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)

Wechselwirkungen · Lysodren

Lysodren 500 mg tablets · Abschnitt 4.5 · PDF-Seite 5

HOS-112484 · Präparat HOS-093689

Substances metabolised through cytochrome P450: Mitotane has been shown to have an inductive effect on cytochrome P450 enzymes. Therefore, the plasma concentrations of the substances metabolised via cytochrome P450 may be modified. In the absence of information on the specific P450 isoenzymes involved, caution should be taken when co-prescribing active substances metabolised by this route such as, among others, anticonvulsants, rifabutin, rifampicin, griseofulvin and St. John’s wort (Hypericum perforatum). Particularly, mitotane has been shown to have an inductive effect on cytochrome 3A4. Therefore, the plasma concentrations of the substances metabolised via cytochrome 3A4 may be modified. Caution should be taken when co-prescribing active substances metabolised by this pathway such as, among others, sunitinib, etoposide and midazolam and dose should be adjusted as appropriate when coadministered with mitotane.

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): rifabutin (HOS-086262) etoposide (HOS-086021) sunitinib (HOS-109453) griseofulvin (HOS-091156) midazolam (HOS-086167)

Gegenanzeigen · Sutent

Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.3 · PDF-Seite 4

HOS-115654 · Präparat HOS-094337

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 · Sutent

Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.5 · PDF-Seite 8

HOS-115655 · Präparat HOS-094337

Interaction studies have only been performed in adults.

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

Wechselwirkungen · Sutent

Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.5 · PDF-Seite 8–9

HOS-115656 · Präparat HOS-094337

8 Medicinal products that may increase sunitinib plasma concentrations Effect of CYP3A4 inhibitors In healthy volunteers, concomitant administration of a single dose of sunitinib with the potent CYP3A4 inhibitor ketoconazole resulted in an increase of the combined [sunitinib + primary metabolite] maximum concentration (Cmax) and area under the curve (AUC0-) values of 49% and 51%, respectively.

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 · Sutent

Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.5 · PDF-Seite 9

HOS-115658 · Präparat HOS-094337

Administration of sunitinib with potent CYP3A4 inhibitors (e.g., ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice) may increase sunitinib concentrations.

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): grapefruit juice (HOS-088787) itraconazole (HOS-084516) clarithromycin (HOS-084517) erythromycin (HOS-084514) ritonavir (HOS-084521)

Wechselwirkungen · Sutent

Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.5 · PDF-Seite 9

HOS-115662 · Präparat HOS-094337

Combination with CYP3A4 inhibitors should therefore be avoided, or the selection of an alternate concomitant medicinal product with no or minimal potential to inhibit CYP3A4 should be considered.

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

Wechselwirkungen · Sutent

Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.5 · PDF-Seite 9

HOS-115663 · Präparat HOS-094337

If this is not possible, the dose of Sutent may need to be reduced to a minimum of 37.5 mg daily for GIST and MRCC or 25 mg daily for pNET, based on careful monitoring of tolerability (see section 4.2).

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

Wechselwirkungen · Sutent

Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.5 · PDF-Seite 9

HOS-115664 · Präparat HOS-094337

Effect of Breast Cancer Resistance Protein (BCRP) inhibitors Limited clinical data are available on the interaction between sunitinib and BCRP inhibitors and the possibility of an interaction between sunitinib and other BCRP inhibitors cannot be excluded (see section 5.2).

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

Wechselwirkungen · Sutent

Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.5 · PDF-Seite 9

HOS-115665 · Präparat HOS-094337

Medicinal products that may decrease sunitinib plasma concentrations Effect of CYP3A4 inducers In healthy volunteers, concomitant administration of a single dose of sunitinib with the CYP3A4 inducer rifampicin resulted in a reduction of the combined [sunitinib + primary metabolite] Cmax and AUC0- values of 23% and 46%, respectively.

