Ledipasvir; Sofosbuvir Tablets

What is this medication?

LEDIPASVIR; SOFOSBUVIR (LED i PAS vir; soe FOS bue vir) treats infections caused by the hepatitis C virus. It is a combination of two antiviral medications. It will not treat colds, the flu, or infections caused by bacteria.

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

COMMON BRAND NAME(S): Harvoni

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
• Other liver disease
• An unusual or allergic reaction to ledipasvir, sofosbuvir, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a full glass of water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Take all of this medication unless your care team tells you to stop it early. Keep taking it even if you think you are better.

Talk to your care team about the use of this medication in children. While it 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
• Antiviral medications for HIV or AIDS such as cobicistat; elvitegravir; emtricitabine; tenofovir, efavirenz; emtricitabine; tenofovir, tenofovir, tipranavir
• Certain antibiotics such as rifabutin, rifampin, rifapentine
• Certain medications for diabetes
• Certain medications for seizures such as carbamazepine, phenobarbital, phenytoin
• Certain medications for stomach problems such as aluminium hydroxide, cimetidine, esomeprazole, famotidine, lansoprazole, magnesium hydroxide, nizatidine, omeprazole, pantoprazole, rabeprazole, ranitidine
• Digoxin
• Rosuvastatin
• Simeprevir
• St. John's Wort
• 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 care team for a follow-up visit as directed. You may need blood work while you are taking this medication. Tell your care team if your symptoms do not improve or if they get worse.

If you have had hepatitis B infection (HBV) in the past, taking this medication could cause the HBV to become active again. If you have had HBV, your care team should monitor you with blood tests. Tell your care team 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 medication may cause changes in your blood sugar. Ask your care team if changes in diet or medications are needed if you have diabetes.

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
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Slow heartbeat—dizziness, feeling faint or lightheaded, confusion, trouble breathing, unusual weakness or fatigue

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.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store between 15 and 30 degrees C (59 and 86 degrees F). 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, take 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.