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 Zepatier® (elbasvir - grazoprevir). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Infection with hepatitis B: The safety and effectiveness of treatment with elbasvir - grazoprevir have not been established for people with hepatitis C who are also infected with 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. This medication has not been studied for safety and effectiveness when used by people with moderately reduced liver function. If you have 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. People with moderately or severely reduced liver function should not use this medication.
This medication has been reported to cause signs of decreased liver function. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
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 if elbasvir - grazoprevir 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 using this medication have not been established for children.