Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Norvir

Norvir 100 mg powder for oral suspension · Abschnitt 4.5 · PDF-Seite 13–14

HOS-086211 · Präparat HOS-083284

13  Ritonavir effects on Non-antiretroviral Co-administered Medicinal Products Co-administered Medicinal Products Dose of Co- Dose of Effect on Co- Effect on Co- administered NORVIR (mg) administered administered Medicinal Products Medicinal Medicinal Products (mg) Products Cmax AUC Apalutamide Apalutamide is a moderate to strong CYP3A4 inducer and this may lead to a decreased exposure of ritonavir and potential loss of virologic response. In addition, serum concentrations may be increased when co-administered with ritonavir resulting in the potential for serious adverse events including seizure.

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): apalutamide (HOS-086212) lead (HOS-085592)

Wechselwirkungen · Norvir

Norvir 100 mg powder for oral suspension · Abschnitt 4.5 · PDF-Seite 14

HOS-086213 · Präparat HOS-083284

Concomitant use of ritonavir with apalutamide is not recommended.

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): apalutamide (HOS-086212)

Wechselwirkungen · Norvir

Norvir 100 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 46

HOS-086419 · Präparat HOS-083284

Apalutamide Apalutamide is a moderate to strong CYP3A4 inducer and this may lead to a decreased exposure of ritonavir and potential loss of virologic response. In addition, serum concentrations may be increased when co-administered with ritonavir resulting in the potential for serious adverse events including seizure.

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): apalutamide (HOS-086212) lead (HOS-085592)

Wechselwirkungen · Norvir

Norvir 100 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 46

HOS-086420 · Präparat HOS-083284

Concomitant use of ritonavir with apalutamide is not recommended.

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): apalutamide (HOS-086212)

Wechselwirkungen · Kaletra

Kaletra (80 mg + 20 mg) / ml oral solution · Abschnitt 4.5 · PDF-Seite 12–13

HOS-108863 · Präparat HOS-093083

12  CYP3A4 inhibition by concomitantly administered with lopinavir/ritonavir. Kaletra. Antianginal Ranolazine Due to CYP3A inhibition by The concomitant administration of lopinavir/ritonavir, concentrations Kaletra and ranolazine is of ranolazine are expected to contraindicated (see section 4.3). increase. Antiarrhythmics Amiodarone, Dronedarone Amiodarone, Dronedarone: Concomitant administration of Concentrations may be increased Kaletra and amiodarone or due to CYP3A4 inhibition by dronedarone is contraindicated (see lopinavir/ritonavir. section 4.3) as the risk of arrhythmias or other serious adverse reactions may be increased. Digoxin Digoxin: Caution is warranted and Plasma concentrations may be therapeutic drug monitoring of increased due to P-glycoprotein digoxin concentrations, if inhibition by lopinavir/ritonavir. available, is recommended in case The increased digoxin level may of co-administration of Kaletra and lessen over time as P-gp digoxin. Particular caution should induction develops. be used when prescribing Kaletra in patients taking digoxin as the acute inhibitory effect of ritonavir on P-gp is expected to significantly increase digoxin levels. Initiation of digoxin in patients already taking Kaletra is likely to result in lower than expected increases of digoxin concentrations. Bepridil, Systemic Bepridil, Systemic Lidocaine, Caution is warranted and Lidocaine, and Quinidine Quinidine: therapeutic drug concentration Concentrations may be increased monitoring is recommended when when co-administered with available. lopinavir/ritonavir. Antibiotics Clarithromycin Clarithromycin: For patients with renal impairment Moderate increases in (CrCL < 30 ml/min) dose reduction clarithromycin AUC are expected of clarithromycin should be due to CYP3A inhibition by considered (see section 4.4). lopinavir/ritonavir. Caution should be exercised in administering clarithromycin with Kaletra to patients with impaired hepatic or renal function. Anticancer agents and kinase inhibitors Abemaciclib Serum concentrations may be Co-administration of abemaciclib increased due to CYP3A and Kaletra should be avoided. If inhibition by ritonavir. this co-administration is judged unavoidable, refer to the abemaciclib SmPC for dosage adjustment recommendations. Monitor for ADRs related to abemaciclib. Apalutamide Apalutamide is a moderate to Decreased exposure of Kaletra may strong CYP3A4 inducer and this result in potential loss of may lead to a decreased exposure virological response. of lopinavir/ritonavir.

