Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Vfend

VFEND 50 mg film-coated tablets VFEND 200 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 11–12

HOS-109445 · Präparat HOS-093201

Erythromycin (1 g BID) Voriconazole Cmax and AUC ↔ [CYP3A4 inhibitor] The effect of voriconazole on either erythromycin or azithromycin is unknown. Rifabutin Concomitant use of voriconazole [potent CYP450 inducer] and rifabutin should be avoided Voriconazole Cmax  69% unless the benefit outweighs the 300 mg QD Voriconazole AUC  78% risk. The maintenance dose of Compared to voriconazole 200 mg voriconazole may be increased to 300 mg QD (coadministered BID, 5 mg/kg intravenously BID or with voriconazole 350 mg Voriconazole Cmax  4% from 200 mg to 350 mg orally BID)* Voriconazole AUC  32% BID (100 mg to 200 mg orally BID in patients less than 40 kg) (see section 4.2). Careful monitoring of full blood Rifabutin Cmax  195% counts and adverse reactions to 300 mg QD (coadministered Rifabutin AUC  331% rifabutin (e.g., uveitis) is with voriconazole 400 mg Compared to voriconazole 200 mg recommended when rifabutin is BID)* BID, coadministered with voriconazole. Voriconazole Cmax  104% Voriconazole AUC  87% Rifampicin (600 mg QD) Voriconazole Cmax  93% Contraindicated (see section [potent CYP450 inducer] Voriconazole AUC  96% 4.3) Anti-cancer agents Glasdegib Although not studied, voriconazole If concomitant use cannot be [CYP3A4 substrate] is likely to increase the plasma avoided, frequent ECG concentrations of glasdegib and monitoring is recommended (see increase risk of QTc prolongation. section 4.4). Tretinoin Although not studied, voriconazole Dose adjustment of tretinoin is [CYP3A4 substrate] may increase tretinoin recommended during treatment concentrations and increase risk of with voriconazole and after its adverse reactions (pseudotumor discontinuation. cerebri, hypercalcaemia). 11 Tyrosine kinase inhibitors Although not studied, voriconazole If concomitant use cannot be (including but not limited to: may increase plasma avoided, dose reduction of the axitinib, bosutinib, concentrations of tyrosine kinase tyrosine kinase inhibitor and cabozantinib, ceritinib, inhibitors metabolised by CYP3A4. close clinical monitoring is cobimetinib, dabrafenib, recommended (see section 4.4). dasatinib, nilotinib, sunitinib, ibrutinib, ribociclib) [CYP3A4 substrates] Venetoclax Although not studied, voriconazole Concomitant administration of [CYP3A substrate] is likely to significantly increase voriconazole is contraindicated the plasma concentrations of at initiation and during venetoclax. venetoclax dose titration phase (see section 4.3). Dose reduction of venetoclax is required as instructed in venetoclax prescribing information during steady daily dosing; close monitoring for signs of toxicity is recommended. Vinca Alkaloids (including but Although not studied, voriconazole Dose reduction of vinca alkaloids not limited to: vincristine and is likely to increase the plasma should be considered. vinblastine) concentrations of vinca alkaloids [CYP3A4 substrates] and lead to neurotoxicity. Anticoagulants Warfarin (30 mg single dose, Maximum increase in prothrombin Close monitoring of prothrombin coadministered with 300 mg time was approximately 2-fold. time or other suitable BID voriconazole) anticoagulation tests is [CYP2C9 substrate] recommended, and the dose of anticoagulants should be adjusted Other oral coumarins Although not studied, voriconazole accordingly. (including but not limited to: may increase the plasma phenprocoumon, concentrations of coumarins that acenocoumarol) may cause an increase in [CYP2C9 and CYP3A4 prothrombin time. substrates] Anticonvulsants Carbamazepine and Although not studied, Contraindicated (see section long-acting barbiturates carbamazepine and long-acting 4.3) (including but not limited to: barbiturates are likely to phenobarbital, mephobarbital) significantly decrease plasma [potent CYP450 inducers] voriconazole concentrations. Phenytoin Concomitant use of voriconazole [CYP2C9 substrate and potent and phenytoin should be avoided CYP450 inducer] unless the benefit outweighs the risk. Careful monitoring of 300 mg QD Voriconazole Cmax  49% phenytoin plasma levels is Voriconazole AUC  69% 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): axitinib (HOS-109448) ceritinib (HOS-086215) dasatinib (HOS-086217) cobimetinib (HOS-109451) phenobarbital (HOS-085617) carbamazepine (HOS-085618) rifabutin (HOS-086262) vinblastine (HOS-086220) glasdegib (HOS-109446) vincristine (HOS-086219) azithromycin (HOS-088112) phenprocoumon (HOS-091031) dabrafenib (HOS-109452) venetoclax (HOS-086143) tretinoin (HOS-109447) lead (HOS-085592) prothrombin (HOS-085093) sunitinib (HOS-109453) erythromycin (HOS-084514) ribociclib (HOS-109454) tyrosine (HOS-108875) acenocoumarol (HOS-109456) cabozantinib (HOS-109450) phenytoin (HOS-084531) warfarin (HOS-085950) bosutinib (HOS-109449) mephobarbital (HOS-109457) nilotinib (HOS-086218) ibrutinib (HOS-086226)

