Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Rapamune

Rapamune 1 mg/mL oral solution · Abschnitt 4.5 · PDF-Seite 10

HOS-090616 · Präparat HOS-084095

Inhibitors of CYP3A4 may decrease the metabolism of sirolimus and increase sirolimus blood levels. Such inhibitors include certain antifungals (e.g. clotrimazole, fluconazole, itraconazole, voriconazole), certain antibiotics (e.g. troleandomycin, telithromycin, clarithromycin), certain protease inhibitors (e.g. ritonavir, indinavir, boceprevir, telaprevir), nicardipine, bromocriptine, cimetidine, danazol and letermovir.

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): indinavir (HOS-084518) letermovir (HOS-090621) nicardipine (HOS-090619) protease (HOS-085623) cimetidine (HOS-085835) clotrimazole (HOS-090574) voriconazole (HOS-084524) telaprevir (HOS-090618) telithromycin (HOS-084523) itraconazole (HOS-084516) danazol (HOS-085473) fluconazole (HOS-087945) boceprevir (HOS-090617) clarithromycin (HOS-084517) troleandomycin (HOS-090575) bromocriptine (HOS-090620) ritonavir (HOS-084521)

Wechselwirkungen · Rapamune

Rapamune 0.5 mg coated tablets Rapamune 1 mg coated tablets Rapamune 2 mg coated tablets · Abschnitt 4.5 · PDF-Seite 30

HOS-090685 · Präparat HOS-084095

Inhibitors of CYP3A4 may decrease the metabolism of sirolimus and increase sirolimus blood levels. Such inhibitors include certain antifungals (e.g. clotrimazole, fluconazole, itraconazole, voriconazole), certain antibiotics (e.g. troleandomycin, telithromycin, clarithromycin), certain protease inhibitors (e.g. ritonavir, indinavir, boceprevir, and telaprevir), nicardipine, bromocriptine, cimetidine, danazol and letermovir.

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): indinavir (HOS-084518) letermovir (HOS-090621) nicardipine (HOS-090619) protease (HOS-085623) cimetidine (HOS-085835) clotrimazole (HOS-090574) voriconazole (HOS-084524) telaprevir (HOS-090618) telithromycin (HOS-084523) itraconazole (HOS-084516) danazol (HOS-085473) fluconazole (HOS-087945) boceprevir (HOS-090617) clarithromycin (HOS-084517) troleandomycin (HOS-090575) bromocriptine (HOS-090620) ritonavir (HOS-084521)

Wechselwirkungen · Vfend

VFEND 50 mg film-coated tablets VFEND 200 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 14

HOS-109467 · Präparat HOS-093201

Compared to efavirenz 600 mg Voriconazole may be QD, coadministered with efavirenz if Efavirenz 300 mg QD, Efavirenz Cmax ↔ the voriconazole maintenance coadministered with Efavirenz AUC  17% dose is increased to 400 mg BID voriconazole 400 mg BID* and the efavirenz dose is Compared to voriconazole 200 mg decreased to 300 mg QD. When BID, voriconazole treatment is Voriconazole Cmax  23% stopped, the initial dose of efavirenz should be restored (see Voriconazole AUC  7% sections 4.2 and 4.4). Other Non-Nucleoside Reverse Not studied clinically. In vitro Careful monitoring for any Transcriptase Inhibitors studies show that the metabolism occurrence of drug toxicity (NNRTIs) (including but not of voriconazole may be inhibited and/or lack of efficacy, and dose limited to: delavirdine, by NNRTIs and voriconazole may adjustment may be needed. nevirapine)* inhibit the metabolism of NNRTIs. [CYP3A4 substrates, inhibitors The findings of the effect of or CYP450 inducers] efavirenz on voriconazole suggest that the metabolism of voriconazole may be induced by an NNRTI. Antipsychotics Lurasidone Although not studied, Contraindicated (see section [CYP3A4 substrate] voriconazole is likely to 4.3) significantly increase the plasma concentrations of lurasidone. Pimozide Although not studied, increased Contraindicated (see section [CYP3A4 substrate] plasma concentrations of pimozide 4.3) can lead to QTc prolongation and rare occurrences of torsades de pointes. Anti virals Letermovir Voriconazole Cmax ↓ 39% If concomitant administration of [CYP2C9 and CYP2C19 Voriconazole AUC0-12 ↓ 44% voriconazole with letermovir inducer] Voriconazole C12 ↓ 51% cannot be avoided, monitor for loss of voriconazole effectiveness.

