It is a fixed-dose combination of ledipasvir,a hepatitis C virus (HCV) NS5A inhibitor,and sofosbuvir,an HCV nucleotide analog NS5B polymerase inhibitor,and is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults
(HCV) NS5A inhibitor,HCV nucleotide analog NS5B polymerase inhibitor
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.
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-na?ve 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
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
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 its metabolites are present in human breast milk.
No specific antidote is available for overdose with HARVONI. If overdose occurs the
patient must be monitored for evidence of toxicity. Treatment of overdose with
HARVONI consists of general supportive measures including monitoring of vital signs
as well as observation of the clinical status of the patient. Hemodialysis is unlikely to
result in significant removal of ledipasvir since ledipasvir is highly bound to plasma
protein. Hemodialysis can efficiently remove the predominant circulating metabolite of
sofosbuvir, GS-331007, with an extraction ratio of 53%.
Keep out of the reach of children. Keep in a cool & dry place. Protect from light.
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