Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Rapamune

Rapamune 1 mg/mL oral solution · Abschnitt 4.5 · PDF-Seite 9

HOS-090608 · Präparat HOS-084095

Cannabidiol (P-gp inhibitor)

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): cannabidiol (HOS-090609)

Wechselwirkungen · Rapamune

Rapamune 1 mg/mL oral solution · Abschnitt 4.5 · PDF-Seite 9

HOS-090610 · Präparat HOS-084095

There have been reports of increased blood levels of sirolimus during concomitant use with cannabidiol. Co-administration of cannabidiol with another orally administered mTOR inhibitor in a healthy volunteer study led to an increase in exposure to the mTOR inhibitor of approximately 2.5-fold for both Cmax and AUC, due to inhibition of intestinal P-gp efflux by cannabidiol. Caution should be used when cannabidiol and Rapamune are co-administered, closely monitoring for side effects. Monitor sirolimus blood levels and adjust the dose as needed (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): cannabidiol (HOS-090609)

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-090680 · Präparat HOS-084095

Cannabidiol (P-gp inhibitor)

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): cannabidiol (HOS-090609)

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-090681 · Präparat HOS-084095

There have been reports of increased blood levels of sirolimus during concomitant use with cannabidiol. Co-administration of cannabidiol with another orally administered mTOR inhibitor in a healthy volunteer study led to an increase in exposure to the mTOR inhibitor of approximately 2.5-fold for both Cmax and AUC, due to inhibition of intestinal P-gp efflux by cannabidiol. Caution should be used when cannabidiol and Rapamune are co-administered, closely monitoring for side effects. Monitor sirolimus blood levels and adjust the dose as needed (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): cannabidiol (HOS-090609)

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 12

HOS-116832 · Präparat HOS-094481

Caspofungin May decrease tacrolimus whole Monitor tacrolimus whole blood trough concentrations and blood trough concentrations increase the risk of rejection. and increase tacrolimus dose if Mechanism of interaction has not needed [see section 4.2]. been confirmed. Monitor graft function closely. Cannabidiol (P-gp inhibitor) There have been reports of Tacrolimus and cannabidiol increased tacrolimus blood levels should be co-administered with during concomitant use of caution, closely monitoring for tacrolimus with cannabidiol. This side effects. Monitor may be due to inhibition of tacrolimus whole blood trough intestinal P-glycoprotein, leading to concentrations and adjust the increased bioavailability of tacrolimus dose if needed [see tacrolimus. 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): caspofungin (HOS-109306) cannabidiol (HOS-090609)

Wechselwirkungen · Torisel

Torisel 30 mg concentrate and solvent for solution for infusion · Abschnitt 4.5 · PDF-Seite 10

HOS-208976 · Präparat HOS-154221

Cannabidiol (P-gp inhibitor)

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): cannabidiol (HOS-090609)

Wechselwirkungen · Torisel

Torisel 30 mg concentrate and solvent for solution for infusion · Abschnitt 4.5 · PDF-Seite 10

HOS-208978 · Präparat HOS-154221

There have been reports of increased blood levels of other mTOR inhibitors during concomitant use with cannabidiol. Co-administration of cannabidiol with another orally administered mTOR inhibitor in a healthy volunteer study led to an increase in exposure to the mTOR inhibitor of approximately 2.5- fold for both Cmax and AUC, due to inhibition of intestinal P-gp efflux by cannabidiol. Temsirolimus was demonstrated to be a substrate for P-gp in vitro. Caution should be used when cannabidiol and temsirolimus are co-administered, closely monitoring for side effects and adjusting the temsirolimus dose as needed (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): cannabidiol (HOS-090609)

Wechselwirkungen · Modigraf

Modigraf 0.2 mg granules for oral suspension Modigraf 1 mg granules for oral suspension · Abschnitt 4.5 · PDF-Seite 12–13

