Ein Paarvergleich findet Originalpassagen, die den anderen Wirkstoff wörtlich nennen. Aussagen gelten für das jeweilige Präparat und seine Formulierung. Klassenbegriffe und abweichende Synonyme können fehlen. Kein Treffer bedeutet nicht, dass keine Wechselwirkung besteht.
RxNorm 05-Oct-2026 · geprüft 2026-10-25 · 1009 Präparate · 54812 Quellenpassagen · 148 strukturierte Aussagen. Automatisch aktualisiert, ohne menschliche Freigabe.
Gegenanzeigen · Pradaxa
Pradaxa 75 mg hard capsules · Abschnitt 4.3 · PDF-Seite 6
HOS-118621 · Präparat HOS-094855
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
• Severe renal impairment (CrCL < 30 mL/min) in adult patients
• eGFR < 50 mL/min/1.73 m2 in paediatric patients
• Active clinically significant bleeding
• Lesion or condition, if considered a significant risk factor for major bleeding. This may include
current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of
bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent
intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous
malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
• Concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low
molecular weight heparins (enoxaparin, dalteparin etc), heparin derivatives (fondaparinux etc),
oral anticoagulants (warfarin, rivaroxaban, apixaban etc) except under specific circumstances.
These are switching anticoagulant therapy (see section 4.2), when UFH is given at doses
necessary to maintain an open central venous or arterial catheter or when UFH is given during
catheter ablation for atrial fibrillation (see section 4.5)
• Hepatic impairment or liver disease expected to have any impact on survival
• Concomitant treatment with the following strong P-gp inhibitors: systemic ketoconazole,
cyclosporine, itraconazole, dronedarone and the fixed-dose combination
glecaprevir/pibrentasvir (see section 4.5)
• Prosthetic heart valves requiring anticoagulant treatment (see section 5.1).
6
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): dronedarone (HOS-086144) ketoconazole (HOS-084513) pibrentasvir (HOS-086298) fondaparinux (HOS-110096) glecaprevir (HOS-086297) heparin (HOS-086930) rivaroxaban (HOS-086236) itraconazole (HOS-084516) apixaban (HOS-112091) cyclosporine (HOS-084512) enoxaparin (HOS-118623) dalteparin (HOS-118624) warfarin (HOS-085950)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-24T16:05:00Z · SHA-256 6fdebd4ffab4d65c0f88f2d9fedf86e816358c723b5b8edac8e90f1c47487499 · Passage 58c4826e564b5c5b7f1abc93ec498be4215981e3fc8a5222c2a54f71816b01c4 · Zeichen 0–1751 im Abschnitt
Gegenanzeigen · Pradaxa
Pradaxa 110 mg hard capsules · Abschnitt 4.3 · PDF-Seite 38–39
HOS-118701 · Präparat HOS-094855
38
bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent
intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous
malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
• Concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low
molecular weight heparins (enoxaparin, dalteparin etc), heparin derivatives (fondaparinux etc),
oral anticoagulants (warfarin, rivaroxaban, apixaban etc) except under specific circumstances.
These are switching anticoagulant therapy (see section 4.2), when UFH is given at doses
necessary to maintain an open central venous or arterial catheter or when UFH is given during
catheter ablation for atrial fibrillation (see section 4.5)
• Hepatic impairment or liver disease expected to have any impact on survival
• Concomitant treatment with the following strong P-gp inhibitors: systemic ketoconazole,
cyclosporine, itraconazole, dronedarone and the fixed-dose combination
glecaprevir/pibrentasvir (see section 4.5)
• Prosthetic heart valves requiring anticoagulant treatment (see section 5.1).
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): dronedarone (HOS-086144) ketoconazole (HOS-084513) pibrentasvir (HOS-086298) fondaparinux (HOS-110096) glecaprevir (HOS-086297) heparin (HOS-086930) rivaroxaban (HOS-086236) itraconazole (HOS-084516) apixaban (HOS-112091) cyclosporine (HOS-084512) enoxaparin (HOS-118623) dalteparin (HOS-118624) warfarin (HOS-085950)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-24T16:05:00Z · SHA-256 6fdebd4ffab4d65c0f88f2d9fedf86e816358c723b5b8edac8e90f1c47487499 · Passage ec2e999673d5b90adcb3018232692e9cba05e46844ff8f9fe74dad3d32d8172e · Zeichen 520–1753 im Abschnitt
Gegenanzeigen · Pradaxa
Pradaxa 150 mg hard capsules · Abschnitt 4.3 · PDF-Seite 78–79
HOS-118789 · Präparat HOS-094855
78
bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent
intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous
malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
• Concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low
molecular weight heparins (enoxaparin, dalteparin etc), heparin derivatives (fondaparinux etc),
oral anticoagulants (warfarin, rivaroxaban, apixaban etc) except under specific circumstances.
These are switching anticoagulant therapy (see section 4.2), when UFH is given at doses
necessary to maintain an open central venous or arterial catheter or when UFH is given during
catheter ablation for atrial fibrillation (see section 4.5)
• Hepatic impairment or liver disease expected to have any impact on survival
• Concomitant treatment with the following strong P-gp inhibitors: systemic ketoconazole,
cyclosporine, itraconazole, dronedarone and the fixed-dose combination
glecaprevir/pibrentasvir (see section 4.5)
• Prosthetic heart valves requiring anticoagulant treatment (see section 5.1).
