VEMLIDY Film-coated tablet Ref.[7482] Active ingredients: Tenofovir alafenamide

Therapy should be initiated by a physician experienced in the management of CHB.

Posology

Adults and paediatric patients at least 6 years of age and older weighing at least 25 kg: one tablet once daily.

Treatment discontinuation

Treatment discontinuation may be considered as follows (see section 4.4):

• 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 section 4.4). 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 this medicinal product 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 the treatment, the patient should take another tablet. If the patient vomits more than 1 hour after taking the treatment, the patient does not need to take another tablet.

Special populations

Elderly

No dose adjustment of this medicinal product is required in patients aged 65 years and older (see section 5.2).

Renal impairment

No dose adjustment of this medicinal product 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, this medicinal product should be administered after completion of haemodialysis treatment (see section 5.2).

No dosing recommendations can be given for patients with CrCl <15 mL/min who are not receiving haemodialysis (see section 4.4).

No data are available to make dose recommendations in children aged less than 12 years and of less than 35 kg body weight with renal impairment.

Hepatic impairment

No dose adjustment of this medicinal product is required in patients with hepatic impairment (see sections 4.4 and 5.2).

Paediatric population

The safety and efficacy of Vemlidy in children younger than 6 years of age or weighing <25 kg have not yet been established. No data are available.

Method of administration

Oral use. Vemlidy film-coated tablets should be taken with food (see section 5.2).

If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8).

Treatment of overdose with tenofovir alafenamide consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.

Tenofovir is efficiently removed by haemodialysis with an extraction coefficient of approximately 54%. It is not known whether tenofovir can be removed by peritoneal dialysis.

4 years.

Store in the original package in order to protect from moisture. Keep the bottle tightly closed.

High density polyethylene (HDPE) bottles, enclosed with a polypropylene continuous-thread, child-resistant cap, lined with an induction-activated aluminium foil liner. Each bottle contains silica gel desiccant and polyester coil.

The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 90 (3 bottles of 30) film-coated tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.