LediHep 28Tabs

Ledipasvir + Sofosbuvir

Recommended Retail Price $287

Each tablet contains:

  • Ledipasvir 90 mg
  • Sofosbuvir 400 mg

Manufacturer: Natco Pharma Ltd., India

Distributor: Zydus Heptiza, India

 

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Description

Dosage Forms & Strengths

Ledipasvir/Sofosbuvir

Tablet

  • 90mg/400mg

Hepatitis C Virus Infection

Indicated for adults with chronic hepatitis C virus (HCV) genotypes 1, 4, 5, or 6 infection.

1 tablet (90 mg/400 mg) PO qDay.

Treatment duration

  • The following regimens also apply to HCV/HIV-1 coinfection.
  • Genotype 1
    • Treatment-naïve without cirrhosis or with compensated cirrhosis (Child-Pugh A): 12 weeks.
    • Treatment-experienced without cirrhosis: 12 weeks.
    • Treatment-experienced with compensated cirrhosis (Child-Pugh A): 24 weeks; may also consider adding daily weight-based ribavirin.
    • Treatment-naïve and treatment-experienced with decompensated cirrhosis (Child-Pugh B or C), including those who have undergone liver transplantation: 12 weeks in combination with ribavirin.
  • Note:
    • 8 weeks can be considered in treatment-naïve patients without cirrhosis who have pretreatment HCV RNA <6 million IU/mL.
    • Treatment –experienced patients include those who have failed a peginterferon alfa + ribavirin based regimen with or without an HCV protease inhibitor.
    • LediHep + ribavirin for 12 weeks can be considered in treatment-experienced genotype 1 patients with cirrhosis who are eligible for ribavirin; see ribavirin dosage recommendations below.
    • In patients with decompensated cirrhosis, the starting dosage of ribavirin is 600 mg and can be titrated up to 1000 mg for patients <75 kg and 1200 mg for those ≥75 kg in two divided doses with food; if starting dosage of ribavirin is not well tolerated, reduce dosage as clinically indicated based on hemoglobin levels.
    • Ribavirin dosage recommendations: The daily dosage of ribavirin is weight-based (1000 mg for patients <75 kg and 1200 mg for those ≥75 kg) administered orally in two divided doses with food.
    • For further information on ribavirin dosing and dosage modifications, refer to the ribavirin prescribing information.
  • Genotypes 1 or 4
    • Treatment-naïve and treatment-experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A), including those who have undergone liver transplantation: 12 weeks in combination with ribavirin.
  • Genotypes 4, 5, or 6
    • Treatment-naïve and treatment-experienced, without cirrhosis or with compensated cirrhosis (Child-Pugh A): 12 weeks.

Dosage Modifications

Renal impairment

  • Mild or moderate: No dosage adjustment required.
  • Severe (eGFR <30 mL/min/1.73 m²) or ESRD: No dosage recommendation can be given owing to higher exposures (up to 20-fold) of the predominant sofosbuvir metabolite.

Hepatic impairment

  • Mild, moderate, or severe: No dosage adjustment required.
  • Decompensated cirrhosis: Safety and efficacy not established.

Dosing Considerations

Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with HCV direct acting antivirals (DDAs).

Cautions

Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV DDAs, and who were not receiving HBV antiviral therapy; HBV reactivation is characterized as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level (see Black Box Warnings and Dosing Considerations).

Do not use with other products that contain sofosbuvir (Sovaldi, Epclusa); duplicate therapy and increased risk for adverse effects.

Postmarketing cases of symptomatic bradycardia and cases requiring pacemaker intervention have been reported when amiodarone is coadministered with sofosbuvir in combination with an investigational agent (daclatasvir, an investigational NS5A inhibitor) or simeprevir; coadministration is not recommended, if no alternative exists, inpatient cardiac monitoring is recommended for the first 48 hr and then daily home monitoring for at least the first 2 weeks.

Due to amiodarone’s long half-life, patients discontinuing amiodarone just prior to starting LediHep therapy should undergo cardiac monitoring; patients who develop signs or symptoms of bradycardia, including near-fainting or fainting, dizziness or lightheadedness, malaise, weakness, excessive tiredness, shortness of breath, chest pains, confusion or memory problems should seek medical evaluation immediately.

LediHep is substrates of P-gp and BCRP; coadministration with P-gp inducers (eg, rifampin, St. John’s wort) is not recommended; may significantly decrease ledipasvir and sofosbuvir plasma concentrations and reduce therapeutic effect.

Ledipasvir is an inhibitor of P-gp and BCRP; may increase intestinal absorption of coadministered substrates for these transporters.

Coadministration of ledipasvir with acid-reducing agents may decrease ledipasvir solubility, resulting in decreased serum concentrations.

If coadministered with ribavirin, the warnings and precautions for ribavirin also apply to this combination regimen.

Pregnancy

If the drug combination is administered with ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant; refer to ribavirin prescribing information for more information on ribavirin-associated risks of use during pregnancy.

No adequate human data are available to establish whether or not the drug combination poses a risk to pregnancy outcomes; in animal reproduction studies, no evidence of adverse developmental outcomes was observed with the drug combination ledipasvir or sofosbuvir at exposures greater than those in humans at the recommended human dose (RHD).

Lactation

It is not known whether ledipasvir or sofosbuvir, the drug combination, or their metabolites are present in human breast milk, affect human milk production or have effects on the breastfed infant.

The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug combination and any potential adverse effects on the breastfed child from the drug combination or from the underlying maternal condition.

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Oral Administration

May take with or without food.

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