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Ledipasvir and Sofosbuvir

Generic name: ledipasvir and sofosbuvir [le-DIP-as-vir-and-soe-FOS-bue-vir]
Brand name: Harvoni
Dosage forms: oral pellet (33.75 mg–150 mg; 45 mg–200 mg); oral tablet (45 mg–200 mg; 90 mg–400 mg)
Drug class: antiviral combinations

What are Ledipasvir and Sofosbuvir?

Ledipasvir and sofosbuvir can be used in combination to treat chronic hepatitis C, which is found in adults and children older than 3 years. Ledipasvir, sofosbuvir, or ribavirin may be given together.Ledipasvir or sofosbuvir only treat certain genotypes of hepatitis C. Only take the medication prescribed to you. Don't share your medication with anyone else.Ledipasvir or sofosbuvir may be prescribed to people with HIV. Ledipasvir and sofosbuvir are not used to treat HIV or AIDS.This medication guide does not list all possible uses for ledipasvir or sofosbuvir.

Side effects of Ledipasvir and sofosbuvir

If you experience symptoms indicative of an allergic reaction, such as hives, difficulty breathing or swelling to lips, face, tongue or throat - seek medical assistance immediately!

If you experience new or worsening signs and symptoms, such as:

  • Right-sided upper abdominal pain
  • Nausea; loss of appetite
  • Jaundice (yellowing skin or eyes) and feeling unwell.

This combination can have dangerous side effects for your heart if you take both ledipasvir (and sofosbuvir) and amiodarone.If you are taking these medications and experience:

  • Chest pain, shortness of breath
  • Memory problems or confusion
  • Feeling weak, tired, or light-headed (like you could pass out)

Some of the common side effects caused by ledipasvir or sofosbuvir include:

  • Weakness;
  • Headache
  • Tired feeling

There may be other side effects. For medical advice on side effects, call your doctor. Contacting the FDA with side-effect reports is simple at 1-800-FDA-1088.


You may experience an increase in symptoms if you have ever had hepatitis B. This can happen while you are taking ledipasvir or sofosbuvir, or even after stopping. You may require frequent liver function testing for several months.Ledipasvir or sofosbuvir may be used with other medications. Be sure to read the patient instructions or medication guide that comes with each drug in your combination therapy. Don't change your medication schedule or dose without consulting your doctor.

Before you take this drug

If you have an allergy to either ledipasvir or sofosbuvir, then you should avoid using ledipasvir. You should not use this combination treatment if you are allergic to ledipasvir or sofosbuvir. Inform your doctor of all medical conditions.

Make an appointment to speak to your physician if any of the following apply to you:

  • Hepatitis B: (You may be tested before taking sofosbuvir.)
  • Other liver diseases other than hepatitis, including a transplant;
  • Kidney disease (or dialysis if you have it);
  • HIV or AIDS
  • A heart rhythm disorder for which you are taking a medicine named amiodarone
  • If you are taking a blood thinner (warfarin Coumadin Jantoven) and have routine "INR", or prothrombin-time tests,

Ledipasvir or sofosbuvir can be used with ribavirin. Ribavirin is used by both men and women. Both should use birth control to avoid pregnancy.Use birth control while taking ledipasvir, sofosbuvir, and ribavirin to prevent pregnancy. This is true for both men and women.Continue to use birth control at least six months after you have taken your last dose. If you become pregnant while taking ribavirin, either as a mother or father, tell your doctor immediately.Breastfeeding may not be possible while taking this medication. You should consult your doctor if you are concerned about any risks.Ledipasvir and sofosbuvir are not recommended for children under 3 years of age.

How to take Ledipasvir and Sofosbuvir?

Read all instructions or guides that come with your medication and follow all directions. Follow the directions on the label.Take ledipasvir or sofosbuvir either with food or without. Take your medicine every day at the same time.Please read and follow all instructions for use that come with your medication. If you don't understand the instructions, ask your doctor or pharmacist.The oral pellets should not be chewed. You can mix the oral pellets into a soft, non-acidic food at room temperature (puddings, chocolate syrups, mashed potatoes, ice creams, etc.) to take along with your food. Do not chew the mixture for more than 30 minutes after mixing. The mixture should not be saved for future use.The doses of ledipasvir or sofosbuvir are determined by weight, especially in children and adolescents. Your dose needs may change if you gain or lose weight.Your liver will require frequent blood tests.This virus can become active while taking this medication or even worsen in the months following your last dose. After your last dose, you may still need to have liver function tests.Do not suddenly stop taking ledipasvir or sofosbuvir. This could make it harder for you to get the antiviral medication that is needed to treat hepatitis C.You should always follow the instructions on your medication, and be sure to read any medication guides that you may receive. Do not alter your dosage or schedule without consulting your doctor. Everyone with chronic hepatitis should be under the care and supervision of a physician.Keep this medicine at room temperature, away from heat and moisture. Open the packet of pellets only when you are ready.

What happens if I miss the dose?

If you are almost due for your next dose, skip the missed one. Never take two doses of the same medicine at once.

Refill your prescription before you run out.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.

What should be avoided?

Consult your doctor before taking any antacids or medicines that reduce stomach acid. Only use the amount and type of medicine that your doctor has prescribed.Ledipasvir and sofosbuvir do not stop the spread of your illness. Share razors and toothbrushes. Do not engage in unprotected sexual activity. Speak to your doctor about the best ways to avoid hepatitis C during sex. Even healthy people should never share drug or medicine syringes.

Interaction with other drug

Your doctor may adjust your regular doses of other medications if you stop or start taking ledipasvir or sofosbuvir.If you are also taking an antacid, wait at least 4 hours before you take ledipasvir or sofosbuvir.If you are also taking a stomach acid reducer, you may need to wait up to 12 hours before you can take ledipasvir or sofosbuvir. Cimetidine is included, as are famotidine, nizatidine, ranitidine, Axid Pepcid, Tagamet Zantac, and other medications.Consult your doctor or pharmacist prior to taking other acid-reducing medications such as esomeprazole (lansoprazole), omeprazole (omeprazole), pantoprazole (pantoprazole), Nexium, Prevacid, Prilosec, Protonix, and others.There are many drugs that can interact with ledipasvir or sofosbuvir. These include prescription and over-the-counter medicines, vitamins, and herbal products. This list does not include all possible interactions. Inform your doctor of all medications you are currently taking and those that you will stop or start using.




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