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): dronedarone (HOS-086144) ketoconazole (HOS-084513) pibrentasvir (HOS-086298) fondaparinux (HOS-110096) glecaprevir (HOS-086297) heparin (HOS-086930) rivaroxaban (HOS-086236) itraconazole (HOS-084516) apixaban (HOS-112091) cyclosporine (HOS-084512) enoxaparin (HOS-118623) dalteparin (HOS-118624) warfarin (HOS-085950)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-24T16:05:00Z · SHA-256 6fdebd4ffab4d65c0f88f2d9fedf86e816358c723b5b8edac8e90f1c47487499 · Passage 30c550ec0ab8ef152af1fe03e09c53747fb57851a2196eef5c1b464bb4db5f2f · Zeichen 520–1753 im Abschnitt
Gegenanzeigen · Pradaxa
Pradaxa 20 mg coated granules Pradaxa 30 mg coated granules Pradaxa 40 mg coated granules Pradaxa 50 mg coated granules Pradaxa 110 mg coated granules Pradaxa 150 mg coated granules · Abschnitt 4.3 · PDF-Seite 113–114
HOS-118875 · Präparat HOS-094855
113
intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous
malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
• Concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low
molecular weight heparins (enoxaparin, dalteparin etc), heparin derivatives (fondaparinux etc),
oral anticoagulants (warfarin, rivaroxaban, apixaban etc) except under specific circumstances.
These are switching anticoagulant therapy (see section 4.2) or when UFH is given at doses
necessary to maintain an open central venous or arterial catheter (see section 4.5).
• Hepatic impairment or liver disease expected to have any impact on survival
• Concomitant treatment with the following strong P-gp inhibitors: systemic ketoconazole,
cyclosporine, itraconazole, dronedarone and the fixed-dose combination
glecaprevir/pibrentasvir (see section 4.5)
• Prosthetic heart valves requiring anticoagulant treatment (see section 5.1).
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): dronedarone (HOS-086144) ketoconazole (HOS-084513) pibrentasvir (HOS-086298) fondaparinux (HOS-110096) glecaprevir (HOS-086297) heparin (HOS-086930) rivaroxaban (HOS-086236) itraconazole (HOS-084516) apixaban (HOS-112091) cyclosporine (HOS-084512) enoxaparin (HOS-118623) dalteparin (HOS-118624) warfarin (HOS-085950)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-24T16:05:00Z · SHA-256 6fdebd4ffab4d65c0f88f2d9fedf86e816358c723b5b8edac8e90f1c47487499 · Passage 308c96bdc025271910c30c2a89b1c7a62217151b0bbcfcdea4bed4d500b70ffb · Zeichen 551–1650 im Abschnitt
Wechselwirkungen · Pradaxa
Pradaxa 75 mg hard capsules · Abschnitt 4.5 · PDF-Seite 11
HOS-118632 · Präparat HOS-094855
Ketoconazole Ketoconazole increased total dabigatran AUC0-∞ and Cmax values by 2.38-fold and
2.35-fold, respectively, after a single oral dose of 400 mg, and by 2.53-fold and
2.49-fold, respectively, after multiple oral dosing of 400 mg ketoconazole once
daily.
Dronedarone When dabigatran etexilate and dronedarone were given at the same time total
dabigatran AUC0-∞ and Cmax values increased by about 2.4-fold and 2.3-fold,
respectively, after multiple dosing of 400 mg dronedarone bid, and about 2.1-fold
and 1.9-fold, respectively, after a single dose of 400 mg.
Itraconazole, Based on in vitro results a similar effect as with ketoconazole may be expected.
cyclosporine
Glecaprevir / The concomitant use of dabigatran etexilate with the fixed-dose combination of
pibrentasvir the P-gp inhibitors glecaprevir/pibrentasvir has been shown to increase exposure
of dabigatran and may increase the risk of bleeding.
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): dronedarone (HOS-086144) ketoconazole (HOS-084513) pibrentasvir (HOS-086298) glecaprevir (HOS-086297) dabigatran (HOS-112096) itraconazole (HOS-084516) cyclosporine (HOS-084512)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-24T16:05:00Z · SHA-256 6fdebd4ffab4d65c0f88f2d9fedf86e816358c723b5b8edac8e90f1c47487499 · Passage b497c2d17a671eadd6d3621f31894d932a018ff0cc8853d598c918ee52245e3c · Zeichen 637–1725 im Abschnitt
Wechselwirkungen · Pradaxa
Pradaxa 110 mg hard capsules · Abschnitt 4.5 · PDF-Seite 44
HOS-118708 · Präparat HOS-094855
Ketoconazole Ketoconazole increased total dabigatran AUC0-∞ and Cmax values by 2.38-fold and
2.35-fold, respectively, after a single oral dose of 400 mg, and by 2.53-fold and
2.49-fold, respectively, after multiple oral dosing of 400 mg ketoconazole once
daily.
Dronedarone When dabigatran etexilate and dronedarone were given at the same time total
dabigatran AUC0-∞ and Cmax values increased by about 2.4-fold and 2.3-fold,
respectively, after multiple dosing of 400 mg dronedarone bid, and about 2.1-fold
and 1.9-fold, respectively, after a single dose of 400 mg.
Itraconazole, Based on in vitro results a similar effect as with ketoconazole may be expected.
cyclosporine
Glecaprevir / The concomitant use of dabigatran etexilate with the fixed-dose combination of
pibrentasvir the P-gp inhibitors glecaprevir/pibrentasvir has been shown to increase exposure
of dabigatran and may increase the risk of bleeding.
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): dronedarone (HOS-086144) ketoconazole (HOS-084513) pibrentasvir (HOS-086298) glecaprevir (HOS-086297) dabigatran (HOS-112096) itraconazole (HOS-084516) cyclosporine (HOS-084512)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-24T16:05:00Z · SHA-256 6fdebd4ffab4d65c0f88f2d9fedf86e816358c723b5b8edac8e90f1c47487499 · Passage b000b61f23f21217cd1eeb72ccdd6aefcf2bf6361ee5c839ed6c379c8e124d16 · Zeichen 638–1714 im Abschnitt
Wechselwirkungen · Pradaxa
Pradaxa 150 mg hard capsules · Abschnitt 4.5 · PDF-Seite 84
HOS-118796 · Präparat HOS-094855
Ketoconazole Ketoconazole increased total dabigatran AUC0-∞ and Cmax values by 2.38-fold and
2.35-fold, respectively, after a single oral dose of 400 mg, and by 2.53-fold and
2.49-fold, respectively, after multiple oral dosing of 400 mg ketoconazole once
daily.
