- Approval Id
- d5048bdd83a90968
- Drug Name
- VEMLIDY FILM COATED TABLET 25 MG
- Product Name
- VEMLIDY FILM COATED TABLET 25 MG
- Approval Number
- SIN15392P
- Approval Date
- 2017-12-11
- Registrant
- GILEAD SCIENCES SINGAPORE PTE. LTD.
- Licence Holder
- GILEAD SCIENCES SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>2 DOSAGE AND ADMINISTRATION</strong></p>
<p><strong>2.1 Testing Prior to Initiation of VEMLIDY</strong></p>
<p>Prior to initiation of VEMLIDY, patients should be tested for HIV-1 infection. VEMLIDY alone should not be used in patients with HIV-1 infection <em>[see Warnings and Precautions (5.2)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
<p>Prior to or when initiating VEMLIDY, and during treatment with VEMLIDY on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus <em>[see Warnings and Precautions (5.3)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
<p><strong>2.2 Recommended Dosage in Adults and Pediatric Patients 6 Years of Age and Older and Weighing at Least 25 kg</strong></p>
<p>The recommended dosage of VEMLIDY in adults and pediatric patients 6 years of age and older weighing at least 25 kg is one 25 mg tablet taken orally once daily with or without food <em>[see Clinical Pharmacology (11.3)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
<p><strong>2.3 Dosage in Patients with Renal Impairment</strong></p>
<p>No dosage adjustment of VEMLIDY is required in adult patients with estimated creatinine clearance greater than or equal to 15 mL per minute, or in patients with end stage renal disease (ESRD; estimated creatinine clearance below 15 mL per minute) who are receiving chronic hemodialysis. On days of hemodialysis, administer VEMLIDY after completion of hemodialysis treatment.</p>
<p>VEMLIDY is not recommended in patients with ESRD who are not receiving chronic hemodialysis <em>[see Use in Specific Populations (8.5) and Clinical Pharmacology (11.3)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
<p>No data are available to make dose recommendations in pediatric patients with renal impairment.</p>
<p><strong>2.4 Dosage in Patients with Hepatic Impairment</strong></p>
<p>No dosage adjustment of VEMLIDY is required in patients with mild hepatic impairment (Child-Pugh A). VEMLIDY is not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment <em>[see Use in Specific Populations (8.6) and Clinical Pharmacology (11.3)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>1 INDICATIONS AND USAGE</strong></p>
<p>VEMLIDY is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults and pediatric patients 6 years of age and older and weighing at least 25 kg with compensated liver disease <em>[see Clinical Studies (13)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
- Contraindications
- <p><strong>4 CONTRAINDICATIONS</strong></p>
<p>None.</p>
- Atc Code
- J05AF13
- Atc Item Name
- tenofovir alafenamide
- Pharma Manufacturer Name
- GILEAD SCIENCES SINGAPORE PTE. LTD.
