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Exakte Wirkstoffkennungen und zitierbare Passagen zu Wechselwirkungen, Gegenanzeigen und Nebenwirkungen.

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.

Quellenpassagen (45)

Gegenanzeigen · Prezista

PREZISTA 400 mg film-coated tablets PREZISTA 800 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 87

HOS-116580 · Präparat HOS-094447

Darunavir boosted with either ritonavir or cobicistat inhibits the elimination of active substances that are highly dependent on CYP3A for clearance, which results in increased exposure to the co-administered medicinal product. Therefore, concomitant treatment with such medicinal products for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated (applies to darunavir boosted with either ritonavir or cobicistat). These active substances include e.g.: - alfuzosin - amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine - astemizole, terfenadine - colchicine when used in patients with renal and/or hepatic impairment (see section 4.5) - ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine) - elbasvir/grazoprevir - cisapride

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) alfuzosin (HOS-086139) methylergonovine (HOS-086155) dronedarone (HOS-086144) cisapride (HOS-085610) cobicistat (HOS-088111) bepridil (HOS-085612) quinidine (HOS-085593) grazoprevir (HOS-108815) ivabradine (HOS-109426) colchicine (HOS-086147) astemizole (HOS-085608) ergotamine (HOS-086154) ritonavir (HOS-084521) amiodarone (HOS-085596) terfenadine (HOS-085607) ranolazine (HOS-086141) dihydroergotamine (HOS-086152)

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Version 2024-07-26T09:44:00Z · SHA-256 457dafbe8b3b9cee45b9ca7b46919ded598e0d0cd16715525d161e54f80b9117 · Passage 986882b0b712a9a949916f43fb05836de98ea933859327e753cd9346903445da · Zeichen 1383–2254 im Abschnitt

Wechselwirkungen · Prezista

PREZISTA 100 mg/ml oral suspension · Abschnitt 4.5 · PDF-Seite 20–21

HOS-116410 · Präparat HOS-094447

20 ENDOTHELIN RECEPTOR ANTAGONISTS Bosentan Not studied. Concomitant use of bosentan When administered concomitantly and boosted PREZISTA may increase with PREZISTA and low dose plasma concentrations of bosentan. ritonavir, the patient’s tolerability of bosentan should be monitored. Bosentan is expected to decrease plasma concentrations of darunavir and/or its Co-administration of PREZISTA pharmacoenhancer. co-administered with cobicistat (CYP3A induction) and bosentan is not recommended. HEPATITIS C VIRUS (HCV) DIRECT-ACTING ANTIVIRALS NS3-4A protease inhibitors Elbasvir/grazoprevir Boosted PREZISTA may increase the Concomitant use of boosted exposure to grazoprevir. PREZISTA and (CYP3A and OATP1B inhibition) elbasvir/grazoprevir is contraindicated (see section 4.3). Glecaprevir/pibrentasvir Based on theoretical considerations It is not recommended to boosted PREZISTA may increase the co-administer boosted PREZISTA exposure to glecaprevir and pibrentasvir. with glecaprevir/pibrentasvir. (P-gp, BCRP and/or OATP1B1/3 inhibition) HERBAL PRODUCTS St John's Wort Not studied. St John’s Wort is expected Boosted PREZISTA must not be (Hypericum perforatum) to decrease the plasma concentrations of used concomitantly with products darunavir or its pharmacoenhancers. containing St John’s Wort (CYP450 induction) (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 increased lovastatin or simvastatin may plasma concentrations when cause myopathy, including co-administered with boosted rhabdomyolysis. Concomitant use PREZISTA. of boosted PREZISTA with (CYP3A inhibition) lovastatin and simvastatin is therefore contraindicated (see section 4.3). Atorvastatin atorvastatin AUC ↑ 3-4 fold When administration of 10 mg once daily atorvastatin Cmin ↑ ≈5.5-10 fold atorvastatin and boosted atorvastatin Cmax ↑ ≈2 fold PREZISTA is desired, it is # darunavir/ritonavir recommended to start with an atorvastatin dose of 10 mg once atorvastatin AUC ↑ 290% Ω daily. A gradual dose increase of atorvastatin may be tailored to the atorvastatin Cmax ↑ 319% Ω clinical response. atorvastatin Cmin ND Ω Ω with darunavir/cobicistat 800/150 mg Pravastatin pravastatin AUC ↑ 81%¶ When administration of pravastatin 40 mg single dose pravastatin Cmin ND and boosted PREZISTA is pravastatin Cmax ↑ 63% required, it is recommended to ¶ an up to five-fold increase was seen in a start with the lowest possible dose limited subset of subjects of pravastatin and titrate up to the desired clinical effect while monitoring for safety.

