Sofosbuvir Oral Tablet

What is this medication?

SOFOSBUVIR (soe fos' bue vir) 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): Sovaldi

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
• kidney disease
• man with a partner who is pregnant or trying to get pregnant
• organ transplant
• other liver disease
• an unusual or allergic reaction to sofosbuvir, ribavirin, interferons, 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 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
• certain antibiotics like rifabutin, rifampin, rifapentine
• certain medicines for diabetes
• certain medicines for seizures like carbamazepine, oxcarbazepine, phenobarbital, phenytoin
• St. John's Wort
• tipranavir
• 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?

See your doctor or health care professional for a follow-up visit as directed. You may need blood work while you are taking this medicine. Tell your doctor if your symptoms do not improve or if they get worse.

If you have had hepatitis B infection (HBV) in the past, taking this medicine could cause the HBV to become active again. If you have had HBV, your doctor should monitor you with blood tests. Tell your doctor right away if you develop a general ill feeling, light-colored stools, loss of appetite, unusual weakness, or yellowing of the eyes or skin.

This medicine may be given with ribavirin. Ribavirin can cause birth defects or death to an unborn child. Women taking this medicine must avoid pregnancy while taking this medicine and for 6 months after stopping this medicine. Men who are taking this medicine must avoid getting a woman pregnant while taking this medicine and for 6 months after stopping this medicine. Use 2 forms of effective birth control. Women who can still have children must have a negative pregnancy test before starting treatment. Take monthly pregnancy tests while you are taking this medicine and for 6 months after this medicine is stopped. Talk to your doctor 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 like skin rash, itching or hives, swelling of the face, lips, or tongue
• depressed mood
• fever or chills, sore throat
• 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):

• headache
• 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.

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

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.