Sofomax Duo
Cheaper & Alternative Brands
Same generic (Ledipasvir + Sofosbuvir), same form (Tablet)
Clinical Prescribing Information
Medical monograph and safety information for healthcare professionals & patients.Indications & Clinical Uses
Ledipasvir and Sofosbuvir combination is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults.
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.
Contraindications
This combination is contraindicated in patients with Known hypersensitivity to Ledipasvir, Sofosbuvir or any other ingredient in the product.
Side Effects & Adverse Reactions
The most common adverse reactions (incidence greater than or equal to 10%, all grades) observed with treatment with this tablet for 8, 12, or 24 weeks are fatigue, headache, nausea, diarrhea and insomnia.
Warnings & Precautions
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 this tablet is not recommended. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Use with other drugs containing sofosbuvir, is not recommended.
Pharmacology & Mechanism of Action
This 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. Following oral administration of this tablet, ledipasvir median peak concentrations were observed 4 to 4.5 hours post-dose.