Patients

Generic Name : Ledipasvir and Sofosbuvir
Brand Name : Ledihep

Usual Adult Dose for Chronic Hepatitis C

1 tablet orally once a day

Duration of Therapy :

  • Therapy-naive patients without cirrhosis : 12 weeks
  • Therapy-naive patients with cirrhosis : 12 weeks
  • Therapy-experienced patients without cirrhosis : 12 weeks
  • Therapy-experienced patients with cirrhosis : 24 weeks

Comments :

  • Relapse rates are affected by baseline host and viral factors and differ between durations of therapy for some subgroups.
  • Therapy-experienced patients are those patients who have failed treatment with either peginterferon alfa/ribavirin or peginterferon alfa/ribavirin/HCV protease inhibitor.
  • Use : For the treatment of chronic hepatitis C genotype 1/4 infection

Renal Dose Adjustments

  • Mild or moderate renal dysfunction : No adjustment recommended.
  • Severe renal dysfunction (estimated glomerular filtration rate less than 30 mL/min/1.73 m2).
  • Comments : Safety and efficacy have not been established in patients with severe renal dysfunction; dose not established due to higher exposures of the main sofosbuvir metabolite.

Liver Dose Adjustments

  • Mild, moderate, or severe liver dysfunction (Child-Pugh A, B, or C) : No adjustment recommended.
  • Comments : Safety and efficacy not established in patients with decompensated cirrhosis.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

  • End-stage renal disease (ESRD) requiring hemodialysis : Data not available
  • Comments : Safety and efficacy have not been established in ESRD patients requiring hemodialysis; dose not established due to higher exposures of the main sofosbuvir metabolite.

Other Comments

Administration advice :

  • May take without regard to food
  • Consult the manufacturer product information regarding missed doses.

Storage requirements :

  • Store in the original container at room temperature below 30C (86F)

Do NOT use ledipasvir and sofosbuvir if :

  • You are allergic to any ingredient in ledipasvir and sofosbuvir
  • You are taking another medicine that has sofosbuvir in it
  • You are taking a medicine that has cobicistat, elvitegravir, emtricitabine, and tenofovir in it
  • You are taking carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, rosuvastatin, simeprevir, St. John's wort, or tipranavir/ritonavir Contact your doctor or health care provider right away if any of these apply to you.

Before using ledipasvir and sofosbuvir

Some medical conditions may interact with ledipasvir and sofosbuvir. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you :

  • If you are pregnant, planning to become pregnant, or are breast-feeding
  • If you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • If you have allergies to medicines, foods, or other substances
  • If you have liver problems other than HCV (eg, cirrhosis)
  • if you have kidney problems or you are on dialysis
  • if you are taking tenofovir with HIV medicines
  • if you are taking amiodarone. The risk of slow heartbeat may be increased, especially if you are taking a beta blocker (eg, metoprolol), have heart problems, or have severe liver disease

Some MEDICINES MAY INTERACT with ledipasvir and sofosbuvir. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Simeprevir because it may increase the risk of ledipasvir and sofosbuvir's side effects
  • Carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, St. John's wort, or tipranavir because they may decrease ledipasvir and sofosbuvir's effectiveness
  • Digoxin or rosuvastatin because the risk of their side effects may be increased by ledipasvir and sofosbuvir

This may not be a complete list of all interactions that may occur. Ask your health care provider if ledipasvir and sofosbuvir may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use LediHep (ledipasvir and sofosbuvir)?

Use ledipasvir and sofosbuvir as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take ledipasvir and sofosbuvir by mouth with or without food.
  • Do not take an antacid that has aluminum or magnesium in it within 4 hours of ledipasvir and sofosbuvir.
  • If you take cimetidine, dexlansoprazole, esomeprazole, famotidine, lansoprazole, nizatidine, omeprazole, pantoprazole, rabeprazole, or ranitidine, ask your doctor or pharmacist how to take it with ledipasvir and sofosbuvir.
  • Ledipasvir and sofosbuvir works best if it is taken at the same time each day.
  • Continue to take ledipasvir and sofosbuvir even if you feel well. Do not miss any doses.
  • If you miss a dose of ledipasvir and sofosbuvir, take it as soon as you remember the same day and go back to your regular dosing schedule. Do not take more than 1 dose of ledipasvir and sofosbuvir in the same day. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use ledipasvir and sofosbuvir.

Important safety information

  • Tell your doctor or dentist that you take ledipasvir and sofosbuvir before you receive any medical or dental care, emergency care, or surgery.
  • Ledipasvir and sofosbuvir does not stop the spread of HCV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HCV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HCV to others.
  • Do not change your dose or stop taking ledipasvir and sofosbuvir or any of your medicines without checking with your doctor.
  • Cases of slow heartbeat and the need to get a pacemaker have happened when amiodarone was given with ledipasvir and sofosbuvir and certain other HCV medicines. Sometimes, this has been fatal. Slow heartbeat has happened up to 2 weeks after starting HCV treatment. You will need to be monitored closely if you will be taking amiodarone with HCV treatment. Follow what your doctor has told you to do. Call your doctor right away if you have symptoms of slow heartbeat (eg, chest pain, confusion, dizziness or lightheadedness, fainting or near-fainting, memory problems, shortness of breath, tiredness or weakness).
  • PREGNANCY and BREAST-FEEDING : If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using ledipasvir and sofosbuvir while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use ledipasvir and sofosbuvir, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of LediHep (ledipasvir and sofosbuvir)

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome :

Headache; Tiredness.

