ne
AUC ↑ 16%*
Cmin ↔*
Cmax ↑ 43%*
* compared to 25 mg once daily rilpivirine alone
(induction of CYP3A enzymes).
Co-administration is likely to cause significant decreases in rilpivirine plasma concentrations (induction of CYP3A enzymes). When Juluca is co-administered with rifabutin, an additional 25 mg tablet of rilpivirine per day should be taken at the same time with Juluca, for the duration of the rifabutin co-administration (a separate formulation of rilpivirine is available for this dose adjustment, see section 4.2).
Rifapentine/ Dolutegravir
Rifapentine/ Rilpivirine
Dolutegravir ↓
(Not studied)
Rilpivirine ↓
Not studied. Significant decreases in rilpivirine plasma concentrations are expected.
Co-administration may cause significant decreases in rilpivirine plasma concentrations. This may result in loss of therapeutic effect of Juluca (induction of CYP3A enzymes). Co-administration of Juluca with rifapentine is contraindicated (see section 4.3).
Antimalarials
Artemether/ Lumefantrine/ Dolutegravir
Artemether/ Lumefantrine/ Rilpivirine
Dolutegravir ↔
(Not studied)
Rilpivirine ↓
Not studied. Decreased exposure of rilpivirine is expected
(induction of CYP3A enzymes).
The combination of Juluca and artemether/lumefantrine should be used with caution.
Atovaquone/ Proguanil/ Dolutegravir
Atovaquone/ Proguanil/ Rilpivirine
Dolutegravir ↔
(Not studied)
Rilpivirine ↔
(Not studied).
No dose adjustment is required.
Macrolide antibiotics
Clarithromycin
Erythromycin /Dolutegravir
Clarithromycin
Erythromycin /Rilpivirine
Dolutegravir ↔
(Not studied)
Rilpivirine ↑
Not studied. Increased exposure of rilpivirine is expected
(inhibition of CYP3A enzymes).
Where possible, alternatives such as azithromycin should be considered.
Oral contraceptives
Ethinyl estradiol (EE)1 and Norelgestromin (NGMN)1 / Dolutegravir
Ethinyl estradiol (EE)1 and Norethindrone1/ Rilpivirine
Dolutegravir ↔
EE ↔
AUC ↑ 3%
Cmax ↓ 1%
NGMN ↔
AUC ↓ 2%
Cmax ↓ 11%
Rilpivirine ↔*
EE ↔
AUC ↔
Cmin ↔
Cmax ↑ 17%
Norethindrone ↔
AUC ↔
Cmin ↔
Cmax ↔
*based on historic controls.
Dolutegravir or rilpivirine did not change ethinyl estradiol and norelgestromin (dolutegravir) or norethindrone (rilpivirine) plasma concentrations to a clinically relevant extent. No dose adjustment of oral contraceptives is required when co-administered with Juluca.
Analgesics
Methadone/ Dolutegravir1
Methadone / Rilpivirine1
Dolutegravir ↔
Methadone ↔
AUC ↓ 2%
Cmax ↔ 0%
C ↓ 1%
Rilpivirine:
AUC: ↔*
Cmin: ↔*
Cmax: ↔*
R(-) methadone:
AUC: ↓ 16%
Cmin: ↓ 22%
Cmax: ↓ 14%
*based on historic controls.
No dose adjustments are required when initiating co-administration of methadone with Juluca. However, clinical monitoring is recommended as methadone maintenance therapy may need to be adjusted in some patients.
Paracetamol/ Dolutegravir
Paracetamol / Rilpivirine1,2
Dolutegravir ↔
(Not studied)
Rilpivirine
AUC ↔
Cmin ↑ 26%
Cmax ↔
Paracetamol
AUC ↔
Cmin NA
Cmax ↔
No dose adjustment is required.
Anticoagulants
Dabigatran etexilate/ Dolu |