Dronedarone When dabigatran etexilate and dronedarone were given at the same time total
dabigatran AUC0-∞ and Cmax values increased by about 2.4-fold and 2.3-fold,
respectively, after multiple dosing of 400 mg dronedarone bid, and about 2.1-fold
and 1.9-fold, respectively, after a single dose of 400 mg.
Itraconazole, Based on in vitro results a similar effect as with ketoconazole may be expected.
cyclosporine
Glecaprevir / The concomitant use of dabigatran etexilate with the fixed-dose combination of
pibrentasvir the P-gp inhibitors glecaprevir/pibrentasvir has been shown to increase exposure
of dabigatran and may increase the risk of bleeding.
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): dronedarone (HOS-086144) ketoconazole (HOS-084513) pibrentasvir (HOS-086298) glecaprevir (HOS-086297) dabigatran (HOS-112096) itraconazole (HOS-084516) cyclosporine (HOS-084512)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-24T16:05:00Z · SHA-256 6fdebd4ffab4d65c0f88f2d9fedf86e816358c723b5b8edac8e90f1c47487499 · Passage b000b61f23f21217cd1eeb72ccdd6aefcf2bf6361ee5c839ed6c379c8e124d16 · Zeichen 638–1714 im Abschnitt
Wechselwirkungen · Pradaxa
Pradaxa 20 mg coated granules Pradaxa 30 mg coated granules Pradaxa 40 mg coated granules Pradaxa 50 mg coated granules Pradaxa 110 mg coated granules Pradaxa 150 mg coated granules · Abschnitt 4.5 · PDF-Seite 118
HOS-118883 · Präparat HOS-094855
Ketoconazole Ketoconazole increased total dabigatran AUC0-∞ and Cmax values by 2.38-fold and
2.35-fold, respectively, after a single oral dose of 400 mg, and by 2.53-fold and
2.49-fold, respectively, after multiple oral dosing of 400 mg ketoconazole once
daily.
Dronedarone When dabigatran etexilate and dronedarone were given at the same time total
dabigatran AUC0-∞ and Cmax values increased by about 2.4-fold and 2.3-fold,
respectively, after multiple dosing of 400 mg dronedarone bid, and about 2.1-fold
and 1.9-fold, respectively, after a single dose of 400 mg.
Itraconazole, Based on in vitro results a similar effect as with ketoconazole may be expected.
cyclosporine
Glecaprevir / The concomitant use of dabigatran etexilate with the fixed-dose combination of
pibrentasvir the P-gp inhibitors glecaprevir/pibrentasvir has been shown to increase exposure
of dabigatran and may increase the risk of bleeding.
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): dronedarone (HOS-086144) ketoconazole (HOS-084513) pibrentasvir (HOS-086298) glecaprevir (HOS-086297) dabigatran (HOS-112096) itraconazole (HOS-084516) cyclosporine (HOS-084512)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-24T16:05:00Z · SHA-256 6fdebd4ffab4d65c0f88f2d9fedf86e816358c723b5b8edac8e90f1c47487499 · Passage b000b61f23f21217cd1eeb72ccdd6aefcf2bf6361ee5c839ed6c379c8e124d16 · Zeichen 680–1756 im Abschnitt
Wechselwirkungen · Modigraf
Modigraf 0.2 mg granules for oral suspension Modigraf 1 mg granules for oral suspension · Abschnitt 4.5 · PDF-Seite 11–12
HOS-209751 · Präparat HOS-154375
11
Drug/Substance Class or Drug interaction effect Recommendations concerning co-
Name administration
The effect on tacrolimus
blood concentrations may
remain for several days after
co-administration is
completed.
Moderate or weak CYP3A4 May increase tacrolimus Monitor tacrolimus whole blood
inhibitors: whole blood trough trough concentrations frequently,
antifungal agents (e.g., concentrations and increase starting within the first few days
fluconazole, isavuconazole, the risk of serious adverse of co-administration. Reduce
clotrimazole, miconazole), reactions (e.g., neurotoxicity, tacrolimus dose if needed [see
the macrolide antibiotics QT prolongation) [see section 4.2]. Monitor renal
(e.g., azithromycin), calcium section 4.4]. A rapid increase function, ECG for QT
channel blockers (e.g., in tacrolimus level may prolongation, and other side
nifedipine, nicardipine, occur. effects closely.
diltiazem, verapamil),
amiodarone, danazol,
ethinylestradiol, lansoprazole,
omeprazole, the HCV
antivirals elbasvir/grazoprevir
and glecaprevir/pibrentasvir,
the CMV antiviral letermovir,
and the tyrosine kinase
inhibitors nilotinib, crizotinib
and imatinib and (Chinese)
herbal remedies containing
extracts of Schisandra
sphenanthera
In vitro the following May increase tacrolimus Monitor tacrolimus whole blood
substances have been shown whole blood trough trough concentrations and reduce
to be potential inhibitors of concentrations and increase tacrolimus dose if needed [see
tacrolimus metabolism: the risk of serious adverse section 4.2].
bromocriptine, cortisone, reactions (e.g., neurotoxicity, Monitor renal function, ECG for
dapsone, ergotamine, QT prolongation) [see QT prolongation, and other side
gestodene, lidocaine, section 4.4]. effects closely.
