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ledipasvir and sofosbuvir

Pronunciation: le DIP as vir and soe FOS bue vir

Brand: Harvoni

Harvoni

slide 1 of 1, Harvoni,

90 mg-400 mg, diamond, orange, imprinted with GSI, 7985

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

If you've ever had hepatitis B, using ledipasvir and sofosbuvir can cause this virus to become active or get worse. Tell your doctor if you don't feel well and you have right-sided upper stomach pain, vomiting, loss of appetite, or yellowing of your skin or eyes.

Ledipasvir and sofosbuvir is sometimes used in combination with other medication. Read the medication guide or patient instructions provided with each medication in your combination therapy. Do not change your doses or medication schedule without your doctor's advice.

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?

You should not use this medicine if you are allergic to ledipasvir or sofosbuvir.

If you take ledipasvir and sofosbuvir with ribavirin: There may be other reasons you should not take this combination treatment. Tell your doctor about all your medical conditions.

Tell your doctor if you have ever had:

  • hepatitis B;
  • 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 (Cordarone, Pacerone); or
  • if you use a blood thinner (warfarin, Coumadin, Jantoven) and you have routine "INR" or prothrombin time tests.

Both men and women using ledipasvir and sofosbuvir with ribavirin should use at least 2 effective forms of birth control to prevent pregnancy. Ribavirin can cause birth defects or death in an unborn baby if the mother or father is using this medicine.

  • If you are a woman, do not use ribavirin if you are pregnant. You may need to have a negative pregnancy test before taking ribavirin and every month during your treatment.
  • If you are a man, do not use ribavirin if your sex partner is pregnant.

Keep using 2 forms of birth control while using ribavirin, and for at least 6 months after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using ribavirin.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Ledipasvir and sofosbuvir is not approved for use by anyone younger than 3 years old.

How should I take ledipasvir and sofosbuvir?

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using 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.

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, using ledipasvir and sofosbuvir can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.

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.

Store this medicine in the original container at room temperature away from moisture and heat. Do not open the packet of oral pellets until you are ready to use the medicine.

You should not stop using ledipasvir and sofosbuvir suddenly. Stopping suddenly could make your condition harder to treat with hepatitis C antiviral medicine.

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.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking ledipasvir and sofosbuvir?

If you also take an antacid, do not take it for at least 4 hours after you have taken your dose of ledipasvir and sofosbuvir.

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?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have new or worsening symptoms such as:

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

If you take ledipasvir and sofosbuvir and you also take a heart rhythm medicine called amiodarone: This combination of medicines can cause dangerous side effects on your heart. Get medical help right away if you take these medicines and you have:

  • 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?

When you start or stop taking ledipasvir and sofosbuvir, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

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.

Copyright 1996-2019 Cerner Multum, Inc. Version: 4.01. Revision date: 10/10/2019.

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