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) pravastatin (HOS-086306)

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Version 2024-07-26T09:44:00Z · SHA-256 457dafbe8b3b9cee45b9ca7b46919ded598e0d0cd16715525d161e54f80b9117 · Passage 6c740a1d89386aee87cf1f30365ea4ce6beb0a0dc719c309b037ce4e6094f9e7 · Zeichen 57628–63489 im Abschnitt

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 62–63

HOS-116528 · Präparat HOS-094447

62 ENDOTHELIN RECEPTOR ANTAGONISTS Bosentan Not studied. Concomitant use of bosentan When administered concomitantly and PREZISTA co-administered with with PREZISTA and low dose low dose ritonavir may increase plasma ritonavir, the patient’s tolerability concentrations of bosentan. of bosentan should be monitored. 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 PREZISTA with low dose ritonavir may Concomitant use of PREZISTA increase the exposure to grazoprevir. with 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 boosted PREZISTA may increase the co-administer boosted PREZISTA exposure to glecaprevir and pibrentasvir. with glecaprevir/pibrentasvir. (P-gp, BCRP and/or OATP1B1/3 inhibition) HERBAL PRODUCTS St John's Wort Not studied. St John’s Wort is expected PREZISTA co-administered with (Hypericum perforatum) to decrease the plasma concentrations of low dose ritonavir must not be darunavir and ritonavir. used 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 increased lovastatin or simvastatin may plasma concentrations when cause myopathy, including co-administered with rhabdomyolysis. Concomitant use PREZISTAco-administered with low of PREZISTA co-administered dose ritonavir. with low dose ritonavir with (CYP3A inhibition) lovastatin and simvastatin is therefore contraindicated (see section 4.3). Atorvastatin atorvastatin AUC ↑ 3-4 fold When administration of 10 mg once daily atorvastatin Cmin ↑ ≈5.5-10 fold atorvastatin and PREZISTA atorvastatin Cmax ↑ ≈2 fold co-administered with low dose # darunavir/ritonavir ritonavir is desired, it is 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. Pravastatin pravastatin AUC ↑ 81%¶ When administration of pravastatin 40 mg single dose pravastatin Cmin ND and PREZISTA co-administered pravastatin Cmax ↑ 63% with low dose ritonavir is required, ¶ an up to five-fold increase was seen in a it is recommended to start with the limited subset of subjects lowest possible dose of pravastatin and titrate up to the desired clinical effect while monitoring for safety.

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) pravastatin (HOS-086306)

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Version 2024-07-26T09:44:00Z · SHA-256 457dafbe8b3b9cee45b9ca7b46919ded598e0d0cd16715525d161e54f80b9117 · Passage f0e95b466409a0cf2f8a9197f2461639fabe461c2c18b467893f52ceb3fe5916 · Zeichen 48435–54296 im Abschnitt

Wechselwirkungen · Prezista

PREZISTA 400 mg film-coated tablets PREZISTA 800 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 102–103

