Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Advagraf

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HOS-116788 · Präparat HOS-094481

Hypersensitivity to tacrolimus, or to any of the excipients listed in section 6.1. Hypersensitivity to other macrolides.

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

Wechselwirkungen · Advagraf

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HOS-116789 · Präparat HOS-094481

Metabolic interactions Systemically available tacrolimus is metabolised by hepatic CYP3A4. There is also evidence of gastrointestinal metabolism by CYP3A4 in the intestinal wall. Concomitant use of medicinal products or herbal remedies known to inhibit or induce CYP3A4 may affect the metabolism of tacrolimus and thereby increase or decrease tacrolimus blood levels. Similarly, discontinuation of such products or herbal remedies may affect the rate of metabolism of tacrolimus and thereby the blood levels of tacrolimus.

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

Wechselwirkungen · Advagraf

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HOS-116790 · Präparat HOS-094481

Pharmacokinetics studies have indicated that the increase in tacrolimus blood levels when co- administered with inhibitors of CYP3A4 is mainly a result of increase in oral bioavailability of tacrolimus owing to the inhibition of gastrointestinal metabolism. Effect on hepatic clearance is less pronounced. It is recommended strongly to closely monitor tacrolimus blood levels under supervision of a transplant specialist, as well as, monitor for graft function, QT prolongation (with ECG), renal function and other side effects including neurotoxicity, whenever substances which have the potential to alter CYP3A4 metabolism are used concomitantly, and to adjust or interrupt the tacrolimus dose if appropriate in order to maintain similar tacrolimus exposure (see sections 4.2 and 4.4). Similarly, patients should be closely monitored when using tacrolimus concomitantly with multiple substances that affect CYP3A4 as the effects on tacrolimus exposure may be enhanced or counteracted.

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

Wechselwirkungen · Advagraf

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HOS-116791 · Präparat HOS-094481

Medicinal products which have effects on tacrolimus are listed in the table below. The examples of drug-drug interactions are not intended to be inclusive or comprehensive and therefore the label of each drug that is co-administered with tacrolimus should be consulted for information related to the route of metabolism, interaction pathways, potential risks, and specific actions to be taken with regards to co-administration.

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

Wechselwirkungen · Advagraf

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HOS-116792 · Präparat HOS-094481

Medicinal products which have effects on tacrolimus Drug/Substance Class or Drug interaction effect Recommendations concerning Name co-administration Grapefruit or grapefruit juice May increase tacrolimus whole Avoid grapefruit or grapefruit blood trough concentrations and juice. increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see section 4.4]. Ciclosporin May increase tacrolimus whole The simultaneous use of blood trough concentrations. In ciclosporin and tacrolimus addition, synergistic/additive should be avoided [see nephrotoxic effects can occur. section 4.4]. Products known to have May enhance nephrotoxic or Concurrent use of tacrolimus nephrotoxic or neurotoxic neurotoxic effects of tacrolimus. with drugs known to have effects: nephrotoxic effects should be aminoglycosides, gyrase avoided. When co- inhibitors, vancomycin, administration cannot be sulfamethoxazole + avoided, monitor renal trimethoprim, NSAIDs, function and other side effects ganciclovir, acyclovir, and adjust tacrolimus dose if amphotericin B, ibuprofen, needed. cidofovir, foscarnet

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): foscarnet (HOS-110484) sulfamethoxazole (HOS-084533) ibuprofen (HOS-087884) amphotericin B (HOS-109312) trimethoprim (HOS-085184) cidofovir (HOS-110482) grapefruit juice (HOS-088787) vancomycin (HOS-110486) ganciclovir (HOS-085194) acyclovir (HOS-088527)

Wechselwirkungen · Advagraf

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HOS-116802 · Präparat HOS-094481