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

Wechselwirkungen · Sutent

Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.5 · PDF-Seite 9

HOS-115666 · Präparat HOS-094337

Administration of sunitinib with potent CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital or herbal preparations containing St. John’s Wort/Hypericum perforatum) may decrease sunitinib concentrations. Combination with CYP3A4 inducers should therefore be avoided, or selection of an alternate concomitant medicinal product, with no or minimal potential to induce CYP3A4 should be considered. If this is not possible, the dose of Sutent may need to be increased in 12.5 mg increments (up to 87.5 mg per day for GIST and MRCC or 62.5 mg per day for pNET), based on careful monitoring of tolerability (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): phenobarbital (HOS-085617) carbamazepine (HOS-085618) dexamethasone (HOS-084535) phenytoin (HOS-084531)

Nebenwirkungen · Sutent

Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.8 · PDF-Seite 10

HOS-115668 · Präparat HOS-094337

Summary of the safety profile The most serious adverse reactions associated with sunitinib, some fatal, are renal failure, heart failure, pulmonary embolism, gastrointestinal perforation, and haemorrhages (e.g., respiratory tract, gastrointestinal, tumour, urinary tract, and brain haemorrhages). The most common adverse reactions of any grade (experienced by patients in RCC, GIST, and pNET registrational trials) included decreased appetite, taste disturbance, hypertension, fatigue, gastrointestinal disorders (i.e. diarrhoea, nausea, stomatitis, dyspepsia, and vomiting), skin discolouration, and palmar-plantar erythrodysaesthesia syndrome. These symptoms may diminish as treatment continues. Hypothyroidism may develop during treatment. Haematological disorders (e.g., neutropenia, thrombocytopenia, and anaemia) are amongst the most common adverse drug reactions.

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

Nebenwirkungen · Sutent

Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.8 · PDF-Seite 10

HOS-115669 · Präparat HOS-094337

Fatal events other than those listed in section 4.4 above or in section 4.8 below that were considered possibly related to sunitinib included multi-system organ failure, disseminated intravascular coagulation, peritoneal haemorrhage, adrenal insufficiency, pneumothorax, shock, and sudden death.

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

Nebenwirkungen · Sutent

Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.8 · PDF-Seite 10

HOS-115670 · Präparat HOS-094337

Tabulated list of adverse reactions Adverse reactions that were reported in GIST, MRCC, and pNET patients in a pooled dataset of 7,115 patients are listed below, by system organ class, frequency and grade of severity (NCI-CTCAE). Post-marketing adverse reactions identified in clinical studies are also included. 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 · Sutent

Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.8 · PDF-Seite 10

HOS-115671 · Präparat HOS-094337

Frequencies are defined as: 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).

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

Nebenwirkungen · Sutent

Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.8 · PDF-Seite 10

HOS-115672 · Präparat HOS-094337

Table 1. Adverse reactions reported in clinical trials System organ class Very common Common Uncommon Rare Not known

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

Nebenwirkungen · Sutent

Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.8 · PDF-Seite 10

HOS-115673 · Präparat HOS-094337

Infections and Viral infectionsa Necrotising infestations Respiratory fasciitis* infectionsb,* Bacterial infectionsg Abscessc,* Fungal infectionsd Urinary tract infection Skin infectionse Sepsisf,* Blood and Neutropoenia Lymphopoenia Pancytopenia Thrombotic lymphatic system Thrombocytopoenia microangiopathy h,* disorders Anaemia Leukopoenia Immune system Hypersensitivity Angioedema disorders Endocrine Hypothyroidism Hyperthyroidism Thyroiditis disorders Metabolism and Decreased appetitei Dehydration Tumour lysis nutrition disorders Hypoglycaemia syndrome* Psychiatric Insomnia Depression disorders

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

Nebenwirkungen · Sutent

Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.8 · PDF-Seite 10–11

HOS-115674 · Präparat HOS-094337

10 System organ class Very common Common Uncommon Rare Not known

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