TRIUMEQ Film-coated tablet Ref.[107695] Active ingredients: Abacavir Dolutegravir Lamivudine Lamivudine, Abacavir and Dolutegravir

Therapy should be prescribed by a physician experienced in the management of HIV infection.

Posology

Adults, adolescents and children (weighing at least 25kg)

The recommended dose of Triumeq in adults, adolescents and children is one tablet once daily.

Triumeq film-coated tablets should not be administered to adults, adolescents or children who weigh less than 25 kg because it is a fixed-dose tablet that cannot be dose reduced. Triumeq dispersible tablets should be administered to children who weigh at least 14 kg to less than 25 kg.

Separate preparations of dolutegravir, abacavir or lamivudine are available in cases where discontinuation or dose adjustment of one of the active substances is indicated. In these cases the physician should refer to the individual product information for these medicinal products.

A separate dose of dolutegravir (film-coated tablets or dispersible tablets) is applicable where a dose adjustment is indicated due to drug-drug interactions (e.g. rifampicin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St. John’s wort, etravirine (without boosted protease inhibitors), efavirenz, nevirapine, or tipranavir/ritonavir (see sections 4.4 and 4.5).

Dispersible tablets

Triumeq is available as dispersible tablets for patients who weigh at least 14 kg to less than 25 kg. The bioavailability of dolutegravir from film-coated tablets and dispersible tablets is not comparable; therefore, they must not be used as direct replacements (see section 5.2).

Missed doses

If the patient misses a dose of Triumeq, the patient should take it as soon as possible, providing the next dose is not due within 4 hours. If the next dose is due within 4 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.

Special populations

Elderly

There are limited data available on the use of dolutegravir, abacavir and lamivudine in patients aged 65 years and over. There is no evidence that elderly patients require a different dose than younger adult patients (see section 5.2). Special care is advised in this age group due to age associated changes such as the decrease in renal function and alteration of haematological parameters.

Renal impairment

Triumeq is not recommended for use in patients with a creatinine clearance <30 mL/min (see section 5.2). No dose adjustment is required in patients with mild or moderate renal impairment. However, the lamivudine exposure is significantly increased in patients with a creatinine clearance <50 mL/min (see section 4.4).

Hepatic impairment

Abacavir is primarily metabolised by the liver. No clinical data are available in patients with moderate or severe hepatic impairment, therefore the use of Triumeq is not recommended unless judged necessary. In patients with mild hepatic impairment (Child-Pugh score 5-6) close monitoring is required, including monitoring of abacavir plasma levels if feasible (see sections 4.4 and 5.2).

Paediatric population

The safety and efficacy of Triumeq in children weighing less than 14 kg have not yet been established.

Currently available data are described in section 4.8, 5.1 and 5.2, but no recommendation on a posology can be made.

Method of administration

Oral use.

Triumeq can be taken with or without food (see section 5.2).

No specific symptoms or signs have been identified following acute overdose with dolutegravir, abacavir or lamivudine, apart from those listed as adverse reactions.

Further management should be as clinically indicated or as recommended by the national poisons centre, where available. There is no specific treatment for an overdose of Triumeq. If overdose occurs, the patient should be treated 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.

3 years.

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

This medicinal product does not require any special temperature storage conditions.

White HDPE (high density polyethylene) bottles closed with polypropylene child-resistant closures, with a polyethylene faced induction heat seal liner.

Each bottle contains 30 film-coated tablets and a desiccant.

Multipacks containing 90 (3 packs of 30) film-coated tablets. Each pack of 30 film-coated tablets contains a desiccant.

Not all pack sizes may be marketed.

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