10 Drug/Substance Class or Drug interaction effect Recommendations concerning Name co-administration Strong CYP3A4 inhibitors: May increase tacrolimus whole It is recommended that antifungal agents (e.g., blood trough concentrations and concomitant use should be ketoconazole, itraconazole, increase the risk of serious adverse avoided. If co-administration posaconazole, voriconazole), reactions (e.g., nephrotoxicity, of a strong CYP3A4 inhibitor the macrolide antibiotics neurotoxicity, QT prolongation) is unavoidable, consider (e.g., telithromycin, which requires close monitoring omitting the dose of tacrolimus troleandomycin, [see section 4.4]. the day the strong CYP3A4 clarithromycin, josamycin), Rapid and sharp increases in inhibitor is initiated. Reinitiate HIV protease inhibitors tacrolimus levels may occur, as tacrolimus the next day at a (e.g., ritonavir, nelfinavir, early as within 1-3 days after co- reduced dose based on saquinavir), HCV protease administration, despite immediate tacrolimus blood inhibitors (e.g., telaprevir, reduction of tacrolimus dose. concentrations. Changes in boceprevir, and the Overall tacrolimus exposure may both tacrolimus dose and/or combination of ombitasvir increase > 5 fold. When ritonavir dosing frequency should be and paritaprevir with combinations are co-administered, individualized and adjusted as ritonavir, when used with tacrolimus exposure may increase needed based on tacrolimus and without dasabuvir), > 50 fold. Nearly all patients may trough concentrations, which nefazodone, the require a reduction in tacrolimus should be assessed at initiation, pharmacokinetic enhancer dose and temporary interruption of monitored frequently cobicistat, and the kinase tacrolimus may also be necessary. throughout (starting within the inhibitors idelalisib, The effect on tacrolimus blood first few days) and re- ceritinib. concentrations may remain for evaluated on and after Strong interactions have also several days after co-administration completion of the CYP3A4 been observed with the is completed. inhibitor. Upon completion, macrolide antibiotic appropriate dose and dosing erythromycin frequency of tacrolimus should be guided by tacrolimus blood concentrations. Monitor renal function, ECG for QT prolongation, and other side effects closely. Moderate or weak CYP3A4 May increase tacrolimus whole Monitor tacrolimus whole inhibitors: blood trough concentrations and blood trough concentrations antifungal agents (e.g., increase the risk of serious adverse frequently, starting within the fluconazole, isavuconazole, reactions (e.g., neurotoxicity, QT first few days of co- clotrimazole, miconazole), prolongation) [see section 4.4]. A administration. Reduce the macrolide antibiotics rapid increase in tacrolimus level tacrolimus dose if needed [see (e.g., azithromycin), calcium may occur. section 4.2]. Monitor renal channel blockers (e.g., function, ECG for QT nifedipine, nicardipine, prolongation, and other side diltiazem, verapamil), effects closely. amiodarone, danazol, ethinylestradiol, lansoprazole, omeprazole, the HCV antivirals elbasvir/grazoprevir and glecaprevir/pibrentasvir, the CMV antiviral letermovir, and the tyrosine kinase inhibitors nilotinib, crizotinib and imatinib and (Chinese) herbal remedies containing extracts of Schisandra sphenanthera

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): lansoprazole (HOS-085166) letermovir (HOS-090621) ceritinib (HOS-086215) josamycin (HOS-113844) diltiazem (HOS-086288) nefazodone (HOS-084519) elbasvir (HOS-108814) isavuconazole (HOS-085186) nifedipine (HOS-086289) nelfinavir (HOS-084520) nicardipine (HOS-090619) protease (HOS-085623) ketoconazole (HOS-084513) pibrentasvir (HOS-086298) crizotinib (HOS-116818) cobicistat (HOS-088111) glecaprevir (HOS-086297) azithromycin (HOS-088112) clotrimazole (HOS-090574) calcium (HOS-085615) imatinib (HOS-110212) dasabuvir (HOS-110302) voriconazole (HOS-084524) telaprevir (HOS-090618) telithromycin (HOS-084523) grazoprevir (HOS-108815) itraconazole (HOS-084516) saquinavir (HOS-084522) danazol (HOS-085473) fluconazole (HOS-087945) ombitasvir (HOS-110300) boceprevir (HOS-090617) clarithromycin (HOS-084517) erythromycin (HOS-084514) troleandomycin (HOS-090575) ritonavir (HOS-084521) amiodarone (HOS-085596) paritaprevir (HOS-110301) tyrosine (HOS-108875) posaconazole (HOS-085622) nilotinib (HOS-086218) miconazole (HOS-115630) idelalisib (HOS-116811) omeprazole (HOS-085912) verapamil (HOS-090602)

Wechselwirkungen · Advagraf

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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): cortisone (HOS-114161) 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) 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)

Wechselwirkungen · Advagraf

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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 · Advagraf

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HOS-116835 · Präparat HOS-094481

12  Drug/Substance Class or Drug interaction effect Recommendations concerning Name co-administration Products known to have high Tacrolimus is extensively bound to Monitor tacrolimus whole affinity for plasma proteins, plasma proteins. Possible blood trough concentrations e.g.: NSAIDs, oral interactions with other active and adjust tacrolimus dose if anticoagulants, oral substances known to have high needed [see section 4.2]. antidiabetics affinity for plasma proteins should be considered. Prokinetic agents: May increase tacrolimus whole Monitor tacrolimus whole metoclopramide, cimetidine blood trough concentrations and blood trough concentrations and magnesium-aluminium- increase the risk of serious adverse and reduce tacrolimus dose if hydroxide reactions (e.g., neurotoxicity, QT needed [see section 4.2]. prolongation). Monitor closely for renal function, for QT prolongation with ECG, and for other side effects. Maintenance doses of May decrease tacrolimus whole Monitor tacrolimus whole corticosteroids blood trough concentrations and blood trough concentrations increase the risk of rejection [see and increase tacrolimus dose if section 4.4]. needed [see section 4.2]. Monitor graft function closely. High dose prednisolone or May have impact on tacrolimus Monitor tacrolimus whole methylprednisolone blood levels (increase or decrease) blood trough concentrations when administered for the treatment and adjust tacrolimus dose if of acute rejection. needed.

