Product Overview
[Drug Name]
Generic Name: Tenofovir Alafenamide Fumarate Tablets
Trade Name: Telihui Tenofovir Alafenamide Fumarate Tablets 25mg*30 Tablets
Pinyin Full Code: TeLiZuoFuMaSuanBingFenTiNuoFuWeiPian 25mg*30 Tablets
[Main Ingredients]
The main ingredient of this product is tenofovir alafenamide fumarate. Chemical Name: Propan-2-yl N-[(S)-({[(2R)+-(6-amino-9H-purin-9-yl)propan-2-yl]-oxy)methyl)(phenoxy)phosphoyl]-1-alaninate, (2E)-but-2-enedioic acid (2:1). Molecular Formula: C21H29O5N6P-1/2(C4H4O4). Molecular Weight: 534.50
[Properties]
This product is a yellow, round, film-coated tablet that appears white or off-white after removal of the coating.
[Indications/Main Functions]
Tenofovir alafenamide tablets are indicated for the treatment of chronic hepatitis B in adults and adolescents (ages 12 years and older, weighing at least 35 kg) (see [Pharmacology and Toxicology]).
[Specifications]
25 mg x 30 tablets
[Dosage and Administration]
Treatment should be initiated by a physician experienced in the management of chronic hepatitis B. Adults and adolescents (ages 12 years and older, weighing at least 35 kg): One tablet once daily. Orally. Take with food. Missed Dose: If a dose of tenofovir alafenamide tablets is missed and less than 18 hours have passed since the usual dosing time, the patient should take the next dose as soon as possible and resume the usual dosing schedule. If more than 18 hours have passed since the usual dosing time, the patient should not take the missed dose and should resume the usual dosing schedule. If the patient vomits within 1 hour after taking tenofovir alafenamide tablets, the patient should take another tablet. If a patient vomits more than one hour after taking a tenofovir alafenamide tablet, the patient does not need to take another tablet. Special Populations: Elderly: No dose adjustment is required for tenofovir alafenamide tablets in patients 65 years of age and older (see [Pharmacology and Toxicology]). Renal Impairment: No dose adjustment is required for adults or adolescents (aged at least 12 years and weighing at least 35 kg) with an estimated creatinine clearance (CrCl) of 215 mL/min or for patients with a CrCl <15 mL/min undergoing hemodialysis. On the day of hemodialysis, tenofovir alafenamide tablets should be administered after the hemodialysis treatment is completed (see [Pharmacology and Toxicology]). No dosage recommendation is available for patients with a CrCl <15 mL/min not undergoing hemodialysis (see [Pharmacology and Toxicology]). Hepatic Impairment: No dose adjustment is required for patients with hepatic impairment (see [Precautions] and [Pharmacology and Toxicology]). Pediatric Population: The safety and efficacy of tenofovir alafenamide fumarate tablets in children under 12 years of age or weighing less than 35 kg have not been established. No data are available.
[Adverse Reactions]
See package insert for details.
[Contraindications]
Hypersensitivity to the active ingredient or any of the following excipients: alpha-lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide yellow.
[Precautions]
1. Hepatitis Exacerbation 1.1 Post-Discontinuation Warning: Acute exacerbations of hepatitis (usually associated with elevated plasma HBV DNA levels) have been reported in patients who discontinued hepatitis B treatment. Most cases are self-limited, but severe exacerbations, including fatal outcomes, can occur after discontinuation of hepatitis B treatment. Liver function should be monitored regularly with clinical and laboratory follow-up for at least 6 months after discontinuation of hepatitis B treatment. If appropriate, hepatitis B treatment may need to be resumed. Discontinuation of treatment is not recommended in patients with advanced liver disease or cirrhosis, as worsening hepatitis after treatment may lead to hepatic decompensation. Hepatitis flares are particularly severe and sometimes fatal in patients with decompensated liver disease. 1.2 Spontaneous exacerbations of chronic hepatitis B are relatively common during treatment and are characterized by a transient increase in serum alanine aminotransferase (ALT). After initiating antiviral therapy, some patients may experience an increase in serum ALT. In patients with compensated liver disease, such increases in serum ALT are typically not accompanied by an increase in serum bilirubin concentration or hepatic decompensation. Patients with cirrhosis may be at increased risk of hepatic decompensation following an exacerbation of hepatitis and should therefore be closely monitored during treatment. 2. HBV Transmission: Patients must be informed that tenofovir alafenamide does not protect against the risk of HBV transmission through sexual contact or blood contamination. Appropriate preventive measures must continue. 3. Patients with Decompensated Liver Disease: There are no data on the safety and efficacy of tenofovir alafenamide tablets in HBV-infected patients with decompensated liver disease and a Child-Pugh-Turcotte (CPT) score >9 (i.e., Class C). These patients may be at increased risk for severe hepatic or renal adverse reactions. Therefore, hepatobiliary and renal parameters should be closely monitored in this patient population (see [Pharmacology and Toxicology]). 4. Lactic Acidosis/Severe Hepatomegaly: Lactic acidosis and severe hepatomegaly, including fatal cases, have been reported with nucleoside analogs (including tenofovir disoproxil fumarate or other tenofovir prodrugs) alone or in combination with other antiretroviral drugs. Treatment with tenofovir alafenamide tablets should be discontinued in any patient with clinical or laboratory findings suggestive of lactic acidosis or significant hepatotoxicity (which may include hepatomegaly and steatosis, even in the absence of significant transaminase elevations). 5. Patients with Renal Impairment (CrCl <30 mL/min): The use of once-daily tenofovir alafenamide tablets in patients with CrCl >15 mL/min but <30 mL/min and patients with CrCl <15 mL/min undergoing hemodialysis is based on very limited pharmacokinetic data and modeling and simulations. There are no safety data for the use of tenofovir alafenamide tablets in HBV-infected patients with CrCl <30 mL/min. Tenofovir alafenamide tablets are not recommended for patients with CrCl <15 mL/min who are not undergoing hemodialysis (see [Dosage and Administration]). 6. Nephrotoxicity: The potential risk of nephrotoxicity from prolonged low-level exposure to tenofovir alafenamide administration cannot be ruled out (see [Pharmacology and Toxicology]). 7. Patients Co-infected with HBV and Hepatitis C or Hepatitis D Virus: There are no data on the safety and efficacy of tenofovir alafenamide tablets in patients co-infected with hepatitis C or Hepatitis D Virus. Coadministration guidelines for the treatment of hepatitis C should be followed (see [Drug Interactions]). 8. Hepatitis B and HIV Co-infection: Due to the risk of HIV drug resistance, tenofovir alafenamide tablets are not recommended for the treatment of HIV-1 infection. The safety and efficacy of tenofovir alafenamide tablets in patients co-infected with HIV-1 and HBV have not been established. Before initiating treatment with tenofovir alafenamide tablets, all HBV-infected patients should undergo HIV antibody testing. If positive, the appropriate antiretroviral combination regimen recommended for patients co-infected with HIV-1 should be used. 9. Combination with Other Medications: Tenofovir alafenamide tablets should not be used with products containing tenofovir alafenamide, tenofovir disoproxil fumarate, or adefovir dipivoxil. 10. Lactose Intolerance: Tenofovir alafenamide tablets contain lactose. Therefore, patients with rare genetic problems of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medication. 11. Effects on the ability to drive and use machines: Tenofovir alafenamide tablets have no or negligible effects on the ability to drive and use machines. Patients should be informed that dizziness has been reported during treatment with tenofovir alafenamide tablets.
