Therapy should be initiated by a physician experienced in the management of chronic hepatitis B.
Posology: Adults and adolescents (aged 12 years and older with body weight at least 35 kg): one tablet once daily.
Treatment discontinuation: Treatment discontinuation may be considered as follows (See Precautions): In HBeAg-positive patients without cirrhosis, treatment should be administered for at least 6-12 months after HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection) is confirmed or until HBs seroconversion or until there is loss of efficacy. (See Precautions). Regular reassessment is recommended after treatment discontinuation to detect virological relapse.
In HBeAg-negative patients without cirrhosis, treatment should be administered at least until HBs seroconversion or until there is evidence of loss of efficacy. With prolonged treatment for more than 2 years, regular reassessment is recommended to confirm that continuing the selected therapy remains appropriate for the patient.
Missed dose: If a dose is missed and less than 18 hours have passed from the time it is usually taken, the patient should take Tenofovir alafenamide as soon as possible and then resume their normal dosing schedule. If more than 18 hours have passed from the time it is usually taken, the patient should not take the missed dose and should simply resume the normal dosing schedule. If the patient vomits within 1 hour of taking Tenofovir alafenamide, the patient should take another tablet. If the patient vomits more than 1 hour after taking Tenofovir alafenamide, the patient does not need to take another tablet.
Special populations: Elderly: No dose adjustment of Tenofovir alafenamide is required in patients aged 65 years and older (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment of Tenofovir alafenamide is required in adults or adolescents (aged at least 12 years and of at least 35 kg body weight) with estimated creatinine clearance (CrCl) ≥ 15 mL/min or in patients with CrCl < 15 mL/min who are receiving haemodialysis.
On days of haemodialysis, Tenofovir alafenamide should be administered after completion of haemodialysis treatment (see Pharmacology: Pharmacokinetics under Actions).
No dosing recommendations can be given for patients with CrCl < 15 mL/min who are not receiving haemodialysis (See Precautions).
Hepatic impairment: No dose adjustment of Tenofovir alafenamide is required in patients with hepatic impairment (See Precautions & Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of Tenofovir alafenamide in children younger than 12 years of age, or weighing < 35 kg, have not yet been established. No data are available.
MODE OF ADMINISTRATION: Oral. Tenofovir alafenamide film-coated tablets should be taken with food.