HOS-209770 · Präparat HOS-154375

12 Drug/Substance Class or Drug interaction effect Recommendations concerning co- Name administration dose may need to be adjusted gradually. Monitor graft function closely. Moderate CYP3A4 inducers: May decrease tacrolimus Monitor tacrolimus whole blood metamizole, phenobarbital, whole blood trough trough concentrations and isoniazid rifabutin, efavirenz, concentrations and increase increase tacrolimus dose if needed etravirine, nevirapine; weak the risk of rejection [see [see section 4.2]. CYP3A4 inducers: section 4.4]. Monitor graft function closely. flucloxacillin Caspofungin May decrease tacrolimus Monitor tacrolimus whole blood whole blood trough trough concentrations and concentrations and increase increase tacrolimus dose if needed the risk of rejection. [see section 4.2]. Monitor graft Mechanism of interaction has function closely. not been confirmed. Cannabidiol (P-gp inhibitor) There have been reports of Tacrolimus and cannabidiol increased tacrolimus blood should be co-administered with levels during concomitant caution, closely monitoring for use of tacrolimus with side effects. Monitor tacrolimus cannabidiol. This may be due whole blood trough to inhibition of intestinal P- concentrations and adjust the glycoprotein, leading to tacrolimus dose if needed [see increased bioavailability of sections 4.2 and 4.4]. tacrolimus. Products known to have high Tacrolimus is extensively Monitor tacrolimus whole blood affinity for plasma proteins, bound to plasma proteins. trough concentrations and adjust e.g.: NSAIDs, oral Possible interactions with tacrolimus dose if needed [see anticoagulants, oral other active substances section 4.2]. antidiabetics known to have high affinity for plasma proteins should be considered. Prokinetic agents: May increase tacrolimus Monitor tacrolimus whole blood metoclopramide, cimetidine whole blood trough trough concentrations and reduce and magnesium-aluminium- concentrations and increase tacrolimus dose if needed [see hydroxide the risk of serious adverse section 4.2]. reactions (e.g., neurotoxicity, Monitor closely for renal QT prolongation). function, for QT prolongation with ECG, and for other side effects. Maintenance doses of May decrease tacrolimus Monitor tacrolimus whole blood corticosteroids whole blood trough trough concentrations and concentrations and increase increase tacrolimus dose if needed the risk of rejection [see [see section 4.2]. section 4.4]. Monitor graft function closely. High dose prednisolone or May have impact on Monitor tacrolimus whole blood methylprednisolone tacrolimus blood levels trough concentrations and adjust (increase or decrease) when tacrolimus dose if needed. administered for the treatment of acute rejection.

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): prednisolone (HOS-086337) caspofungin (HOS-109306) phenobarbital (HOS-085617) cimetidine (HOS-085835) rifabutin (HOS-086262) methylprednisolone (HOS-088374) metoclopramide (HOS-090626) etravirine (HOS-088088) cannabidiol (HOS-090609) efavirenz (HOS-087947) nevirapine (HOS-088064) isoniazid (HOS-088590)

Wechselwirkungen · Afinitor

Afinitor 2.5 mg tablets Afinitor 5 mg tablets Afinitor 10 mg tablets · Abschnitt 4.5 · PDF-Seite 9

HOS-210305 · Präparat HOS-154501

Active substance by Interaction – Change in Recommendations concerning interaction Everolimus AUC/Cmax co-administration Geometric mean ratio (observed range) Potent CYP3A4/PgP inhibitors Ketoconazole AUC ↑15.3-fold Concomitant treatment of Afinitor (range 11.2-22.5) and potent inhibitors is not Cmax ↑4.1-fold recommended. (range 2.6-7.0) Itraconazole, posaconazole, Not studied. Large increase in voriconazole everolimus concentration is Telithromycin, expected. clarithromycin Nefazodone Ritonavir, atazanavir, saquinavir, darunavir, indinavir, nelfinavir Moderate CYP3A4/PgP inhibitors Erythromycin AUC ↑4.4-fold Use caution when (range 2.0-12.6) co-administration of moderate Cmax ↑2.0-fold CYP3A4 inhibitors or PgP (range 0.9-3.5) inhibitors cannot be avoided. If Imatinib AUC ↑ 3.7-fold patients require co-administration Cmax ↑ 2.2-fold of a moderate CYP3A4 or PgP Verapamil AUC ↑3.5-fold inhibitor, dose reduction to 5 mg (range 2.2-6.3) daily or 2.5 mg daily may be Cmax ↑2.3-fold considered. However, there are no (range1.3-3.8) clinical data with this dose Ciclosporin oral AUC ↑2.7-fold adjustment. Due to between (range 1.5-4.7) subject variability the Cmax ↑1.8-fold recommended dose adjustments (range 1.3-2.6) may not be optimal in all Cannabidiol (PgP inhibitor) AUC ↑2.5-fold individuals, therefore close Cmax ↑2.5-fold monitoring of side effects is Fluconazole Not studied. Increased exposure recommended (see sections 4.2 and Diltiazem expected. 4.4). If the moderate inhibitor is Dronedarone Not studied. Increased exposure discontinued, consider a washout expected. period of at least 2 to 3 days Amprenavir, fosamprenavir Not studied. Increased exposure (average elimination time for most expected. commonly used moderate inhibitors) before the Afinitor dose is returned to the dose used prior to initiation of the co-administration. Grapefruit juice or other Not studied. Increased exposure Combination should be avoided. food affecting CYP3A4/PgP expected (the effect varies widely).