HOS-116618 · Präparat HOS-094447

102 ENDOTHELIN RECEPTOR ANTAGONISTS Bosentan Not studied. Concomitant use of bosentan When administered concomitantly and boosted PREZISTA may increase with PREZISTA and low dose plasma concentrations of bosentan. ritonavir, the patient’s tolerability Bosentan is expected to decrease plasma of bosentan should be monitored. concentrations of darunavir and/or its pharmacoenhancer. Co-administration of PREZISTA (CYP3A induction) co-administered with cobicistat and bosentan is not recommended. HEPATITIS C VIRUS (HCV) DIRECT-ACTING ANTIVIRALS NS3-4A protease inhibitors Elbasvir/grazoprevir Boosted PREZISTA may increase the Concomitant use of boosted exposure to grazoprevir. PREZISTA and (CYP3A and OATP1B inhibition) elbasvir/grazoprevir is contraindicated (see section 4.3). Glecaprevir/pibrentasvir Based on theoretical considerations It is not recommended to boosted PREZISTA may increase the co-administer boosted PREZISTA exposure to glecaprevir and pibrentasvir. with glecaprevir/pibrentasvir. (P-gp, BCRP and/or OATP1B1/3 inhibition) HERBAL PRODUCTS St John's Wort Not studied. St John’s Wort is expected Boosted PREZISTA must not be (Hypericum perforatum) to decrease the plasma concentrations of used concomitantly with products darunavir or its pharmacoenhancers. containing St John’s Wort (CYP450 induction) (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 increased lovastatin or simvastatin may plasma concentrations when cause myopathy, including co-administered with boosted rhabdomyolysis. Concomitant use PREZISTA. of boosted PREZISTA with (CYP3A inhibition) lovastatin and simvastatin is therefore contraindicated (see section 4.3). Atorvastatin atorvastatin AUC ↑ 3-4 fold When administration of 10 mg once daily atorvastatin Cmin ↑ ≈5.5-10 fold atorvastatin and boosted atorvastatin Cmax ↑ ≈2 fold PREZISTA is desired, it is # darunavir/ritonavir recommended to start with an atorvastatin dose of 10 mg once atorvastatin AUC ↑ 290% Ω daily. A gradual dose increase of atorvastatin Cmax ↑ 319% Ω atorvastatin may be tailored to the clinical response. atorvastatin Cmin ND Ω Ω with darunavir/cobicistat 800/150 mg Pravastatin pravastatin AUC ↑ 81%¶ When administration of pravastatin 40 mg single dose pravastatin Cmin ND and boosted PREZISTA is pravastatin Cmax ↑ 63% required, it is recommended to ¶ an up to five-fold increase was seen in a start with the lowest possible dose limited subset of subjects of pravastatin and titrate up to the desired clinical effect while monitoring for safety.

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) pravastatin (HOS-086306)

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Version 2024-07-26T09:44:00Z · SHA-256 457dafbe8b3b9cee45b9ca7b46919ded598e0d0cd16715525d161e54f80b9117 · Passage bf054a2c5f8c6d1a5be5b88714b31789a51a1dde2eabf2bbfe2ccb65fdbce96b · Zeichen 57100–62897 im Abschnitt

Wechselwirkungen · Advagraf

Advagraf 0.5 mg prolonged-release hard capsules Advagraf 1 mg prolonged-release hard capsules Advagraf 3 mg prolonged-release hard capsules Advagraf 5 mg prolonged-release hard capsules · Abschnitt 4.5 · PDF-Seite 10–11

