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 Neupogen (filgrastim). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Chronic use: When used for long periods of time, filgrastim may increase the risk of myelodysplasia (bone marrow disorders) and certain types of leukemia. It is not known if this increased risk is directly related to filgrastim or to the conditions filgrastim is being used to treat. If you are receiving long-term treatment with filgrastim, your doctor will monitor your blood regularly and check your bone marrow annually.
Cytotoxic chemotherapy: The safety of using filgrastim at the same time as cytotoxic chemotherapy (a type of chemotherapy that kills cells, especially cancer cells) has not been established. Filgrastim should not be used within 24 hours before or 24 hours after chemotherapy is administered.
Heart conditions: Heart-related conditions such as heart attacks and abnormal heart rhythms have been observed in rare cases with filgrastim. If you have had a heart condition before starting filgrastim, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Lung problems: Filgrastim may cause adult respiratory distress syndrome (ARDS), a serious lung condition, when people with neutropenia have a bacterial infection in the blood. If you experience difficulty breathing, fever or coughing blood while using filgrastim, contact your doctor immediately.
Osteoporosis: Long-term use of filgrastim may increase the risk of osteoporosis in some people. If you have chronic neutropenia or have osteoporosis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Your doctor may want to check your bone density regularly while you are receiving this medication.
Sickle cell disease: Filgrastim 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 filgrastim in these circumstances if you have sickle cell disease.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known whether filgrastim passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of filgrastim have not been established for newborn babies.