Lesovir

Rx

Indication

• For the treatment of patients with chronic hepatitis C virus (HCV) genotype 1, 4, 5, or 6 infection.

Dosage

• One tablet taken orally once daily with or without food.
• Duration of treatment based on patient status (usually from 8 to 12 weeks).

Usage

• Administered orally.

• Known hypersensitivity to any of the active substances or excipients.
• If Lesovir is administered with ribavirin, the contraindications to ribavirin also apply to this combination regimen.
• Co-administration of Lesovir with rosuvastatin and medicinal products that are potent P-glycoprotein (P-gp) inducers in the intestine (rifampicin, rifabutin, St. John’s wort, carbamazepine, phenobarbital and phenytoin) are contraindicated.

• Headache, fatigue (very common),
• Rash (common).

• Lesovir is not recommended for use in children and adolescents under 18 years of age.
• Consider the benefits and risks of Lesovir when prescribing Lesovir to a pregnant woman. If Lesovir is administered with ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant.
• The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for Lesovir and any potential adverse effects on the breastfed infant from Lesovir or from the underlying maternal condition. If Lesovir is administered with ribavirin, the nursing mother information for ribavirin also applies to this combination regimen.
• Lesovir should not be administered concomitantly with other medicinal products containing sofosbuvir.
• Use with caution when Lesovir is used concomitantly with amiodarone with or without other drugs that lower heart rate. Appropriate monitoring should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated on Lesovir.
• Caution is advised in patients with prior exposure to HCV direct-acting antivirals, consideration should be given to longer treatment for patients with uncertain subsequent retreatment options.
• No dose adjustment of Lesovir is required for patients with mild or moderate renal impairment. The safety of Lesovir has not been assessed in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m²) or end stage renal disease (ESRD) requiring haemodialysis.
• Lesovir should be given cautiously to patients with decompensated cirrhosis and/or who are awaiting liver transplant or post-liver transplant.
• Use with caution when administered Lesovir together with an HIV regimen containing tenofovir disoproxil fumarate and a pharmacokinetic enhancer (ritonavir or cobicistat). The potential risks and benefits associated with co-administration of Lesovir with the fixed-dose combination tablet containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or tenofovir disoproxil fumarate given in conjunction with a boosted HIV protease inhibitor (e.g. atazanavir or darunavir) should be considered, particularly in patients at increased risk of renal dysfunction.
• Caution should be born in mind about the risk of myopathy and rhabdomyolysis when Co-administration of Lesovir and HMG-CoA reductase inhibitors (statins).
• HBV screening should be performed in all patients before initiation of treatment, some of cases of hepatitis B virus (HBV) reactivation fatal have been reported during or after treatment with direct-acting antiviral agents.
• Lesovir contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• Patients should be aware of how they react to drug before driving or operating machinery.