Sofosbuvir; Velpatasvir Oral Tablets

What is this medication?

SOFOSBUVIR; VELPATASVIR (soe fos' bue veer; vel pat' us veer) is an antiviral medicine. It is used with other medicines to treat hepatitis C. It will not work for colds, flu, or other viral infections.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Epclusa

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

They need to know if you have any of these conditions:

• diabetes (high blood sugar)
• heart disease
• HIV or AIDS
• organ transplant
• other liver disease
• an unusual or allergic reaction to sofosbuvir, velpatasvir, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take your medicine more often than directed. Take all of your medicine as directed even if you think you are better. Do not skip doses or stop your medicine early.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 6 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.

What may interact with this medication?

• amiodarone
• antacids
• certain antibiotics like rifabutin, rifampin, rifapentine
• certain medicines for cholesterol like atorvastatin and rosuvastatin
• certain medicines for diabetes
• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
• certain medicines for stomach problems like 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 health care provider for regular checks on your progress. Tell your health care provider if your symptoms do not start to get better or if they get worse.

You may need blood work while you are taking this medicine.

If you have had hepatitis B in the past, talk to your health care provider. Taking this medicine could cause the hepatitis B virus to become active again.

This medicine may be given with ribavirin. Ribavirin may cause serious birth defects. If you take this medicine with ribavirin, talk to your health care provider if you think that you or your partner are pregnant or are trying to become pregnant.

This medicine may cause changes in your blood sugar. Ask your health care provider if changes in diet or medicines are needed if you have diabetes.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives, swelling of the face, lips, or tongue)
• breathing problems
• depressed mood
• dizziness
• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• headache
• irritable
• nausea
• tiredness
• trouble sleeping

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.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature below 30 degrees C (86 degrees F). Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, empty the medicine out of the container. Mix the medicine 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.