HOS-116802 · Präparat HOS-094481

10 Drug/Substance Class or Drug interaction effect Recommendations concerning Name co-administration Strong CYP3A4 inhibitors: May increase tacrolimus whole It is recommended that antifungal agents (e.g., blood trough concentrations and concomitant use should be ketoconazole, itraconazole, increase the risk of serious adverse avoided. If co-administration posaconazole, voriconazole), reactions (e.g., nephrotoxicity, of a strong CYP3A4 inhibitor the macrolide antibiotics neurotoxicity, QT prolongation) is unavoidable, consider (e.g., telithromycin, which requires close monitoring omitting the dose of tacrolimus troleandomycin, [see section 4.4]. the day the strong CYP3A4 clarithromycin, josamycin), Rapid and sharp increases in inhibitor is initiated. Reinitiate HIV protease inhibitors tacrolimus levels may occur, as tacrolimus the next day at a (e.g., ritonavir, nelfinavir, early as within 1-3 days after co- reduced dose based on saquinavir), HCV protease administration, despite immediate tacrolimus blood inhibitors (e.g., telaprevir, reduction of tacrolimus dose. concentrations. Changes in boceprevir, and the Overall tacrolimus exposure may both tacrolimus dose and/or combination of ombitasvir increase > 5 fold. When ritonavir dosing frequency should be and paritaprevir with combinations are co-administered, individualized and adjusted as ritonavir, when used with tacrolimus exposure may increase needed based on tacrolimus and without dasabuvir), > 50 fold. Nearly all patients may trough concentrations, which nefazodone, the require a reduction in tacrolimus should be assessed at initiation, pharmacokinetic enhancer dose and temporary interruption of monitored frequently cobicistat, and the kinase tacrolimus may also be necessary. throughout (starting within the inhibitors idelalisib, The effect on tacrolimus blood first few days) and re- ceritinib. concentrations may remain for evaluated on and after Strong interactions have also several days after co-administration completion of the CYP3A4 been observed with the is completed. inhibitor. Upon completion, macrolide antibiotic appropriate dose and dosing erythromycin frequency of tacrolimus should be guided by tacrolimus blood concentrations. Monitor renal function, ECG for QT prolongation, and other side effects closely. Moderate or weak CYP3A4 May increase tacrolimus whole Monitor tacrolimus whole inhibitors: blood trough concentrations and blood trough concentrations antifungal agents (e.g., increase the risk of serious adverse frequently, starting within the fluconazole, isavuconazole, reactions (e.g., neurotoxicity, QT first few days of co- clotrimazole, miconazole), prolongation) [see section 4.4]. A administration. Reduce the macrolide antibiotics rapid increase in tacrolimus level tacrolimus dose if needed [see (e.g., azithromycin), calcium may occur. section 4.2]. Monitor renal channel blockers (e.g., function, ECG for QT nifedipine, nicardipine, prolongation, and other side diltiazem, verapamil), effects closely. 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

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) ceritinib (HOS-086215) josamycin (HOS-113844) diltiazem (HOS-086288) nefazodone (HOS-084519) elbasvir (HOS-108814) isavuconazole (HOS-085186) nifedipine (HOS-086289) nelfinavir (HOS-084520) nicardipine (HOS-090619) protease (HOS-085623) ketoconazole (HOS-084513) pibrentasvir (HOS-086298) crizotinib (HOS-116818) cobicistat (HOS-088111) glecaprevir (HOS-086297) azithromycin (HOS-088112) clotrimazole (HOS-090574) calcium (HOS-085615) imatinib (HOS-110212) dasabuvir (HOS-110302) voriconazole (HOS-084524) telaprevir (HOS-090618) telithromycin (HOS-084523) grazoprevir (HOS-108815) itraconazole (HOS-084516) saquinavir (HOS-084522) danazol (HOS-085473) fluconazole (HOS-087945) ombitasvir (HOS-110300) boceprevir (HOS-090617) clarithromycin (HOS-084517) erythromycin (HOS-084514) troleandomycin (HOS-090575) ritonavir (HOS-084521) amiodarone (HOS-085596) paritaprevir (HOS-110301) tyrosine (HOS-108875) posaconazole (HOS-085622) nilotinib (HOS-086218) miconazole (HOS-115630) idelalisib (HOS-116811) omeprazole (HOS-085912) verapamil (HOS-090602)

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Version 2025-02-27T10:10:00Z · SHA-256 0ed42bc08ffe6bd7e6c8ed94445bdb8b8c9971dabe41ef3a899ec75fc2f97c0e · Passage 871fa2c72a31ddd6873cbb2f1b3b0dd9ad898b46eba141ac32a052a178cc3bc9 · Zeichen 3910–8415 im Abschnitt

Gegenanzeigen · Intelence

INTELENCE 25 mg tablets INTELENCE 100 mg tablets INTELENCE 200 mg tablets · Abschnitt 4.3 · PDF-Seite 4