mephenytoin, midazolam,
nilvadipine, norethisterone,
quinidine, tamoxifen
Strong CYP3A4 inducers: May decrease tacrolimus It is recommended that
rifampicin, phenytoin whole blood trough concomitant use should be
carbamazepine, apalutamide, concentrations and increase avoided. If unavoidable, patients
enzalutamide, mitotane or St. the risk of rejection [see may require an increase in
John’s wort (Hypericum section 4.4]. tacrolimus dose. Changes in
perforatum) Maximal effect on tacrolimus tacrolimus dose should be
blood concentrations may be individualized and adjusted as
achieved 1-2 weeks after co- needed based on tacrolimus
administration. The effect trough concentrations, which
may remain 1-2 weeks after should be assessed at initiation,
completion of the treatment. monitored frequently throughout
(starting within the first few days)
and re-evaluated on and after
completion of the CYP3A4
inducer. After use of the CYP3A4
inducer has ended, tacrolimus
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) letermovir (HOS-090621) diltiazem (HOS-086288) elbasvir (HOS-108814) isavuconazole (HOS-085186) nifedipine (HOS-086289) cortisone (HOS-114161) nicardipine (HOS-090619) pibrentasvir (HOS-086298) lidocaine (HOS-108866) carbamazepine (HOS-085618) crizotinib (HOS-116818) apalutamide (HOS-086212) tamoxifen (HOS-088380) quinidine (HOS-085593) glecaprevir (HOS-086297) azithromycin (HOS-088112) clotrimazole (HOS-090574) mephenytoin (HOS-109801) calcium (HOS-085615) imatinib (HOS-110212) grazoprevir (HOS-108815) danazol (HOS-085473) mitotane (HOS-112479) fluconazole (HOS-087945) bromocriptine (HOS-090620) nilvadipine (HOS-116826) gestodene (HOS-116824) ergotamine (HOS-086154) amiodarone (HOS-085596) tyrosine (HOS-108875) dapsone (HOS-088141) phenytoin (HOS-084531) enzalutamide (HOS-116829) nilotinib (HOS-086218) miconazole (HOS-115630) midazolam (HOS-086167) omeprazole (HOS-085912) verapamil (HOS-090602)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-03-03T17:00:00Z · SHA-256 1a464ac051c5783e49ce08a9d103d0d319997aa4add60584450928c1b11144a7 · Passage 1e7cc303a6d0d182851c23281c6a79a17f96d714a9cddc0ab3d6ada78ab947ab · Zeichen 6985–10993 im Abschnitt
Wechselwirkungen · Zoely
Zoely 2.5 mg/1.5 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 12
HOS-123131 · Präparat HOS-095645
Direct acting antiviral agents (DAAs) and ethinylestradiol-containing medicinal products such as CHCs
During clinical trials with the HCV combination drug regimen ombitasvir/paritaprevir/ritonavir and
dasabuvir with or without ribavirin, ALT elevations greater than 5 times the upper limit of normal
(ULN) were significantly more frequent in women using ethinylestradiol-containing medicinal
products such as CHCs. Additionally, also in patients treated with glecaprevir/pibrentasvir or
sofosbuvir/velpatasvir/voxilaprevir, ALT elevations were observed in women using ethinylestradiol-
containing medications such as CHCs.
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): sofosbuvir (HOS-108928) pibrentasvir (HOS-086298) glecaprevir (HOS-086297) ribavirin (HOS-088127) dasabuvir (HOS-110302) voxilaprevir (HOS-108930) ombitasvir (HOS-110300) velpatasvir (HOS-108929) ritonavir (HOS-084521) paritaprevir (HOS-110301)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-02-19T01:25:00Z · SHA-256 dc49cf8021f816c4c7a796f72b78aa51d7e7cdb416565d60506c315b6ddcb3e2 · Passage 24ea5c47b8281fb85662d78cf5c0f9fcf46ea2b10396e0ac0ec89d7d3df9a088 · Zeichen 2975–3597 im Abschnitt
Wechselwirkungen · Zoely
Zoely 2.5 mg/1.5 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 12
HOS-123141 · Präparat HOS-095645
Direct acting antiviral agents (DAAs) and medicinal products containing oestrogens other than
ethinylestradiol, such as estradiol
Women using medicinal products containing oestrogens other than ethinylestradiol, such as estradiol,
and ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin had a rate of ALT
elevation similar to those not receiving any oestrogens; however, due to the limited number of women
taking these other oestrogens, caution is warranted for co-administration with the following
combination drug regimens: ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin;
glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see 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): sofosbuvir (HOS-108928) pibrentasvir (HOS-086298) glecaprevir (HOS-086297) ribavirin (HOS-088127) dasabuvir (HOS-110302) voxilaprevir (HOS-108930) ombitasvir (HOS-110300) velpatasvir (HOS-108929) ritonavir (HOS-084521) paritaprevir (HOS-110301)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-02-19T01:25:00Z · SHA-256 dc49cf8021f816c4c7a796f72b78aa51d7e7cdb416565d60506c315b6ddcb3e2 · Passage 947c42be34de05e9f1fa6a962b97fee4c516c794ae509f0f584d04179575481e · Zeichen 3599–4304 im Abschnitt
Wechselwirkungen · Pravafenix
Pravafenix 40 mg/160 mg hard capsules · Abschnitt 4.5 · PDF-Seite 6
HOS-123827 · Präparat HOS-095735
Glecaprevir/pibrentasvir
Concomitant use of pravastatin and glecaprevir/pibrentasvir may increase the plasma concentration of
pravastatin and may lead to an increase of dose-dependent adverse events including myopathy risk.
Patients treated with glecaprevir/pibrentasvir should not exceed 20 mg per day of pravastatin.
Therefore Pravafenix is not recommended in those patients.
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): pibrentasvir (HOS-086298) glecaprevir (HOS-086297) lead (HOS-085592)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-01-17T01:00:00Z · SHA-256 555d912c3c1635440482163c25a3d73a1dd04513baaad39957f8d1035f451ae2 · Passage 4ea64c706c586e13f73d1cf49764248d441a3a03b3fc9b70b61b600c8a407d22 · Zeichen 2749–3126 im Abschnitt
Wechselwirkungen · Efavirenz Teva
Efavirenz Teva 600 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 11–12
HOS-215282 · Präparat HOS-155418
11
Medicinal product by Effects on drug levels Recommendation concerning
therapeutic areas Mean percent change in AUC, co-administration with
(dose) Cmax, Cmin with confidence efavirenz
intervals if availablea
(mechanism)
Velpatasvir/sofosbuvir/voxilap ↓velpatasvir Concomitant administration of
revir ↓voxilaprevir velpatasvir/sofosbuvir/
voxilaprevir with efavirenz is
not recommended, as it may
decrease concentrations of
velpatasvir and voxilaprevir.
Refer to the prescribing
information for
velpatasvir/sofosbuvir/
voxilaprevir for more
information.
