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 Epclusa.
Hepatitis B co-infection: Talk to your doctor before taking Epclusa if you have or have had hepatitis B. People with hepatitis B infection that is dormant may experience a recurrence of the hepatitis B while they are taking sofosbuvir – velpatasvir or after they stop taking Epclusa. This can result in severe liver damage and possibly life-threatening liver failure. If you experience symptoms of worsening liver function, 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.
Human immunodeficiency virus (HIV) co-infection: Sofosbuvir - velpatasvir has been found to be a safe and effective treatment for hepatitis C, for people who also have HIV infection. Some of the medications used to treat HIV infection may affect sofosbuvir or velpatasvir and change how these medications work in the body. If you have HIV infection, discuss with your doctor how Epclusa may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Epclusa, and whether any special monitoring is needed.
Liver transplant: The safety and effectiveness of using sofosbuvir - velpatasvir after having a liver transplant have not been determined. Epclusa is not recommended for anyone who has had a liver transplant.
Pregnancy and contraception: The use of Epclusa is not recommended for pregnant women or women who may become pregnant, as it is not known if sofosbuvir - velpatasvir will harm an unborn child. If you become pregnant while taking Epclusa, contact your doctor immediately.
If you are using ribavirin along with sofosbuvir - velpatasvir, you must use 2 forms of effective birth control (one for each partner) during treatment and for 6 months after stopping the medication. During this time, women will have monthly pregnancy tests to ensure they are not pregnant. Tell your doctor immediately if you become pregnant while using Epclusa.
Breast-feeding: It is not known if sofosbuvir or velpatasvir pass into breast milk. If you are breast-feeding and are taking Epclusa, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using Epclusa have not been established for children less than 12 years of age or who weigh less than 30kg. Epclusa has not been studied for children with moderate or severe liver impairment.