Sofosbuvir and Velpatasvir

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. In this case, taking the combination of sofosbuvir and velpatasvir may increase the risk that your infection will become more serious or life-threatening and you will develop symptoms. 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 have ever had 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 the combination of sofosbuvir and velpatasvir. 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 or 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 the combination of sofosbuvir and velpatasvir.

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

The combination of sofosbuvir and velpatasvir is used alone or with ribavirin to treat chronic hepatitis C (an ongoing viral infection that damages the liver) in adults and children 3 years of age and older. Sofosbuvir is in a class of antiviral medications called nucleotide hepatitis C virus (HCV) NS5B polymerase inhibitors. Velpatasvir is in a class of antiviral medications called HCV NS5A replication complex inhibitors. The combination of sofosbuvir and velpatasvir works by stopping the virus that causes hepatitis C from spreading inside the body.

The combination of sofosbuvir and velpatasvir comes as a tablet and pellets to take by mouth. It is usually taken usually with or without food once a day for 12 weeks. For children younger than 6 years of age, sofosbuvir and velpatasvir pellets should be taken with food. Take sofosbuvir and velpatasvir at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take sofosbuvir and velpatasvir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Sofosbuvir and velpatasvir pellets can be swallowed (without chewing) or they can be taken with food. To prepare a dose of sofosbuvir and velpatasvir 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, or ice cream. Take the entire mixture within 15 minutes of sprinkling the pellets on food. To avoid a bitter aftertaste, do not chew the pellets. Sofosbuvir and velpatasvir pellets should be taken with food in children younger than 6 years of age.

Continue to take sofosbuvir and velpatasvir even if you feel well. Do not stop taking sofosbuvir and velpatasvir without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

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

Before taking sofosbuvir and velpatasvir,

• tell your doctor and pharmacist if you are allergic to sofosbuvir, velpatasvir, any other medications, or any of the ingredients in sofosbuvir and velpatasvir tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking antacids, take them 4 hours before or 4 hours after sofosbuvir and velpatasvir. If you are taking a medication for indigestion, heartburn, or ulcers (H₂ blockers) such as cimetidine, ranitidine (Zantac), famotidine (Pepcid, in Duexis), or nizatidine, take them 12 hours before or 12 hours after sofosbuvir and velpatasvir.
• The following nonprescription or herbal products may interact with sofosbuvir and velpatasvir: Proton-pump inhibitors such as esomeprazole (Nexium), lansoprazole (Prevacid), or omeprazole (Prilosec, Zegerid); or St. John's wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking sofosbuvir and velpatasvir. Do not start any of these medications while taking sofosbuvir and velpatasvir without discussing with your healthcare provider.
• tell your doctor if you have had a liver transplant or if you have human immunodeficiency virus (HIV), or have or have ever had any type of liver problem other than hepatitis C, kidney disease, or are on dialysis.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking sofosbuvir and velpatasvir, call your doctor. If you are taking sofosbuvir and velpatasvir in combination with ribavirin, you should not become pregnant during your treatment with these medications and for 6 months after your treatment. Ribavirin may cause seriosuly harm the fetus.

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

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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

• headache
• fatigue
• diarrhea
• vomiting (in children younger than 6 years of age)
• spitting up the medicine (in children younger than 6 years of age)
• rash
• lack of energy
• feeling irritable
• feeling depressed
• difficulty falling asleep or staying asleep

Sofosbuvir and velpatasvir 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).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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