Pregnancy Cat

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

Precautions

Bradycardia with amiodarone coadministration: Serious symptomatic bradycardia may occur in patients takingamiodarone, 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.

Overdose Effects

n/a

Drug Classes

Hepatic viral infections (Hepatitis C)

Storage Conditions

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

Composition

n/a

Mode 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.

Reconstitution

n/a