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): letermovir (HOS-090621) lead (HOS-085592) pimozide (HOS-085600) efavirenz (HOS-087947) delavirdine (HOS-109468) nevirapine (HOS-088064) lurasidone (HOS-086148)

Wechselwirkungen · Vfend

VFEND 200 mg powder for solution for infusion · Abschnitt 4.5 · PDF-Seite 45–46

HOS-109544 · Präparat HOS-093201

45 Other Non-Nucleoside Reverse Not studied clinically. In vitro Careful monitoring for any Transcriptase Inhibitors studies show that the metabolism occurrence of drug toxicity (NNRTIs) (including but not of voriconazole may be inhibited and/or lack of efficacy, and dose limited to: delavirdine, by NNRTIs and voriconazole may adjustment may be needed. nevirapine)* inhibit the metabolism of NNRTIs. [CYP3A4 substrates, inhibitors The findings of the effect of or CYP450 inducers] efavirenz on voriconazole suggest that the metabolism of voriconazole may be induced by an NNRTI. Antipsychotics Lurasidone Although not studied, Contraindicated (see section [CYP3A4 substrate] voriconazole is likely to 4.3) significantly increase the plasma concentrations of lurasidone. Pimozide Although not studied, increased Contraindicated (see section [CYP3A4 substrate] plasma concentrations of pimozide 4.3) can lead to QTc prolongation and rare occurrences of torsades de pointes. Anti virals Letermovir Voriconazole Cmax ↓ 39% If concomitant administration of [CYP2C9 and CYP2C19 Voriconazole AUC0-12 ↓ 44% voriconazole with letermovir inducer] Voriconazole C12 ↓ 51% cannot be avoided, monitor for loss of voriconazole effectiveness. Benzodiazepines [CYP3A4 substrates] Dose reduction of Midazolam (0.05 mg/kg IV In an independent published study, benzodiazepines should be single dose) Midazolam AUC0-  3.7-fold considered.

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): letermovir (HOS-090621) lead (HOS-085592) pimozide (HOS-085600) efavirenz (HOS-087947) delavirdine (HOS-109468) nevirapine (HOS-088064) lurasidone (HOS-086148) midazolam (HOS-086167)

Wechselwirkungen · Vfend

VFEND 40 mg/ml powder for oral suspension · Abschnitt 4.5 · PDF-Seite 78

HOS-109609 · Präparat HOS-093201

Voriconazole may be Compared to efavirenz 600 mg coadministered with efavirenz if Efavirenz 300 mg QD, QD, the voriconazole maintenance coadministered with Efavirenz Cmax ↔ dose is increased to 400 mg BID voriconazole 400 mg BID* Efavirenz AUC  17% and the efavirenz dose is decreased to 300 mg QD. When Compared to voriconazole 200 mg voriconazole treatment is BID, stopped, the initial dose of Voriconazole Cmax  23% efavirenz should be restored (see sections 4.2 and 4.4). Voriconazole AUC  7% Other Non-Nucleoside Reverse Not studied clinically. In vitro Careful monitoring for any Transcriptase Inhibitors studies show that the metabolism occurrence of drug toxicity (NNRTIs) (including but not of voriconazole may be inhibited and/or lack of efficacy, and dose limited to: delavirdine, by NNRTIs and voriconazole may adjustment may be needed. nevirapine)* inhibit the metabolism of NNRTIs. [CYP3A4 substrates, inhibitors The findings of the effect of or CYP450 inducers] efavirenz on voriconazole suggest that the metabolism of voriconazole may be induced by an NNRTI. Antipsychotics Lurasidone Although not studied, Contraindicated (see section [CYP3A4 substrate] voriconazole is likely to 4.3) significantly increase the plasma concentrations of lurasidone. Pimozide Although not studied, increased Contraindicated (see section [CYP3A4 substrate] plasma concentrations of pimozide 4.3) can lead to QTc prolongation and rare occurrences of torsades de pointes. Anti virals Letermovir Voriconazole Cmax ↓ 39% If concomitant administration of [CYP2C9 and CYP2C19 Voriconazole AUC0-12 ↓ 44% voriconazole with letermovir inducer] Voriconazole C12 ↓ 51% cannot be avoided, monitor for loss of voriconazole effectiveness.

