Twinvir Tablet
Ledipasvir + Sofosbuvir
90/400mg
Incepta Pharmaceuticals Ltd.
| Pack size | 6's |
|---|---|
| Unite Price | 1000.00 BDT |
Indications
Twinvir Tablet is used for:
Chronic hepatitis C (CHC), genotype 1, 4 & 6 infection in adults.
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
Administration
Can be taken with or without food.
Contra Indications
Hypersensitivity.
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 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
Pregnancy-Lactation
Pregnancy
If the drug combination is administered with ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant; refer to ribavirin prescribing information for more information on ribavirin-associated risks of use during pregnancy
No adequate human data are available to establish whether or not the drug combination poses a risk to pregnancy outcomes; in animal reproduction studies, no evidence of adverse developmental outcomes was observed with the drug combination ledipasvir or sofosbuvir at exposures greater than those in humans at the recommended human dose (RHD)
Lactation
It is not known whether ledipasvir or sofosbuvir, the drug combination, or their metabolites are present in human breast milk, affect human milk production or have effects on the breastfed infant.
The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug combination and any potential adverse effects on the breastfed child from the drug combination or from the underlying maternal condition
Interactions
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.
Side Effects
Side effects of Ledipasvir + Sofosbuvir :
>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
Mode of Action
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.
Note
Twinvir 90/400mg Tablet generic name is Ledipasvir + Sofosbuvir. Twinvir 90/400mg Tablet is manufactured by Incepta Pharmaceuticals Ltd.Twinvir is availble in all over Bangladesh.
Mes BD drug index information on Twinvir Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.