DOVATO Film-coated tablet Ref.[10718] Active ingredients: Dolutegravir Lamivudine Lamivudine and Dolutegravir

Dovato should be prescribed by physicians experienced in the management of HIV infection.

Posology

Adults and adolescents (above 12 years of age weighing at least 40 kg).

The recommended dose of Dovato in adults and adolescents is one 50 mg/300 mg tablet once daily.

Dose adjustments

A separate preparation of dolutegravir is available 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). In these cases the physician should refer to the individual product information for dolutegravir.

Missed doses

If the patient misses a dose of Dovato, the patient should take Dovato 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.

Elderly

There are limited data available on the use of Dovato in patients aged 65 years and over. No dose adjustment is necessary (see section 5.2).

Renal impairment

Dovato 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

No dosage adjustment is required in patients with mild or moderate hepatic impairment (Child-Pugh grade A or B). No data are available in patients with severe hepatic impairment (Child-Pugh grade C); therefore Dovato should be used with caution in these patients (see section 5.2).

Paediatric population

The safety and efficacy of Dovato in children aged less than 12 years or weighing less than 40 kg have not been established. No data are available.

Method of administration

Oral use.

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

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

There is no specific treatment for an overdose of Dovato. 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. As dolutegravir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis.

Bottle pack: 3 years.

Blister pack: 2 years.

This medicinal product does not require any special storage conditions.

Bottle pack:

Opaque, white HDPE (high density polyethylene) bottles closed with child-resistant polypropylene closures, with a polyethylene faced induction heat seal liner. Each pack consists of one bottle containing 30 filmcoated tablets.

Multipacks containing 90 (3 bottle packs of 30) film-coated tablets.

Blister pack:

Blister strips comprising poly(chlorotrifluoroethylene) (PCTFE), both sides laminated with a Polyvinyl Chloride (PVC) film, sealed with child-resistant push through aluminium lidding foil using a heat seal lacquer. Each 30 film-coated tablets blister pack consists of four blister strips containing 7 film-coated tablets and one blister strip containing 2 film-coated tablets.

Multipacks containing 90 (3 blister packs 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.