Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
April 10, 2014
Health Canada has issued new restrictions concerning the use of Neulasta (pegfilgrastim). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Cytotoxic chemotherapy: The safety of using pegfilgrastim at the same time as cytotoxic chemotherapy (a type of chemotherapy that kills cells, especially cancer cells) has not been established. Pegfilgrastim should not be used within 14 days before or 24 hours after chemotherapy. In addition, it is not known whether is is safe and effective to use pegfilgrastim after certain chemotherapy medications (e.g., mitomycin C, 5-flurouracil, and nitrosoureas such as carmustine and lomustine).
Lung problems: Pegfilgrastim may cause adult respiratory distress syndrome (ARDS), a serious lung condition, when people with neutropenia have sepsis (bacterial infection in the blood). If ARDS occurs, this medication should be stopped until the ARDS resolves.
Radiation: It is nnot known whether it is safe and effective to use pegfilgrastim with radiation therapy. Pegfilgrastim should not be used during radiation therapy.
Sickle cell disease: Pegfilgrastim may cause sickle cell crisis when used by people who have sickle cell disease. You and your doctor should carefully consider the benefits and risks of using pegfilgrastim in these circumstances.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, stop taking it immediately and call your doctor.
Breast-feeding: It is not known whether pegfilgrastim passes into breast milk. Pegfilgrastim is not recommended by breast-feeding mothers.
Children: The safety and effectiveness of pegfilgrastim have not been established for children.