Ledipasvir and Sofosbuvir

Pediatric Medication

Brand Names: US

Harvoni

Brand Names: Canada

Harvoni

Warning

  • Your child will be tested for hepatitis B before starting this drug. If your child has had hepatitis B, the hepatitis B virus may become active during or after treatment with this drug. This could lead to very bad liver problems or death. Those who have hepatitis B and hepatitis C need to be watched closely during and after treatment with this drug. If you have questions, talk with your child’s doctor.

What is this drug used for?

  • It is used to treat hepatitis C infection.

What do I need to tell the doctor BEFORE my child takes this drug?

  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has liver problems other than hepatitis C.
  • If your child is taking another drug that has the same drug in it.
  • If your child takes any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this drug, like certain drugs that are used for HIV, infections, or seizures. There are many drugs that must not be taken with this drug.
  • If your child is taking St. John’s wort. Do not give St. John’s wort with this drug. This drug may not work as well.
This is not a list of all drugs or health problems that interact with this drug.
Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.

What are some things I need to know or do while my child takes this drug?

  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • This drug may be used with ribavirin. If your child is also taking ribavirin, talk with the doctor about the risks and side effects that may happen.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • It is not known if this drug stops the spread of diseases like hepatitis that are passed through blood. Be sure needles or other things like toothbrushes or razors are not shared.
  • This drug may affect how much of some other drugs are in the body. If your child is taking other drugs, talk with the doctor. Your child may need to have blood work checked more closely while taking this drug with other drugs.
  • Slow heartbeat and the need to get a pacemaker have happened when amiodarone was given with sofosbuvir and certain other hepatitis C drugs. Sometimes, this has been deadly. Slow heartbeat has happened up to 2 weeks after starting hepatitis C treatment. Your child will need to be watched closely if your child will be taking amiodarone with hepatitis C treatment. Follow what your child’s doctor has told you to do. Call your child’s doctor right away if your child has signs of slow heartbeat like chest pain, confusion, dizziness, passing out or near-passing out, memory problems, shortness of breath, tiredness, or weakness.

If your child is or may be sexually active:

  • It is not known if this drug stops the spread of diseases like hepatitis that are passed through having sex. Be sure your child does not have any kind of sex without using a latex or polyurethane condom.

If your child is pregnant or breast-feeding a baby:

  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks of using this drug.

What are some side effects that I need to call my child’s doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Feeling tired or weak.
  • Headache.
  • Upset stomach.
  • Loose stools (diarrhea).
  • Not able to sleep.
  • Cough.
  • Muscle pain.
  • Feeling irritable.
  • Dizziness.
These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
You may report side effects to your national health agency.

How is this drug best given?

Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • Give this drug with or without food.
  • Do not give your child an antacid that has aluminum or magnesium in it within 4 hours of this drug.
  • If your child takes cimetidine, dexlansoprazole, esomeprazole, famotidine, lansoprazole, nizatidine, omeprazole, pantoprazole, rabeprazole, or ranitidine, ask your child’s doctor or pharmacist how to give it with this drug.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
  • It is important that your child does not miss or skip a dose of this drug during treatment.

What do I do if my child misses a dose?

  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
  • If you are not sure what to do if you miss giving your child a dose, call the doctor.

How do I store and/or throw out this drug?

  • Store in the original container at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

General drug facts

  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Last Reviewed Date

2017-11-27

Copyright

© 2018 Wolters Kluwer Clinical Drug Information, Inc. and its affiliates and/or licensors. All rights reserved.

Last Updated