Epclusa contains the active ingredients sofosbuvir and velpatasvir in a fixed-dose combination tablet, intended for oral administration. Sofosbuvir is a nucleotide analog HCV NS5B polymerase inhibitor, while velpatasvir is an NS5A inhibitor. Each tablet contains 400 mg of sofosbuvir and 100 mg of velpatasvir and includes inactive ingredients such as copovidone, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The film coating contains iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

How should I use this medication?

Take this medication by mouth. For your therapy to work as well as possible, take each dose exactly as prescribed on the prescription label. Do not skip doses. Keep taking this medication unless your care team tells you to stop. How to take the pellets WITHOUT food: Pour all of the oral pellets from the packet into mouth. Swallow the pellets whole. Do not chew them. You may drink water after taking the pellets. How to mix the pellets WITH food: Mix the contents of the oral pellets packet in a small amount of non-acidic soft food, such as pudding or ice cream. Take the dose within 15 minutes of mixing. Swallow the mixture without chewing. This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions. Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 3 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets. Store below 30 degrees C (86 degrees F). Keep this medication in the original packaging until you are ready to take it. Get rid of any unused medication after the expiration date. To get rid of medications that are no longer needed or have expired: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Diarrhea -Fatigue -Headache -Nausea -Trouble sleeping -Worsening mood, feelings of depression

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Diabetes -Heart disease -HIV or AIDS -Organ transplant -Other liver disease -An unusual or allergic reaction to sofosbuvir, velpatasvir, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breast-feeding

What may interact with this medication?

-Amiodarone -Antacids -Certain antibiotics, such as rifabutin, rifampin, rifapentine -Certain medications for cholesterol, such as atorvastatin or rosuvastatin -Certain medications for diabetes -Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin -Certain medications for stomach problems, such as cimetidine, famotidine, omeprazole, lansoprazole -Digoxin -Efavirenz -St. John's wort -Tipranavir -Topotecan -Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. You may need blood work while you are taking this medication. If you have had hepatitis B in the past, talk to your care team. Taking this medication could cause the hepatitis B virus to become active again. This medication may cause changes in your blood sugar. Ask your care team if changes in diet or medications are needed if you have diabetes. Talk to your care team if you are pregnant or think you might be pregnant. Talk to your care team before breastfeeding. Changes to your treatment plan may be needed.

What are the most serious risks of this medication?

Before you take this medicine, tell your healthcare provider if you ever had hepatitis B. This medicine can cause hepatitis B to flare-up or return. If that happens, you will need to see a specialist and may need treatment. Your liver function will be monitored while you take this medicine.