Generic name: tenofovir alafenamide fumarate 25mg
Dosage form: tablet
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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 infection [see Warnings and Precautions (5.3)].
It is recommended that serum creatinine, serum phosphorous, estimated creatinine clearance, urine glucose, and urine protein be assessed before initiating VEMLIDY and during therapy in all patients as clinically appropriate [see Warnings and Precautions (5.4)].
Recommended Dosage in Adults
The recommended dosage of VEMLIDY is 25 mg (one 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 mild, moderate, or severe renal impairment. VEMLIDY is not recommended in patients with end stage renal disease (estimated creatinine clearance below 15 mL per minute) [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
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)].