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Juluca 50 mg/25 mg film-coated tablets(六)
2019-04-16 22:48:43 来源: 作者: 【 】 浏览:10389次 评论:0
ofosbuvir / Rilpivirine
Dolutegravir ↔
(Not studied)
Rilpivirine ↔
AUC ↓ 5%
Cmin ↓ 7%
Cmax ↓ 3%
Ledipasvir ↔
AUC ↑ 2%
Cmin ↑ 2%
Cmax ↑ 1%
Sofosbuvir ↔
AUC ↑ 5%
Cmax ↓ 4%
Sofosbuvir metabolite GS-331007 ↔
AUC ↑ 8%
Cmin ↑ 10%
Cmax ↑ 8%
No dose adjustment is required.
Sofosbuvir/ Velpatasvir/ Dolutegravir1
Sofosbuvir/ Velpatasvir/ Rilpivirine
Dolutegravir ↔
(Not studied)
Rilpivirine ↔
AUC ↔
Cmin ↔
Cmax ↔
Sofosbuvir ↔
AUC ↔
Cmax ↔
Sofosbuvir metabolite GS-331007 ↔
AUC ↔
Cmin ↔
Cmax ↔
Velpatasvir ↔
AUC ↔
Cmin ↔
Cmax ↔
No dose adjustment is required.
Ribavirin/ Dolutegravir
 
Ribavirin/ Rilpivirine
Dolutegravir ↔
(Not studied)
Rilpivirine ↔
(Not studied)
No dose adjustment is required.
Other active substances
Antiarrhythmics
Dofetilide/ Dolutegravir
Dofetilide ↑
Not studied. Potential increase via inhibition of OCT2 transporter.
Dolutegravir and dofetilide co-administration is contraindicated due to potential life-threatening toxicity caused by high dofetilide concentration (see section 4.3).
Digoxin/ Dolutegravir
Digoxin/ Rilpivirine1
Dolutegravir ↔
(Not studied)
Rilpivirine ↔
Digoxin
AUC ↔
Cmin NA
Cmax ↔
No dose adjustment is required.
Anticonvulsants
Carbamazepine/ Dolutegravir1
Carbamazepine/ Rilpivirine
Dolutegravir ↓
AUC ↓ 49%
Cmax ↓ 33%
C ↓ 73%
Rilpivirine↓
Not studied. Significant decreases in rilpivirine plasma concentrations are expected (induction of CYP3A enzymes).
Metabolic inducers may significantly decrease dolutegravir/rilpivirine plasma concentrations, resulting in loss of therapeutic effect. Co-administration of Juluca with these metabolic inducers is contraindicated (see section 4.3).
Oxcarbazepine
Phenytoin
Phenobarbital/ Dolutegravir
Oxcarbazepine
Phenytoin
Phenobarbital/ Rilpivirine
Dolutegravir ↓
Not studied. Decrease expected due to induction of UGT1A1 and CYP3A enzymes, a similar reduction in exposure as observed with carbamazepine is expected.
Rilpivirine ↓
Not studied. Significant decreases in rilpivirine plasma concentrations are expected
(induction of CYP3A enzymes).
Metabolic inducers may significantly decrease dolutegravir/rilpivirine plasma concentrations, resulting in loss of therapeutic effect. Co-administration of Juluca with these metabolic inducers is contraindicated (see section 4.3).
Azole anti-fungals
Ketoconazole/ Dolutegravir
Ketoconazole/ Rilpivirine1,2
Dolutegravir ↔
(Not studied)
Rilpivirine
AUC ↑ 49%
Cmin ↑ 76%
Cmax ↑ 30%
(inhibition of CYP3A enzymes).
Ketoconazole
AUC ↓ 24%
Cmin ↓ 66%
Cmax ↔
(induction of CYP3A due to high rilpivirine dose in the study).
No dose adjustment is required.
Fluconazole
Itraconazole
Isavuconazole
Posaconazole
Voriconazole/ Dolutegravir
Fluconazole
Itraconazole
Isavuconazole
Posaconazole
Voriconazole/ Rilpivirine
Dolutegravir ↔
(Not studied)
Rilpivirine ↑
Not studied. May cause an increase in the plasma concentrations of rilpivirine
(inhibition of CYP3A enzymes).
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