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): letermovir (HOS-090621) lead (HOS-085592) pimozide (HOS-085600) efavirenz (HOS-087947) delavirdine (HOS-109468) nevirapine (HOS-088064) lurasidone (HOS-086148)

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)

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)

Wechselwirkungen · Voriconazole Hikma (previously Voriconazole Hospira)

Voriconazole Hikma 200 mg powder for solution for infusion · Abschnitt 4.5 · PDF-Seite 14–15

HOS-130954 · Präparat HOS-096981

14 Other Non-Nucleoside Reverse Not studied clinically. In vitro Careful monitoring for any Transcriptase Inhibitors studies show that the metabolism occurrence of drug toxicity (NNRTIs) (including but not of voriconazole may be inhibited and/or lack of efficacy, and dose limited to: delavirdine, by NNRTIs and voriconazole may adjustment may be needed. nevirapine)* inhibit the metabolism of NNRTIs. [CYP3A4 substrates, inhibitors The findings of the effect of or CYP450 inducers] efavirenz on voriconazole suggest that the metabolism of voriconazole may be induced by an NNRTI. Antipsychotics Lurasidone Although not studied, Contraindicated (see section [CYP3A4 substrate] voriconazole is likely to 4.3) significantly increase the plasma concentrations of lurasidone. Pimozide Although not studied, increased Contraindicated (see section [CYP3A4 substrate] plasma concentrations of pimozide 4.3) can lead to QTc prolongation and rare occurrences of torsades de pointes. Anti virals Letermovir Voriconazole Cmax ↓ 39% If concomitant administration of [CYP2C9 and CYP2C19 Voriconazole AUC0-12 ↓ 44% voriconazole with letermovir inducer] Voriconazole C12 ↓ 51% cannot be avoided, monitor for loss of voriconazole effectiveness. Benzodiazepines [CYP3A4 substrates] Dose reduction of Midazolam (0.05 mg/kg IV In an independent published study, benzodiazepines should be single dose) Midazolam AUC0-∞ ↑ 3.7-fold considered.

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): letermovir (HOS-090621) lead (HOS-085592) pimozide (HOS-085600) efavirenz (HOS-087947) delavirdine (HOS-109468) nevirapine (HOS-088064) lurasidone (HOS-086148) midazolam (HOS-086167)

Wechselwirkungen · Tacforius

Tacforius 0.5 mg prolonged-release hard capsules Tacforius 1 mg prolonged-release hard capsules Tacforius 3 mg prolonged-release hard capsules Tacforius 5 mg prolonged-release hard capsules · Abschnitt 4.5 · PDF-Seite 11–12

HOS-139158 · Präparat HOS-098290

11 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 (e.g., neurotoxicity, QT prolongation) is unavoidable, consider 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 (e.g., tacrolimus levels may occur, as tacrolimus the next day at a 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 and tacrolimus exposure may increase needed based on tacrolimus 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, ceritinib. The effect on tacrolimus blood first few days) and re- Strong interactions have also concentrations may remain for evaluated on and after been observed with the several days after co-administration completion of the CYP3A4 macrolide antibiotic is completed. inhibitor. Upon completion, erythromycin. appropriate dose and dosing 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), the prolongation) (see section 4.4). A administration. Reduce macrolide antibiotics (e.g., rapid increase in tacrolimus level tacrolimus dose if needed (see 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)

Gegenanzeigen · Prevymis

PREVYMIS 240 mg film-coated tablets PREVYMIS 480 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 5

HOS-139768 · Präparat HOS-098408

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Concomitant administration with pimozide (see sections 4.4 and 4.5). Concomitant administration with ergot alkaloids (see sections 4.4 and 4.5). Concomitant administration with St. John’s wort (Hypericum perforatum) (see section 4.5). When letermovir is combined with cyclosporine: • Concomitant use of dabigatran, atorvastatin, simvastatin, rosuvastatin or pitavastatin is contraindicated (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): atorvastatin (HOS-086304) simvastatin (HOS-086158) rosuvastatin (HOS-086307) dabigatran (HOS-112096) ergot alkaloids (HOS-108807) pimozide (HOS-085600) cyclosporine (HOS-084512) pitavastatin (HOS-125743)

Gegenanzeigen · Prevymis

PREVYMIS 240 mg concentrate for solution for infusion PREVYMIS 480 mg concentrate for solution for infusion · Abschnitt 4.3 · PDF-Seite 37

HOS-139845 · Präparat HOS-098408

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Concomitant administration with pimozide (see sections 4.4 and 4.5). Concomitant administration with ergot alkaloids (see sections 4.4 and 4.5). Concomitant administration with St. John’s wort (Hypericum perforatum) (see section 4.5). When letermovir is combined with cyclosporine: • Concomitant use of dabigatran, atorvastatin, simvastatin, rosuvastatin or pitavastatin is contraindicated (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): atorvastatin (HOS-086304) simvastatin (HOS-086158) rosuvastatin (HOS-086307) dabigatran (HOS-112096) ergot alkaloids (HOS-108807) pimozide (HOS-085600) cyclosporine (HOS-084512) pitavastatin (HOS-125743)

