Ledipasvir; Sofosbuvir oral pellets

What is this medication?

LEDIPASVIR; SOFOSBUVIR (LED i PAS vir; soe FOS bue vir) is two antiviral medicines in one tablet. It is used 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): 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 medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth. For your therapy to work as well as possible, take each dose exactly as prescribed on the prescription label. Do not skip doses. Keep taking this medicine unless your health care provider tells you to stop.

How to take the pellets WITHOUT food: Pour all of the oral pellets from the packet into mouth. Swallow the pellets whole. Do not chew them. You may drink water after taking the pellets.

How to mix the pellets WITH food: Mix the contents of the oral pellets packet in a small amount of non-acidic soft food, such as pudding, mashed potatoes, or ice cream. Take the dose within 30 minutes of mixing. Swallow the mixture without chewing.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 3 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
• antiviral medicines for HIV or AIDS like cobicistat; elvitegravir; emtricitabine; tenofovir, efavirenz; emtricitabine; tenofovir, tenofovir, tipranavir
• certain antibiotics like rifabutin, rifampin, rifapentine
• certain medicines for diabetes
• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
• certain medicines for stomach problems like aluminium hydroxide, cimetidine, esomeprazole, famotidine, lansoprazole, magnesium hydroxide, nizatidine, omeprazole, pantoprazole, rabeprazole, ranitidine
• digoxin
• rosuvastatin
• 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 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 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

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
• 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.