Protease inhibitor : ↓elbasvir Concomitant administration of
Elbasvir/grazoprevir ↓grazoprevir efavirenz with
elbasvir/grazoprevir is
↔efavirenz
contraindicated because it may
lead to loss of virologic
response to
elbasvir/grazoprevir. This loss
is due to significant decreases
in elbasvir and grazoprevir
plasma concentrations caused
by CYP3A4 induction. Refer
to the prescribing information
for elbasvir/grazoprevir for
more information.
Glecaprevir/pibrentasvir ↓glecaprevir Concomitant administration of
↓ pibrentasvir glecaprevir/pibrentasvir with
efavirenz may significantly
decrease plasma
concentrations of glecaprevir
and pibrentasvir, leading to
reduced therapeutic effect.
Coadministration of
glecaprevir/pibrentasvir with
efavirenz is not recommended.
Refer to the prescribing
information for
glecaprevir/pibrentasvir for
more information.
Antibiotics
Azithromycin/efavirenz No clinically significant No dose adjustment is necessary
(600 mg single dose/400 mg once pharmacokinetic interaction for either medicinal product.
daily)
Clarithromycin/efavirenz Clarithromycin: The clinical significance of these
(500 mg q12h/400 mg once daily) AUC: ↓ 39% (↓ 30 to ↓ 46) changes in clarithromycin plasma
Cmax: ↓ 26% (↓ 15 to ↓ 35) levels is not known. Alternatives
to clarithromycin (e.g.
Clarithromycin azithromycin) may be considered.
14-hydroxymetabolite: No dose adjustment is necessary
AUC: ↑ 34% (↑ 18 to ↑ 53) for efavirenz.
Cmax: ↑ 49% (↑ 32 to ↑ 69)
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): elbasvir (HOS-108814) sofosbuvir (HOS-108928) protease (HOS-085623) pibrentasvir (HOS-086298) glecaprevir (HOS-086297) azithromycin (HOS-088112) lead (HOS-085592) voxilaprevir (HOS-108930) grazoprevir (HOS-108815) clarithromycin (HOS-084517) velpatasvir (HOS-108929)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2023-03-03T18:18:00Z · SHA-256 d2c4a637bb18ba1e0c98c69218ce14671957659a5aa55fba40e74b1bf5620382 · Passage 310c6908c5167c5c566d1779df72c19d73a6e857af22bb69c467f9646bad659d · Zeichen 23908–28723 im Abschnitt
Gegenanzeigen · Cholib
Cholib 145 mg/20 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 3
HOS-126950 · Präparat HOS-096355
• Hypersensitivity to the active substances, peanut, soya or to any of the excipients listed in
section 6.1 (see also section 4.4)
• Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen
• Active liver disease or unexplained persistent elevations of serum transaminases
• Known gallbladder disease
• Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe
hypertriglyceridaemia
• Moderate to severe renal insufficiency (estimated glomerular filtration rate
< 60 mL/min/1.73 m2)
• Concomitant administration of potent CYP3A4 inhibitors (agents that increase AUC
approximately 5 fold or greater) (e.g. itraconazole, ketoconazole, posaconazole, voriconazole,
HIV protease inhibitors (e.g. nelfinavir), boceprevir, telaprevir, erythromycin, clarithromycin,
telithromycin, nefazodone, and medicinal products containing cobicistat) (see sections 4.4 and
4.5)
• Concomitant administration of gemfibrozil, ciclosporin, or danazol (see sections 4.4 and 4.5)
• Concomitant administration of glecaprevir/ pibrentasvir (see section 4.5)
• Paediatric population (age below 18 years)
• Pregnancy and breast-feeding (see section 4.6)
• Personal history of myopathy and/or rhabdomyolysis with statins and/or fibrates or confirmed
creatine phosphokinase elevation above 5 times the upper limit of normal (ULN) under previous
statin treatment (see 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): ketoprofen (HOS-089671) nefazodone (HOS-084519) nelfinavir (HOS-084520) protease (HOS-085623) ketoconazole (HOS-084513) pibrentasvir (HOS-086298) cobicistat (HOS-088111) creatine (HOS-123819) gemfibrozil (HOS-088403) glecaprevir (HOS-086297) voriconazole (HOS-084524) telaprevir (HOS-090618) telithromycin (HOS-084523) itraconazole (HOS-084516) danazol (HOS-085473) boceprevir (HOS-090617) clarithromycin (HOS-084517) erythromycin (HOS-084514) posaconazole (HOS-085622)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-08-06T10:28:00Z · SHA-256 348750d8a2030faed77c9c061fe6342a446d1448175630ef5f5390d9ff5afaad · Passage 01cd865d152730ea7f87e81073b6bc3ccb3f2ff3a9e8e7ee83649a48ba092bdb · Zeichen 0–1506 im Abschnitt
Gegenanzeigen · Cholib
Cholib 145 mg/40 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 25
HOS-127022 · Präparat HOS-096355
• Hypersensitivity to the active substances, peanut, soya or to any of the excipients listed in
section 6.1 (see also section 4.4)
• Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen
• Active liver disease or unexplained persistent elevations of serum transaminases
• Known gallbladder disease
• Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe
hypertriglyceridaemia
• Moderate to severe renal insufficiency (estimated glomerular filtration rate
< 60 mL/min/1.73 m2)
• Concomitant administration of potent CYP3A4 inhibitors (agents that increase AUC
approximately 5 fold or greater) (e.g. itraconazole, ketoconazole, posaconazole, voriconazole,
HIV protease inhibitors (e.g. nelfinavir), boceprevir, telaprevir, erythromycin, clarithromycin,
telithromycin, nefazodone, and medicinal products containing cobicistat) (see sections 4.4 and
4.5)
• Concomitant administration of gemfibrozil, ciclosporin, or danazol (see sections 4.4 and 4.5)
• Concomitant administration of glecaprevir, pibrentasvir, elbasvir or grazoprevir (see section
4.5)
• Paediatric population (age below 18 years)
• Pregnancy and breast-feeding (see section 4.6)
• Personal history of myopathy and/or rhabdomyolysis with statins and/or fibrates or confirmed
creatine phosphokinase elevation above 5 times the upper limit of normal (ULN) under previous
