Tenofovir Alafenamide

Indications & Dose:

treatment of chronic hepatitis B virus (HBV) infection in adults and adolescents (aged 12 years or above having body weight at least 35 kg).

DOSAGE AND ADMINISTRATION

Recommended Dosing The recommended dose of (Tenofovir alafenamide) is 25mg once daily.  (Tenofovir alafenamide) Tablets may be taken with or without food. Patients with renal impairment No dosage adjustment of  (Tenofovir alafenamide) is required in patients with mild, moderate, or severe renal impairment.  (Tenofovir alafenamide) is not recommended in patients with end stage renal disease (estimated creatinine clearance below 15 mL per minute). Patients with hepatic impairment No dosage adjustment of  (Tenofovir alafenamide) is required in patients with mild hepatic impairment (Child-Pugh A).  (Tenofovir alafenamide) is not recommended in patients with decompensated (Child- Pugh B or C) hepatic impairment. Elderly No dose adjustment of  (Tenofovir alafenamide) is required in patients aged 65 years and older. Treatment Discontinuation Treatment discontinuation may be considered as follows:

• 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. 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.

Contraindications:

Tenofovir alafenamide is contraindicated in patients with hypersensitivity to active substance or to any excipient of the product.

Side Effects:

Cautions:

Precautions:

Interaction:

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Adverse Effects:

Lactations:

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Counselling:

Side Effects Or Adverse Reactions:

Very common Headache. [ Tenofovir Alafenamide] TM Tablets 25mg NH2 HO N N O N N O OPh O P NH O CH OH 3 O 1/2 H3C O Please read the contents carefully before use. This package insert is continually updated from time to time. Common Dizziness, rash, pruritus, increased ALT, arthralgia, diarrhea, vomiting, nausea, abdominal pain, abdominal distension, flatulence, fatigue and cough

Patient And Carer Advice: