TRELAVUE Film-coated tablet Ref.[115292] Active ingredients: Abacavir Dolutegravir Lamivudine

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

TRELAVUE should not be administered to patients younger than 18 years.

TRELAVUE can be taken with or without food.

TRELAVUE is a fixed-dose tablet and should not be prescribed for patients requiring dosage adjustments, such as those with creatinine clearance less than 50 ml/min. Separate preparations of dolutegravir, abacavir or lamivudine should be administered in cases where discontinuation or dose adjustment is indicated. In these cases, the medical practitioner should refer to the individual product information for these medicinal products.

Since the recommended dose of dolutegravir is 50 mg twice daily for patients with resistance to integrase inhibitors, the use of TRELAVUE is not recommended for patients with integrase inhibitor resistance.

Populations

Adults and adolescents

The recommended dose of TRELAVUE in adults and adolescents weighing more than 40 kg is one tablet once daily.

Elderly

There are limited data available on the use of dolutegravir, abacavir and lamivudine in patients aged 65 years and over. However, there is no evidence that elderly patients require a different dose than younger adult patients (see Pharmacokinetic properties – Special Patient Populations). When treating elderly patients, consideration needs to be given to the greater frequency of decreased hepatic, renal and cardiac function, concomitant medicinal products or disease.

Renal impairment

Whilst no dosage adjustment of dolutegravir or abacavir is necessary in patients with renal impairment, a dose reduction of lamivudine is required due to decreased clearance. Therefore, TRELAVUE should not be used in patients with a creatinine clearance less than 50 ml/min (see Pharmacokinetic properties – Special Patient Populations and CONTRAINDICATIONS).

Hepatic impairment

A dose reduction of abacavir may be required for patients with mild hepatic impairment (Child-Pugh grade A). As dose reduction is not possible with TRELAVUE, the separate preparations of dolutegravir, abacavir or lamivudine should be used when this is judged necessary. TRELAVUE is not recommended in patients with moderate and severe hepatic impairment (Child-Pugh grade B or C) (see Pharmacokinetic properties – Special Patient Populations and CONTRAINDICATIONS).

Symptoms and Signs

There is currently limited experience with overdosage in dolutegravir.

Treatment

The patient should be treated symptomatically and supportively with appropriate monitoring as necessary. Since lamivudine is dialysable, continuous haemodialysis could be used in the treatment of overdose, although this has not been studied. It is not known whether abacavir can be removed by peritoneal dialysis or haemodialysis. As dolutegravir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis.

TRELAVUE tablets are packed into opaque, white High Density Polyethylene (HDPE) bottles and closed with white polypropylene child resistant closures, with a polyethylene faced induction heat seal liner. A silica gel desiccant is included in each bottle. The HDPE bottle is pigmented white with titanium dioxide and is packed into an outer cardboard carton.

Store at or below 30°C.

Store in the original package to protect from moisture. Keep bottle tightly closed. Do not remove the desiccant.