Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Viread

Viread 245 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 140

HOS-110806 · Präparat HOS-093385

Rilpivirine: AUC: ↔ 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): rilpivirine (HOS-088090)

Wechselwirkungen · Viread

Viread 33 mg/g granules · Abschnitt 4.5 · PDF-Seite 176

HOS-110877 · Präparat HOS-093385

Tenofovir: AUC: ↑ 98% Cmax: ↑ 79% Cmin: ↑ 163% Ledipasvir/Sofosbuvir Ledipasvir: No dose adjustment is (90 mg/400 mg q.d.) + AUC: ↔ recommended. The increased Emtricitabine/Rilpivirine/Tenofovir Cmax: ↔ exposure of tenofovir could disoproxil Cmin: ↔ potentiate adverse reactions (200 mg/25 mg/245 mg q.d.) associated with tenofovir Sofosbuvir: disoproxil, including renal AUC: ↔ disorders. Renal function should Cmax: ↔ be closely monitored (see section 4.4). GS-3310072: AUC: ↔ 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) sofosbuvir (HOS-108928) ledipasvir (HOS-110493) rilpivirine (HOS-088090) emtricitabine (HOS-085840)

Wechselwirkungen · Viread

Viread 33 mg/g granules · Abschnitt 4.5 · PDF-Seite 176

HOS-110878 · Präparat HOS-093385

Rilpivirine: AUC: ↔ 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): rilpivirine (HOS-088090)

Wechselwirkungen · Viread

Viread 33 mg/g granules · Abschnitt 4.5 · PDF-Seite 181–182

HOS-110900 · Präparat HOS-093385

181  Medicinal product by Effects on drug levels Recommendation concerning therapeutic areas Mean percent change in AUC, co-administration with 245 mg (dose in mg) Cmax, Cmin tenofovir disoproxil Sofosbuvir/Velpatasvir Sofosbuvir: No dose adjustment is (400 mg/100 mg q.d.) + AUC: ↔ recommended. The increased Emtricitabine/Rilpivirine/Tenofovir Cmax: ↔ exposure of tenofovir could disoproxil potentiate adverse reactions (200 mg/25 mg/245 mg q.d.) GS-3310072: associated with tenofovir AUC: ↔ disoproxil, including renal Cmax: ↔ disorders. Renal function should Cmin: ↔ be closely monitored (see section 4.4). Velpatasvir: AUC: ↔ 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) sofosbuvir (HOS-108928) velpatasvir (HOS-108929) rilpivirine (HOS-088090) emtricitabine (HOS-085840)

Wechselwirkungen · Truvada

Truvada 200 mg/245 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 14

HOS-113738 · Präparat HOS-093961

Tenofovir: AUC: ↑ 98% (↑ 77 to ↑ 123) Cmax: ↑ 79% (↑ 56 to ↑ 104) Cmin: ↑ 163% (↑ 137 to ↑ 197) Ledipasvir/Sofosbuvir Ledipasvir: No dose adjustment is (90 mg/400 mg q.d.) + AUC: ↔ recommended. The increased Emtricitabine/Rilpivirine/ Cmax: ↔ exposure of tenofovir could Tenofovir disoproxil Cmin: ↔ potentiate adverse reactions (200 mg/25 mg/245 mg q.d.) associated with tenofovir Sofosbuvir: disoproxil, including renal AUC: ↔ disorders. Renal function should Cmax: ↔ be closely monitored (see section 4.4). GS-3310072: AUC: ↔ 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) sofosbuvir (HOS-108928) ledipasvir (HOS-110493) rilpivirine (HOS-088090)

Wechselwirkungen · Truvada

Truvada 200 mg/245 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 14

HOS-113739 · Präparat HOS-093961

Rilpivirine: AUC: ↔ 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): rilpivirine (HOS-088090)