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): clarithromycin (HOS-084517) abemaciclib (HOS-086209) apalutamide (HOS-086212) lead (HOS-085592) ranolazine (HOS-086141) amiodarone (HOS-085596) dronedarone (HOS-086144) digoxin (HOS-086172) bepridil (HOS-085612) lidocaine (HOS-108866) quinidine (HOS-085593)

Wechselwirkungen · Kaletra

Kaletra (80 mg + 20 mg) / ml oral solution · Abschnitt 4.5 · PDF-Seite 13–14

HOS-108871 · Präparat HOS-093083

13  In addition, co-administration of Serum concentrations of apalutamide and Kaletra may lead apalutamide may be increased to serious adverse events including due to CYP3A inhibition by seizure due to higher apalutamide lopinavir/ritonavir. levels. Concomitant use of Kaletra with apalutamide is not recommended. Afatinib Afatinib: Caution should be exercised in AUC: ↑ administering afatinib with Kaletra. (Ritonavir 200 mg twice Cmax: ↑ Refer to the afatinib SmPC for daily) dosage adjustment The extent of increase depends on recommendations. Monitor for the timing of ritonavir ADRs related to afatinib. administration.

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): apalutamide (HOS-086212) lead (HOS-085592) afatinib (HOS-086207)

Wechselwirkungen · Kaletra

Kaletra 200 mg/50 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 49–50

HOS-109006 · Präparat HOS-093083

49 Antiarrhythmics Amiodarone, Amiodarone, Dronedarone: Concomitant administration of Dronedarone Concentrations may be increased Kaletra and amiodarone or due to CYP3A4 inhibition by dronedarone is contraindicated (see lopinavir/ritonavir. section 4.3) as the risk of arrhythmias or other serious adverse reactions may be increased. Digoxin Digoxin: Caution is warranted and therapeutic Plasma concentrations may be drug monitoring of digoxin increased due to P-glycoprotein concentrations, if available, is inhibition by lopinavir/ritonavir. recommended in case of The increased digoxin level may co-administration of Kaletra and lessen over time as P-gp digoxin. Particular caution should be induction develops. used when prescribing Kaletra in patients taking digoxin as the acute inhibitory effect of ritonavir on P-gp is expected to significantly increase digoxin levels. Initiation of digoxin in patients already taking Kaletra is likely to result in lower than expected increases of digoxin concentrations. Bepridil, Systemic Bepridil, Systemic Lidocaine, Caution is warranted and therapeutic Lidocaine, and Quinidine: drug concentration monitoring is Quinidine Concentrations may be increased recommended when available. when co-administered with lopinavir/ritonavir. Antibiotics Clarithromycin Clarithromycin: For patients with renal impairment Moderate increases in (CrCL < 30 ml/min) dose reduction clarithromycin AUC are expected of clarithromycin should be due to CYP3A inhibition by considered (see section 4.4). Caution lopinavir/ritonavir. should be exercised in administering clarithromycin with Kaletra to patients with impaired hepatic or renal function. Anticancer agents and kinase inhibitors Abemaciclib Serum concentrations may be Co-administration of abemaciclib increased due to CYP3A and Kaletra should be avoided. If inhibition by ritonavir. this co-administration is judged unavoidable, refer to the abemaciclib SmPC for dosage adjustment recommendations. Monitor for ADRs related to abemaciclib. Apalutamide Apalutamide is a moderate to Decreased exposure of Kaletra may strong CYP3A4 inducer and this result in potential loss of virological may lead to a decreased exposure response. of lopinavir/ritonavir. In addition, co-administration of apalutamide and Kaletra may lead to Serum concentrations of serious adverse events including apalutamide may be increased due seizure due to higher apalutamide to CYP3A inhibition by levels. Concomitant use of Kaletra lopinavir/ritonavir. with apalutamide is not recommended. Afatinib Afatinib: Caution should be exercised in AUC: ↑ administering afatinib with Kaletra. (Ritonavir 200 mg twice Cmax: ↑ Refer to the afatinib SmPC for daily)

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): amiodarone (HOS-085596) dronedarone (HOS-086144) digoxin (HOS-086172) bepridil (HOS-085612) lidocaine (HOS-108866) quinidine (HOS-085593) clarithromycin (HOS-084517) abemaciclib (HOS-086209) apalutamide (HOS-086212) lead (HOS-085592) afatinib (HOS-086207)

Wechselwirkungen · Kaletra

Kaletra 100 mg/25 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 85–86

HOS-109081 · Präparat HOS-093083

85 Apalutamide Apalutamide is a moderate to Decreased exposure of Kaletra may strong CYP3A4 inducer and this result in potential loss of virological may lead to a decreased exposure response. of lopinavir/ritonavir. In addition, co-administration of apalutamide and Kaletra may lead Serum concentrations of to serious adverse events including apalutamide may be increased seizure due to higher apalutamide due to CYP3A inhibition by levels. Concomitant use of Kaletra lopinavir/ritonavir. with apalutamide is not recommended. Afatinib Afatinib: Caution should be exercised in AUC: ↑ administering afatinib with Kaletra. (Ritonavir 200 mg twice Cmax: ↑ Refer to the afatinib SmPC for daily) dosage adjustment The extent of increase depends on recommendations. Monitor for the timing of ritonavir ADRs related to afatinib. administration.

