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
October 18, 2016
Health Canada has issued new restrictions concerning the use of Faslodex (fulvestrant). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Drowsiness/reduced alertness: This medication may cause weakness or fatigue. Do not drive, operate machinery, or perform other potentially hazardous tasks until you have determined how this medication affects you.
Kidney function: If you have reduced kidney function or kidney disease, 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.
Liver disease: The liver changes fulvestrant into components of the drug that are active in the body. If your liver is not working properly, fulvestrant builds up in the body and may lead to increased side effects.
If you have reduced liver function or liver disease, 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.
Red blood cells: Fulvestrant may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.
Risk of bleeding: Because this medication is given by injection, caution should be used by people at an increased risk of bleeding, such as those taking blood thinners (e.g., warfarin) or those with medical conditions that can cause bleeding.
Pregnancy: Fulvestrant can cause harm to the unborn baby if it is used during pregnancy. This medication should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known whether fulvestrant passes into breast milk, however it has the potential to cause serious side effects in infants who are exposed to it. 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 using this medication have not been established for children.