Gegenanzeigen · Prevymis

PREVYMIS 20 mg granules in sachet PREVYMIS 120 mg granules in sachet · Abschnitt 4.3 · PDF-Seite 71

HOS-139912 · Präparat HOS-098408

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Concomitant administration with pimozide (see sections 4.4 and 4.5). Concomitant administration with ergot alkaloids (see sections 4.4 and 4.5). Concomitant administration with St. John’s wort (Hypericum perforatum) (see section 4.5). When letermovir is combined with cyclosporine: • Concomitant use of dabigatran, atorvastatin, simvastatin, rosuvastatin or pitavastatin is contraindicated (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): atorvastatin (HOS-086304) simvastatin (HOS-086158) rosuvastatin (HOS-086307) dabigatran (HOS-112096) ergot alkaloids (HOS-108807) pimozide (HOS-085600) cyclosporine (HOS-084512) pitavastatin (HOS-125743)

Wechselwirkungen · Prevymis

PREVYMIS 240 mg film-coated tablets PREVYMIS 480 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6

HOS-139770 · Präparat HOS-098408

General information about differences in exposure between different letermovir treatment regimens

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

Wechselwirkungen · Prevymis

PREVYMIS 240 mg film-coated tablets PREVYMIS 480 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6

HOS-139771 · Präparat HOS-098408

-The estimated letermovir plasma exposure is different depending on the dose regimen used (see table in section 5.2). Therefore, the clinical consequences of drug interactions for letermovir will be dependent on which letermovir regimen is used and whether or not letermovir is combined with cyclosporine. -The combination of cyclosporine and letermovir may lead to more marked or additional effects on concomitant medicinal products as compared to letermovir alone (see Table 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): lead (HOS-085592) cyclosporine (HOS-084512)

Wechselwirkungen · Prevymis

PREVYMIS 240 mg film-coated tablets PREVYMIS 480 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6

HOS-139772 · Präparat HOS-098408

Effect of other medicinal products on letermovir

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

Wechselwirkungen · Prevymis

PREVYMIS 240 mg film-coated tablets PREVYMIS 480 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6

HOS-139773 · Präparat HOS-098408

The elimination pathways of letermovir in vivo are biliary excretion and glucuronidation. The relative importance of these pathways is unknown. Both elimination pathways involve active uptake into the hepatocyte through the hepatic uptake transporters OATP1B1/3. After uptake, glucuronidation of letermovir is mediated by UGT1A1 and 3. Letermovir also appears to be subject to P-gp and BCRP mediated efflux in the liver and intestine (see section 5.2).

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

Wechselwirkungen · Prevymis

PREVYMIS 240 mg film-coated tablets PREVYMIS 480 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6

HOS-139774 · Präparat HOS-098408

Inducers of drug metabolising enzymes or transporters

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

Wechselwirkungen · Prevymis

PREVYMIS 240 mg film-coated tablets PREVYMIS 480 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6

HOS-139775 · Präparat HOS-098408

Co-administration of letermovir (with or without cyclosporine) with strong and moderate inducers of transporters (e.g., P-gp) and/or enzymes (e.g., UGTs) is not recommended, as it may lead to subtherapeutic letermovir exposure (see Table 1). -Examples of strong inducers include rifampicin, phenytoin, carbamazepine, rifabutin and phenobarbital. -Examples of moderate inducers include thioridazine, modafinil, ritonavir, lopinavir, efavirenz and etravirine.

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): lopinavir (HOS-086269) phenobarbital (HOS-085617) modafinil (HOS-090546) carbamazepine (HOS-085618) rifabutin (HOS-086262) thioridazine (HOS-086281) etravirine (HOS-088088) lead (HOS-085592) efavirenz (HOS-087947) ritonavir (HOS-084521) cyclosporine (HOS-084512) phenytoin (HOS-084531)

Wechselwirkungen · Prevymis

PREVYMIS 240 mg film-coated tablets PREVYMIS 480 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6

HOS-139776 · Präparat HOS-098408

Rifampicin co-administration resulted in an initial increase in letermovir plasma concentrations (due to OATP1B1/3 and/or P-gp inhibition) that is not clinically relevant, followed by clinically relevant decreases in letermovir plasma concentrations (due to induction of P-gp/UGT) with continued rifampicin co-administration (see Table 1).

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

Wechselwirkungen · Prevymis

PREVYMIS 240 mg film-coated tablets PREVYMIS 480 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6–7

HOS-139777 · Präparat HOS-098408

6 Additional effects of other products on letermovir relevant when combined with cyclosporine

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): cyclosporine (HOS-084512)