Tenofovir Alafenamide Fumarate Tablets 25mg (30tabs/box)

• Dossier: Ctd
• Transport Package: Free
• Specification: 25mg
• Trademark: Sinolead
• Origin: China
• Model NO.: tablets

Product Description

 

 

Basic Info.

 

Generic Name	Tenofovir Alafenamide Fumarate tablets 25mg
Strength	25mg
Packing	30tabs/box
Origin	China

Component:
Tenofovir Alafenamide Fumarate.

Character:

Tablets.

Indications:

It is indicated for the treatment of adults with chronic hepatitis B virus (HBV) infection and children with compensatory liver disease aged 12 years and older (weighing at least 35kg)
 

Usage and dosage:

1. Treatment should be initiated by a physician experienced in the management of chronic hepatitis B.
2. Adults and adolescents (aged 12 years and above and weighing at least 35kg) : 25 mg tablet once daily, taken orally with food
3. Missed dose:
If a dose of Pofol tenofovir fumarate is missed and is less than 18 hours past the usual dose time, the patient should take a dose as soon as possible and return to normal dosing time.
If it has been more than 18 hours past the usual dosing time, the patient should not take the missed medication and should only return to the normal dosing time.
If the patient vomits within 1 hour of taking Pofol tenofovir fumarate tablets, the patient should take another tablet.
If the patient vomits more than 1 hour after taking Pofol tenofovir fumarate tablets, the patient does not need to take another tablet.
4. Recommended dosage for patients with kidney damage
For patients with estimated creatinine clearance greater than or equal to 15 ml per minute, or with end-stage renal disease (ESRD; Estimated creatinine clearance of less than 15 ml per minute in patients undergoing chronic hemodialysis. Use this drug after the completion of hemodialysis treatment.
It is not recommended for ESRD patients who have not received chronic hemodialysis.
5. Recommended dosage for patients with liver damage
Patients with mild liver damage (Child-Pugh A) do not need to adjust the dose. It is not recommended for patients with decompensated (Child-Pugh B or C) liver damage.

Matters needing attention:

1. Severe acute exacerbation of hepatitis B after drug withdrawal
Discontinuation of anti-hepatitis B therapy, including tenofovir and phenolamine, may result in severe acute exacerbation of hepatitis B. Discontinuation patients should be closely monitored for at least several months after discontinuation of treatment, with clinical and laboratory follow-up. If appropriate, it may be necessary to resume anti-hepatitis B therapy.
2. Risk of HIV-1 resistance in patients co-infected with HBV and HIV-1
Due to the risk of developing HIV-1 resistance, Tenofovir alphenolamine alone is not recommended for the treatment of HIV-1 infection, and its safety and efficacy in patients co-infected with HBV and HIV-1 have not been proven. Before starting treatment, all HBV-infected patients should be tested for HIV antibodies, and if positive, the appropriate combination antiretroviral regimen recommended for patients co-infected with HIV-1 should be used.
3. New or aggravated kidney damage
Patients with impaired renal function taking pretenofovir and patients taking nephrotoxic drugs, including NSaids, are at increased risk for nephro-related adverse events
Serum creatinine was assessed and creatinine clearance, urinary glucose, and urinary protein were estimated in all patients before or while taking the drug, and during clinically appropriate tenofovir and alphenamine therapy. Serum phosphorus is also evaluated in patients with chronic kidney disease.
4. Lactic acidosis/severe hepatomegaly with steatosis
Treatment should be discontinued in any patient whose clinical or laboratory findings suggest lactic acidosis or significant hepatotoxicity, which may include hepatomegalysis and steatosis, even without significant aminotransferase elevation