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) cimetidine (HOS-085835) methylprednisolone (HOS-088374) metoclopramide (HOS-090626)

Wechselwirkungen · Advagraf

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HOS-116839 · Präparat HOS-094481

Direct-acting antiviral May have impact on the Monitor tacrolimus whole (DAA) therapy pharmacokinetics of tacrolimus by blood trough concentrations changes in liver function during and adjust tacrolimus dose if DAA therapy, related to clearance needed to ensure continued of hepatitis virus. A decrease in efficacy and safety. tacrolimus blood levels may occur. However, the CYP3A4 inhibiting potential of some DAAs may counteract that effect or lead to increased tacrolimus blood levels.

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 · Advagraf

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HOS-116840 · Präparat HOS-094481

Concomitant administration of tacrolimus with a mammalian target of rapamycin (mTOR) inhibitor (e.g., sirolimus, everolimus) may increase the risk of thrombotic microangiopathy (including haemolytic uraemic syndrome and thrombotic thrombocytopenic purpura) (see section 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): everolimus (HOS-086310) sirolimus (HOS-085172)

Wechselwirkungen · Advagraf

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HOS-116841 · Präparat HOS-094481

As tacrolimus treatment may be associated with hyperkalaemia, or may increase pre-existing hyperkalaemia, high potassium intake, or potassium-sparing diuretics (e.g. amiloride, triamterene, or spironolactone) should be avoided (see section 4.4). Care should be taken when tacrolimus is co- administered with other agents that increase serum potassium, such as trimethoprim and cotrimoxazole (trimethoprim/sulfamethoxazole), as trimethoprim is known to act as a potassium-sparing diuretic like amiloride. Close monitoring of serum potassium is 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): sulfamethoxazole (HOS-084533) amiloride (HOS-089052) triamterene (HOS-089051) trimethoprim (HOS-085184) potassium (HOS-086929) spironolactone (HOS-112481)

Wechselwirkungen · Advagraf

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HOS-116846 · Präparat HOS-094481

Effect of tacrolimus on the metabolism of other medicinal products Tacrolimus is a known CYP3A4 inhibitor; thus concomitant use of tacrolimus with medicinal products known to be metabolised by CYP3A4 may affect the metabolism of such medicinal products. The half-life of ciclosporin is prolonged when tacrolimus is given concomitantly. In addition, synergistic/additive nephrotoxic effects can occur. For these reasons, the combined administration of

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

Wechselwirkungen · Advagraf

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HOS-116847 · Präparat HOS-094481

13 ciclosporin and tacrolimus is not recommended and care should be taken when administering tacrolimus to patients who have previously received ciclosporin (see sections 4.2 and 4.4). Tacrolimus has been shown to increase the blood level of phenytoin. As tacrolimus may reduce the clearance of steroid-based contraceptives leading to increased hormone exposure, particular care should be exercised when deciding upon contraceptive measures. Limited knowledge of interactions between tacrolimus and statins is available. Clinical data suggest that the pharmacokinetics of statins are largely unaltered by the co-administration of tacrolimus. Animal data have shown that tacrolimus could potentially decrease the clearance and increase the half- life of pentobarbital and antipyrine.

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): pentobarbital (HOS-116848) phenytoin (HOS-084531) antipyrine (HOS-091378)

Wechselwirkungen · Advagraf

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HOS-116850 · Präparat HOS-094481

Mycophenolic acid. Caution should be exercised when switching combination therapy from ciclosporin, which interferes with enterohepatic recirculation of mycophenolic acid, to tacrolimus, which is devoid of this effect, as this might result in changes of mycophenolic acid exposure. Drugs which interfere with mycophenolic acid's enterohepatic cycle have potential to reduce the plasma level and efficacy of mycophenolic acid. Therapeutic drug monitoring of mycophenolic acid may be appropriate when switching from ciclosporin to tacrolimus or vice versa.

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): mycophenolic acid (HOS-085156)

Wechselwirkungen · Advagraf

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HOS-116852 · Präparat HOS-094481

Immunosuppressants may affect the response to vaccination and vaccination during treatment with tacrolimus may be less effective. The use of live attenuated vaccines should be avoided (see section 4.4).

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

Nebenwirkungen · Advagraf

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HOS-116853 · Präparat HOS-094481

The adverse reaction profile associated with immunosuppressive agents is often difficult to establish owing to the underlying disease and the concurrent use of multiple medicinal products.

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

Nebenwirkungen · Advagraf

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HOS-116854 · Präparat HOS-094481

The most commonly reported adverse reactions (occurring in > 10% of patients) are tremor, renal impairment, hyperglycaemic conditions, diabetes mellitus, hyperkalaemia, infections, hypertension and insomnia.

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

Nebenwirkungen · Advagraf

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HOS-116855 · Präparat HOS-094481

The frequency of adverse reactions is defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

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

Nebenwirkungen · Advagraf

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HOS-116856 · Präparat HOS-094481

Infections and infestations As is well known for other potent immunosuppressive agents, patients receiving tacrolimus are frequently at increased risk for infections (viral, bacterial, fungal, protozoal). The course of pre- existing infections may be aggravated. Both generalised and localised infections can occur. Cases of CMV infection, BK virus associated nephropathy, as well as cases of JC virus associated progressive multifocal leukoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including Advagraf.

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