HOS-119724 · Präparat HOS-095005

Co-administration with elbasvir/grazoprevir (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): elbasvir (HOS-108814) grazoprevir (HOS-108815)

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Version 2024-08-13T16:37:00Z · SHA-256 b6b2c3fd3d600c0f1fd17ddc8f6c1da50bcb8b2181089113d0397c5ec46864c4 · Passage b4be8ded457e6ae9199b280755fc52792aa838e1b028ac2847d500718e1f9a35 · Zeichen 93–155 im Abschnitt

Wechselwirkungen · Intelence

INTELENCE 25 mg tablets INTELENCE 100 mg tablets INTELENCE 200 mg tablets · Abschnitt 4.5 · PDF-Seite 12–13

HOS-119741 · Präparat HOS-095005

12 OESTROGEN-BASED CONTRACEPTIVES Ethinylestradiol ethinylestradiol The combination of 0.035 mg once daily AUC ↑ 1.22 (1.13-1.31) oestrogen- and/or Norethindrone Cmin ↔ 1.09 (1.01-1.18) progesterone-based 1 mg once daily Cmax ↑ 1.33 (1.21-1.46) contraceptives and norethindrone INTELENCE can be used AUC ↔ 0.95 (0.90-0.99) without dose adjustment. Cmin ↓ 0.78 (0.68-0.90) Cmax ↔ 1.05 (0.98-1.12) etravirine AUC ↔a Cmin ↔a Cmax ↔a HEPATITIS C VIRUS (HCV) DIRECT-ACTING ANTIVIRALS Ribavirin Not studied, but no interaction expected based The combination of on the renal elimination pathway of ribavirin. INTELENCE and ribavirin can be used without dose adjustments. Daclatasvir Not studied. Co-administration of etravirine Co-administration of with daclatasvir may decrease daclatasvir INTELENCE and daclatasvir concentrations. is not recommended. Elbasvir/grazoprevir Not studied. Co-administration of etravirine Co-administration is with elbasvir/grazoprevir may decrease elbasvir contraindicated (see and grazoprevir concentrations, leading to section 4.3). reduced therapeutic effect of elbasvir/grazoprevir. HERBAL PRODUCTS St John’s wort Not studied. St John’s wort is expected to Combination not (Hypericum perforatum) decrease the plasma concentrations of recommended. etravirine. HMG CO-A REDUCTASE INHIBITORS Atorvastatin atorvastatin The combination of 40 mg once daily AUC ↓ 0.63 (0.58-0.68) INTELENCE and Cmin ND atorvastatin can be given Cmax ↑ 1.04 (0.84-1.30) without any dose 2-OH-atorvastatin adjustments, however, the AUC ↑ 1.27 (1.19-1.36) dose of atorvastatin may Cmin ND need to be altered based on Cmax ↑ 1.76 (1.60-1.94) clinical response. etravirine AUC ↔ 1.02 (0.97-1.07) Cmin ↔ 1.10 (1.02-1.19) Cmax ↔ 0.97 (0.93-1.02) Fluvastatin Not studied. No interaction between pravastatin Dose adjustments for these Lovastatin and etravirine is expected. HMG Co-A reductase Pravastatin Lovastatin, rosuvastatin and simvastatin are inhibitors may be necessary. Rosuvastatin CYP3A4 substrates and co-administration with Simvastatin etravirine may result in lower plasma concentrations of the HMG Co-A reductase inhibitor. Fluvastatin, and rosuvastatin are metabolised by CYP2C9 and co-administration with etravirine may result in higher plasma concentrations of the HMG Co-A reductase inhibitor. H2-RECEPTOR ANTAGONISTS Ranitidine etravirine INTELENCE can be 150 mg twice daily AUC ↓ 0.86 (0.76-0.97) co-administered with Cmin ND H2-receptor antagonists Cmax ↓ 0.94 (0.75-1.17) without dose adjustments.

