Ledipasvir (le-DIP-as-vir), Sofosbuvir (soe-FOS-bue-vir)

Treats chronic hepatitis C. Used together with or without ribavirin.

Brand Name(s):

Harvoni

When This Medicine Should Not Be Used:

How to Use This Medicine:

Pellet, Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Oral pellets:
  • Do not open the packet until ready to use. Do not use a packet if the seal is broken or damaged.
  • Hold the packet with the cut line on top and shake it gently to settle the pellets.
  • Tear or cut the packet along the cut line.
  • Swallow the oral pellets with water. Do not crush or chew them.
  • If the oral pellets are taken with food, sprinkle the pellets on 1 or more spoonfuls of non-acidic soft food (such as pudding, chocolate syrup, mashed potato, and ice cream) at or below room temperature.
  • Swallow the mixture right away (within 30 minutes). Do not save any of the mixture to use later.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Take all of the medicine in your prescription to clear up your infection, even if you feel better after the first few doses.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep the medicine in its original container.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Amiodarone can cause serious side effects if used together with this medicine.
• Some medicines can affect how this medicine works. Tell your doctor if you are using any of the following:
  • Atorvastatin, digoxin, rifabutin, rifampin, rifapentine, rosuvastatin, simeprevir, tenofovir, tipranavir/ritonavir, St John's wort
  • Blood pressure medicine
  • Cancer medicine
  • Medicine to treat seizures (including carbamazepine, oxcarbazepine, phenobarbital, phenytoin)
  • Steroid medicine
  • Stomach medicine (including famotidine, omeprazole)
• If you take an antacid that contains aluminum or magnesium, take it 4 hours before or after you take this medicine.

Warnings While Using This Medicine:

• Ribavirin may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. Follow all directions about birth control.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, other liver disease (including hepatitis B), or heart disease. Tell your doctor if you had a liver transplant.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, slow heartbeat
• Lightheadedness or fainting

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, nausea
• Headache, trouble sleeping
• Tiredness, weakness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088