Sofosbuvir

You may already be infected with hepatitis B (a virus that infects the liver and may cause severe liver damage) but not have any symptoms of the disease. Sofosbuvir may increase the risk that you will develop symptoms and your infection will become more serious or life-threatening. Tell your doctor if you have or ever had a hepatitis B virus infection. Your doctor will order a blood test to see if you have or ever had a hepatitis B infection. Your doctor will also monitor you for signs of hepatitis B infection during and for several months after your treatment. If necessary, your doctor may give you medication to treat this infection before and during your treatment with sofosbuvir. If you experience any of the following symptoms during or after your treatment, call your doctor immediately: excessive tiredness, yellowing of the skin or eyes, loss of appetite, nausea, vomiting, pale stools, stomach pain, or dark urine.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests before, during, and after your treatment to check your body's response to sofosbuvir.

Talk to your doctor about the risk(s) of taking sofosbuvir.

Sofosbuvir is used to treat certain types of chronic hepatitis C (an ongoing viral infection that damages the liver) in adults. Sofosbuvir is in a class of antiviral medications called nucleotide polymerase inhibitors. It works by decreasing the amount of hepatitis C virus (HCV) in the body. Sofosbuvir may not prevent the spread of hepatitis C to other people.

Sofosbuvir comes as a tablet and pellets to take by mouth. Take with or without food once a day. Take sofosbuvir at around the same time every day.

Take sofosbuvir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Sofosbuvir pellets can be swallowed (without chewing) or they can be taken with food. To prepare a dose of sofosbuvir pellets with food, sprinkle the entire packet of pellets on one or more spoonfuls of cold or room temperature non-acidic soft food such as pudding, chocolate syrup, mashed potato, or ice cream. Take the entire mixture within 30 minutes of sprinkling the pellets on food. To avoid a bitter aftertaste, do not chew the pellets.

Continue to take sofosbuvir even if you feel well. Your doctor will prescribe other medications to take while you take sofosbuvir. It is important that you take all of these medicines together exactly as prescribed. Your doctor will tell you how long you should receive treatment. The length of your treatment depends on your condition, how well you respond to the medication, and whether you experience severe side effects. Do not stop taking sofosbuvir or any of the other prescribed medicines unless told to do so by your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking sofosbuvir,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• you should know that some medications should not be taken with sofosbuvir. Other medications may cause dosing changes or extra monitoring when taken with sofosbuvir. Make sure you have discussed any medications you are currently taking or plan to take before starting sofosbuvir with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking sofosbuvir, please get the advice of your doctor or pharmacist.
• the following herbal product may interact with sofosbuvir: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking sofosbuvir. Do not start this medication while taking sofosbuvir without discussing with your healthcare provider.
• tell your doctor if you have had a liver transplant or if you have or have ever had human immunodeficiency virus (HIV), any type of liver disease other than hepatitis C, kidney disease, or are on dialysis.
• tell your doctor if you or your partner are pregnant, plan to become pregnant, or can possibly become pregnant. Some of the medications prescribed with sofosbuvir should not be taken while you or your partner are pregnant as they may harm the fetus. You may be asked to take pregnancy test prior to starting sofosbuvir and during treatment. Talk to your doctor about the most effective form of birth control for you or your partner during treatment.
• tell your doctor if you are breast-feeding.

Unless your doctor tells you otherwise, continue your normal diet.

If you remember the missed dose on the day that you were supposed to take it, take the missed dose as soon as you remember it on that day. However, if you do not remember the missed dose until the next day, skip the missed dose and continue your regular dosing schedule. Do not take two doses on the same day.

Sofosbuvir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• headache
• muscle pain
• difficulty falling asleep or staying asleep
• irritability
• itching
• rash

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• pale skin, dizziness, shortness of breath, weakness, chest pains, confusion, memory problems

Sofosbuvir may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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