Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Zydelig

Zydelig 100 mg film-coated tablets Zydelig 150 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13

HOS-132135 · Präparat HOS-097192

Rash Rash was generally mild to moderate and resulted in discontinuation of treatment in 2.1% of subjects. In studies 312-0116/0117 and 312-0119, rash (reported as dermatitis exfoliative generalised, drug eruption, rash, rash erythematous, rash generalised, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, rash vesicular, papule and skin plaque) occurred in 31.1% of subjects who received idelalisib + an anti-CD20 monoclonal antibody (rituximab or ofatumumab) and 8.2% who received an anti-CD20 monoclonal antibody only (rituximab or ofatumumab). Of these, 5.7% who received idelalisib + an anti-CD20 monoclonal antibody (rituximab or ofatumumab) and 1.5% who received an anti-CD20 monoclonal antibody only (rituximab or ofatumumab) had rash of Grade 3, and no subjects had an adverse reaction of Grade 4. Rash typically resolved with treatment (e.g., topical and/or oral steroids, diphenhydramine) and dose interruption for severe cases (see section 5.3, phototoxicity).

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

Nebenwirkungen · Zydelig

Zydelig 100 mg film-coated tablets Zydelig 150 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13

HOS-132136 · Präparat HOS-097192

Severe cutaneous reactions (see section 4.4) Cases of SJS, TEN and DRESS have occurred when idelalisib was administered concomitantly with other medicinal products associated with these syndromes (bendamustine, rituximab, allopurinol, amoxicillin, and sulfamethoxazole / trimethoprim). SJS or TEN occurred within one month of the medicinal combination and fatal outcomes have resulted.

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

Nebenwirkungen · Zydelig

Zydelig 100 mg film-coated tablets Zydelig 150 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13

HOS-132137 · Präparat HOS-097192

Reporting of suspected adverse reactions

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

Nebenwirkungen · Zydelig

Zydelig 100 mg film-coated tablets Zydelig 150 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13

HOS-132138 · Präparat HOS-097192

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

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

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)

Wechselwirkungen · Elahere

ELAHERE 5 mg/mL concentrate for solution for infusion · Abschnitt 4.5 · PDF-Seite 8

HOS-144055 · Präparat HOS-099100

DM4 is a CYP3A4 substrate. Concomitant use of ELAHERE with strong CYP3A4 inhibitors may increase unconjugated DM4 exposure (see section 5.2), which may increase the risk of ELAHERE adverse reactions (see section 4.8). If concomitant use with strong CYP3A4 inhibitors (e.g. ceritinib, clarithromycin, cobicistat, idelalisib, itraconazole, ketoconazole, nefazodone, posaconazole, ritonavir, telithromycin, voriconazole) cannot be avoided, patients should be closely monitored for adverse reactions. Strong CYP3A4 inducers (e.g., phenytoin, rifampicin, carbamazepine) may decrease the exposure of unconjugated DM4.

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): ceritinib (HOS-086215) nefazodone (HOS-084519) ketoconazole (HOS-084513) carbamazepine (HOS-085618) cobicistat (HOS-088111) voriconazole (HOS-084524) telithromycin (HOS-084523) itraconazole (HOS-084516) clarithromycin (HOS-084517) ritonavir (HOS-084521) phenytoin (HOS-084531) posaconazole (HOS-085622) idelalisib (HOS-116811)

Wechselwirkungen · Camzyos

CAMZYOS 2.5 mg hard capsules CAMZYOS 5 mg hard capsules CAMZYOS 10 mg hard capsules CAMZYOS 15 mg hard capsules · Abschnitt 4.5 · PDF-Seite 11

