ments/ Dolutegravir1
Dolutegravir ↓
AUC ↓ 39%
Cmax ↓ 37%
C24 ↓ 39%
(Complex binding to polyvalent ions).
The combination of Juluca and supplements should be used with particular caution. Calcium supplements, iron supplements or multivitamins should be co-administered at the same time as Juluca with a meal.
If calcium supplements, iron supplements or multivitamins cannot be taken at the same time as Juluca, these supplements should be taken well separated in time from the administration of Juluca (minimum 6 hours before or 4 hours after).
Iron supplements/ Dolutegravir1
Dolutegravir ↓
AUC ↓ 54%
Cmax ↓ 57%
C24 ↓ 56%
(Complex binding to polyvalent ions).
Multivitamin/ Dolutegravir1
Dolutegravir ↓
AUC ↓ 33%
Cmax ↓ 35%
C24 ↓ 32%
(Complex binding to polyvalent ions).
Corticosteroids
Prednisone/ Dolutegravir1
Prednisone/ Rilpivirine
Dolutegravir ↔
AUC ↑ 11%
Cmax ↑ 6%
C ↑ 17%
Rilpivirine ↔
(Not studied)
No dose adjustment is required.
Dexamethasone/ Dolutegravir
Dexamethasone/ Rilpivirine
(systemic, except for single dose use)
Dolutegravir ↔
(Not studied)
Rilpivirine ↓
Not studied. Dose dependent decreases in rilpivirine plasma concentrations are expected
(induction of CYP3A enzymes).
Co-administration may cause significant decreases in rilpivirine plasma concentrations. This may result in loss of therapeutic effect of Juluca. Co-administration of Juluca with systemic dexamethasone is contraindicated (except as a single dose) see section 4.3. Alternatives should be considered, particularly for long-term use.
Antidiabetics
Metformin/ Dolutegravir1
Metformin/ Rilpivirine1
Metformin ↑
AUC ↑ 79%
Cmin NA
Cmax ↑ 66%
Metformin
AUC ↔
Cmin NA
Cmax ↔
A dose adjustment of metformin should be considered when starting and stopping co-administration of Juluca with metformin, to maintain glycaemic control. In patients with moderate renal impairment a dose adjustment of metformin should be considered when co-administered with dolutegravir, because of the increased risk for lactic acidosis in patients with moderate renal impairment due to increased metformin concentration (section 4.4).
Antimycobacterials
Rifampicin/ Dolutegravir1
Rifampicin/ Rilpivirine1,2
Dolutegravir ↓
AUC ↓ 54%
Cmax ↓ 43%
C ↓72%
(induction of UGT1A1 and CYP3A enzymes).
Rilpivirine
AUC ↓ 80%
Cmin ↓ 89%
Cmax ↓ 69%
(induction of CYP3A enzymes).
Rifampicin
AUC ↔
Cmin NA
Cmax ↔
25-desacetyl-rifampicin
AUC ↓ 9%
Cmin NA
Cmax ↔
Co-administration may cause significant decreases in rilpivirine plasma concentrations. This may result in loss of therapeutic effect of Juluca. Co-administration of Juluca with rifampicin is contraindicated (see section 4.3).
Rifabutin/ Dolutegravir1
Rifabutin/ Rilpivirine1
300 mg once daily2
300 mg once daily
(+ 25 mg once daily rilpivirine)
300 mg once daily
(+ 50 mg once daily rilpivirine)
Dolutegravir ↔
AUC ↓ 5%
Cmax ↑ 16%
C ↓ 30%
(induction of UGT1A1 and CYP3A enzymes).
Rifabutin
AUC ↔
Cmin ↔
Cmax ↔
25-O-desacetyl-rifabutin
AUC ↔
Cmin ↔
Cmax ↔
Rilpivirine
AUC ↓ 42%
Cmin ↓ 48%
Cmax ↓ 31%
Rilpiviri |
