Juluca 50mg/25mg film-coated tablets
1. Name of the medicinal product
Juluca 50 mg/25 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and rilpivirine hydrochloride equivalent to 25 mg rilpivirine.
Excipient with known effect
Each film-coated tablet contains 52 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet).
Pink, oval, biconvex tablets, approximately 14 x 7 mm, debossed with 'SV J3T' on one side.
4. Clinical particulars
4.1 Therapeutic indications
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).
4.2 Posology and method of administration
Juluca should be prescribed by physicians experienced in the management of HIV infection.
Posology
The recommended dose of Juluca is one tablet once daily. Juluca 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.
Missed doses
If the patient misses a dose of Juluca, the patient should take Juluca 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 Juluca, another Juluca tablet should be taken with a meal. If a patient vomits more than 4 hours after taking Juluca, the patient does not need to take another dose of Juluca 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 dosage adjustment is required in patients with mild or moderate renal impairment. In patients with severe renal impairment or end stage renal disease, the combination of Juluca with a strong CYP3A inhibitor should only be used if the benefit outweighs the risk. No data are available in subjects receiving dialysis although differences in pharmacokinetics are not expected in this population (see section 5.2).
Hepatic impairment
No dosage adjustment is required in patients with mild or moderate hepatic impairment (Child-Pugh score A or B). Juluca 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 Juluca 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. Currently available data are described in section 5.2, but no recommendation on a posology can be made.
Pregnancy
The safety and efficacy of Juluca in pregnancy have not ye |