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): apalutamide (HOS-086212) lead (HOS-085592) afatinib (HOS-086207)

Gegenanzeigen · Reyataz

REYATAZ 200 mg hard capsules REYATAZ 300 mg hard capsules · Abschnitt 4.3 · PDF-Seite 4

HOS-112045 · Präparat HOS-093615

Co-administration with medicinal products that are strong inducers of CYP3A4 due to the potential for loss of therapeutic effect and development of possible resistance (e.g., rifampicin, St. John's wort, apalutamide, encorafenib, ivosidenib, carbamazepine, phenobarbital and phenytoin) (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): apalutamide (HOS-086212) encorafenib (HOS-086222) ivosidenib (HOS-112046) carbamazepine (HOS-085618) phenobarbital (HOS-085617) phenytoin (HOS-084531)

Gegenanzeigen · Reyataz

REYATAZ 50 mg oral powder · Abschnitt 4.3 · PDF-Seite 40

HOS-112153 · Präparat HOS-093615

Co-administration with medicinal products that are strong inducers of CYP3A4 due to the potential for loss of therapeutic effect and development of possible resistance (e.g., rifampicin, St. John's wort, apalutamide, encorafenib, ivosidenib, carbamazepine, phenobarbital and phenytoin) (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): apalutamide (HOS-086212) encorafenib (HOS-086222) ivosidenib (HOS-112046) carbamazepine (HOS-085618) phenobarbital (HOS-085617) phenytoin (HOS-084531)

Wechselwirkungen · Reyataz

REYATAZ 200 mg hard capsules REYATAZ 300 mg hard capsules · Abschnitt 4.5 · PDF-Seite 18–19

HOS-112101 · Präparat HOS-093615

18 Medicinal products by Interaction Recommendations concerning co- therapeutic area administration ANTINEOPLASTICS AND IMMUNOSUPRESSANTS Antineoplastics Apalutamide The mechanism of interaction is CYP3A4 Co-administration with REYATAZ induction by apalutamide and CYP3A4 (with or without ritonavir) is inhibition by atazanavir/ritonavir. contraindicated due to the potential for decreased atazanavir and ritonavir plasma concentration with subsequent loss of virologic response and possible resistance to the class of protease inhibitors (see section 4.3). In addition, serum concentrations of apalutamide may be increased when coadministered with atazanavir/ritonavir, resulting in the potential for serious adverse events including seizure. Encorafenib The mechanism of interaction is CYP3A4 Co-administration of encorafenib inhibition by atazanavir and/or ritonavir. with REYATAZ (with or without ritonavir) is contraindicated due to the potential for loss of virologic response, development of resistance, increase in encorafenib plasma concentration and subsequent risk of serious adverse events such as QT interval prolongation (see section 4.3). Ivosidenib The mechanism of interaction is CYP3A4 Co-administration of ivosidenib inhibition by atazanavir and/or ritonavir. with REYATAZ (with or without ritonavir) is contraindicated due to potential for loss of virologic response, development of resistance, increase in ivosidenib plasma concentration and subsequent risk of serious adverse events such as QT interval prolongation (see section 4.3). Irinotecan Atazanavir inhibits UGT and may interfere If REYATAZ is co-administered with the metabolism of irinotecan, with irinotecan, patients should be resulting in increased irinotecan toxicities. closely monitored for adverse events related to irinotecan. Immunosuppressants Cyclosporin Concentrations of these More frequent therapeutic Tacrolimus immunosuppressants may be increased concentration monitoring of these Sirolimus when co-administered with REYATAZ medicinal products is recommended due to CYP3A4 inhibition. until plasma levels have been stabilised. CARDIOVASCULAR AGENTS Antiarrhythmics Amiodarone, Concentrations of these antiarrhythmics Caution is warranted and Systemic lidocaine, may be increased when co-administered therapeutic concentration Quinidine with REYATAZ. The mechanism of monitoring is recommended when amiodarone or systemic available. The concomitant use of lidocaine/atazanavir interaction is CYP3A quinidine is contraindicated inhibition. Quinidine has a narrow (see section 4.3). therapeutic window and is contraindicated due to potential inhibition of CYP3A by REYATAZ.