Wechselwirkungen · Truvada

Truvada 200 mg/245 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 19–20

HOS-113762 · Präparat HOS-093961

19  Medicinal product by Effects on drug levels Recommendation concerning therapeutic areas Mean percent change in AUC, co-administration with Truvada Cmax, Cmin with 90% confidence (emtricitabine 200 mg, tenofovir intervals if available disoproxil 245 mg) (mechanism) Sofosbuvir/Velpatasvir Sofosbuvir: No dose adjustment is (400 mg/100 mg q.d.) + AUC: ↔ recommended. The increased Emtricitabine/Rilpivirine/Tenofovir Cmax: ↔ exposure of tenofovir could disoproxil potentiate adverse reactions (200 mg/25 mg/245 mg q.d.) GS-3310072: associated with tenofovir AUC: ↔ disoproxil, including renal Cmax: ↔ disorders. Renal function should Cmin: ↔ be closely monitored (see section 4.4). Velpatasvir: AUC: ↔ 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) sofosbuvir (HOS-108928) velpatasvir (HOS-108929) rilpivirine (HOS-088090)

Wechselwirkungen · Truvada

Truvada 200 mg/245 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 20

HOS-113764 · Präparat HOS-093961

Rilpivirine: AUC: ↔ 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): rilpivirine (HOS-088090)

Wechselwirkungen · Aptivus

Aptivus 250 mg soft capsules · Abschnitt 4.5 · PDF-Seite 11

HOS-114814 · Präparat HOS-094169

Concomitant use of Aptivus/ritonavir caused a decrease of etravirine exposure that could significantly impair the virologic response to etravirine. Nevirapine The limited data available from a No dosage adjustment necessary. No interaction study phase IIa study in HIV-infected performed patients suggest that no significant interaction is expected between nevirapine and TPV/r. Moreover a study with TPV/r and another NNRTI (efavirenz) did not show any clinically relevant interaction (see above). Rilpivirine Concomitant use of rilpivirine Close monitoring for signs of No interaction study with some ritonavir-boosted rilpivirine toxicity and possibly performed protease inhibitors has also dose adjustment of rilpivirine demonstrated an increase in the is recommended when co- plasma concentrations of administered with rilpivirine. Aptivus/ritonavir. Protease inhibitors (PIs) According to current treatment guidelines, dual therapy with protease inhibitors is generally not recommended Amprenavir/ritonavir Amprenavir Cmax ↓ 39% The concomitant use of Aptivus, 600/100 mg BID Amprenavir AUC ↓ 44% co-administered with low dose Amprenavir Cmin ↓ 55% ritonavir, with amprenavir/ritonavir is not The clinical relevance of this recommended. reduction in amprenavir If the combination is nevertheless concentrations has not been considered necessary, a established. monitoring of the plasma levels of amprenavir is strongly Mechanism unknown. encouraged (see section 4.4). Atazanavir/ritonavir Atazanavir Cmax ↓ 57% The concomitant use of Aptivus, 300/100 mg QD Atazanavir AUC ↓ 68% co-administered with low dose (TPV/r 500/100 mg BID) Atazanavir Cmin ↓ 81% ritonavir, with atazanavir/ritonavir is not Mechanism unknown. recommended. If the co-administration is Tipranavir Cmax  8% nevertheless considered Tipranavir AUC  20% necessary, a close monitoring of Tipranavir Cmin  75% the safety of tipranavir and a monitoring of plasma Inhibition of CYP 3A4 by concentrations of atazanavir are atazanavir/ritonavir and strongly encouraged (see induction by tipranavir/r. section 4.4).

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): atazanavir (HOS-086180) protease (HOS-085623) etravirine (HOS-088088) amprenavir (HOS-086183) rilpivirine (HOS-088090) efavirenz (HOS-087947) nevirapine (HOS-088064) ritonavir (HOS-084521)

Wechselwirkungen · Prezista

PREZISTA 100 mg/ml oral suspension · Abschnitt 4.5 · PDF-Seite 13

HOS-116352 · Präparat HOS-094447

Co-administration with PREZISTA co-administered with cobicistat is not recommended (see section 4.4). Etravirine etravirine AUC ↓ 37% PREZISTA co-administered with 100 mg twice daily etravirine Cmin ↓ 49% low dose ritonavir and etravirine etravirine Cmax ↓ 32% 200 mg twice daily can be used darunavir AUC ↑ 15% without dose adjustments. darunavir Cmin ↔ darunavir Cmax ↔ Co-administration with PREZISTA co-administered with cobicistat is not recommended (see section 4.4). Nevirapine nevirapine AUC ↑ 27% PREZISTA co-administered with 200 mg twice daily nevirapine Cmin ↑ 47% low dose ritonavir and nevirapine nevirapine Cmax ↑ 18% can be used without dose # darunavir: concentrations were adjustments. consistent with historical data (↑ nevirapine from CYP3A inhibition) Co-administration with PREZISTA co-administered with cobicistat is not recommended (see section 4.4). Rilpivirine rilpivirine AUC ↑ 130% Boosted PREZISTA and rilpivirine 150 mg once daily rilpivirine Cmin ↑ 178% can be used without dose rilpivirine Cmax ↑ 79% adjustments. darunavir AUC ↔ darunavir Cmin ↓ 11% darunavir Cmax ↔