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) diltiazem (HOS-086288) nefazodone (HOS-084519) atazanavir (HOS-086180) nelfinavir (HOS-084520) dronedarone (HOS-086144) ketoconazole (HOS-084513) grapefruit juice (HOS-088787) cannabidiol (HOS-090609) imatinib (HOS-110212) voriconazole (HOS-084524) telithromycin (HOS-084523) itraconazole (HOS-084516) saquinavir (HOS-084522) fluconazole (HOS-087945) clarithromycin (HOS-084517) erythromycin (HOS-084514) amprenavir (HOS-086183) darunavir (HOS-086181) fosamprenavir (HOS-086182) ritonavir (HOS-084521) posaconazole (HOS-085622) verapamil (HOS-090602)

Wechselwirkungen · Votubia

Votubia 2.5 mg tablets Votubia 5 mg tablets Votubia 10 mg tablets · Abschnitt 4.5 · PDF-Seite 11

HOS-214256 · Präparat HOS-155312

Active substance by Interaction – Change in Recommendations concerning interaction Everolimus AUC/Cmax co-administration Geometric mean ratio (observed range) Potent CYP3A4/PgP inhibitors Ketoconazole AUC ↑15.3-fold Concomitant treatment of Votubia (range 11.2-22.5) and potent inhibitors is not Cmax ↑4.1-fold recommended. (range 2.6-7.0) Itraconazole, posaconazole, Not studied. Large increase in voriconazole everolimus concentration is Telithromycin, expected. clarithromycin Nefazodone Ritonavir, atazanavir, saquinavir, darunavir, indinavir, nelfinavir Moderate CYP3A4/PgP inhibitors Erythromycin AUC ↑4.4-fold Use caution when co-administration (range 2.0-12.6) of moderate CYP3A4 inhibitors or Cmax ↑2.0-fold PgP inhibitors cannot be avoided. (range 0.9-3.5) Imatinib AUC ↑ 3.7-fold For patients with renal Cmax ↑ 2.2-fold angiomyolipoma associated with Verapamil AUC ↑3.5-fold TSC: (range 2.2-6.3) If patients require co-administration Cmax ↑2.3-fold of a moderate CYP3A4 or PgP (range1.3-3.8) inhibitor, dose reduction to 5 mg or Ciclosporin oral AUC ↑2.7-fold 2.5 mg daily may be considered. (range 1.5-4.7) However, there are no clinical data Cmax ↑1.8-fold with this dose adjustment. Due to (range 1.3-2.6) between subject variability the Cannabidiol (PgP inhibitor) AUC ↑2.5-fold recommended dose adjustments may Cmax ↑2.5-fold not be optimal in all individuals, Fluconazole Not studied. Increased exposure therefore close monitoring of side Diltiazem expected. effects is recommended. If the Dronedarone Not studied. Increased exposure moderate inhibitor is discontinued, expected. consider a washout period of at least Amprenavir, fosamprenavir Not studied. Increased exposure 2 to 3 days (average elimination time expected. for most commonly used moderate inhibitors) before the Votubia dose is returned to the dose used prior to initiation of the co-administration (see also Therapeutic drug monitoring in section 4.2).