HOS-147604 · Präparat HOS-099694

Concomitant CYP2C19 poor metaboliser phenotype* CYP2C19 intermediate, medicinal product normal, rapid and ultra-rapid metaboliser phenotype Inhibitors Combined use of a Contra-indicated (see section 4.3) Contra-indicated (see strong CYP2C19 section 4.3) inhibitor and a strong CYP3A4 inhibitor Strong CYP2C19 No dose adjustment. Monitor LVEF 4 weeks Initiate mavacamten at a dose of inhibitor (e.g., later, and then resume the patient’s monitoring 2.5 mg. ticlopidine, fluconazole, and titration schedule (see section 4.2). The dose should be reduced from fluvoxamine) 15 mg to 5 mg and from 10 mg If CYP2C19 phenotype has not yet been and 5 mg to 2.5 mg or pause determined: treatment if on 2.5 mg. No adjustment of the starting dose of 2.5 mg Monitor LVEF 4 weeks later, is needed. and then resume the patient’s The dose should be reduced from 5 mg to monitoring and titration schedule 2.5 mg or pause treatment if on 2.5 mg. (see section 4.2). Monitor LVEF 4 weeks later, and then resume the patient’s monitoring and titration schedule (see section 4.2). Strong CYP3A4 Contra-indicated (see section 4.3) No dose adjustment. Monitor inhibitor (e.g., LVEF 4 weeks later, and then clarithromycin, resume the patient’s monitoring itraconazole, and titration schedule (see ketoconazole, section 4.2). voriconazole, ritonavir, cobicistat, ceritinib, idelalisib, tucatinib) Moderate CYP2C19 No dose adjustment. Monitor LVEF 4 weeks No adjustment of the starting inhibitor (e.g., later, and then resume the patient’s monitoring dose of 5 mg is needed. fluconazole, fluoxetine, and titration schedule. Adjust mavacamten Initiating or increasing the dose omeprazolea) dose based on clinical assessment (see of a moderate inhibitor while on section 4.2). mavacamten treatment: Dose should be reduced by one If CYP2C19 phenotype has not yet been dose level or pause treatment if determined: on 2.5 mg. Monitor LVEF No adjustment of the starting dose of 2.5 mg 4 weeks later, and then resume is needed. the patient’s monitoring and The dose should be reduced from 5 mg to titration schedule (see 2.5 mg or pause treatment if on 2.5 mg. section 4.2). Monitor LVEF 4 weeks later, and then resume the patient’s monitoring and titration schedule. Adjust mavacamten dose based on clinical assessment (see section 4.2). Moderate CYP3A4 If on medication when starting mavacamten, No dose adjustment. Monitor inhibitor (e.g., no adjustment of the starting dose of 2.5 mg is LVEF 4 weeks later, and then erythromycin, grapefruit needed. resume the patient’s monitoring juice, verapamil, and titration schedule (see diltiazem) Initiating or increasing the dose of a moderate section 4.2). inhibitor while on mavacamten treatment: If patients are receiving a 5 mg dose of mavacamten, their dose should be reduced to 2.5 mg or if on 2.5 mg pause treatment for 4 weeks. Monitor LVEF 4 weeks later, and then resume the patient’s monitoring and titration schedule (see 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): ceritinib (HOS-086215) diltiazem (HOS-086288) ketoconazole (HOS-084513) cobicistat (HOS-088111) voriconazole (HOS-084524) itraconazole (HOS-084516) fluconazole (HOS-087945) clarithromycin (HOS-084517) erythromycin (HOS-084514) fluoxetine (HOS-085946) ritonavir (HOS-084521) fluvoxamine (HOS-085908) tucatinib (HOS-145562) ticlopidine (HOS-087946) idelalisib (HOS-116811) verapamil (HOS-090602)

Wechselwirkungen · Truqap

TRUQAP 160 mg film-coated tablets TRUQAP 200 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 10

HOS-150749 · Präparat HOS-100380

Strong CYP3A4 inhibitors Co-administration of TRUQAP with strong CYP3A4 inhibitors increases capivasertib concentration, which may increase the risk of TRUQAP toxicity. Co-administration with strong CYP3A4 inhibitors should be avoided (e.g. boceprevir, ceritinib, clarithromycin, cobicistat, conivaptan, ensitrelvir, idelalisib, indinavir, itraconazole, josamycin, ketoconazole, lonafarnib, mibefradil, mifepristone, nefazodone, nelfinavir, posaconazole, ribociclib, ritonavir, saquinavir, telaprevir, telithromycin, troleandomycin, tucatinib, voriconazole, grapefruit or grapefruit juice). If co-administration cannot be avoided, TRUQAP dose should be reduced (see section 4.2). Co-administration of multiple 200 mg doses of the strong CYP3A4 inhibitor itraconazole increased capivasertib total exposure (AUCinf) and the peak concentration (Cmax) by 95% and 70%, respectively, relative to capivasertib given alone.

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) ceritinib (HOS-086215) josamycin (HOS-113844) nefazodone (HOS-084519) ensitrelvir (HOS-150750) nelfinavir (HOS-084520) lonafarnib (HOS-150752) ketoconazole (HOS-084513) cobicistat (HOS-088111) conivaptan (HOS-128737) mibefradil (HOS-125440) grapefruit juice (HOS-088787) voriconazole (HOS-084524) telaprevir (HOS-090618) telithromycin (HOS-084523) itraconazole (HOS-084516) saquinavir (HOS-084522) boceprevir (HOS-090617) clarithromycin (HOS-084517) ribociclib (HOS-109454) troleandomycin (HOS-090575) ritonavir (HOS-084521) mifepristone (HOS-150754) tucatinib (HOS-145562) posaconazole (HOS-085622) idelalisib (HOS-116811)