Instructions for Tenofovir Alafenamide Fumarate Tablets/Veride

1. Common name: tenofovir alafenamide fumarate tablets

Product name: Vemlidy, Vemlidy

Other names:Tenofovir alafenamide fumarate, TAF

2. Who can take tenofovir alafenamide fumarate tablets? Indications?

Tenofovir alafenamide tablets/Veride (TAF) is suitable for the treatment of chronic hepatitis B virus (HBV) infection in adults and children with compensated liver disease who are 6 years old and above and weigh at least 25 kilograms (kg).

3. What are the side effects of tenofovir alafenamide fumarate tablets?

The most common side effects of tenofovir alafenamide fumarate tablets are headache, nausea and fatigue, abdominal pain, cough, back pain, joint pain, diarrhea, indigestion, etc. After the drug was put on the market, adverse events such as angioedema, urticaria, acute renal failure, acute tubular necrosis, proximal tubulopathy andFanconi syndrome have also been reported.

4. How should you take tenofovir alafenamide fumarate tablets?

Tenofovir alafenamide fumarate is available as an oral tablet. The recommended dose for adult and pediatric patients 6 years of age and older and weighing at least 25 kg is one 25 milligram (mg) tablet to be taken orally once daily with food.

5. How to store tenofovir alafenamide tablets?

Tenofovir alafenamide fumarate tablets are yellow, round, and film-coated. Each bottle contains 30 tablets, silica gel desiccant, polyester coil, and is closed with a child-resistant cap. Store below 30°C (86°F), keep containers tightly closed, and dispense only in original containers.

6. How does tenofovir alafenamide fumarate tablets work?

Tenofovir alafenamide fumarate tablets are an antiviral drug against hepatitis B virus. Tenofovir alafenamide is tenofovir (2'-deoxyadenosine monophosphate analogue)A phosphonamide prodrug. As a lipophilic cell-penetrating compound, it enters primary hepatocytes via passive diffusion and hepatic uptake transporters OATP1B1 and OATP1B3. Tenofovir alafenamide is then converted to tenofovir in primary hepatocytes primarily by hydrolysis by carboxylesterase 1 (CES1). Intracellular tenofovir is subsequently phosphorylated by cellular kinases to the pharmacologically active metabolite tenofovir diphosphate. Tenofovir diphosphate is incorporated into viral DNA through HBV reverse transcriptase to inhibit HBV replication, leading to DNA chain termination.

7. What will happen if you take too much tenofovir alafenamide fumarate tablets?

If overdose occurs with tenofovir alafenamide, monitor patients for evidence of toxicity. Treatment of overdose includes general supportive measures, including monitoring of vital signs and observation of the patient's clinical status. Tenofovir can be effectively removed by hemodialysis with an extraction coefficient of approximately54%.

8. Who cannot use tenofovir alafenamide fumarate tablets?

1. Tenofovir alafenamide fumarate tablets should not be used alone in patients with HIV-1 infection;

2. Tenofovir alafenamide fumarate tablets are not recommended for patients with end-stage renal disease (ESRD) who have not received chronic hemodialysis.