VEMLIDY FILM COATED TABLET 25 MG

GILEAD SCIENCES SINGAPORE PTE. LTD.

GILEAD SCIENCES SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

TABLET, FILM COATED

**2 DOSAGE AND ADMINISTRATION** **2.1 Testing Prior to Initiation of VEMLIDY** 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 _\[see Warnings and Precautions (5.2)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. 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 _\[see Warnings and Precautions (5.3)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. **2.2 Recommended Dosage in Adults** The recommended dosage of VEMLIDY is 25 mg (one tablet) taken orally once daily with or without food _\[see Clinical Pharmacology (11.3)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. **2.3 Dosage in Patients with Renal Impairment** No dosage adjustment of VEMLIDY is required in 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. VEMLIDY is not recommended in patients with ESRD who are not receiving chronic hemodialysis _\[see Use in Specific Populations (8.5) and Clinical Pharmacology (11.3)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. **2.4 Dosage in Patients with Hepatic Impairment** 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 _\[see Use in Specific Populations (8.6) and Clinical Pharmacology (11.3)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_.