statin treatment (see section 4.4)
Concomitant administration of amiodarone, verapamil, amlodipine or diltiazem (see section 4.5)
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): diltiazem (HOS-086288) ketoprofen (HOS-089671) nefazodone (HOS-084519) elbasvir (HOS-108814) nelfinavir (HOS-084520) protease (HOS-085623) ketoconazole (HOS-084513) pibrentasvir (HOS-086298) cobicistat (HOS-088111) amlodipine (HOS-086287) creatine (HOS-123819) gemfibrozil (HOS-088403) glecaprevir (HOS-086297) voriconazole (HOS-084524) telaprevir (HOS-090618) telithromycin (HOS-084523) grazoprevir (HOS-108815) itraconazole (HOS-084516) danazol (HOS-085473) boceprevir (HOS-090617) clarithromycin (HOS-084517) erythromycin (HOS-084514) amiodarone (HOS-085596) posaconazole (HOS-085622) verapamil (HOS-090602)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-08-06T10:28:00Z · SHA-256 348750d8a2030faed77c9c061fe6342a446d1448175630ef5f5390d9ff5afaad · Passage b3e383eea6addd5e17e74e7e066bd16291ed5af47e0e656fd20c321af353dadc · Zeichen 0–1610 im Abschnitt
Wechselwirkungen · Cholib
Cholib 145 mg/20 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 10
HOS-126998 · Präparat HOS-096355
Interacting substances Prescribing recommendations
Potent CYP 3A4 inhibitors:
Itraconazole
Ketoconazole
Fluconazole
Posaconazole
Erythromycin Contraindicated with Cholib
Clarithromycin
Telithromycin
HIV protease inhibitors (e.g. nelfinavir)
Nefazodone
Cobicistat
Danazol
Contraindicated with Cholib
Ciclosporin
Gemfibrozil, Other statins and fibrates Contraindicated with Cholib
Amiodarone
Verapamil Do not exceed one Cholib 145 mg/20 mg per
Diltiazem day, unless clinical benefit outweigh the risk
Amlodipine
Elbasvir Do not exceed one Cholib 145 mg/20 mg per
Grazoprevir day
Glecaprevir
Contraindicated with Cholib
Pibrentasvir
Avoid with Cholib unless clinical benefit
Niacin (nicotinic acid) ≥ 1 g/day
outweigh the risk
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): diltiazem (HOS-086288) nefazodone (HOS-084519) elbasvir (HOS-108814) nelfinavir (HOS-084520) protease (HOS-085623) ketoconazole (HOS-084513) pibrentasvir (HOS-086298) cobicistat (HOS-088111) amlodipine (HOS-086287) gemfibrozil (HOS-088403) glecaprevir (HOS-086297) niacin (HOS-126975) telithromycin (HOS-084523) grazoprevir (HOS-108815) itraconazole (HOS-084516) danazol (HOS-085473) fluconazole (HOS-087945) clarithromycin (HOS-084517) erythromycin (HOS-084514) amiodarone (HOS-085596) posaconazole (HOS-085622) verapamil (HOS-090602)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-08-06T10:28:00Z · SHA-256 348750d8a2030faed77c9c061fe6342a446d1448175630ef5f5390d9ff5afaad · Passage e0d38b712e1242faa215e464aecc01b778cbd894151f3fb6e0a8a225fb75b5e1 · Zeichen 10739–11977 im Abschnitt
Wechselwirkungen · Cholib
Cholib 145 mg/40 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 32
HOS-127062 · Präparat HOS-096355
Interacting substances Prescribing recommendations
Potent CYP 3A4 inhibitors:
Itraconazole
Ketoconazole
Fluconazole
Posaconazole
Erythromycin Contraindicated with Cholib
Clarithromycin
Telithromycin
HIV protease inhibitors (e.g. nelfinavir)
Nefazodone
Cobicistat
Danazol
Contraindicated with Cholib
Ciclosporin
Gemfibrozil, Other statins and fibrates Contraindicated with Cholib
Amiodarone
Verapamil
Contraindicated with Cholib 145 mg/40 mg
Diltiazem
Amlodipine
Elbasvir
Contraindicated with Cholib 145 mg/40 mg
Grazoprevir
Glecaprevir
Contraindicated with Cholib
Pibrentasvir
Avoid with Cholib unless clinical benefit
outweigh the risk
Niacin (nicotinic acid) ≥ 1 g/day
Monitor patients for any signs and symptoms of
muscle pain, tenderness or weakness
Patients should be closely monitored.
Fusidic acid Temporary suspension of Cholib treatment may
be considered
Grapefruit juice Avoid when taking Cholib
Adjust the dose of these oral anticoagulants
Vitamin K antagonists
according to INR monitoring
Monitor HDL-C and stop either therapy
Glitazones
(glitazone or Cholib) if HDL-C is too low
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): diltiazem (HOS-086288) nefazodone (HOS-084519) elbasvir (HOS-108814) nelfinavir (HOS-084520) protease (HOS-085623) fusidic acid (HOS-086146) ketoconazole (HOS-084513) pibrentasvir (HOS-086298) cobicistat (HOS-088111) vitamin K (HOS-091176) amlodipine (HOS-086287) gemfibrozil (HOS-088403) glecaprevir (HOS-086297) grapefruit juice (HOS-088787) niacin (HOS-126975) telithromycin (HOS-084523) grazoprevir (HOS-108815) itraconazole (HOS-084516) danazol (HOS-085473) fluconazole (HOS-087945) clarithromycin (HOS-084517) erythromycin (HOS-084514) amiodarone (HOS-085596) posaconazole (HOS-085622) verapamil (HOS-090602)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-08-06T10:28:00Z · SHA-256 348750d8a2030faed77c9c061fe6342a446d1448175630ef5f5390d9ff5afaad · Passage 6d5c5fec1da2b5e3bb3b7b5c49df8bee2d9cf49df82aef774324124447b7a727 · Zeichen 10741–12812 im Abschnitt
Wechselwirkungen · Darunavir Viatris (previously Darunavir Mylan)
Darunavir Viatris 75 mg film-coated tablets Darunavir Viatris 150 mg film-coated tablets Darunavir Viatris 300 mg film-coated tablets Darunavir Viatris 600 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 18–19
HOS-134512 · Präparat HOS-097580
18
INTERACTIONS AND DOSE RECOMMENDATIONS WITH OTHER MEDICINAL PRODUCTS
Medicinal products by Interaction Geometric mean change Recommendations concerning co-
therapeutic areas (%) administration
ENDOTHELIN RECEPTOR ANTAGONISTS
Bosentan Not studied. Concomitant use of When administered concomitantly
bosentan and darunavir co- with darunavir and low dose
administered with low dose ritonavir ritonavir, the patient’s tolerability of
may increase plasma concentrations of bosentan should be monitored.
