Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Modigraf

Modigraf 0.2 mg granules for oral suspension Modigraf 1 mg granules for oral suspension · Abschnitt 4.3 · PDF-Seite 6

HOS-209737 · Präparat HOS-154375

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 · Modigraf

Modigraf 0.2 mg granules for oral suspension Modigraf 1 mg granules for oral suspension · Abschnitt 4.5 · PDF-Seite 10

HOS-209738 · Präparat HOS-154375

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 · Modigraf

Modigraf 0.2 mg granules for oral suspension Modigraf 1 mg granules for oral suspension · Abschnitt 4.5 · PDF-Seite 10

HOS-209739 · Präparat HOS-154375

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.

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

Wechselwirkungen · Modigraf

Modigraf 0.2 mg granules for oral suspension Modigraf 1 mg granules for oral suspension · Abschnitt 4.5 · PDF-Seite 10

HOS-209740 · Präparat HOS-154375

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 · Modigraf

Modigraf 0.2 mg granules for oral suspension Modigraf 1 mg granules for oral suspension · Abschnitt 4.5 · PDF-Seite 10

HOS-209741 · Präparat HOS-154375

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 · Modigraf

Modigraf 0.2 mg granules for oral suspension Modigraf 1 mg granules for oral suspension · Abschnitt 4.5 · PDF-Seite 10–11

HOS-209742 · Präparat HOS-154375

10 Medicinal products which have effects on tacrolimus Drug/Substance Class or Drug interaction effect Recommendations concerning co- Name administration Grapefruit or grapefruit juice May increase tacrolimus Avoid grapefruit or grapefruit whole blood trough juice. concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see section 4.4]. Ciclosporin May increase tacrolimus The simultaneous use of whole blood trough ciclosporin and tacrolimus should concentrations. In addition, be avoided [see section 4.4]. synergistic/additive nephrotoxic effects can occur. Products known to have May enhance nephrotoxic or Concurrent use of tacrolimus with nephrotoxic or neurotoxic neurotoxic effects of drugs known to have nephrotoxic effects: tacrolimus. effects should be avoided. When aminoglycosides, gyrase co-administration cannot be inhibitors, vancomycin, avoided, monitor renal function sulfamethoxazole + and other side effects and adjust trimethoprim, NSAIDs, tacrolimus dose if needed. ganciclovir, acyclovir, amphotericin B, ibuprofen cidofovir, foscarnet Strong CYP3A4 inhibitors: May increase tacrolimus It is recommended that antifungal agents (e.g., whole blood trough concomitant use should be ketoconazole, itraconazole, concentrations and increase avoided. If co-administration of a posaconazole, voriconazole), the risk of serious adverse strong CYP3A4 inhibitor is the macrolide antibiotics reactions (e.g., unavoidable, consider omitting (e.g., telithromycin, nephrotoxicity, the dose of tacrolimus the day the troleandomycin, neurotoxicity, QT strong CYP3A4 inhibitor is clarithromycin, josamycin), prolongation) which requires initiated. Reinitiate tacrolimus the HIV protease inhibitors (e.g., close monitoring [see next day at a reduced dose based ritonavir, nelfinavir, section 4.4]. on tacrolimus blood saquinavir), HCV protease Rapid and sharp increases in concentrations. Changes in both inhibitors (e.g., telaprevir, tacrolimus levels may occur, tacrolimus dose and/or dosing boceprevir, and the as early as within 1-3 days frequency should be combination of ombitasvir after co-administration, individualized and adjusted as and paritaprevir with despite immediate reduction needed based on tacrolimus ritonavir, when used with and of tacrolimus dose. Overall trough concentrations, which without dasabuvir), tacrolimus exposure may should be assessed at initiation, nefazodone, the increase > 5 fold. When monitored frequently throughout pharmacokinetic enhancer ritonavir combinations are (starting within the first few days) cobicistat and the kinase co-administered, tacrolimus and re-evaluated on and after inhibitors idelalisib, ceritinib. exposure may increase > 50 completion of the CYP3A4 Strong interactions have also fold. inhibitor. Upon completion, been observed with the Nearly all patients may appropriate dose and dosing macrolide antibiotic require a reduction in frequency of tacrolimus should be erythromycin tacrolimus dose and guided by tacrolimus blood temporary interruption of concentrations. Monitor renal tacrolimus may also be function, ECG for QT necessary. prolongation, and other side effects closely.