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): ritonavir (HOS-084521) protease (HOS-085623) encorafenib (HOS-086222) ivosidenib (HOS-112046) irinotecan (HOS-112102) tacrolimus (HOS-085202) sirolimus (HOS-085172) amiodarone (HOS-085596) lidocaine (HOS-108866) quinidine (HOS-085593) apalutamide (HOS-086212)

Wechselwirkungen · Reyataz

REYATAZ 50 mg oral powder · Abschnitt 4.5 · PDF-Seite 54

HOS-112191 · Präparat HOS-093615

Close monitoring of patient's virologic response should be exercised. Lamotrigine Co-administration of lamotrigine and Lamotrigine should be used REYATAZ/ritonavir may decrease with caution in combination lamotrigine plasma concentrations due to with REYATAZ/ritonavir. UGT1A4 induction. If necessary, monitor lamotrigine concentrations and adjust the dose accordingly. ANTINEOPLASTICS AND IMMUNOSUPRESSANTS Antineoplastics Apalutamide The mechanism of interaction is CYP3A4 Co-administration with induction by apalutamide and CYP3A4 REYATAZ (with or without inhibition by atazanavir/ritonavir. ritonavir) is contraindicated due to the potential for decreased atazanavir and ritonavir plasma concentration with subsequent loss of virologic response and possible resistance to the class of protease inhibitors (see section 4.3). In addition, serum concentrations of apalutamide may be increased when coadministered with atazanavir/ritonavir, resulting in the potential for serious adverse events including seizure. Encorafenib The mechanism of interaction is CYP3A4 Co-administration of inhibition by atazanavir and/or ritonavir. encorafenib with REYATAZ (with or without ritonavir) is contraindicated due to potential for loss of virologic response, development of resistance, increase in encorafenib plasma concentration and subsequent risk of serious adverse events such as QT interval prolongation (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): lamotrigine (HOS-086242) ritonavir (HOS-084521) apalutamide (HOS-086212) protease (HOS-085623) encorafenib (HOS-086222)

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 11–12

HOS-116820 · Präparat HOS-094481

11 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 section 4.4]. patients may require an St. 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, increase the risk of rejection [see and increase tacrolimus dose if efavirenz, etravirine, section 4.4]. needed [see section 4.2]. nevirapine; weak CYP3A4 Monitor graft function closely. inducers: flucloxacillin

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): tamoxifen (HOS-088380) phenytoin (HOS-084531) bromocriptine (HOS-090620) cortisone (HOS-114161) dapsone (HOS-088141) ergotamine (HOS-086154) gestodene (HOS-116824) lidocaine (HOS-108866) mephenytoin (HOS-109801) midazolam (HOS-086167) nilvadipine (HOS-116826) quinidine (HOS-085593) carbamazepine (HOS-085618) apalutamide (HOS-086212) enzalutamide (HOS-116829) mitotane (HOS-112479) phenobarbital (HOS-085617) isoniazid (HOS-088590) rifabutin (HOS-086262) efavirenz (HOS-087947) etravirine (HOS-088088) nevirapine (HOS-088064)

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): phenytoin (HOS-084531) bromocriptine (HOS-090620) cortisone (HOS-114161) dapsone (HOS-088141) ergotamine (HOS-086154) gestodene (HOS-116824) lidocaine (HOS-108866) mephenytoin (HOS-109801) midazolam (HOS-086167) nilvadipine (HOS-116826) quinidine (HOS-085593) tamoxifen (HOS-088380) carbamazepine (HOS-085618) apalutamide (HOS-086212) enzalutamide (HOS-116829) mitotane (HOS-112479) phenobarbital (HOS-085617) isoniazid (HOS-088590) rifabutin (HOS-086262) efavirenz (HOS-087947) etravirine (HOS-088088) nevirapine (HOS-088064) caspofungin (HOS-109306) cannabidiol (HOS-090609)

Gegenanzeigen · Erleada

Erleada 60 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 3

HOS-139351 · Präparat HOS-098330

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 · Erleada

Erleada 60 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 3–4

HOS-139352 · Präparat HOS-098330

3 Women who are or may become pregnant (see section 4.6).

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

Gegenanzeigen · Erleada

Erleada 240 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 23

HOS-139401 · Präparat HOS-098330

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 · Erleada

Erleada 240 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 23–24

HOS-139402 · Präparat HOS-098330

23 Women who are or may become pregnant (see section 4.6).

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

Wechselwirkungen · Erleada

Erleada 60 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 5

HOS-139353 · Präparat HOS-098330

The elimination of apalutamide and formation of its active metabolite, N-desmethyl apalutamide, is mediated by both CYP2C8 and CYP3A4 to a similar extent at steady-state. No clinically meaningful changes in their overall exposure is expected as a result of drug interaction with inhibitors or inducers of CYP2C8 or CYP3A4. Apalutamide is an inducer of enzymes and transporters and may lead to an increase in elimination of many commonly used medicinal products.

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)

Wechselwirkungen · Erleada

Erleada 60 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 5

HOS-139354 · Präparat HOS-098330

Potential for other medicinal products to affect apalutamide exposures

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