Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Emtricitabine/Tenofovir disoproxil Krka

Emtricitabine/Tenofovir disoproxil Krka 200 mg/245 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 11–14

HOS-136585 · Präparat HOS-097888

11 Lamivudine/Tenofovir disoproxil Lamivudine: Lamivudine and AUC: ↓ 3% (↓ 8% to ↑ 15) Emtricitabine/Tenofovir disoproxil Cmax: ↓ 24% (↓ 44 to ↓ 12) Krka should not be administered Cmin: NC concomitantly (see section 4.4). Tenofovir: AUC: ↓ 4% (↓ 15 to ↑ 8) Cmax: ↑ 102% (↓ 96 to ↑ 108) Cmin: NC Efavirenz/Tenofovir disoproxil Efavirenz: No dose adjustment of efavirenz is AUC: ↓ 4% (↓ 7 to ↓ 1) required. Cmax: ↓ 4% (↓ 9 to ↑ 2) Cmin: NC Tenofovir: AUC: ↓ 1% (↓ 8 to ↑ 6) Cmax: ↑ 7% (↓ 6 to ↑ 22) Cmin: NC ANTI-INFECTIVES Hepatitis B virus (HBV) antiviral agents Adefovir dipivoxil /Tenofovir Adefovir dipivoxil: Adefovir dipivoxil and disoproxil AUC: ↓ 11% (↓ 14 to ↓ 7) Emtricitabine/Tenofovir disoproxil Cmax: ↓ 7% (↓ 13 to ↓ 0) Krka should not be administered Cmin: NC concomitantly (see section 4.4). Tenofovir: AUC: ↓ 2% (↓ 5 to ↑ 0) Cmax: ↓ 1% (↓ 7 to ↑ 6) Cmin: NC Hepatitis C virus (HCV) antiviral agents Ledipasvir/Sofosbuvir Ledipasvir: Increased plasma concentrations of (90 mg/400 mg q.d.) + AUC: ↑ 96% (↑ 74 to ↑ 121) tenofovir resulting from co- Atazanavir/Ritonavir Cmax: ↑ 68% (↑ 54 to ↑ 84) administration of tenofovir disoproxil, (300 mg q.d./100 mg q.d.) + Cmin: ↑ 118% (↑ 91 to ↑ 150) ledipasvir/sofosbuvir and Emtricitabine/Tenofovir disoproxil Sofosbuvir: atazanavir/ritonavir may increase (200 mg/245 mg q.d.)1 AUC: ↔ adverse reactions related to tenofovir Cmax: ↔ disoproxil, including renal disorders. GS-3310072: The safety of tenofovir disoproxil when AUC: ↔ used with ledipasvir/sofosbuvir and a Cmax: ↔ pharmacokinetic enhancer (e.g. Cmin: ↑ 42% (↑ 34 to ↑ 49) ritonavir or cobicistat) has not been Atazanavir: established. AUC: ↔ The combination should be used with Cmax: ↔ caution with frequent renal monitoring, Cmin: ↑ 63% (↑ 45 to ↑ 84) if other alternatives are not available Ritonavir: (see section 4.4). AUC: ↔ Cmax: ↔ Cmin: ↑ 45% (↑ 27 to ↑ 64) Emtricitabine: AUC: ↔ Cmax: ↔ Cmin: ↔ Tenofovir: AUC: ↔ Cmax: ↑ 47% (↑ 37 to ↑ 58) Cmin: ↑ 47% (↑ 38 to ↑ 57) Ledipasvir/Sofosbuvir Ledipasvir: Increased plasma concentrations of (90 mg/400 mg q.d.) + AUC: ↔ tenofovir resulting from co- Darunavir/Ritonavir Cmax: ↔ administration of tenofovir disoproxil, (800 mg q.d./100 mg q.d.) + Cmin: ↔ ledipasvir/sofosbuvir and Emtricitabine/Tenofovir disoproxil Sofosbuvir: darunavir/ritonavir may increase (200 mg/245 mg q.d.)1 AUC: ↓ 27% (↓ 35 to ↓ 18) adverse reactions related to tenofovir 12  Cmax: ↓ 37% (↓ 48 to ↓ 