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) daclatasvir (HOS-119742) lovastatin (HOS-086157) atorvastatin (HOS-086304) simvastatin (HOS-086158) rosuvastatin (HOS-086307) fluvastatin (HOS-086305) hepatitis C virus (HOS-108813) ribavirin (HOS-088127) grazoprevir (HOS-108815) ranitidine (HOS-085660) norethindrone (HOS-088136) pravastatin (HOS-086306)

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Version 2024-08-13T16:37:00Z · SHA-256 b6b2c3fd3d600c0f1fd17ddc8f6c1da50bcb8b2181089113d0397c5ec46864c4 · Passage b4ae62f3b56de12cf8406dcb55d38bc3538cd806a08b537965c6bb7ead0cc339 · Zeichen 24913–29265 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)

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Version 2025-03-03T17:00:00Z · SHA-256 1a464ac051c5783e49ce08a9d103d0d319997aa4add60584450928c1b11144a7 · Passage 1e7cc303a6d0d182851c23281c6a79a17f96d714a9cddc0ab3d6ada78ab947ab · Zeichen 6985–10993 im Abschnitt

Gegenanzeigen · Efavirenz Teva

Efavirenz Teva 600 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 3

HOS-215254 · Präparat HOS-155418

Co-administration with elbasvir (EBR) and grazoprevir (GZR) due to the potential for significant decreases in plasma concentrations of EBR and GZR (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): elbasvir (HOS-108814) grazoprevir (HOS-108815)

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Version 2023-03-03T18:18:00Z · SHA-256 d2c4a637bb18ba1e0c98c69218ce14671957659a5aa55fba40e74b1bf5620382 · Passage dd30853a014ed61c7aa8a427aaf63c1ab15e9733131efdf809aa6250b618163d · Zeichen 638–803 im Abschnitt

Wechselwirkungen · Efavirenz Teva

Efavirenz Teva 600 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-215270 · Präparat HOS-155418

Elbasvir/grazoprevir Concomitant administration of efavirenz with elbasvir/grazoprevir is 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. (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) lead (HOS-085592) grazoprevir (HOS-108815)

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Version 2023-03-03T18:18:00Z · SHA-256 d2c4a637bb18ba1e0c98c69218ce14671957659a5aa55fba40e74b1bf5620382 · Passage acf5b124708e3ef00edf7ef40e3e0aec25c19b8fa8eb807b62cecc56703cf280 · Zeichen 2110–2429 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)

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Version 2023-03-03T18:18:00Z · SHA-256 d2c4a637bb18ba1e0c98c69218ce14671957659a5aa55fba40e74b1bf5620382 · Passage 310c6908c5167c5c566d1779df72c19d73a6e857af22bb69c467f9646bad659d · Zeichen 23908–28723 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)

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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 8

HOS-126966 · Präparat HOS-096355

Inhibitors of Breast Cancer Resistant Protein (BCRP) Concomitant administration of medicinal products that are inhibitors of BCRP, including products containing elbasvir or grazoprevir, may lead to increased plasma concentrations of simvastatin and an increased risk of myopathy (see sections 4.2 and 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): elbasvir (HOS-108814) lead (HOS-085592) grazoprevir (HOS-108815)

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Version 2026-08-06T10:28:00Z · SHA-256 348750d8a2030faed77c9c061fe6342a446d1448175630ef5f5390d9ff5afaad · Passage 1760a2e65123d536db791d97cbb96f70573b5b8eac1829020d184678500206b5 · Zeichen 3537–3843 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)

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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 30

HOS-127039 · Präparat HOS-096355

Inhibitors of Breast Cancer Resistant Protein (BCRP) Concomitant administration of medicinal products that are inhibitors of BCRP, including products containing elbasvir or grazoprevir, may lead to increased plasma concentrations of simvastatin and an increased risk of myopathy (see sections 4.2 and 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): elbasvir (HOS-108814) lead (HOS-085592) grazoprevir (HOS-108815)

