Tenofovir alafenamide Fumarate is a novel nucleotide reverse transcriptase inhibitor primarily used for the treatment of chronic hepatitis B (CHB) in adults and adolescents (aged 12 years and older, weighing at least 35kg).

1、 Drug name

Product Name: Vemlidy

Common name: Propionine Fumarate Tenofovir Tablets

English name: Tenofovir Alafenamide Tablets

2、 Indications

Vemlidy is suitable for treating chronic hepatitis B virus (HBV) infection in adults with compensatory liver disease.

3、 Specifications and characteristics

Specification: Each tablet contains 25mg of propafenone fumarate (equivalent to 28mg of propafenone 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: including cross-linked carboxymethyl cellulose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose, etc. The film coating material contains yellow iron oxide, polyethylene glycol, polyvinyl alcohol, talc powder, and titanium dioxide.

5、 Usage and dosage

Recommended dosage: 25mg (one tablet) once daily for adults, taken orally with food.

6、 Dose adjustment

Patients with renal insufficiency: Mild, moderate, or severe renal insufficiency patients do not require dose adjustment.

However, it is not recommended for patients with end-stage renal disease (estimated creatinine clearance rate below 15mL/min) to use it.

Patients with liver dysfunction: Mild liver dysfunction (Child Pugh A grade) patients do not require dose adjustment.

However, it is not recommended for patients with decompensated stage (Child Pugh B or C) liver disease.

7、 Medication precautions

Before and after meals: It should be taken with food to improve the bioavailability of the medication.

Missed dose: If missed once, it should be taken as soon as possible, unless it is close to the next medication time. At this time, the missed dose should be skipped and the normal dose should be continued.

Vomiting: If vomiting occurs within 1 hour after taking the medication, an additional tablet should be taken; If it exceeds 1 hour, there is no need to take additional medication, and the next dose should continue at the normal time.

8、 Medication for special populations

Pregnant and lactating women: Due to limited data on medication for pregnant women, it is important to weigh the pros and cons before use; Breastfeeding should be suspended during the medication period for lactating women.

Children: Safety and efficacy have not been established in children under 18 years old.

Elderly people: Clinical studies did not include a sufficient number of elderly people aged 65 and above to determine whether their reactions were different from those of young people.

9、 Adverse reactions

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

Serious adverse reactions: including lactic acidosis/severe hepatomegaly with fatty degeneration, severe acute exacerbation of hepatitis B after treatment, newly developed or worsening renal dysfunction, etc.

10、 Contraindications

Prohibited for individuals allergic to Vemlidy or any excipients.

11、 Drug interactions

Vemlidy is the substrate of P-glycoprotein (P-gp) and breast cancer resistant protein (BCRP). Drugs that strongly affect the activity of P-gp and BCRP may change the absorption of Vemlidy.

Avoid co administration with potent P-gp inducers such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin sodium, rifampicin, rifampicin, and St. John's wort, as it may significantly reduce the plasma concentration of Vemlidy.

12、 Storage method

Store below 30 ° C (86 ° F), keep the container tightly closed, and only use the original container for distribution.

Vemlidyinformation