Wechselwirkungen · Vfend

VFEND 200 mg powder for solution for infusion · Abschnitt 4.5 · PDF-Seite 42–43

HOS-109537 · Präparat HOS-093201

42 Rifabutin Concomitant use of voriconazole [potent CYP450 inducer] and rifabutin should be avoided Voriconazole Cmax  69% unless the benefit outweighs the 300 mg QD Voriconazole AUC  78% risk. The maintenance dose of Compared to voriconazole 200 mg voriconazole may be increased to 300 mg QD (coadministered BID, 5 mg/kg intravenously BID or with voriconazole 350 mg Voriconazole Cmax  4% from 200 mg to 350 mg orally BID)* Voriconazole AUC  32% BID (100 mg to 200 mg orally BID in patients less than 40 kg) (see section 4.2). Careful monitoring of full blood Rifabutin Cmax  195% counts and adverse reactions to 300 mg QD (coadministered Rifabutin AUC  331% rifabutin (e.g., uveitis) is with voriconazole 400 mg Compared to voriconazole 200 mg recommended when rifabutin is BID)* BID, coadministered with voriconazole. Voriconazole Cmax  104% Voriconazole AUC  87% Rifampicin (600 mg QD) Voriconazole Cmax  93% Contraindicated (see section [potent CYP450 inducer] Voriconazole AUC  96% 4.3) Anti-cancer agents Glasdegib Although not studied, voriconazole If concomitant use cannot be [CYP3A4 substrate] is likely to increase the plasma avoided, frequent ECG concentrations of glasdegib and monitoring is recommended (see increase risk of QTc prolongation. section 4.4). Tretinoin Although not studied, voriconazole Dose adjustment of tretinoin is [CYP3A4 substrate] may increase tretinoin recommended during treatment concentrations and increase risk of with voriconazole and after its adverse reactions (pseudotumor discontinuation. cerebri, hypercalcaemia). Tyrosine kinase inhibitors Although not studied, voriconazole If concomitant use cannot be (including but not limited to: may increase plasma avoided, dose reduction of the axitinib, bosutinib, concentrations of tyrosine kinase tyrosine kinase inhibitor and cabozantinib, ceritinib, inhibitors metabolised by CYP3A4. close clinical monitoring is cobimetinib, dabrafenib, recommended (see section 4.4). dasatinib, nilotinib, sunitinib, ibrutinib, ribociclib) [CYP3A4 substrates] Venetoclax Although not studied, voriconazole Concomitant administration of [CYP3A substrate] is likely to significantly increase voriconazole is contraindicated the plasma concentrations of at initiation and during venetoclax. venetoclax dose titration phase (see section 4.3). Dose reduction of venetoclax is required as instructed in venetoclax prescribing information during steady daily dosing; close monitoring for signs of toxicity is recommended. Vinca Alkaloids (including but Although not studied, voriconazole Dose reduction of vinca alkaloids not limited to: vincristine and is likely to increase the plasma should be considered. vinblastine) concentrations of vinca alkaloids [CYP3A4 substrates] and lead to neurotoxicity.