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Version 2026-08-06T10:28:00Z · SHA-256 348750d8a2030faed77c9c061fe6342a446d1448175630ef5f5390d9ff5afaad · Passage 1760a2e65123d536db791d97cbb96f70573b5b8eac1829020d184678500206b5 · Zeichen 3536–3842 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)

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Version 2026-08-06T10:28:00Z · SHA-256 348750d8a2030faed77c9c061fe6342a446d1448175630ef5f5390d9ff5afaad · Passage 6d5c5fec1da2b5e3bb3b7b5c49df8bee2d9cf49df82aef774324124447b7a727 · Zeichen 10741–12812 im Abschnitt

Gegenanzeigen · 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 4.3 · PDF-Seite 5

HOS-134441 · Präparat HOS-097580

Co-administration of darunavir with low dose ritonavir, with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. These active substances include e.g.: - alfuzosin - amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine - astemizole, terfenadine - colchicine when used in patients with renal and/or hepatic impairment (see section 4.5) - ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine) - elbasvir/grazoprevir - cisapride - dapoxetine - domperidone - naloxegol - lurasidone, pimozide, quetiapine, sertindole (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): sertindole (HOS-085601) quetiapine (HOS-086150) elbasvir (HOS-108814) alfuzosin (HOS-086139) methylergonovine (HOS-086155) dronedarone (HOS-086144) cisapride (HOS-085610) bepridil (HOS-085612) quinidine (HOS-085593) domperidone (HOS-114656) naloxegol (HOS-109428) grazoprevir (HOS-108815) ivabradine (HOS-109426) pimozide (HOS-085600) colchicine (HOS-086147) astemizole (HOS-085608) ergotamine (HOS-086154) ritonavir (HOS-084521) amiodarone (HOS-085596) terfenadine (HOS-085607) lurasidone (HOS-086148) ranolazine (HOS-086141) dihydroergotamine (HOS-086152)

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Version 2026-10-20T12:32:00Z · SHA-256 50f4771a683f17214737463c6df88a158b1e699bbb9916413602e547e369e804 · Passage 0623acf1b29e890c85fc94e283370387704b0e29df5d70432cea48b4e0948b1f · Zeichen 452–1192 im Abschnitt

Gegenanzeigen · Darunavir Viatris (previously Darunavir Mylan)

Darunavir Viatris 400 mg film-coated tablets Darunavir Viatris 800 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 44

HOS-134580 · Präparat HOS-097580

Darunavir boosted with either ritonavir or cobicistat inhibits the elimination of active substances that are highly dependent on CYP3A for clearance, which results in increased exposure to the co- administered medicinal product. Therefore, concomitant treatment with such medicinal products for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated (applies to darunavir boosted with either ritonavir or cobicistat). These active substances include e.g.: - alfuzosin - amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine - astemizole, terfenadine - colchicine when used in patients with renal and/or hepatic impairment (see section 4.5) - ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine) - elbasvir/grazoprevir

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) alfuzosin (HOS-086139) methylergonovine (HOS-086155) dronedarone (HOS-086144) cobicistat (HOS-088111) bepridil (HOS-085612) quinidine (HOS-085593) grazoprevir (HOS-108815) ivabradine (HOS-109426) colchicine (HOS-086147) astemizole (HOS-085608) ergotamine (HOS-086154) ritonavir (HOS-084521) amiodarone (HOS-085596) terfenadine (HOS-085607) ranolazine (HOS-086141) dihydroergotamine (HOS-086152)

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Version 2026-10-20T12:32:00Z · SHA-256 50f4771a683f17214737463c6df88a158b1e699bbb9916413602e547e369e804 · Passage dc54d993409459377eca2778cf25b8655b8f68649a72da054ab0f0fc3b77b4d4 · Zeichen 1379–2234 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)

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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)

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Version 2026-10-20T12:32:00Z · SHA-256 50f4771a683f17214737463c6df88a158b1e699bbb9916413602e547e369e804 · Passage f66edf1b3f3cfbd4637db6965ebe86d3757f4304c50a485b30a8dd4fa4ed1608 · Zeichen 54456–59041 im Abschnitt

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