Uses of Sofoled: - Chronic hepatitis C virus (HCV) infection Chronic hepatitis C (CHC), genotype 1, 4 & 6 infection in adults. Hypersensitivity.

Hepatic viral infections (Hepatitis C)

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.

How to use Ledipasvir + Sofosbuvir: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Ledipasvir + Sofosbuvir may be taken with or without food, but it is better to take it at a fixed time. Administration: Can be taken with or without food. Adult Dose: Oral Hepatitis C Indicated for adults with chronic hepatitis C virus (HCV) genotypes 1, 4, 5, or 6 infection Recommended dosage: One tablet (90 mg of Ledipasvir and 400 mg of Sofosbuvir) taken once daily. Recommended treatment duration: Treatment-naive with or without cirrhosis: 12 weeks Treatment-experienced without cirrhosis: 12 weeks Treatment-experienced with cirrhosis: 24 weeks Hepatic impairment Mild, moderate, or severe: No dosage adjustment required Decompensated cirrhosis: Safety and efficacy not established Child Dose: Safety and efficacy not established Renal Dose: 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

Reduced therapeutic effect w/ drugs that are potent P-gp inducers in the intestine (eg rifampicin, St. John's wort, carbamazepine & phenytoin), modafinil, phenobarb/oxcarbazepine, rifabutin/rifapentine. P-gp &/or BCRP inhibitors. May result in serious symptomatic bradycardia when co-administered w/ amiodarone in combination w/ another direct acting antiviral.

Hypersensitivity.

Common - Tiredness - Headache >10% Asthenia (31-36%),Fatigue (4-18%),Headache (13-29%),Cough (5-11%) 1-10% Nausea (6-9%),Diarrhea (3-7%),Dizziness (1-5%),Dyspnea (3-9%),Insomnia (3-6%),Increased bilirubin >1.5 x ULN (<1 to 3%),Increased lipase >3 x ULN (<1 to 3%),Myalgia (4-9%),Irritability (7-8%) Frequency Not Defined Asymptomatic creatine kinase elevation, Grades 3/4

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.

Precaution: 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. Lactation: Unknown if distributed in human breast milk

No specific antidote is available for overdose

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

Hepatic viral infections (Hepatitis C)

Ledipasvir is an HCV NS5A inhibitor and Sofosbuvir is a nucleotide analog inhibitor of HCV NS5B polymerase. Ledipasvir is a potent inhibitor of HCV NS5A, a viral phosphoprotein that plays an important role in viral replication, assembly, and secretion. Sofosbuvir is a nucleotide analog inhibitor of hepatitis C virus NS5B polymerase—the key enzyme mediating HCV RNA replication. The triphosphate form of sofosbuvir (GS-461203) mimics the natural cellular uridine nucleotide and is incorporated by the HCV RNA polymerase into the elongating RNA primer strand, resulting in chain termination.

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.