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) diltiazem (HOS-086288) nefazodone (HOS-084519) atazanavir (HOS-086180) nelfinavir (HOS-084520) dronedarone (HOS-086144) ketoconazole (HOS-084513) cannabidiol (HOS-090609) imatinib (HOS-110212) voriconazole (HOS-084524) telithromycin (HOS-084523) itraconazole (HOS-084516) saquinavir (HOS-084522) fluconazole (HOS-087945) clarithromycin (HOS-084517) erythromycin (HOS-084514) amprenavir (HOS-086183) darunavir (HOS-086181) fosamprenavir (HOS-086182) ritonavir (HOS-084521) posaconazole (HOS-085622) verapamil (HOS-090602)

Wechselwirkungen · Votubia

Votubia 1 mg dispersible tablets Votubia 2 mg dispersible tablets Votubia 3 mg dispersible tablets Votubia 5 mg dispersible tablets · Abschnitt 4.5 · PDF-Seite 38

HOS-214306 · Präparat HOS-155312

Active substance by Interaction – Change in Recommendations concerning interaction Everolimus AUC/Cmax co-administration Geometric mean ratio (observed range) Potent CYP3A4/PgP inhibitors Ketoconazole AUC ↑15.3-fold Concomitant treatment of Votubia (range 11.2-22.5) and potent inhibitors is not Cmax ↑4.1-fold recommended. (range 2.6-7.0) Itraconazole, posaconazole, Not studied. Large increase in voriconazole everolimus concentration is Telithromycin, expected. clarithromycin Nefazodone Ritonavir, atazanavir, saquinavir, darunavir, indinavir, nelfinavir Moderate CYP3A4/PgP inhibitors Erythromycin AUC ↑4.4-fold Use caution when co-administration (range 2.0-12.6) of moderate CYP3A4 inhibitors or Cmax ↑2.0-fold PgP inhibitors cannot be avoided. (range 0.9-3.5) Imatinib AUC ↑ 3.7-fold If patients require co-administration Cmax ↑ 2.2-fold of a moderate CYP3A4 or PgP Verapamil AUC ↑3.5-fold inhibitor, reduce the daily dose by (range 2.2-6.3) approximately 50%. Further dose Cmax ↑2.3-fold reduction may be required to manage (range1.3-3.8) adverse reactions (see sections 4.2 Ciclosporin oral AUC ↑2.7-fold and 4.4). Everolimus trough (range 1.5-4.7) concentrations should be assessed at Cmax ↑1.8-fold least 1 week after the addition of a (range 1.3-2.6) moderate CYP3A4 or PgP inhibitor. Cannabidiol (PgP inhibitor) AUC ↑2.5-fold If the moderate inhibitor is Cmax ↑2.5-fold discontinued, consider a washout Fluconazole Not studied. Increased exposure period of at least 2 to 3 days Diltiazem expected. (average elimination time for most Dronedarone Not studied. Increased exposure commonly used moderate inhibitors) expected. before the Votubia dose is returned Amprenavir, fosamprenavir Not studied. Increased exposure to the dose used prior to initiation of expected. the co-administration. The everolimus trough concentration should be assessed at least 1 week later (see sections 4.2 and 4.4). Grapefruit juice or other Not studied. Increased exposure Combination should be avoided. food affecting CYP3A4/PgP expected (the effect varies widely).

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) diltiazem (HOS-086288) nefazodone (HOS-084519) atazanavir (HOS-086180) nelfinavir (HOS-084520) dronedarone (HOS-086144) ketoconazole (HOS-084513) grapefruit juice (HOS-088787) cannabidiol (HOS-090609) imatinib (HOS-110212) voriconazole (HOS-084524) telithromycin (HOS-084523) itraconazole (HOS-084516) saquinavir (HOS-084522) fluconazole (HOS-087945) clarithromycin (HOS-084517) erythromycin (HOS-084514) amprenavir (HOS-086183) darunavir (HOS-086181) fosamprenavir (HOS-086182) ritonavir (HOS-084521) posaconazole (HOS-085622) verapamil (HOS-090602)

