Sovir Plus

Sovir Plus

sofosbuvir + ledipasvir

Manufacturer:

Zifam Pinnacle

Distributor:

Pinnacle House
Concise Prescribing Info
Contents
Ledipasvir 90 mg, sofosbuvir 400 mg
Indications/Uses
Treatment of chronic hepatitis C (CHC) w/ or w/o cirrhosis in adults & adolescents 12 - <18 yr (wt ≥35 kg).
Dosage/Direction for Use
Recommended dose: 1 tab once daily. HCV/HIV-1 coinfection Adult: Genotype 1 (Child-Pugh A) 12 wk, treatment-experienced w/ compensated cirrhosis (Child-Pugh A) 24 wk, w/ decompensated cirrhosis (Child-Pugh B or C) plus ribavirin for 12 wk. Genotype 1 or 4: liver transplant recipients w/o cirrhosis or w/ compensated cirrhosis (Child-Pugh A) plus ribavirin for 12 wk. Genotype 4, 5 or 6 (Child-Pugh A) 12 wk. Ped ≥12 yr (wt ≥35 kg) Genotype 1, 4, 5 or 6 12 wk.
Administration
May be taken with or without food: Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity. Should not be co-administered w/ rosuvastatin or St. John's wort.
Special Precautions
Risk of HBV reactivation: Prior to initiation of HCV therapy, test for evidence of current or prior HBV infection, & monitor HCV/HBV coinfected patients for HBV reactivation & hepatitis flare during & post-treatment follow-up. Not recommended for coadministration w/ amiodarone as serious symptomatic bradycardia may occur. Concomitant use w/ P-gp inducers (eg, rifampicin, St. John's wort) may reduce therapeutic effect of Sovir Plus. Pregnancy & lactation. Avoid pregnancy when used in combination w/ ribavirin or peginterferon/ribavirin. Paed <12 yr.
Adverse Reactions
Drug Interactions
Coadministration w/ amiodarone may result in serious symptomatic bradycardia. P-gp inducers (eg, rifampicin, St. John's wort) may alter conc of ledipasvir & sofosbuvir. Monitor INR values frequently when receiving warfarin.
MIMS Class
Antivirals
ATC Classification
J05AP51 - sofosbuvir and ledipasvir ; Belongs to the class of antivirals for treatment of HCV infections. Used in the treatment of hepatitis C viral infections.
Presentation/Packing
Form
Sovir Plus FC tab
Packing/Price
28's
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