Fumarate propafenone tablets (Vemlidy) are nucleoside analogue reverse transcriptase inhibitors (NRTI) that inhibit the reverse transcriptase activity of hepatitis B virus (HBV), block the extension of viral DNA strands, and thus inhibit viral replication.

1. Drug name

Common name: Propionine Fumarate Tenofovir Tablets

Product Name: VEMLIDY ®

English name: Tenofovir Alafenamide Tablets

2. Indications

Used for the treatment of chronic hepatitis B virus (HBV) infection in adults, with good liver function compensation (no decompensated liver cirrhosis).

3. Specifications and characteristics

Specification: Each tablet contains 25mg of propafenone (equivalent to 28mg of fumarate).

Appearance: Yellow circular film coated piece, with "GSI" engraved on one side and "25" engraved on the other side.

4. Main components

Active ingredient: Tenofovir Alafenamide.

Accessories: cross-linked carboxymethyl cellulose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose; The coating contains iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc powder, and titanium dioxide.

5. Usage and dosage

Conventional dose: 25mg (1 tablet) once daily, taken with food.

Omission treatment: If missed, it should be replenished as soon as possible; If it is close to the next medication time, skip the missed dose and do not double the dosage.

Vomiting treatment: If vomiting occurs after taking medication, there is no need to take additional medication. Follow the original plan for the next dose.

6. Dose adjustment

Renal insufficiency:

Mild to moderate (eGFR ≥ 15mL/min): No adjustment required.

End stage renal disease (eGFR<15mL/min) or dialysis patients: Not recommended for use.

Liver dysfunction:

Mild (Child Pugh A): No adjustment required.

Moderate to severe (Child Pugh B/C): Not recommended for use.

7. Medication precautions

Dietary requirements: Must be taken with food to increase absorption rate.

Contraindications: There are no clear contraindications, but one should be cautious of HIV co infection (requiring combined anti HIV treatment).

Monitoring requirements: Renal function (serum creatinine, urinary protein, etc.), HBV DNA load, and liver function should be monitored before and during medication.

8. Medication for special populations

Pregnant women: It is necessary to weigh the pros and cons, and medication used during pregnancy needs to be registered (antiretroviral pregnancy registration system).

Breastfeeding period: Avoid breastfeeding (safety unknown).

Children: Safety for individuals under 18 years old has not been established.

Elderly: No need to adjust dosage, but close monitoring of kidney function is necessary.

9. Adverse reactions

Common (≥ 5%): headache, abdominal pain, fatigue, cough, nausea, back pain.

Serious:

Lactic acidosis/hepatic steatosis (rare but fatal).

Acute exacerbation after discontinuation of HBV medication.

Renal dysfunction (such as Fanconi syndrome).

10. Drug interactions

P-gp/BCRP inducers (such as rifampicin and St. John's wort): may reduce efficacy, avoid combination use.

Renal toxic drugs (such as NSAIDs, aminoglycosides): increase the risk of kidney injury and require monitoring.

Drugs with no significant interaction: Sofosbuvir/Vepatasvir, Ethynylestradiol, etc.

11. Storage method

Store below 30 ° C (86 ° F), keep the original packaging sealed and moisture-proof.

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