Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
Juluca is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor (see section 5.1).
Dolutegravir/rilpivirine should be prescribed by physicians experienced in the management of HIV infection.
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 Summary of Product Characteristics for these medicinal products.
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.
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).
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).
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).
The safety and efficacy of Juluca in children and adolescents aged less than 18 years have not yet been established. Currently available data are described in section 5.2, but no recommendation on a posology can be made.
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.
No specific symptoms or signs have been identified following acute overdose with dolutegravir or rilpivirine 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 dolutegravir/rilpivirine. If overdose occurs, the patient should be treated supportively with appropriate monitoring, including monitoring of vital signs and ECG (QT interval), as necessary. As dolutegravir and rilpivirine are highly bound to plasma proteins, dialysis is unlikely to result in significant removal of the active substances.
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 pack consists of one bottle containing 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.
No special requirements for disposal.
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