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 Sunvepra® (asunaprevir). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Birth control: The effect of asunaprevir on the development of an unborn baby has not been studied, however for certain types of hepatitis C, asunaprevir 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 asunaprevir 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 asunaprevir interacts with many medications and may change the way that your body uses the hormones. If you are taking ribavirin along with asunaprevir 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 and genotype 4 hepatitis C viruses have been studied and determined to respond to asunaprevir. The safety and effectiveness of using asunaprevir to treat other strains of hepatitis C virus have not been determined.
Infection with HIV or hepatitis B: The safety and effectiveness of treatment with asunaprevir have not been established for people who also have human immunodeficiency virus (HIV) or hepatitis B virus (HBV).
Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. Asunaprevir may reduce liver function and in severe cases, cause liver failure. Asunaprevir 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 asunaprevir have not been established for people with liver or other organ transplants. Asunaprevir may interact with medications used to prevent rejection of the transplanted organ.
Pregnancy: Asunaprevir has not been studied for use by pregnant women. For certain types of hepatitis C it must be taken with daclatasvir, peginterferon alfa, and ribavirin. Ribavirin has been shown to cause serious problems in the developing fetus. As a result, asunaprevir (plus daclatasvir, 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 asunaprevir 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 asunaprevir.
Children: The safety and effectiveness of using this medication have not been established for children.