or a fast rate of breathing. In rare cases, serious allergic reactions can occur, causing shortness of breath, wheezing, dizziness, swelling around the mouth or eyes, fast pulse, sweating, and hives. Sometimes these symptoms could come back within days after stopping treatment for the allergic reaction. If you start to have any of these symptoms, call your doctor or seek emergency care right away. Sickle cell crises have been reported.

In a clinical study, mild to moderate bone pain occurred in 31% of the patients taking Neulasta® and in 26% of the patients taking a placebo injection. In most cases, bone pain was controlled with a non-narcotic pain reliever, such as acetaminophen. Other common side effects reported by patients in the study taking either Neulasta® or placebo were consistent with the underlying cancer diagnosis and its treatment with chemotherapy, with the exception of bone pain.

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.

Please see Prescribing Information and Patient Product Information