Wechselwirkungen · Briviact (in Italy: Nubriveo)

Briviact 10 mg film-coated tablets Briviact 25 mg film-coated tablets Briviact 50 mg film-coated tablets Briviact 75 mg film-coated tablets Briviact 100 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6

HOS-132723 · Präparat HOS-097290

Brivaracetam plasma concentrations may increase when coadministered with CYP2C19 strong inhibitors (e.g. fluconazole, fluvoxamine), but the risk of a clinically relevant CYP2C19-mediated interaction is considered to be low. Limited clinical data are available implying that coadministration of cannabidiol may increase the plasma exposure of brivaracetam, possibly through CYP2C19 inhibition, but the clinical relevance is uncertain.

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): cannabidiol (HOS-090609) fluconazole (HOS-087945) fluvoxamine (HOS-085908)

Wechselwirkungen · Briviact (in Italy: Nubriveo)

Briviact 10 mg/ml oral solution · Abschnitt 4.5 · PDF-Seite 26

HOS-132763 · Präparat HOS-097290

Brivaracetam plasma concentrations may increase when coadministered with CYP2C19 strong inhibitors (e.g. fluconazole, fluvoxamine), but the risk of a clinically relevant CYP2C19-mediated interaction is considered to be low. Limited clinical data are available implying that coadministration of cannabidiol may increase the plasma exposure of brivaracetam, possibly through CYP2C19 inhibition, but the clinical relevance is uncertain.

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): cannabidiol (HOS-090609) fluconazole (HOS-087945) fluvoxamine (HOS-085908)

Wechselwirkungen · Briviact (in Italy: Nubriveo)

Briviact 10 mg/ml solution for injection/infusion · Abschnitt 4.5 · PDF-Seite 42

HOS-132799 · Präparat HOS-097290

Brivaracetam plasma concentrations may increase when coadministered with CYP2C19 strong inhibitors (e.g. fluconazole, fluvoxamine), but the risk of a clinically relevant CYP2C19-mediated interaction is considered to be low. Limited clinical data are available implying that coadministration of cannabidiol may increase the plasma exposure of brivaracetam, possibly through CYP2C19 inhibition, but the clinical relevance is uncertain.

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): cannabidiol (HOS-090609) fluconazole (HOS-087945) fluvoxamine (HOS-085908)

Wechselwirkungen · Fintepla

Fintepla 2.2 mg/ml oral solution · Abschnitt 4.5 · PDF-Seite 8

HOS-132970 · Präparat HOS-097342

Effect of steady state cannabidiol on fenfluramine Co-administration of a single 0.35 mg/kg dose of fenfluramine with repeated doses of cannabidiol increased the AUC 0-INF of fenfluramine by 59% and the C max by 10%, and decreased the AUC 0-INF of norfenfluramine by 22% and the C max by 33%, as compared to fenfluramine administered alone. Co-administration of a single 0.35 mg/kg dose of fenfluramine, with repeated doses of cannabidiol, did not affect the pharmacokinetics of cannabidiol, as compared to cannabidiol alone. No dose adjustment is necessary when fenfluramine is co-administered with cannabidiol.

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): cannabidiol (HOS-090609)

