Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Cancidas (previously Caspofungin MSD)

CANCIDAS 50 mg powder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 9

HOS-109331 · Präparat HOS-093179

The following adverse reactions were reported:

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

Nebenwirkungen · Cancidas (previously Caspofungin MSD)

CANCIDAS 50 mg powder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 9

HOS-109332 · Präparat HOS-093179

System Organ Class Very Common (≥1/100 to <1/10) common (≥1/10) Blood and lymphatic system eosinophil count increased disorders Nervous system disorders headache Cardiac disorders tachycardia Vascular disorders flushing, hypotension Hepatobiliary disorders elevated liver enzyme levels (AST, ALT) Skin and subcutaneous rash, pruritus tissue disorders General disorders and fever chills, catheter site pain administration site conditions Investigations decreased potassium, hypomagnesemia, increased glucose, decreased phosphorus, and increased phosphorus

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

Nebenwirkungen · Cancidas (previously Caspofungin MSD)

CANCIDAS 50 mg powder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 9

HOS-109333 · Präparat HOS-093179

Reporting of suspected adverse reactions 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 · 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 12

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 · 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 · 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): cortisone (HOS-114161) caspofungin (HOS-109306) 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) cannabidiol (HOS-090609) 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)