ledipasvir and sofosbuvir

What is the most important information I should know about ledipasvir and sofosbuvir?

If you've ever had hepatitis B, it may become active or get worse while using or after you stop using ledipasvir and sofosbuvir. You may need frequent liver function tests for several months.

What is ledipasvir and sofosbuvir?

Ledipasvir and sofosbuvir is a combination medicine used to treat chronic hepatitis C in adults and children who are at least 3 years old. Ledipasvir and sofosbuvir is sometimes given in combination with another medicine called ribavirin.

Ledipasvir and sofosbuvir treats specific genotypes of hepatitis C, and only in certain people. Use only the medications prescribed for you. Do not share your medicine with other people.

Ledipasvir and sofosbuvir is sometimes used in people who also have HIV. This medicine is not a treatment for HIV or AIDS.

Ledipasvir and sofosbuvir may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking ledipasvir and sofosbuvir?

Tell your doctor if you have ever had:

• hepatitis B (you may be tested for this before you take sofosbuvir);
• liver problems other than hepatitis (including a liver transplant);
• kidney disease (or if you are on dialysis);
• HIV or AIDS;
• a heart rhythm problem for which you take a medicine called amiodarone; or
• if you use a blood thinner (warfarin, Coumadin, Jantoven) and you have routine "INR" or prothrombin time tests.

While taking ledipasvir and sofosbuvir with ribavirin, use effective birth control to prevent pregnancy, whether you are a man or a woman.

Keep using birth control for at least 6 months after your last dose of ribavirin. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using ribavirin.

How should I take ledipasvir and sofosbuvir?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take ledipasvir and sofosbuvir with or without food. Take the medicine at the same time each day.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Do not chew the oral pellets. To take with food, you may mix the pellets with a non-acidic soft food (pudding, chocolate syrup, mashed potato, ice cream) that is at room temperature or below. Swallow the mixture without chewing, no more than 30 minutes after mixing. Do not save the mixture for later use.

Ledipasvir and sofosbuvir doses are based on weight (especially in children and teenagers). Your dose needs may change if you gain or lose weight.

You will need frequent blood tests to check your liver function.

If you've ever had hepatitis B, this virus may become active or get worse while you are using this medicine or in the months after you stop. You may need liver function tests for several months after your last dose.

Use all medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with chronic hepatitis C should remain under the care of a doctor.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

What should I avoid while taking ledipasvir and sofosbuvir?

Ask your doctor before using an antacid or stomach acid reducing medicine. Use only the type and amount your doctor recommends.

Using this medicine will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent hepatitis C transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

What are the possible side effects of ledipasvir and sofosbuvir?

• right-sided upper stomach pain;
• vomiting, loss of appetite; or
• jaundice (yellowing of the skin or eyes), and not feeling well.

• very slow heartbeats, chest pain, shortness of breath;
• confusion, memory problems; or
• weakness, extreme tiredness, light-headed feeling (like you might pass out).

Common side effects may include:

• weakness;
• headache; or
• tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect ledipasvir and sofosbuvir?

If you also take an antacid: Wait at least 4 hours after taking the antacid before you take ledipasvir and sofosbuvir.

If you also take a stomach acid reducer: You may need to wait 12 hours after taking the stomach acid medicine before you take ledipasvir and sofosbuvir. This includes cimetidine, famotidine, nizatidine, ranitidine, Axid, Pepcid, Tagamet, Zantac, and others.

Ask a doctor or pharmacist before taking certain other stomach acid reducers such as esomeprazole, lansoprazole, omeprazole, pantoprazole Nexium, Prevacid, Prilosec, Protonix, and others.

Many drugs can affect ledipasvir and sofosbuvir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about ledipasvir and sofosbuvir.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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