bosentan.
Bosentan is expected to decrease
plasma concentrations of darunavir
and/or its pharmacoenhancer. (CYP3A
induction)
HEPATITIS C VIRUS (HCV) DIRECT-ACTING ANTIVIRALS
NS3-4A protease inhibitors
Elbasvir/grazoprevir Darunavir with low dose ritonavir may Concomitant use of darunavir with
increase the exposure to grazoprevir. low dose ritonavir and
(CYP3A and OATP1B inhibition). elbasvir/grazoprevir is
contraindicated (see section 4.3).
Glecaprevir/pibrentasvir Based on theoretical considerations It is not recommended to co-
boosted darunavir may increase the administer boosted darunavir with
exposure to glecaprevir and glecaprevir/pibrentasvir.
pibrentasvir.
(P-gp, BCRP and/or OATP1B1/3
inhibition)
HERBAL PRODUCTS
St John's wort Not studied. St John’s wort is expected Darunavir co-administered with low
(Hypericum perforatum) to decrease the plasma concentrations dose ritonavir must not be used
of darunavir and ritonavir. concomitantly with products
(CYP450 induction) containing St John’s wort
(Hypericum perforatum) (see
section 4.3). If a patient is already
taking St John’s wort, stop St
John’s wort and if possible check
viral levels. Darunavir exposure
(and also ritonavir exposure) may
increase on stopping St John’s wort.
The inducing effect may persist for
at least 2 weeks after cessation of
treatment with St John’s wort.
HMG CO-A REDUCTASE INHIBITORS
Lovastatin Not studied. Lovastatin and simvastatin Increased plasma concentrations of
Simvastatin are expected to have markedly lovastatin or simvastatin may cause
increased plasma concentrations when myopathy, including
co-administered with darunavir co- rhabdomyolysis. Concomitant use
administered with low dose ritonavir. of darunavir co-administered with
(CYP3A inhibition) low dose ritonavir with lovastatin
and simvastatin is therefore
contraindicated (see section 4.3).
Atorvastatin atorvastatin AUC ↑ 3-4 fold When administration of atorvastatin
10 mg once daily atorvastatin Cmin ↑ ≈5.5-10 fold and darunavir co- administered with
atorvastatin Cmax ↑ ≈2 fold low dose ritonavir is desired, it is
#
darunavir/ritonavir recommended to start with an
atorvastatin dose of 10 mg once
daily. A gradual dose increase of
atorvastatin may be tailored to the
clinical response.
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): elbasvir (HOS-108814) protease (HOS-085623) lovastatin (HOS-086157) atorvastatin (HOS-086304) pibrentasvir (HOS-086298) simvastatin (HOS-086158) glecaprevir (HOS-086297) hepatitis C virus (HOS-108813) grazoprevir (HOS-108815) ritonavir (HOS-084521) bosentan (HOS-086291)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-10-20T12:32:00Z · SHA-256 50f4771a683f17214737463c6df88a158b1e699bbb9916413602e547e369e804 · Passage 7b1edfe850fde2a2a949b44430e70ed99d603382b1e03aaa3d8a57534a62b67e · Zeichen 48130–53015 im Abschnitt
Wechselwirkungen · Darunavir Viatris (previously Darunavir Mylan)
Darunavir Viatris 400 mg film-coated tablets Darunavir Viatris 800 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 60–61
HOS-134628 · Präparat HOS-097580
60
INTERACTIONS AND DOSE RECOMMENDATIONS WITH OTHER MEDICINAL PRODUCTS
Medicinal products by Interaction Recommendations concerning co-
therapeutic areas Geometric mean change (%) administration
ENDOTHELIN RECEPTOR ANTAGONISTS
Bosentan Not studied. Concomitant use of When administered concomitantly
bosentan and boosted darunavir with darunavir and low dose
may increase plasma concentrations ritonavir, the patient's tolerability of
of bosentan. bosentan should be monitored.
Bosentan is expected to decrease
plasma concentrations of darunavir Co-administration of darunavir co-
and/or its pharmacoenhancer. administered with cobicistat and
(CYP3A induction) bosentan is not recommended.
HEPATITIS C VIRUS (HCV) DIRECT-ACTING ANTIVIRALS
NS3-4A protease inhibitors
Elbasvir/grazoprevir Boosted darunavir may increase the Concomitant use of boosted
exposure to grazoprevir. darunavir and elbasvir/grazoprevir is
(CYP3A and OATP1B inhibition). contraindicated (see section 4.3).
Glecaprevir/pibrentasvir Based on theoretical considerations It is not recommended to co-
boosted darunavir may increase the administer boosted darunavir with
exposure to glecaprevir and glecaprevir/pibrentasvir.
pibrentasvir.
(P-gp, BCRP and/or OATP1B1/3
inhibition)
HERBAL PRODUCTS
St John's wort Not studied. St John's wort is Boosted darunavir must not be used
(Hypericum perforatum) expected to decrease the plasma concomitantly with products
concentrations of darunavir or its containing St John's wort (Hypericum
pharmacoenhancers. perforatum) (see section 4.3). If a
(CYP450 induction) patient is already taking St John's
wort, stop St John's wort and if
possible check viral levels. Darunavir
exposure (and also ritonavir
exposure) may increase on stopping
St John's wort. The inducing effect
may persist for at least 2 weeks after
cessation of treatment with St John's
wort.