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): axitinib (HOS-109448) ceritinib (HOS-086215) dasatinib (HOS-086217) cobimetinib (HOS-109451) rifabutin (HOS-086262) vinblastine (HOS-086220) glasdegib (HOS-109446) vincristine (HOS-086219) dabrafenib (HOS-109452) venetoclax (HOS-086143) tretinoin (HOS-109447) lead (HOS-085592) sunitinib (HOS-109453) ribociclib (HOS-109454) tyrosine (HOS-108875) cabozantinib (HOS-109450) bosutinib (HOS-109449) nilotinib (HOS-086218) ibrutinib (HOS-086226)

Wechselwirkungen · Vfend

VFEND 40 mg/ml powder for oral suspension · Abschnitt 4.5 · PDF-Seite 75–76

HOS-109603 · Präparat HOS-093201

75 Tyrosine kinase inhibitors Although not studied, voriconazole If concomitant use cannot be (including but not limited to: may increase plasma avoided, dose reduction of the axitinib, bosutinib, concentrations of tyrosine kinase tyrosine kinase inhibitor and cabozantinib, ceritinib, inhibitors metabolised by CYP3A4. close clinical monitoring is cobimetinib, dabrafenib, recommended (see section 4.4). dasatinib, nilotinib, sunitinib, ibrutinib, ribociclib) [CYP3A4 substrates] Venetoclax Although not studied, voriconazole Concomitant administration of [CYP3A substrate] is likely to significantly increase voriconazole is contraindicated the plasma concentrations of at initiation and during venetoclax. venetoclax dose titration phase (see section 4.3). Dose reduction of venetoclax is required as instructed in venetoclax prescribing information during steady daily dosing; close monitoring for signs of toxicity is recommended. Vinca Alkaloids (including but Although not studied, voriconazole Dose reduction of vinca alkaloids not limited to: vincristine and is likely to increase the plasma should be considered. vinblastine) concentrations of vinca alkaloids [CYP3A4 substrates] and lead to neurotoxicity. Anticoagulants Warfarin (30 mg single dose, Maximum increase in prothrombin Close monitoring of prothrombin coadministered with 300 mg time was approximately 2-fold. time or other suitable BID voriconazole) anticoagulation tests is [CYP2C9 substrate] recommended, and the dose of anticoagulants should be adjusted Other oral coumarins Although not studied, voriconazole accordingly. (including but not limited to: may increase the plasma phenprocoumon, concentrations of coumarins that acenocoumarol) may cause an increase in [CYP2C9 and CYP3A4 prothrombin time. substrates] Anticonvulsants Carbamazepine and Although not studied, Contraindicated (see section long-acting barbiturates carbamazepine and long-acting 4.3) (including but not limited to: barbiturates are likely to phenobarbital, mephobarbital) significantly decrease plasma [potent CYP450 inducers] voriconazole concentrations. Phenytoin Concomitant use of voriconazole [CYP2C9 substrate and potent and phenytoin should be avoided CYP450 inducer] unless the benefit outweighs the risk. Careful monitoring of 300 mg QD Voriconazole Cmax  49% phenytoin plasma levels is Voriconazole AUC  69% 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): axitinib (HOS-109448) ceritinib (HOS-086215) dasatinib (HOS-086217) cobimetinib (HOS-109451) phenobarbital (HOS-085617) carbamazepine (HOS-085618) vinblastine (HOS-086220) vincristine (HOS-086219) phenprocoumon (HOS-091031) dabrafenib (HOS-109452) venetoclax (HOS-086143) lead (HOS-085592) prothrombin (HOS-085093) sunitinib (HOS-109453) ribociclib (HOS-109454) tyrosine (HOS-108875) acenocoumarol (HOS-109456) cabozantinib (HOS-109450) phenytoin (HOS-084531) warfarin (HOS-085950) bosutinib (HOS-109449) mephobarbital (HOS-109457) nilotinib (HOS-086218) ibrutinib (HOS-086226)

Gegenanzeigen · Tafinlar

Tafinlar 50 mg hard capsules Tafinlar 75 mg hard capsules · Abschnitt 4.3 · PDF-Seite 6

HOS-218694 · Präparat HOS-216245

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.

