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)].

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)].

Recommended Dosage in Adults and Pediatric Patients 12 Years of Age and Older

​The recommended dosage of VEMLIDY in adults and pediatric patients 12 years of age and older is one 25 mg tablet taken orally once daily with food [see Clinical Pharmacology (12.3)].

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 (8.6) and Clinical Pharmacology (12.3)].

No data are available to make dose recommendations in pediatric patients with renal impairment.

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 (8.7) and Clinical Pharmacology (12.3)].