If you've ever had hepatitis B, it may become active or get worse while using or after you stop using Harvoni. You may need frequent liver function tests for several months.
Harvoni is sometimes used in combination with other medication. Read the medication guide or patient instructions provided with each medication in your combination therapy. Do not change your doses or medication schedule without your doctor's advice.
Before taking this medicine
You should not use Harvoni if you are allergic to ledipasvir or sofosbuvir. If you take Harvoni with ribavirin: There may be other reasons you should not take this combination treatment. Tell your doctor about all your medical conditions.
To make sure Harvoni is safe for you, tell your doctor if you have ever had:
hepatitis B (you may be tested for this before you take sofosbuvir);
liver problems other than hepatitis (including a liver transplant);
kidney disease (or if you are on dialysis);
HIV or AIDS;
a heart rhythm problem for which you take a medicine called amiodarone; or
if you use a blood thinner (warfarin, Coumadin, Jantoven) and you have routine "INR" or prothrombin time tests.
Harvoni is sometimes used in combination with ribavirin. Both men and women using ribavirin should use effective birth control to prevent pregnancy. Ribavirin can harm an unborn baby or cause birth defects if the mother or father is using the medicine.
While taking ledipasvir and sofosbuvir with ribavirin, use effective birth control to prevent pregnancy, whether you are a man or a woman.
Keep using birth control for at least 6 months after your last dose of ribavirin. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using ribavirin.
It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.
Harvoni is not approved for use by anyone younger than 3 years old.