Wechselwirkungen · Tafinlar

Tafinlar 50 mg hard capsules Tafinlar 75 mg hard capsules · Abschnitt 4.5 · PDF-Seite 12

HOS-218695 · Präparat HOS-216245

Effect of other medicinal products on dabrafenib

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

Wechselwirkungen · Tafinlar

Tafinlar 50 mg hard capsules Tafinlar 75 mg hard capsules · Abschnitt 4.5 · PDF-Seite 12

HOS-218696 · Präparat HOS-216245

Dabrafenib is a substrate for the metabolising enzymes CYP2C8 and CYP3A4, while the active metabolites hydroxy-dabrafenib and desmethyl-dabrafenib are CYP3A4 substrates. Medicinal products that are strong inhibitors or inducers of CYP2C8 or CYP3A4 are therefore likely to increase or decrease, respectively, dabrafenib concentrations. Alternative agents should be considered during administration with dabrafenib when possible. Dabrafenib should be used with caution if strong inhibitors (e.g. ketoconazole, gemfibrozil, nefazodone, clarithromycin, ritonavir, saquinavir, telithromycin, itraconazole, voriconazole, posaconazole, atazanavir) are co-administered with dabrafenib. Co-administration of dabrafenib with potent inducers (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital, or St John’s wort (Hypericum perforatum)) of CYP2C8 or CYP3A4 should be avoided.

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): nefazodone (HOS-084519) atazanavir (HOS-086180) phenobarbital (HOS-085617) ketoconazole (HOS-084513) carbamazepine (HOS-085618) gemfibrozil (HOS-088403) voriconazole (HOS-084524) telithromycin (HOS-084523) itraconazole (HOS-084516) saquinavir (HOS-084522) clarithromycin (HOS-084517) ritonavir (HOS-084521) phenytoin (HOS-084531) posaconazole (HOS-085622)

Wechselwirkungen · Tafinlar

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HOS-218699 · Präparat HOS-216245

Administration of ketoconazole (a CYP3A4 inhibitor) 400 mg once daily, with dabrafenib 75 mg twice daily, resulted in a 71% increase in dabrafenib AUC and a 33% increase in dabrafenib Cmax relative to administration of dabrafenib 75 mg twice daily alone. Co-administration resulted in increases in hydroxy- and desmethyl-dabrafenib AUC (increases of 82% and 68%, respectively). A decrease of 16% in AUC was noted for carboxy-dabrafenib.

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): ketoconazole (HOS-084513)

Wechselwirkungen · Tafinlar

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HOS-218700 · Präparat HOS-216245

Administration of gemfibrozil (a CYP2C8 inhibitor) 600 mg twice daily, with dabrafenib 75 mg twice daily, resulted in a 47% increase in dabrafenib AUC but did not alter dabrafenib Cmax relative to administration of dabrafenib 75 mg twice daily alone. Gemfibrozil had no clinically relevant effect on the systemic exposure to dabrafenib metabolites (≤13%).

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): gemfibrozil (HOS-088403)

Wechselwirkungen · Tafinlar

Tafinlar 50 mg hard capsules Tafinlar 75 mg hard capsules · Abschnitt 4.5 · PDF-Seite 12

HOS-218701 · Präparat HOS-216245

Administration of rifampin (a CYP3A4/CYP2C8 inducer) 600 mg once daily, with dabrafenib 150 mg twice daily, resulted in a decrease in repeat-dose dabrafenib Cmax (27%) and AUC (34%). No relevant change in AUC was noted for hydroxy-dabrafenib. There was an increase in AUC of 73% for carboxy-dabrafenib and a decrease in AUC of 30% for desmethyl-dabrafenib.

