Ledipasvir + Sofosbuvir

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Generic Name: Ledipasvir + Sofosbuvir Brand Name(s): Generics only. No brands available.

Uses

What is Ledipasvir + Sofosbuvir used for?

This medication is a combination of ledipasvir and sofosbuvir and is used to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. It may sometimes be used with another antiviral medication (ribavirin). These drugs work by reducing the amount of hepatitis C virus in your body, which helps your immune system fight the infection and may help your liver recover. Chronic hepatitis C infection can cause serious liver problems such as scarring (cirrhosis), or liver cancer.

It is not known if this treatment can prevent you from passing the virus to others. Do not share needles, and practice “safer sex” (including the use of latex condoms) to lower the risk of passing the virus to others.

How should I take Ledipasvir + Sofosbuvir?

Take this medication by mouth with or without food as directed by your doctor, usually once daily.

This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time each day.

Tell your doctor if you vomit within 5 hours after taking this medication. You may need to take another dose.

Continue to take ledipasvir/sofosbuvir for the full length of time prescribed, even if symptoms disappear after a short time. Stopping the medication too early may result in a return of the infection.

Antacids lower the absorption of ledipasvir. If you are taking an antacid, take it at least 4 hours before or 4 hours after this medication.

Other acid-lowering medications for indigestion, heartburn, or ulcers (such as prescription or over-the-counter medications including famotidine, omeprazole) may prevent ledipasvir from working. Ask your doctor or pharmacist how to use these medications safely.

How do I store Ledipasvir + Sofosbuvir?

Ledipasvir + Sofosbuvir is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Ledipasvir + Sofosbuvir in the bathroom or the freezer. There may be different brands of Ledipasvir + Sofosbuvir that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Ledipasvir + Sofosbuvir down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Ledipasvir + Sofosbuvir?

Before taking ledipasvir/sofosbuvir, tell your doctor or pharmacist if you are allergic to either of the drugs; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, other liver problems (such as hepatitis B).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Ledipasvir/sofosbuvir, in combination with ribavirin, must not be used during pregnancy by either the pregnant woman or her male partner. The combination may harm an unborn baby. Two reliable forms of birth control (such as condoms, birth control pills) must be used whenever at least one sexual partner is using these medicines together, and for six months after stopping treatment. If you or your partner becomes pregnant, or if you think you or your partner may be pregnant, tell your doctor right away.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding. Breast-feeding is not recommended if this medication is used in combination with ribavirin.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Ledipasvir + Sofosbuvir during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Ledipasvir + Sofosbuvir. Ledipasvir + Sofosbuvir is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Ledipasvir + Sofosbuvir?

Tiredness, headache, nausea, diarrhea, or difficulty sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Ledipasvir + Sofosbuvir?

Some products that may interact with this drug include: amiodarone, a certain other medication used to treat chronic hepatitis C (simeprevir).

This medication can slow down the removal of other medications from your body, which may affect how they work. One example is rosuvastatin, among others.

Other medications can affect the removal of ledipasvir/sofosbuvir from your body, which may affect how this medication works. Examples include rifamycins (such as rifampin, rifabutin), St. John’s wort, tipranavir/ritonavir, drugs used to treat seizures (such as phenobarbital, carbamazepine, phenytoin, primidone), among others.

Do not take this medication with other products that contain sofosbuvir.

Ledipasvir + Sofosbuvir may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Ledipasvir + Sofosbuvir?

Ledipasvir + Sofosbuvir may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Ledipasvir + Sofosbuvir?

Ledipasvir + Sofosbuvir may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Ledipasvir + Sofosbuvir.

What is the dose of Ledipasvir + Sofosbuvir for an adult?

Usual Adult Dose for Chronic Hepatitis C

1 tablet orally once a day

Recommended Regimen and Duration of Therapy:

GENOTYPE 1:

-Therapy-naive patients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 12 weeks

-Therapy-experienced patients without cirrhosis: Ledipasvir-sofosbuvir for 12 weeks

-Therapy-experienced patients with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 24 weeks

-Therapy-naive and therapy-experienced patients with decompensated cirrhosis (Child-Pugh B or C): Ledipasvir-sofosbuvir plus ribavirin for 12 weeks

GENOTYPE 1 OR 4:

-Therapy-naive and therapy-experienced liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir plus ribavirin for 12 weeks

GENOTYPE 4, 5, OR 6:

-Therapy-naive and therapy-experienced patients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 12 weeks

Comments:

-Relapse rates are affected by baseline host and viral factors and differ between durations of therapy for some subgroups.

-Dose recommendations also apply to HCV/HIV-1-coinfected patients.

-Therapy-naive genotype 1 patients without cirrhosis: Ledipasvir-sofosbuvir for 8 weeks can be considered in those who have pretreatment HCV RNA less than 6 million international units/mL.

-Therapy-experienced patients have failed a peginterferon alfa/ribavirin-based regimen with or without an HCV protease inhibitor.

-Therapy-experienced genotype 1 patients with cirrhosis: Ledipasvir-sofosbuvir plus ribavirin for 12 weeks can be considered in those eligible for ribavirin.

-The manufacturer product information for ribavirin should be consulted regarding dosing and dose adjustments (if applicable).

Use: For the treatment of chronic HCV

-For genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis

-In combination with ribavirin: For genotype 1 infection with decompensated cirrhosis

-In combination with ribavirin: For genotype 1 or 4 infection in liver transplant recipients without cirrhosis or with compensated cirrhosis

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): Data not available

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.

-The manufacturer product information for ribavirin should be consulted regarding use in renal dysfunction patients (if applicable).

Liver Dose Adjustments

Mild, moderate, or severe liver dysfunction (Child-Pugh A, B, or C): No adjustment recommended.

Comments:

-Clinical and hepatic monitoring (as clinically indicated) recommended for patients with decompensated cirrhosis using this drug plus ribavirin.

Other Comments

Administration advice:

-Before starting this drug, test all patients for evidence of current/prior HBV infection; measure hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc).

-May administer 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).

General:

-Each fixed-dose combination tablet contains ledipasvir 90 mg and sofosbuvir 400 mg.

-The manufacturer product information for ribavirin should be consulted for additional information (if applicable).

What is the dose of Ledipasvir + Sofosbuvir for a child?

Usual Pediatric Dose for Chronic Hepatitis C

12 years and older or weighing at least 35 kg: 1 tablet orally once a day

Recommended Regimen and Duration of Therapy:

GENOTYPE 1:

-Therapy-naive patients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 12 weeks

-Therapy-experienced patients without cirrhosis: Ledipasvir-sofosbuvir for 12 weeks

-Therapy-experienced patients with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 24 weeks

GENOTYPE 4, 5, OR 6:

-Therapy-naive and therapy-experienced patients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 12 weeks

Comments:

-Dose recommendations also apply to HCV/HIV-1-coinfected patients.

-Therapy-experienced patients have failed an interferon-based regimen with or without ribavirin.

Use: For the treatment of HCV genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis

How is Ledipasvir + Sofosbuvir available?

Ledipasvir + Sofosbuvir is available in the following dosage forms and strengths:

  • Oral Tablet

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Ledipasvir + Sofosbuvir, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: March 14, 2018 | Last Modified: March 14, 2018

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