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Tenofovir Amibufenamide
Tenofovir Amibufenamide Tenofovir Amibufenamide

Tenofovir Amibufenamide(艾米替诺福韦片)

Tenofovir Amibufenamide Tablets is China's first oral original research anti-hepatitis B virus (HBV) drug with independent intellectual property rights, and was approved for marketing in June 2021.

  • 25mg*28tablets
  • 25mg*30tablets

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Introduction of Tenofovir Amibufenamide

As a domestic innovative anti-hepatitis B drug, Tenofovir Amibufenamide Tablets has not only provided a safer, more effective and accessible treatment option for Chinese patients with chronic hepatitis B, but relevant studies have also confirmed its application potential in special populations including pregnant women with chronic hepatitis B and patients with HBV-related hepatocellular carcinoma, and it has also furnished an important evidence-based foundation for the exploration of functional cure for chronic hepatitis B.

Indications

Tenofovir Amibufenamide Tablets is mainly indicated for the treatment of adult patients with chronic hepatitis B. In its Phase III clinical trials, favorable efficacy was also observed in some patients with early-stage liver cirrhosis who received this product.

Overview

Generic Name
Tenofovir Amibufenamide Tablets,艾米替诺福韦片
Brand Name
恒沐
Drug Type
Rx Drug
Approval No.
国药准字H20210029
Active Ingredient
Tenofovir Amibufenamide
Dosage Form
25mg*28tablets;25mg*30tablets
Specification
Tablets
Description
This product is white film-coated tablets, appearing white or off-white after the coating is removed.
Expiry Date
24 months
Manufacturer
Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
Storage
Sealed, store below 30°C.

Dosage and Administration

This product is an antiviral drug for chronic hepatitis B and should be administered under the guidance of a physician with experience in the treatment of chronic hepatitis B. It is generally used for long-term treatment, and patients are not advised to discontinue medication on their own initiative.

Recommended Dose

Take one tablet (25mg) once daily orally, to be taken with food.

Contraindications

It is contraindicated in patients with hypersensitivity to Tenofovir Amibufenamide or any excipient in this product.

Adverse Reactions

Adverse reaction assessment is based on safety data from a Phase III clinical study. A total of patients with hepatitis B virus (HBV) infection received tenofovir amibufenamide in the study, and the median duration of study drug exposure was during the double-blind treatment period. The common adverse reactions of tenofovir amibufenamide include elevated alanine aminotransferase (ALT), hypophosphatemia, elevated serum parathyroid hormone, elevated aspartate aminotransferase (AST), elevated serum creatine phosphokinase and hyperuricemia.

Use in Special Populations

Pregnancy

Data on the use of Tenofovir Amibufenamide during pregnancy are extremely limited, with only 3 cases of pregnancy and childbirth reported up to Week 144. No malformations were observed in the newborns born to these patients who received Tenofovir Amibufenamide. The potential fetal toxicity of Tenofovir Amibufenamide remains unclear to date. Use of this product during pregnancy may be considered only when the expected benefit outweighs the potential risk to the fetus.

Lactation

It is unknown whether Tenofovir Amibufenamide is excreted into human breast milk. Animal study results have shown that tenofovir is excreted into breast milk. It is also unknown whether tenofovir present in breast milk has any effects on newborns or infants. Therefore, the use of Tenofovir Amibufenamide is not recommended during lactation.

Fertility

To date, there are no relevant data on whether Tenofovir Amibufenamide has an impact on human fertility.

Pediatric Use

To date, there are no data on the safety and efficacy of Tenofovir Amibufenamide in patients under 18 years of age.

Geriatric Use

To date, there are no data on the safety and efficacy of Tenofovir Amibufenamide in patients aged 65 years and above.

For more detailed drug information, please consult the official package leaflet.

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