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Vemlidy

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Tenofovir alafenamide Fumarate) is a new nucleotide reverse transcriptase inhibitor mainly used to treat chronic hepatitis B (CHB) in adults and adolescents (age 12 years and above, weighing at least 35kg).

1. Drug name

Trade name: Vemlidy

Common name: Tenofovir alafenamide tablets

English name: T enofovirAlafenamide Tablets

2. Indications

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

3. Specifications and properties

Specifications: Each tablet contains 25 mg of tenofovir alafenamide fumarate (based on tenofovir alafenamide, it is equivalent to 28 mg of tenofovir alafenamide fumarate).

Characteristics: Yellow round film-coated tablet, engraved with "GSI" on one side and "25" on the other side.

IV. Main ingredients

Active ingredient:TenofovirAlafenamide

Excipients: Including croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose, etc. The film coating material contains yellow iron oxide, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.

5. Usage and Dosage

Recommended dosage: Adults take 25 mg (one tablet) once a day, orally with food.

6. Dose adjustment

Patients with renal insufficiency: Patients with mild, moderate or severe renal insufficiency do not need to adjust the dose.

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

Patients with hepatic impairment: No dose adjustment is required for patients with mild hepatic impairment (Child-Pugh Class A).

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

7. Medication Precautions

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

Missed dose: If you miss a dose, you should take it as soon as possible, unless it is close to the time of the next dose, in which case you should skip the missed dose and continue taking it at the normal dose.

Vomiting: If you vomit within 1 hour after taking the medicine, you should take another tablet; if it exceeds 1 hour, there is no need to take a supplement and continue taking the next medicine at the normal time.

8. Medication for Special Populations

Pregnant and lactating women: Pregnant women have limited medication data, and the pros and cons should be weighed before use; lactating women should suspend breastfeeding while taking the medication.

Children: Safety and effectiveness have not been established in children under 18 years of age.

Older adults: Clinical studies did not include sufficient numbers of older adults aged 65 and older to determine whether they respond differently than younger adults.

9. Adverse reactions

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

Serious adverse reactions:Including lactic acidosis/severe hepatomegaly with steatosis, severe acute exacerbation of hepatitis B after treatment, new or worsening renal insufficiency, etc.

10. Contraindications

It is prohibited for those allergic to Vemlidy or any excipients.

11. Drug interactions

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

Avoid coadministration with potent P-gp inducers (such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampicin, rifapentine, St. John's wort), as the plasma concentration of Vemlidy may be significantly reduced.

12. Storage method

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