Product Overview
[Drug Name]
Generic Name: Tenofovir Alafenamide Fumarate Tablets
Trade Name: Belode Tenofovir Alafenamide Fumarate Tablets 25mg x 30 Tablets
[Main Ingredient]
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: 534.5
[Properties]
This product is a light yellow to yellow, round, film-coated tablet. After removing the coating, it appears white or off-white.
[Indications/Main Functions]
Tenofovir alafenamide tablets are indicated for the treatment of chronic hepatitis B in adults and adolescents (aged 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 (aged 12 years and older, weighing at least 35 kg): One tablet once daily. Orally. To be taken 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 who are 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 who are 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 the package insert for details.
[Contraindications]
Hypersensitivity to the active ingredient or any of the following excipients: (a) lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide yellow.
[Precautions]
See the package insert for details.
