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Antifungals & Antivirals

Lesovir

Pack size:

Box of 28 tablets. Bottle of 28 tablets.

 

Composition:

Each film-coated tablet contains Ledipasvir 90 mg and Sofosbuvir 400 mg.

 

Shelf-life:

24 months from the date of manufacturing.

Store in a well-closed container, in a dry place. 

Protect from light. Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

Lesovir is indicated for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1, 4, 5, or 6 infection.

Lesovir is administered orally.

The recommended dosage of Lesovir is one tablet taken orally once daily with or without food. Duration of treatment based on patient status (usually from 8 to 12 weeks).

 

Or as prescribed by physicians.

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 benets 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 benets 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 ltration 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 benets associated with co-administration of Lesovir with the xed-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 deciency or glucose-galactose malabsorption should not take this medicine.

Patients should be aware of how they react to drug before driving or operating machinery.

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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