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Generic Name

Ledipasvir + Sofosbuvir

Therapeutic Class: Anti-Viral / Hepatic viral infections (Hepatitis C)

Indications:
Ledipasvir and Sofosbuvir combination is indicated for the treatment of chronic hepatitis C (CHC) genotype 1, 4 & 6 infection in adults.

Presentation:

Each tablet contains Ledipasvir INN 90 mg and Sofosbuvir INN 400 mg

Description:
It is a fixed-dose combination tablet containing Ledipasvir and Sofosbuvir for oral administration. Ledipasvir is an HCV NS5A inhibitor and Sofosbuvir is a nucleotide analog inhibitor of HCV NS5B polymerase.

Dosage & Administration:
Recommended dosage: One tablet (90 mg of Ledipasvir and 400 mg of Sofosbuvir) taken orally once daily with or without food

Recommended treatment duration:

• Treatment-naive with or without cirrhosis: 12 weeks
• Treatment-experienced without cirrhosis: 12 weeks
• Treatment-experienced with cirrhosis: 24 weeks a dose recommendation cannot be made for patients with severe renal impairment or end-stage renal disease.

Interaction:
Coadministration with amiodarone may result in serious symptomatic bradycardia. Use of Ledipasvir and Sofosbuvir combination with Amiodarone is not recommended
P-gp inducers (e.g., Rifampin, St. John’s wort): May alter concentrations of Ledipasvir and Sofosbuvir. Use of Ledipasvir and Sofosbuvir combination with P-gp inducers is not recommended

Contraindications:
This combination is contraindicated in patients with Known hypersensitivity to Ledipasvir, Sofosbuvir, or any other ingredient in the product.

Side Effects:
The most common adverse reactions with treatment with Ledipasvir and Sofosbuvir combination for 8, 12, or 24 weeks are fatigue and headache.

Pregnancy & Lactation:

• Pregnancy: Category B. There are no adequate and well-controlled studies with Ledipasvir and Sofosbuvir in pregnant women. Because animal reproduction studies are not always predictive of human response, this should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: It is not known whether Ledipasvir and Sofosbuvir and their metabolites are present in human breast milk.

Precautions & Warnings:
Bradycardia with Amiodarone coadministration: Serious symptomatic bradycardia may occur in patients taking Amiodarone, particularly in patients also receiving beta-blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Coadministration of Amiodarone with Ledipasvir and Sofosbuvir combination is not recommended. In patients without viable treatment options, cardiac monitoring is recommended.

Use with other drugs containing sofosbuvir, is not recommended

Use in Special Populations:

• Pediatric Use: The safety and effectiveness of Ledipasvir and Sofosbuvir have not been established in pediatric patients.
• Geriatric Use: No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. No dosage adjustment of Ledipasvir and Sofosbuvir is warranted in geriatric patients.

Overdose:
No specific antidote is available for overdose

Storage:
Keep out of the reach of children. Keep in a cool & dry place. Protect from light.