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): rifampin (HOS-088791)

Wechselwirkungen · Tafinlar

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HOS-218703 · Präparat HOS-216245

Co-administration of repeat doses of dabrafenib 150 mg twice daily and the pH-elevating agent rabeprazole 40 mg once daily resulted in a 3% increase in AUC and a 12% decrease in dabrafenib Cmax. These changes in dabrafenib AUC and Cmax are considered not clinically meaningful. Medicinal products that alter the pH of the upper gastrointestinal (GI) tract (e.g. proton pump inhibitors, H2- receptor antagonists, antacids) are not expected to reduce the bioavailability of dabrafenib.

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): rabeprazole (HOS-114843)

Wechselwirkungen · Tafinlar

Tafinlar 50 mg hard capsules Tafinlar 75 mg hard capsules · Abschnitt 4.5 · PDF-Seite 12

HOS-218705 · Präparat HOS-216245

Effect of dabrafenib on other medicinal products

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

Wechselwirkungen · Tafinlar

Tafinlar 50 mg hard capsules Tafinlar 75 mg hard capsules · Abschnitt 4.5 · PDF-Seite 12

HOS-218706 · Präparat HOS-216245

Dabrafenib is an enzyme inducer and increases the synthesis of drug-metabolising enzymes including CYP3A4, CYP2Cs and CYP2B6 and may increase the synthesis of transporters. This results in reduced plasma levels of medicinal products metabolised by these enzymes and may affect some transported medicinal products. The reduction in plasma concentrations can lead to lost or reduced clinical effect of these medicinal products. There is also a risk of increased formation of active metabolites of these medicinal products. Enzymes that may be induced include CYP3A in the liver and gut, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and UGTs (glucuronide conjugating enzymes). The transport protein P-gp may also be induced as well as other transporters, e.g. MRP-2. Induction of OATP1B1/1B3 and BCRP is not likely based on the observations from a clinical study with rosuvastatin.

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): rosuvastatin (HOS-086307) lead (HOS-085592)

Wechselwirkungen · Tafinlar

Tafinlar 50 mg hard capsules Tafinlar 75 mg hard capsules · Abschnitt 4.5 · PDF-Seite 12

HOS-218707 · Präparat HOS-216245

In vitro, dabrafenib produced dose-dependent increases in CYP2B6 and CYP3A4. In a clinical drug interaction study, Cmax and AUC of oral midazolam (a CYP3A4 substrate) decreased by 47% and 65%, respectively with co-administration of repeat-dose dabrafenib.

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): midazolam (HOS-086167)

Wechselwirkungen · Tafinlar

Tafinlar 50 mg hard capsules Tafinlar 75 mg hard capsules · Abschnitt 4.5 · PDF-Seite 12

HOS-218708 · Präparat HOS-216245

Administration of dabrafenib 150 mg twice daily and warfarin resulted in a decrease in AUC of S- and R- warfarin of 37% and 33%, respectively, compared to administration of warfarin alone. Cmax of S- and R-warfarin increased 18% and 19%.

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): warfarin (HOS-085950)

Wechselwirkungen · Tafinlar

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HOS-218709 · Präparat HOS-216245

12 Interactions with many medicinal products eliminated through metabolism or active transport is expected. If their therapeutic effect is of large importance to the patient, and dose adjustments are not easily performed based on monitoring of efficacy or plasma concentrations, these medicinal products are to be avoided or used with caution. The risk for liver injury after paracetamol administration is suspected to be higher in patients concomitantly treated with enzyme inducers.