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 12–13

HOS-139170 · Präparat HOS-098290

12 Drug/Substance Class or Drug interaction effect Recommendations concerning Name co-administration In vitro the following May increase tacrolimus whole Monitor tacrolimus whole substances have been shown blood trough concentrations and blood trough concentrations to be potential inhibitors of increase the risk of serious adverse and reduce tacrolimus dose if tacrolimus metabolism: reactions (e.g., neurotoxicity, QT needed (see section 4.2). bromocriptine, cortisone, prolongation) (see section 4.4). Monitor renal function, ECG dapsone, ergotamine, for QT prolongation, and other gestodene, lidocaine, side effects closely. mephenytoin, midazolam, nilvadipine, norethisterone, quinidine, tamoxifen. Strong CYP3A4 inducers: May decrease tacrolimus whole It is recommended that rifampicin, phenytoin, blood trough concentrations and concomitant use should be carbamazepine, apalutamide, increase the risk of rejection (see avoided. If unavoidable, enzalutamide, mitotane, or St. section 4.4). patients may require an John’s wort (Hypericum Maximal effect on tacrolimus blood increase in tacrolimus dose. perforatum) concentrations may be achieved 1-2 Changes in tacrolimus dose weeks after co-administration. The should be individualized and effect may remain 1-2 weeks after adjusted as needed based on completion of the treatment. tacrolimus trough concentrations, which should be assessed at initiation, 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 dose may need to be adjusted gradually. Monitor graft function closely. Moderate CYP3A4 inducers: May decrease tacrolimus whole Monitor tacrolimus whole metamizole, phenobarbital, blood trough concentrations and blood trough concentrations isoniazid, rifabutin, efavirenz, increase the risk of rejection (see and increase tacrolimus dose if etravirine, nevirapine section 4.4). needed (see section 4.2). Weak CYP3A4 inducers: Monitor graft function closely. flucloxacillin Caspofungin May decrease tacrolimus whole Monitor tacrolimus whole blood trough concentrations and blood trough concentrations increase the risk of rejection. and increase tacrolimus dose if Mechanism of interaction has not needed (see section 4.2). been confirmed. Monitor graft function closely. Cannabidiol (P-gp inhibitor) There have been reports of Tacrolimus and cannabidiol increased tacrolimus blood levels should be co-administered with during concomitant use of caution, closely monitoring for tacrolimus with cannabidiol. This side effects. Monitor may be due to inhibition of tacrolimus whole blood trough intestinal P-glycoprotein, leading to concentrations and adjust the increased bioavailability of tacrolimus dose if needed (see tacrolimus. 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): cortisone (HOS-114161) caspofungin (HOS-109306) phenobarbital (HOS-085617) lidocaine (HOS-108866) carbamazepine (HOS-085618) rifabutin (HOS-086262) apalutamide (HOS-086212) tamoxifen (HOS-088380) quinidine (HOS-085593) etravirine (HOS-088088) mephenytoin (HOS-109801) cannabidiol (HOS-090609) mitotane (HOS-112479) bromocriptine (HOS-090620) efavirenz (HOS-087947) nilvadipine (HOS-116826) gestodene (HOS-116824) nevirapine (HOS-088064) ergotamine (HOS-086154) isoniazid (HOS-088590) dapsone (HOS-088141) phenytoin (HOS-084531) enzalutamide (HOS-116829) midazolam (HOS-086167)

Gegenanzeigen · Epidyolex

Epidyolex 100 mg/ml oral solution · Abschnitt 4.3 · PDF-Seite 5

HOS-140599 · Präparat HOS-098554

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

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

Gegenanzeigen · Epidyolex

Epidyolex 100 mg/ml oral solution · Abschnitt 4.3 · PDF-Seite 5

HOS-140600 · Präparat HOS-098554

Patients with transaminase elevations greater than 3 times the upper limit of normal (ULN) and bilirubin greater than 2 times the ULN (see section 4.4).

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

Wechselwirkungen · Epidyolex

Epidyolex 100 mg/ml oral solution · Abschnitt 4.5 · PDF-Seite 7

HOS-140601 · Präparat HOS-098554

CYP3A4 or CYP2C19 inducers

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

Wechselwirkungen · Epidyolex

Epidyolex 100 mg/ml oral solution · Abschnitt 4.5 · PDF-Seite 7

HOS-140602 · Präparat HOS-098554

The strong CYP3A4/2C19 inducing agent rifampicin (600 mg administered once daily) decreased plasma concentrations of cannabidiol and of 7-hydroxy-cannabidiol (7-OH-CBD; an active metabolite of cannabidiol) by approximately 30% and 60%, respectively. Other strong inducers of CYP3A4 and/or CYP2C19, such as carbamazepine, enzalutamide, mitotane, and St. John’s wort, when administered concomitantly with cannabidiol, may also cause a decrease in the plasma concentrations of cannabidiol and of 7-OH-CBD by a similar amount. These changes may result in a decrease in the effectiveness of cannabidiol. Dose adjustment may be necessary.

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): carbamazepine (HOS-085618) mitotane (HOS-112479) enzalutamide (HOS-116829)