Seek medical attention right away if any of these SEVERE side effects occur :
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

Proper storage of LediHep (ledipasvir and sofosbuvir) :

Store LediHep (ledipasvir and sofosbuvir) at room temperature below 86 degrees F (30 degrees C). Keep ledipasvir and sofosbuvir in the original container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep ledipasvir and sofosbuvir out of the reach of children and away from pets.

General information :

  • If you have any questions about ledipasvir and sofosbuvir, please talk with your doctor, pharmacist, or other health care provider.
  • Ledipasvir and sofosbuvir is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take ledipasvir and sofosbuvir or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. 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 ledipasvir and sofosbuvir. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to ledipasvir and sofosbuvir. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using ledipasvir and sofosbuvir.

Side Effects

In addition to its needed effects, some unwanted effects may be caused by ledipasvir / sofosbuvir. In the event that any of these side effects do occur, they may require medical attention.

Some of the side effects that can occur with ledipasvir / sofosbuvir may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional :

More Common

  • Diarrhea
  • Headache
  • Nausea
  • Trouble sleeping
  • Unusual Tiredness or Weakness

For Healthcare Professionals

Applies to ledipasvir / sofosbuvir: oral tablet

General

The most common side effects reported with this drug were fatigue and headache. When this drug was studied with ribavirin, the most common side effects to this combination were consistent with known ribavirin side effects; frequency and severity of the expected side effects were not increased. Therapy was permanently discontinued due to side effects in 0%, less than 1%, and 1% of patients using this drug for 8, 12, and 24 weeks, respectively, and less than 1%, 0%, and 2% for patients using this drug with ribavirin for 8, 12, and 24 weeks, respectively.

The manufacturer product information for ribavirin should be consulted, if applicable.[Ref]

Other

Very common (10% or more): Fatigue (up to 18%)[Ref]

Nervous system

Very common (10% or more): Headache (up to 17%)[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea, increased lipase[Ref]

Increased lipase (greater than 3 times the upper limit of normal [3 x ULN]) was reported in less than 1%, 2%, and 3% of subjects using this drug for 8, 12, and 24 weeks, respectively. Lipase elevation was transient and asymptomatic.[Ref]

Psychiatric

Common (1% to 10%): Insomnia[Ref]

Hepatic

Increased bilirubin (greater than 1.5 x ULN) was reported in 3%, less than 1%, and 2% of subjects using this drug for 8, 12, and 24 weeks, respectively.[Ref]

Common (1% to 10%): Increased bilirubin[Ref]

Cardiovascular

Postmarketing reports: Serious symptomatic bradycardia (including fatal cardiac arrest, cases requiring pacemaker intervention)[Ref]

Serious symptomatic bradycardia has been reported in patients taking amiodarone who started therapy with this drug.[Ref]

Musculoskeletal

Frequency not reported: Increased creatine kinase[Ref]

Creatine kinase was not evaluated in clinical trials for this drug. Isolated, asymptomatic creatine kinase elevations (grade 3 or 4) were reported with sofosbuvir in combination with ribavirin or peginterferon alfa/ribavirin in other clinical trials.[Ref]

Ledipasvir / Sofosbuvir Pregnancy Warnings

US FDA pregnancy category: B

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

Use of a ribavirin-containing regimen is contraindicated in pregnant women and in the male partners of women who are pregnant; if applicable, the manufacturer product information for ribavirin should be consulted. -Effective contraception is required during ribavirin therapy and for 6 months after the last dose; local protocol should be consulted regarding contraception timing.

Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. Pregnancy must be avoided in female patients and female partners of male patients using a ribavirin-containing regimen. Ribavirin is contraindicated in pregnant women and men whose female partners are pregnant; all animal species exposed to ribavirin have shown significant teratogenic and/or embryocidal effects. Females of reproductive potential and their male partners should not receive ribavirin unless they are using effective contraception during therapy and for 6 months after therapy. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Ledipasvir / Sofosbuvir Breastfeeding Warnings

Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for the drug; potential side effects in the breastfed child due to the drug or the mother's underlying condition should be considered. Excreted into human milk: Unknown Excreted into animal milk: Yes (ledipasvir, GS-331007 [main circulating metabolite of sofosbuvir])

See references

References for pregnancy information

  • Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  • "Product Information. Harvoni (ledipasvir-sofosbuvir)." Gilead Sciences, Foster City, CA.

References for breastfeeding information

  • "Product Information. Harvoni (ledipasvir-sofosbuvir)." Gilead Sciences, Foster City, CA.
  • Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Medications known to interact with Ledipasvir / Sofosbuvir

  • Major Drug Interactions More..
  • Moderate Drug InteractionsMore..