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): cobicistat (HOS-088111) etravirine (HOS-088088) rilpivirine (HOS-088090) nevirapine (HOS-088064) ritonavir (HOS-084521)

Wechselwirkungen · Prezista

PREZISTA 75 mg film-coated tablets PREZISTA 150 mg film-coated tablets PREZISTA 600 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 54–55

HOS-116512 · Präparat HOS-094447

54  Nevirapine nevirapine AUC ↑ 27% PREZISTA co-administered with 200 mg twice daily nevirapine Cmin ↑ 47% low dose ritonavir and nevirapine nevirapine Cmax ↑ 18% can be used without dose # darunavir: concentrations were adjustments. consistent with historical data (↑ nevirapine from CYP3A inhibition) Rilpivirine rilpivirine AUC ↑ 130% PREZISTA co-administered with 150 mg once daily rilpivirine Cmin ↑ 178% low dose ritonavir and rilpivirine rilpivirine Cmax ↑ 79% can be used without dose darunavir AUC ↔ adjustments. darunavir Cmin ↓ 11% darunavir Cmax ↔ HIV Protease inhibitors (PIs) - without additional co-administration of low dose ritonavir† Atazanavir atazanavir AUC ↔ PREZISTA co-administered with 300 mg once daily atazanavir Cmin ↑ 52% low dose ritonavir and atazanavir atazanavir Cmax ↓ 11% can be used without dose # darunavir AUC ↔ adjustments. # darunavir Cmin ↔ # darunavir Cmax ↔

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): atazanavir (HOS-086180) protease (HOS-085623) rilpivirine (HOS-088090) nevirapine (HOS-088064) ritonavir (HOS-084521)

Wechselwirkungen · Prezista

PREZISTA 400 mg film-coated tablets PREZISTA 800 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 94–95

HOS-116605 · Präparat HOS-094447

94  Etravirine etravirine AUC ↓ 37% PREZISTA co-administered with 100 mg twice daily etravirine Cmin ↓ 49% low dose ritonavir and etravirine etravirine Cmax ↓ 32% 200 mg twice daily can be used darunavir AUC ↑ 15% without dose adjustments. darunavir Cmin ↔ darunavir Cmax ↔ Co-administration with PREZISTA co-administered with cobicistat is not recommended (see section 4.4). Nevirapine nevirapine AUC ↑ 27% PREZISTA co-administered with 200 mg twice daily nevirapine Cmin ↑ 47% low dose ritonavir and nevirapine nevirapine Cmax ↑ 18% can be used without dose # darunavir: concentrations were adjustments. consistent with historical data (↑ nevirapine from CYP3A inhibition) Co-administration with PREZISTA co-administered with cobicistat is not recommended (see section 4.4). Rilpivirine rilpivirine AUC ↑ 130% Boosted PREZISTA and rilpivirine 150 mg once daily rilpivirine Cmin ↑ 178% can be used without dose rilpivirine Cmax ↑ 79% adjustments. darunavir AUC ↔ darunavir Cmin ↓ 11% darunavir Cmax ↔ HIV Protease inhibitors (PIs) - without additional co-administration of low dose ritonavir† Atazanavir atazanavir AUC ↔ PREZISTA co-administered with 300 mg once daily atazanavir Cmin ↑ 52% low dose ritonavir and atazanavir atazanavir Cmax ↓ 11% can be used without dose # darunavir AUC ↔ adjustments. # darunavir Cmin ↔ # PREZISTA co-administered with darunavir Cmax ↔ cobicistat should not be used in combination with another Atazanavir: comparison of antiretroviral agent that requires atazanavir/ritonavir 300/100 mg once pharmacoenhancement by means daily vs. atazanavir 300 mg once daily in of co-administration with an combination with darunavir/ritonavir inhibitor of CYP3A4 (see section 400/100 mg twice daily. 4.5). Darunavir: comparison of darunavir/ritonavir 400/100 mg twice daily vs. darunavir/ritonavir 400/100 mg twice daily in combination with atazanavir 300 mg once daily. Indinavir indinavir AUC ↑ 23% When used in combination with 800 mg twice daily indinavir Cmin ↑ 125% PREZISTA co-administered with indinavir Cmax ↔ low dose ritonavir, dose # darunavir AUC ↑ 24% adjustment of indinavir from # darunavir Cmin ↑ 44% 800 mg twice daily to 600 mg # twice daily may be warranted in darunavir Cmax ↑ 11% case of intolerance. Indinavir: comparison of PREZISTA co-administered with indinavir/ritonavir 800/100 mg twice cobicistat should not be used in daily vs. indinavir/darunavir/ritonavir combination with another 800/400/100 mg twice daily. antiretroviral agent that requires Darunavir: comparison of pharmacoenhancement by means darunavir/ritonavir 400/100 mg twice of co-administration with an daily vs. darunavir/ritonavir 400/100 mg inhibitor of CYP3A4 (see section in combination with indinavir 800 mg 4.5). twice daily.