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

Wechselwirkungen · Tafinlar

Tafinlar 50 mg hard capsules Tafinlar 75 mg hard capsules · Abschnitt 4.5 · PDF-Seite 13

HOS-218710 · Präparat HOS-216245

The number of affected medicinal products is expected to be large, although the magnitude of the interaction will vary. Groups of medicinal products that can be affected include, but are not limited to: • Analgesics (e.g. fentanyl, methadone) • Antibiotics (e.g. clarithromycin, doxycycline) • Anti-cancer agents (e.g. cabazitaxel) • Anticoagulants (e.g. acenocoumarol, warfarin, see section 4.4) • Antiepileptics (e.g. carbamazepine, phenytoin, primidone, valproic acid) • Antipsychotics (e.g. haloperidol) • Calcium channel blockers (e.g. diltiazem, felodipine, nicardipine, nifedipine, verapamil) • Cardiac glycosides (e.g. digoxin, see section 4.4) • Corticosteroids (e.g. dexamethasone, methylprednisolone) • HIV antivirals (e.g. amprenavir, atazanavir, darunavir, delavirdine, efavirenz, fosamprenavir, indinavir, lopinavir, nelfinavir, saquinavir, tipranavir) • Hormonal contraceptives (see section 4.6) • Hypnotics (e.g. diazepam, midazolam, zolpidem) • Immunosuppressants (e.g. cyclosporin, tacrolimus, sirolimus) • Statins metabolised by CYP3A4 (e.g. atorvastatin, simvastatin)

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): doxycycline (HOS-127860) indinavir (HOS-084518) diltiazem (HOS-086288) lopinavir (HOS-086269) nifedipine (HOS-086289) atazanavir (HOS-086180) nelfinavir (HOS-084520) nicardipine (HOS-090619) methadone (HOS-086198) valproic acid (HOS-088515) atorvastatin (HOS-086304) felodipine (HOS-108908) carbamazepine (HOS-085618) methylprednisolone (HOS-088374) simvastatin (HOS-086158) digoxin (HOS-086172) diazepam (HOS-085904) calcium (HOS-085615) zolpidem (HOS-086327) dexamethasone (HOS-084535) saquinavir (HOS-084522) clarithromycin (HOS-084517) tacrolimus (HOS-085202) amprenavir (HOS-086183) cabazitaxel (HOS-124028) darunavir (HOS-086181) efavirenz (HOS-087947) delavirdine (HOS-109468) sirolimus (HOS-085172) fentanyl (HOS-086196) fosamprenavir (HOS-086182) haloperidol (HOS-085602) acenocoumarol (HOS-109456) phenytoin (HOS-084531) warfarin (HOS-085950) tipranavir (HOS-086184) midazolam (HOS-086167) primidone (HOS-090551) verapamil (HOS-090602)

Wechselwirkungen · Tafinlar

Tafinlar 50 mg hard capsules Tafinlar 75 mg hard capsules · Abschnitt 4.5 · PDF-Seite 13

HOS-218720 · Präparat HOS-216245

Onset of induction is likely to occur after 3 days of repeat dosing with dabrafenib. Upon discontinuation of dabrafenib offset of induction is gradual, concentrations of sensitive CYP3A4, CYP2B6, CYP2C8, CYP2C9 and CYP2C19, UDP glucuronosyl transferase (UGT) and transporter substrates (e.g. P-gp or MRP-2) may increase and patients should be monitored for toxicity and dose of these agents may need to be adjusted.

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

Wechselwirkungen · Tafinlar

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HOS-218721 · Präparat HOS-216245

In vitro, dabrafenib is a mechanism based inhibitor of CYP3A4. Therefore, transient inhibition of CYP3A4 may be observed during the first few days of treatment.

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

Wechselwirkungen · Tafinlar

Tafinlar 50 mg hard capsules Tafinlar 75 mg hard capsules · Abschnitt 4.5 · PDF-Seite 13

HOS-218722 · Präparat HOS-216245

Effects of dabrafenib on substance transport systems

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

Wechselwirkungen · Tafinlar

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HOS-218723 · Präparat HOS-216245

Dabrafenib is an in vitro inhibitor of human organic anion transporting polypeptide (OATP) 1B1 (OATP1B1), OATP1B3 and BCRP. Following co-administration of a single dose of rosuvastatin (OATP1B1, OATP1B3 and BCRP substrate) with repeat-dose dabrafenib 150 mg twice daily in 16 patients, Cmax of rosuvastatin increased 2.6-fold whereas the AUC was only minimally changed (7% increase). The increased Cmax of rosuvastatin is unlikely to have clinical relevance.

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): rosuvastatin (HOS-086307)