INDICATIONS AND USAGE（适应症）

VEMLIDY is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease.

DOSAGE（服用剂量）

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.

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.

Recommended Dosage in Adults

The recommended dosage of VEMLIDY is 25 mg (one tablet) taken orally once daily with food.

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.

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.

ADVERSE REACTIONS（不良反应）

Severe Acute Exacerbation of Hepatitis B

New Onset or Worsening of Renal Impairment

Lactic Acidosis/Severe Hepatomegaly with Steatosis

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/72e6b33c-0351-4070-9172-eeaa186c01d2/spl-doc?hl=Vemlidy

TAFERinformation