HMG CO-A REDUCTASE INHIBITORS
Lovastatin Not studied. Lovastatin and Increased plasma concentrations of
Simvastatin simvastatin are expected to have lovastatin or simvastatin may cause
markedly increased plasma myopathy, including rhabdomyolysis.
concentrations when co- Concomitant use of boosted
administered with boosted darunavir with lovastatin and
darunavir. simvastatin is therefore
(CYP3A inhibition) contraindicated (see section 4.3).
Atorvastatin atorvastatin AUC ↑ 3-4 fold When administration of atorvastatin
10 mg once daily atorvastatin Cmin ↑ ≈5.5-10 fold and boosted darunavir is desired, it is
atorvastatin Cmax ↑ ≈2 fold recommended to start with an
#
darunavir/ritonavir atorvastatin dose of 10 mg once
daily. A gradual dose increase of
atorvastatin AUC ↑ 290% Ω atorvastatin may be tailored to the
atorvastatin Cmax ↑ 319% Ω clinical response.
atorvastatin Cmin ND Ω
Ω
with darunavir/cobicistat 800/150 mg
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): elbasvir (HOS-108814) protease (HOS-085623) lovastatin (HOS-086157) atorvastatin (HOS-086304) pibrentasvir (HOS-086298) cobicistat (HOS-088111) simvastatin (HOS-086158) glecaprevir (HOS-086297) hepatitis C virus (HOS-108813) grazoprevir (HOS-108815) ritonavir (HOS-084521) bosentan (HOS-086291)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-10-20T12:32:00Z · SHA-256 50f4771a683f17214737463c6df88a158b1e699bbb9916413602e547e369e804 · Passage f66edf1b3f3cfbd4637db6965ebe86d3757f4304c50a485b30a8dd4fa4ed1608 · Zeichen 54456–59041 im Abschnitt
Wechselwirkungen · Symtuza
Symtuza 800 mg/150 mg/200 mg/10 mg film-coated tablets Symtuza 675 mg/150 mg/200 mg/10 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 14–15
HOS-138493 · Präparat HOS-098200
14
ENDOTHELIN RECEPTOR ANTAGONISTS
Bosentan Based on theoretical considerations Co-administration of Symtuza
bosentan is expected to decrease and bosentan is not
darunavir and/or cobicistat plasma recommended.
concentrations.
(CYP3A induction)
Symtuza is expected to increase
bosentan plasma concentrations.
(CYP3A inhibition)
ERGOT DERIVATIVES
e.g. Based on theoretical considerations Co-administration of Symtuza
Dihydroergotamine DRV/COBI may increase ergot and ergot derivatives is
Ergometrine derivative exposure. contraindicated (see section 4.3).
Ergotamine
Methylergonovine
HEPATITIS C VIRUS (HCV) DIRECT-ACTING ANTIVIRALS
NS3-4A inhibitors
Elbasvir/grazoprevir Based on theoretical considerations Concomitant use of Symtuza with
Symtuza may increase the elbasvir/grazoprevir is
exposure to grazoprevir. contraindicated (see section 4.3).
(OATP1B and CYP3A inhibition)
Glecaprevir/pibrentasvir Based on theoretical considerations It is not recommended to
DRV/COBI may increase the co-administer Symtuza with
exposure to glecaprevir and glecaprevir/pibrentasvir.
pibrentasvir.
(P-gp, BCRP and/or OATP1B1/3
inhibition)
Daclatasvir Based on theoretical Symtuza and sofosbuvir,
Ledipasvir considerations, no clinically sofosbuvir/ledipasvir, or
Sofosbuvir relevant interaction is expected. daclatasvir can be used
concomitantly without dose
adjustment
Herbal products
St. John’s Wort (Hypericum
Based on theoretical consideration, The concomitant use of Symtuza
perforatum) St. John’s Wort may substantially with these medicinal products is
decrease DRV/COBI (CYP3A4 contraindicated (see section 4.3).
induction) and TAF exposures.
(P-gp induction)
HMG CO-A REDUCTASE INHIBITORS
Atorvastatin Atorvastatin (10 mg once daily): Concomitant use of a HMG CoA
Fluvastatin atorvastatin AUC ↑ 290% reductase inhibitor and Symtuza
Pitavastatin atorvastatin Cmax ↑ 319% may increase plasma
Pravastatin atorvastatin Cmin ND concentrations of the lipid
Rosuvastatin lowering agent, which may lead
Rosuvastatin (10 mg once daily): to adverse reactions such as
rosuvastatin AUC ↑ 93% myopathy.
rosuvastatin Cmax ↑ 277% When administration of
rosuvastatin Cmin ND HMG CoA reductase inhibitors
and Symtuza is desired, it is
Based on theoretical considerations recommended to start with the
DRV/COBI is expected to increase lowest dose and titrate up to the
the plasma concentrations of desired clinical effect while
fluvastatin, pitavastatin, monitoring for safety.
pravastatin, lovastatin and
Lovastatin simvastatin. Concomitant use of Symtuza with
Simvastatin (CYP3A inhibition and/or lovastatin and simvastatin is
transport) contraindicated (see section 4.3).
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): elbasvir (HOS-108814) methylergonovine (HOS-086155) daclatasvir (HOS-119742) sofosbuvir (HOS-108928) lovastatin (HOS-086157) atorvastatin (HOS-086304) pibrentasvir (HOS-086298) ledipasvir (HOS-110493) simvastatin (HOS-086158) rosuvastatin (HOS-086307) glecaprevir (HOS-086297) fluvastatin (HOS-086305) hepatitis C virus (HOS-108813) lead (HOS-085592) grazoprevir (HOS-108815) ergotamine (HOS-086154) bosentan (HOS-086291) dihydroergotamine (HOS-086152) pravastatin (HOS-086306) pitavastatin (HOS-125743)
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