Tenofovir alafenamide
VEMLIDY
Pronunciation: ten-OF-oe-veer al-a-FEN-a-mide (VEM-li-dee)
What it isTenofovir prodrug concentrated inside cells; chronic hepatitis B (VEMLIDY 25 mg daily), and the tenofovir of many current HIV combinations.
Why this oneLower plasma tenofovir than the disoproxil form, with less renal tubular and bone toxicity.
What limits itBoxed warning: stopping it can cause a severe acute hepatitis B flare. Not recommended in decompensated cirrhosis, or below CrCl 15 mL/min unless on hemodialysis.
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Chronic hepatitis B with compensated liver disease | Adults | 25 mg QD with food | 25 mg QD | 25 mg QD |
| Chronic hepatitis B with compensated liver disease | Peds ≥6 y and ≥25 kg | 25 mg QD with food | 25 mg QD | 25 mg QD |
Renal CrCl ≥15: no adjustment; ESRD (CrCl <15) on chronic hemodialysis: no adjustment—dose after HD on dialysis days; CrCl <15 not on HD: not recommended. Peds renal impairment: no data.
Hepatic Mild (Child-Pugh A): no adjustment; decompensated (Child-Pugh B or C): not recommended.
Instructions
- Take with food.
- Test for HIV-1 before starting (not for use alone in HIV).
- Before/at start and during therapy: serum creatinine, estimated CrCl, urine glucose, urine protein; add serum phosphorus in CKD.
Available strengths
- tab 25 mg
Cautions
- Severe acute HBV exacerbation after discontinuation
- HIV-1 resistance in HBV/HIV-1 coinfection (not for use alone in HIV)
- New onset or worsening renal impairment (Fanconi syndrome, proximal tubulopathy)
- Lactic acidosis/severe hepatomegaly with steatosis
Adverse reactions
- Headache
- Abdominal pain
- Cough
- Back pain
- Fatigue
- Nausea
- Arthralgia
- Diarrhea
- Dyspepsia
Pregnancy APR data show no significant increase in major birth defects vs background; no adverse developmental effects in animals.
Lactation TAF and tenofovir present in human milk with no reported adverse effects in breastfed children; weigh breastfeeding benefits against maternal need.
Cost
| Strength | #/mo | generic $/mo | brand $/mo | CostPlus | |
|---|---|---|---|---|---|
| 25 mg | tab | 30 qd | — | $1,559.52 | not offered |
Available combined with: bictegravir / emtricitabine / tenofovir / alafenamide · elvitegravir / cobicistat / emtricitabine / tenofovir / alafenamide · emtricitabine / tenofovir / alafenamide
⚠ BOXED WARNING
- Severe acute exacerbation of hepatitis B on discontinuation
Classes and tags
Clinical profile
Legacy pregnancy categoryN/A (post-2015 labeling)
Defining liabilityRenal toxicity and hepatitis flares after discontinuation