Sofosbuvir (soe-FOS-bue-vir), Velpatasvir (vel-PAT-as-vir)

Treats chronic hepatitis C infection.

Brand Name(s):

Epclusa

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.
• Swallow the tablet whole. Do not crush, break, or chew it.
• Oral pellets:
  • You may take the oral pellets with food or directly in your mouth.
  • If you take this medicine directly in your mouth, you may drink water after swallowing the pellets.
  • Take the oral pellets with food for children younger than 6 years of age.
  • If you take this medicine with food, shake the packet gently to settle the pellets to the bottom of packet. Mix the entire packet into a non-acidic soft food (eg, pudding, chocolate syrup, or ice cream) in a bowl and mix it with a spoon. Take the mixture within 15 minutes.
  • Do not chew the oral pellets or the mixture to avoid bitter taste.
• Take all of the medicine in your prescription to clear up your infection, even if you feel better after the first few doses.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• 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 until you are ready to use it. Throw away any unused medicine. Do not store and reuse any leftover pellets or mixture.

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 sofosbuvir or if you have used it recently.
• Some medicines can affect how this medicine works. Tell your doctor if you are using any of the following:
  • Atorvastatin, digoxin, efavirenz, rifabutin, rifampin, rifapentine, rosuvastatin, St John's wort, tenofovir, tipranavir/ritonavir, or topotecan
  • 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 together with this medicine during conception or pregnancy. Females who take this medicine with ribavirin should avoid becoming pregnant during treatment and for at least 6 months after the last dose. 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), HIV infection, or heart disease.
• Your doctor will check your progress and the effects of this medicine at regular visits. 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
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fainting, dizziness, or lightheadedness
• Slow or uneven heartbeat

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

• Diarrhea
• Headache
• Tiredness or weakness, trouble sleeping

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