Posology : מינונים

4.2      Posology and method of administration

Dolutegravir/rilpivirine should be prescribed by physicians experienced in the management of HIV infection.
Posology

The recommended dose of Juluca is one tablet once daily. The tablet must be taken with a meal (see section 5.2).

Separate preparations of dolutegravir or rilpivirine are available in cases where discontinuation or dose adjustment of one of the active substances is indicated (see section 4.5). In these cases the physician should refer to the Physician leaflets for these medicinal products.

Missed doses
If the patient misses a dose of Juluca, the patient should take the missed dose with a meal as soon as possible, providing the next dose is not due within 12 hours. If the next dose is due within 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.

If a patient vomits within 4 hours of taking dolutegravir/rilpivirine, another dolutegravir/rilpivirine tablet should be taken with a meal. If a patient vomits more than 4 hours after taking dolutegravir/rilpivirine, the patient does not need to take another dose of dolutegravir/rilpivirine until the next regularly scheduled dose.

Elderly

There are limited data available on the use of Juluca 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).

Renal impairment
No dose adjustment is required in patients with mild or moderate renal impairment. In patients with severe renal impairment or end-stage renal disease, dolutegravir/rilpivirine should be used with caution, as rilpivirine plasma concentrations may be increased secondary to renal dysfunction (see sections 4.5 and 5.2).
No data are available in subjects receiving dialysis although haemodialysis or peritoneal dialysis are not expected to affect dolutegravir or rilpivirine exposure (see section 5.2).

Hepatic impairment
No dose adjustment is required in patients with mild or moderate hepatic impairment (Child-Pugh score A or B). Dolutegravir/rilpivirine should be used with caution in patients with moderate hepatic impairment. No data are available in patients with severe hepatic impairment (Child-Pugh score C); therefore dolutegravir/rilpivirine is not recommended in these patients (see section 5.2).

Paediatric population
The safety and efficacy of Juluca in children and adolescents aged less than 18 years have not yet been established.

Pregnancy
The safety and efficacy of Juluca in pregnancy have not yet been established. Limited data are available regarding the use of dolutegravir during pregnancy. Lower exposures of dolutegravir and rilpivirine were observed during pregnancy. No recommendations for dose adjustments can be made for Juluca. Therefore, use of Juluca during pregnancy is not recommended (see sections 4.4, 4.6, 5.1 and 5.2).

Method of administration

Oral use
Juluca must be taken orally, once daily with a meal (see section 5.2). It is recommended that the film-coated tablet be swallowed whole with water and not be chewed or crushed.