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) ceritinib (HOS-086215) josamycin (HOS-113844) nefazodone (HOS-084519) nelfinavir (HOS-084520) ibuprofen (HOS-087884) protease (HOS-085623) amphotericin B (HOS-109312) trimethoprim (HOS-085184) ketoconazole (HOS-084513) cobicistat (HOS-088111) cidofovir (HOS-110482) grapefruit juice (HOS-088787) dasabuvir (HOS-110302) voriconazole (HOS-084524) telaprevir (HOS-090618) telithromycin (HOS-084523) itraconazole (HOS-084516) saquinavir (HOS-084522) ombitasvir (HOS-110300) boceprevir (HOS-090617) clarithromycin (HOS-084517) vancomycin (HOS-110486) erythromycin (HOS-084514) troleandomycin (HOS-090575) ritonavir (HOS-084521) ganciclovir (HOS-085194) paritaprevir (HOS-110301) acyclovir (HOS-088527) posaconazole (HOS-085622) idelalisib (HOS-116811)

Wechselwirkungen · Modigraf

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HOS-209751 · Präparat HOS-154375

11 Drug/Substance Class or Drug interaction effect Recommendations concerning co- Name administration The effect on tacrolimus blood concentrations may remain for several days after co-administration is completed. Moderate or weak CYP3A4 May increase tacrolimus Monitor tacrolimus whole blood inhibitors: whole blood trough trough concentrations frequently, antifungal agents (e.g., concentrations and increase starting within the first few days fluconazole, isavuconazole, the risk of serious adverse of co-administration. Reduce clotrimazole, miconazole), reactions (e.g., neurotoxicity, tacrolimus dose if needed [see the macrolide antibiotics QT prolongation) [see section 4.2]. Monitor renal (e.g., azithromycin), calcium section 4.4]. A rapid increase function, ECG for QT channel blockers (e.g., in tacrolimus level may prolongation, and other side nifedipine, nicardipine, occur. effects closely. diltiazem, verapamil), 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 In vitro the following May increase tacrolimus Monitor tacrolimus whole blood substances have been shown whole blood trough trough concentrations and reduce to be potential inhibitors of concentrations and increase tacrolimus dose if needed [see tacrolimus metabolism: the risk of serious adverse section 4.2]. bromocriptine, cortisone, reactions (e.g., neurotoxicity, Monitor renal function, ECG for dapsone, ergotamine, QT prolongation) [see QT prolongation, and other side gestodene, lidocaine, section 4.4]. effects closely. mephenytoin, midazolam, nilvadipine, norethisterone, quinidine, tamoxifen Strong CYP3A4 inducers: May decrease tacrolimus It is recommended that rifampicin, phenytoin whole blood trough concomitant use should be carbamazepine, apalutamide, concentrations and increase avoided. If unavoidable, patients enzalutamide, mitotane or St. the risk of rejection [see may require an increase in John’s wort (Hypericum section 4.4]. tacrolimus dose. Changes in perforatum) Maximal effect on tacrolimus tacrolimus dose should be blood concentrations may be individualized and adjusted as achieved 1-2 weeks after co- needed based on tacrolimus administration. The effect trough concentrations, which may remain 1-2 weeks after should be assessed at initiation, completion of the treatment. 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

