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
December 1, 2016
Health Canada has issued new restrictions concerning the use of Galexos® (simeprevir). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Birth control: The effect of simeprevir on the development of an unborn baby has not been studied, however simeprevir must be used with interferon alfa and ribavirin. Treatment with ribavirin can cause severe birth defects to an unborn child. Both partners should use a reliable form of birth control while taking this medication and for 6 months afterwards (the time it takes for ribavirin to be cleared from the body).
For women, your doctor will not give you simeprevir until you have had a negative pregnancy test. Your doctor should have you continue to do monthly pregnancy tests to ensure that you do not become pregnant while using this medication.
Methods of birth control that use hormones, such as a birth control pill, patch, or injection, may not be fully reliable as simeprevir interacts with many medications and may change the way that your body uses the hormones. At least 2 forms of non-hormonal birth control (condom, diaphragm) must be used while you are taking this medication.
Hepatitis C virus response: Only genotype 1 hepatitis C virus has been studied and determined to respond to simeprevir. The safety and effectiveness of using simeprevir to treat other strains of hepatitis C virus have not been determined.
Infection with hepatitis B: The safety and effectiveness of treatment with simeprevir have not been established for people who also have human immunodeficiency virus (HIV) or hepatitis B virus (HBV).
Liver function: Simeprevir is not recommended for people with active, worsening liver disease, or moderately-to-severely reduced liver function. If you have a history of reduced liver function, 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.
Organ transplantation: The safety and effectiveness of treatment with simeprevir have not been established for people with liver or other organ transplants. Simeprevir may interact with medications used to prevent rejection of the transplanted organ.
Skin reactions: Simeprevir may cause skin rash or itchiness with or without a rash. It may also make your skin more sensitive to ultraviolet light from the sun or tanning beds. While you are taking simeprevir, avoid unnecessary exposure to sunlight. If you notice any unusual skin rash or peeling, contact your doctor.
Pregnancy: Simeprevir has not been studied for use by pregnant women and it must be taken with peginterferon alfa and ribavirin. Ribavirin has been shown to cause serious problems in the developing fetus. As a result, simeprevir (plus peginterferon alfa and ribavirin) should not be used by pregnant women or by men whose partners are pregnant. Both partners should use a reliable form of birth control while taking this medication and for 6 months afterwards. Tell your doctor immediately if you become pregnant while using this medication.
Breast-feeding: It is not known if simeprevir passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Breast-feeding should be stopped before starting treatment with simeprevir.
Children: The safety and effectiveness of using this medication have not been established for children.