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): indinavir (HOS-084518) atazanavir (HOS-086180) protease (HOS-085623) cobicistat (HOS-088111) etravirine (HOS-088088) rilpivirine (HOS-088090) nevirapine (HOS-088064) ritonavir (HOS-084521)

Wechselwirkungen · Intelence

INTELENCE 25 mg tablets INTELENCE 100 mg tablets INTELENCE 200 mg tablets · Abschnitt 4.5 · PDF-Seite 7–8

HOS-119734 · Präparat HOS-095005

7 NNRTIs Efavirenz Combining two NNRTIs has not been shown to It is not recommended to Nevirapine be beneficial. Concomitant use of etravirine co-administer INTELENCE Rilpivirine with efavirenz or nevirapine may cause a with other NNRTIs. significant decrease in the plasma concentration of etravirine and loss of therapeutic effect of etravirine. Concomitant use of etravirine with rilpivirine may cause a decrease in the plasma concentration of rilpivirine and loss of therapeutic effect of rilpivirine. HIV Protease Inhibitors (PIs) – Unboosted (i.e. without co-administration of low-dose ritonavir) Indinavir Concomitant use of etravirine with indinavir It is not recommended to may cause a significant decrease in the plasma co-administer INTELENCE concentration of indinavir and loss of with indinavir. therapeutic effect of indinavir. HIV PIs – Boosted with low-dose ritonavir Atazanavir/ritonavir atazanavir INTELENCE and 300/100 mg once daily AUC ↓ 0.86 (0.79-0.93) atazanavir/ritonavir can be Cmin ↓ 0.62 (0.55-0.71) used without dose Cmax ↔ 0.97 (0.89-1.05) adjustment. etravirine AUC ↑ 1.30 (1.18-1.44) Cmin ↑ 1.26 (1.12-1.42) Cmax ↑ 1.30 (1.17-1.44) Darunavir/ritonavir darunavir INTELENCE and 600/100 mg twice daily AUC ↔ 1.15 (1.05-1.26) darunavir/ritonavir can be Cmin ↔ 1.02 (0.90-1.17) used without dose Cmax ↔ 1.11 (1.01-1.22) adjustments (see also etravirine section 5.1). AUC ↓ 0.63 (0.54-0.73) Cmin ↓ 0.51 (0.44-0.61) Cmax ↓ 0.68 (0.57-0.82) Fosamprenavir/ritonavir amprenavir Amprenavir/ritonavir and 700/100 mg twice daily AUC ↑ 1.69 (1.53-1.86) fosamprenavir/ritonavir may Cmin ↑ 1.77 (1.39-2.25) require dose reduction when Cmax ↑ 1.62 (1.47-1.79) co-administered with etravirine INTELENCE. Using the oral AUC ↔a solution may be considered Cmin ↔a for dose reduction. Cmax ↔a Lopinavir/ritonavir lopinavir INTELENCE and (tablet) AUC ↔ 0.87 (0.83-0.92) lopinavir/ritonavir can be 400/100 mg twice daily Cmin ↓ 0.80 (0.73-0.88) used without dose Cmax ↔ 0.89 (0.82-0.96) adjustments. etravirine AUC ↓ 0.65 (0.59-0.71) Cmin ↓ 0.55 (0.49-0.62) Cmax ↓ 0.70 (0.64-0.78) Saquinavir/ritonavir saquinavir INTELENCE and 1,000/100 mg twice daily AUC ↔ 0.95 (0.64-1.42) saquinavir/ritonavir can be Cmin ↓ 0.80 (0.46-1.38) used without dose Cmax ↔ 1.00 (0.70-1.42) adjustments. etravirine AUC ↓ 0.67 (0.56-0.80) Cmin ↓ 0.71 (0.58-0.87) Cmax ↓ 0.63 (0.53-0.75)

