TAFBIN Film-coated tablet Ref.[115238] Active ingredients: Emtricitabine Tenofovir alafenamide

Therapy should be initiated by a medical practitioner experienced in the management of HIV infection.

Adults and adolescents aged 12 years and older, weighing at least 35 kg

TAFBIN should be administered as shown in table below:

If the patient misses a dose of TAFBIN within 18 hours of the time it is usually taken, the patient should take TAFBIN as soon as possible and resume the normal dosing schedule. If a patient misses a dose of TAFBIN by more than 18 hours, the patient should not take the missed dose and simply resume the usual dosing schedule. If the patient vomits within 1 hour of taking TAFBIN, another tablet should be taken.

Special populations

Elderly (patients ≥65 years old)

No dose adjustment of TAFBIN is required in elderly patients.

Renal impairment

Routine monitoring of calculated creatinine clearance and serum phosphorus should be performed in all individuals (see sections 4.3 and 4.4).

No dose adjustment is required in adults or adolescents (aged at least 12 years and of at least 35 kg body weight) with estimated creatinine clearance (CrCl) ≥30 mL/min. TAFBIN should be discontinued in patients with estimated CrCl that declines below 30 mL/min during treatment (see sections 4.4 and 5.2).

No dose adjustment of TAFBIN is required in adults with end stage renal disease (estimated CrCl ˂15 mL/min) on chronic haemodialysis; however, TAFBIN should generally be avoided but may be used in these patients (see sections 4.4 and 5.2). On days of haemodialysis, TAFBIN should be administered after completion of haemodialysis treatment.

TAFBIN should be avoided in patients with estimated CrCl ≥15 mL/min and ˂30 mL/min as the safety of TAFBIN has not been established in this population. TAFBIN should not be used in 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 less than 18 years with end stage renal disease.

Hepatic impairment

No dose adjustment of TAFBIN is required in patients with mild to moderate hepatic impairment. TAFBIN has not been studied in patients with severe hepatic impairment (Child-Pugh Class C); therefore, TAFBIN is not recommended for use in patients with severe hepatic impairment as no dose recommendations can be made (see sections 4.4 and 5.2).

Paediatric population

The safety and efficacy of TAFBIN in children younger than 12 years or weighing ˂ 35 kg have not been established. No data are available.

Method of administration

TAFBIN should be taken orally, once daily with or without food (see section 5.2). The film-coated tablet should not be chewed, crushed or split.

If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8). Treatment of overdose with TAFBIN consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.

Emtricitabine

Emtricitabine can be removed by haemodialysis, which removes approximately 30% of the emtricitabine dose over a 3-hour dialysis period starting within 1,5 hours of emtricitabine dosing (blood flow rate of 400 mL/min and dialysate flow rate of 600 mL/min). it is not known whether emtricitabine can be removed by peritoneal dialysis.

Tenofovir alafenamide fumarate

Tenofovir is efficiently removed by haemodialysis with an extraction coefficient of approximately 54%.

24 months.

Store in the original container at or below 30°C.

Keep the bottle tightly closed.

TAFBIN is packed in a white high-density polyethylene (HDPE) bottle that is fitted with a white HDPE closure, containing 28, 30 or 90 film-coated tablets and silica gel desiccants.

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