25) disoproxil, including renal disorders. GS-3310072: The safety of tenofovir disoproxil when AUC: ↔ used with ledipasvir/sofosbuvir and a Cmax: ↔ pharmacokinetic enhancer (e.g. Cmin: ↔ ritonavir or cobicistat) has not been Darunavir: established. AUC: ↔ The combination should be used with Cmax: ↔ caution with frequent renal monitoring, Cmin: ↔ if other alternatives are not available Ritonavir: (see section 4.4). AUC: ↔ Cmax: ↔ Cmin: ↑ 48% (↑ 34 to ↑ 63) Emtricitabine: AUC: ↔ Cmax: ↔ Cmin: ↔ Tenofovir: AUC: ↑ 50% (↑ 42 to ↑ 59) Cmax: ↑ 64% (↑ 54 to ↑ 74) Cmin: ↑ 59% (↑ 49 to ↑ 70) Ledipasvir/Sofosbuvir Ledipasvir: No dose adjustment is recommended. (90 mg/400 mg q.d.) + AUC: ↓ 34% (↓ 41 to ↓ 25) The increased exposure of tenofovir Efavirenz/Emtricitabine/Tenofovir Cmax: ↓ 34% (↓ 41 to ↑ 25) could potentiate adverse reactions disoproxil Cmin: ↓ 34% (↓ 43 to ↑ 24) associated with tenofovir disoproxil, (600 mg/200 mg/245 mg q.d.) Sofosbuvir: including renal disorders. Renal AUC: ↔ function should be closely monitored Cmax: ↔ (see section 4.4). GS-3310072: AUC: ↔ Cmax: ↔ Cmin: ↔ Efavirenz: AUC: ↔ Cmax: ↔ Cmin: ↔ Emtricitabine: AUC: ↔ Cmax: ↔ Cmin: ↔ Tenofovir: AUC: ↑ 98% (↑ 77 to ↑ 123) Cmax: ↑ 79% (↑ 56 to ↑ 104) Cmin: ↑ 163% (↑ 137 to ↑ 197) Ledipasvir/Sofosbuvir Ledipasvir: No dose adjustment is recommended. (90 mg/400 mg q.d.) + AUC: ↔ The increased exposure of tenofovir Emtricitabine/Rilpivirine/ Tenofovir Cmax: ↔ could potentiate adverse reactions disoproxil Cmin: ↔ associated with tenofovir disoproxil, (200 mg/25 mg/245 mg q.d.) Sofosbuvir: including renal disorders. Renal AUC: ↔ function should be closely monitored Cmax: ↔ (see section 4.4). GS-3310072: AUC: ↔ Cmax: ↔ Cmin: ↔ Emtricitabine: AUC: ↔ Cmax: ↔ Cmin: ↔ Rilpivirine: AUC: ↔ Cmax: ↔ 13  Cmin: ↔ Tenofovir: AUC: ↑ 40% (↑ 31 to ↑ 50) Cmax: ↔ Cmin: ↑ 91% (↑ 74 to ↑ 110) Ledipasvir/Sofosbuvir Sofosbuvir: No dose adjustment is required. The (90 mg/400 mg q.d.) + Dolutegravir AUC: ↔ increased exposure of tenofovir could (50 mg q.d.) + Cmax: ↔ potentiate adverse reactions associated Emtricitabine/Tenofovir disoproxil with tenofovir disoproxil, including (200 mg/245 mg q.d.) GS-3310072 renal disorders. Renal function should AUC: ↔ be closely monitored (see section 4.4). Cmax: ↔ Cmin: ↔

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): tenofovir (HOS-088083) adefovir dipivoxil (HOS-110478) atazanavir (HOS-086180) sofosbuvir (HOS-108928) ledipasvir (HOS-110493) cobicistat (HOS-088111) dolutegravir (HOS-089992) hepatitis C virus (HOS-108813) lamivudine (HOS-085829) rilpivirine (HOS-088090) darunavir (HOS-086181) hepatitis B virus (HOS-113725) efavirenz (HOS-087947) ritonavir (HOS-084521)