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): indinavir (HOS-084518) lopinavir (HOS-086269) atazanavir (HOS-086180) protease (HOS-085623) saquinavir (HOS-084522) amprenavir (HOS-086183) rilpivirine (HOS-088090) darunavir (HOS-086181) efavirenz (HOS-087947) nevirapine (HOS-088064) fosamprenavir (HOS-086182) ritonavir (HOS-084521)

Gegenanzeigen · Edurant

EDURANT 25 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 3

HOS-213916 · Präparat HOS-155234

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

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

Gegenanzeigen · Edurant

EDURANT 25 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 3

HOS-213917 · Präparat HOS-155234

EDURANT should not be co-administered with the following medicinal products, as significant decreases in rilpivirine plasma concentrations may occur (due to CYP3A enzyme induction or gastric pH increase), which may result in loss of therapeutic effect of EDURANT (see section 4.5): - the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin - the antimycobacterials rifampicin, rifapentine

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): phenobarbital (HOS-085617) carbamazepine (HOS-085618) rifapentine (HOS-116386) oxcarbazepine (HOS-110224) phenytoin (HOS-084531)

Gegenanzeigen · Edurant

EDURANT 25 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 3–4

HOS-213920 · Präparat HOS-155234

3 - proton pump inhibitors, such as omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole - the systemic glucocorticoid dexamethasone, except as a single dose treatment - St John’s wort (Hypericum perforatum).

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): lansoprazole (HOS-085166) rabeprazole (HOS-114843) esomeprazole (HOS-087944) pantoprazole (HOS-085167) dexamethasone (HOS-084535) omeprazole (HOS-085912)

Gegenanzeigen · Edurant

EDURANT 2.5 mg dispersible tablets · Abschnitt 4.3 · PDF-Seite 27

HOS-213988 · Präparat HOS-155234

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

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

Gegenanzeigen · Edurant

EDURANT 2.5 mg dispersible tablets · Abschnitt 4.3 · PDF-Seite 27

HOS-213989 · Präparat HOS-155234

EDURANT should not be co-administered with the following medicinal products, as significant decreases in rilpivirine plasma concentrations may occur (due to CYP3A enzyme induction or gastric pH increase), which may result in loss of therapeutic effect of EDURANT (see section 4.5): - the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin - the antimycobacterials rifampicin, rifapentine - proton pump inhibitors, such as omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole - the systemic glucocorticoid dexamethasone, except as a single dose treatment - St John’s wort (Hypericum perforatum).

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): lansoprazole (HOS-085166) rabeprazole (HOS-114843) esomeprazole (HOS-087944) phenobarbital (HOS-085617) carbamazepine (HOS-085618) pantoprazole (HOS-085167) dexamethasone (HOS-084535) rifapentine (HOS-116386) oxcarbazepine (HOS-110224) phenytoin (HOS-084531) omeprazole (HOS-085912)

Wechselwirkungen · Edurant

EDURANT 25 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 5

HOS-213922 · Präparat HOS-155234

Medicinal products that affect rilpivirine exposure

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

Wechselwirkungen · Edurant

EDURANT 25 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 5

HOS-213923 · Präparat HOS-155234

Rilpivirine is primarily metabolised by cytochrome P450 (CYP)3A. Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine (see section 5.2). Co-administration of rilpivirine and medicinal products that induce CYP3A has been observed to decrease the plasma concentrations of rilpivirine, which could reduce the therapeutic effect of rilpivirine. Co-administration of rilpivirine and medicinal products that inhibit CYP3A has been observed to increase the plasma concentrations of rilpivirine. Co-administration of rilpivirine with medicinal products that increase gastric pH may result in decreased plasma concentrations of rilpivirine which could potentially reduce the therapeutic effect of EDURANT.

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