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) diltiazem (HOS-086288) elbasvir (HOS-108814) isavuconazole (HOS-085186) nifedipine (HOS-086289) cortisone (HOS-114161) nicardipine (HOS-090619) pibrentasvir (HOS-086298) lidocaine (HOS-108866) carbamazepine (HOS-085618) crizotinib (HOS-116818) apalutamide (HOS-086212) tamoxifen (HOS-088380) quinidine (HOS-085593) glecaprevir (HOS-086297) azithromycin (HOS-088112) clotrimazole (HOS-090574) mephenytoin (HOS-109801) calcium (HOS-085615) imatinib (HOS-110212) grazoprevir (HOS-108815) danazol (HOS-085473) mitotane (HOS-112479) fluconazole (HOS-087945) bromocriptine (HOS-090620) nilvadipine (HOS-116826) gestodene (HOS-116824) ergotamine (HOS-086154) amiodarone (HOS-085596) tyrosine (HOS-108875) dapsone (HOS-088141) phenytoin (HOS-084531) enzalutamide (HOS-116829) nilotinib (HOS-086218) miconazole (HOS-115630) midazolam (HOS-086167) omeprazole (HOS-085912) verapamil (HOS-090602)

Wechselwirkungen · Modigraf

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

HOS-209770 · Präparat HOS-154375

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

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): prednisolone (HOS-086337) caspofungin (HOS-109306) phenobarbital (HOS-085617) cimetidine (HOS-085835) rifabutin (HOS-086262) methylprednisolone (HOS-088374) metoclopramide (HOS-090626) etravirine (HOS-088088) cannabidiol (HOS-090609) efavirenz (HOS-087947) nevirapine (HOS-088064) isoniazid (HOS-088590)

Wechselwirkungen · Modigraf

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HOS-209773 · Präparat HOS-154375

13  Drug/Substance Class or Drug interaction effect Recommendations concerning co- Name administration Direct-acting antiviral (DAA) May have impact on the Monitor tacrolimus whole blood therapy pharmacokinetics of trough concentrations and adjust tacrolimus by changes in tacrolimus dose if needed to liver function during DAA ensure continued efficacy and therapy, related to clearance safety. of HCV virus. A decrease in 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 · Modigraf

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HOS-209774 · Präparat HOS-154375

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 · Modigraf

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HOS-209775 · Präparat HOS-154375

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 · Modigraf

Modigraf 0.2 mg granules for oral suspension Modigraf 1 mg granules for oral suspension · Abschnitt 4.5 · PDF-Seite 14

HOS-209779 · Präparat HOS-154375

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 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 phenazone.

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)

Wechselwirkungen · Modigraf

Modigraf 0.2 mg granules for oral suspension Modigraf 1 mg granules for oral suspension · Abschnitt 4.5 · PDF-Seite 14

HOS-209781 · Präparat HOS-154375

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 · Modigraf

Modigraf 0.2 mg granules for oral suspension Modigraf 1 mg granules for oral suspension · Abschnitt 4.5 · PDF-Seite 14

HOS-209782 · Präparat HOS-154375

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 · Modigraf

Modigraf 0.2 mg granules for oral suspension Modigraf 1 mg granules for oral suspension · Abschnitt 4.8 · PDF-Seite 15

HOS-209783 · Präparat HOS-154375

Summary of the safety profile 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 · Modigraf

Modigraf 0.2 mg granules for oral suspension Modigraf 1 mg granules for oral suspension · Abschnitt 4.8 · PDF-Seite 15

HOS-209784 · Präparat HOS-154375

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 · Modigraf

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HOS-209785 · Präparat HOS-154375

List of adverse reactions 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

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

Nebenwirkungen · Modigraf

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HOS-209786 · Präparat HOS-154375

15 known (cannot be estimated from the available data). Within each frequency grouping adverse reactions 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 · Modigraf

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HOS-209787 · Präparat HOS-154375

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 Modigraf.

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

Nebenwirkungen · Modigraf

Modigraf 0.2 mg granules for oral suspension Modigraf 1 mg granules for oral suspension · Abschnitt 4.8 · PDF-Seite 16

HOS-209788 · Präparat HOS-154375

Neoplasms benign, malignant and unspecified (incl. cysts and polyps) Patients receiving immunosuppressive therapy are at increased risk of developing malignancies. Benign as well as malignant neoplasms including EBV-associated lymphoproliferative disorders, skin malignancies and Kaposi’s sarcoma have been reported in association with tacrolimus treatment.

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