natgillin/translations-raw huggingface dataset:
Hvis dette ikke er muligt, bør dosis af SUTENT øges med en dosistilvækst på 12, 5 mg ad gangen (op til 87, 5 mg dagligt) med omhyggelig monitorering af tolerans (se pkt.
If this is not possible, the dosage of SUTENT may need to be increased in 12.5 mg increments (up to 87,5 mg per day) based on careful monitoring of tolerability (see section 4.2).
For at vedligeholde sunitinibs målkoncentration bør valg af samtidig medicin med lav enzyminduktionspotentiale overvejes.
To maintain sunitinib target concentrations, selection of co-medications with less enzyme induction potential, should be considered.
4. 2).
If this is not possible, dose-adjustments of SUTENT may be necessary (see section 4.2).
4. 4).
Haemorrhage has been observed rarely in patients treated with SUTENT (see section 4.4).
Patienter, der samtidigt behandles med antikoagulantia (f. eks. warfarin; acenocumarol) bør regelmæssigt have foretaget fuldstændig blodtælling (trombocyttal), koagulationsfaktor (PT/ INR) og objektiv undersøgelse.
Patients receiving concomitant treatment with anti-coagulants (e. g. warfarin; acenocumarole) may be periodically monitored by complete blood counts (platelets), coagulation factors (PT/ INR), and physical examination.
Graviditet Der foreligger ikke data vedrørende anvendelsen af SUTENT hos gravide kvinder.
Pregnancy There are no studies in pregnant women using SUTENT.
5. 3).
Studies in animals have shown reproductive toxicity including foetal malformations (see section 5.3).
SUTENT bør derfor ikke anvendes ved graviditet eller hos kvinder, der ikke anvender sikker antikonception, medmindre den potentielle fordel for kvinden opvejer den potentielle risiko for fostret.
SUTENT should not be used during pregnancy or in any woman not employing adequate contraception unless the potential benefit justifies the potential risk to the foetus.
Hvis lægemidlet anvendes under graviditet, eller patienten bliver gravid under behandling med lægemidlet, skal patienten underrettes om den potentielle risiko for fostret.
If the drug is used during pregnancy or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the foetus.
Kvinder i den fødedygtige alder bør rådes til ikke at blive gravide under behandling med SUTENT.
7 Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with SUTENT.
5. 3).
Based on non-clinical findings, male and female fertility may be compromised by treatment with SUTENT (see section 5.3).
Amning Sunitinib og/ eller dets metabolitter udskilles i mælk hos rotter.
Lactation Sunitinib and/ or its metabolites are excreted in rat milk.
Det vides ikke, om sunitinib eller dets aktive hovedmetabolit udskilles i modermælk hos mennesker.
It is not known whether sunitinib or its primary active metabolite are excreted in human milk.
Da lægemidler almindeligvis udskilles i modermælk, og da der er risiko for alvorlige bivirkninger hos det ammede barn, bør SUTENT ikke anvendes i ammeperioden.
Because drugs are commonly excreted in human milk and because of the potential for serious adverse reactions in nursing infants, women should not breast feed while taking SUTENT.
Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj eller betjene maskiner.
No studies on the effects on the ability to drive or operate machinery have been performed.
Patienter bør informeres om, at de kan opleve svimmelhed under behandling med SUTENT.
Patients should be advised that they may experience dizziness during treatment with SUTENT.
De vigtigste alvorlige behandlingsrelaterede bivirkninger forbundet med behandling med SUTENT hos patienter med solide tumorer er lungeemboli (1%), trombocytopeni (1%), tumorblødning (0, 9%), febril neutropeni (0, 4%) og hypertension (0, 4%).
The most important treatment-related serious adverse events associated with SUTENT treatment of patients with solid tumours were pulmonary embolism (1%), thrombocytopoenia (1%), tumour haemorrhage (0.9%), febrile neutropoenia (0.4%), and hypertension (0.4%).
De mest almindelige behandlingsrelaterede bivirkninger (oplevet hos mindst 20% af patienterne) af enhver grad omfatter: træthed, gastrointestinale forstyrrelser, som f. eks. diarré, kvalme, stomatitis, dyspepsi og opkastning; misfarvning af huden; smagsforstyrrelser og appetitløshed.
The most common treatment-related adverse events (experienced by at least 20% of the patients) of any grade included: fatigue; gastrointestinal disorders, such as diarrhoea, nausea, stomatitis, dyspepsia and vomiting; skin discolouration; dysgeusia and anorexia.
Træthed, hypertension og neutropeni er de mest almindelige behandlingsrelaterede bivirkninger af grad 3 maksimal sværhedsgrad og forhøjet lipase er den hyppigste behandlingsrelaterede bivirkning af grad 4 maksimal sværhedsgrad hos patienter med solide tumorer.
Fatigue, hypertension and neutropoenia were the most common treatment-related adverse events of Grade 3 maximum severity and increased lipase was the most frequently occurring treatment-related adverse event of Grade 4 maximum severity in patients with solid tumours.
4. 4).
Hepatitis and hepatic failure occurred in < 1% of patients and prolonged QT interval in < 0.1% (see section 4.4).
4. 8 nedenfor og som betragtes mulig relateret til SUTENT, omfatter multiorgansvigt, dissemineret intravaskulær koagulation, peritoneal blødning, rhabdomyolyse, cerebrovaskulær hændelse, dehydrering, adrenal insufficiens, nyresvigt, pleuraeffusion, pneumothorax, shock og pludselig død af ukendt årsag.
Fatal events other than those listed in section 4.4 above or section 4.8 below that were considered possibly related to SUTENT included multi-system organ failure, disseminated intravascular coagulation, peritonoeal haemorrhage, rhabdomyolysis, cerebrovascular accident, dehydration, adrenal insufficiency, renal failure, respiratory failure, pleural effusion, pneumothorax, shock, and sudden death.
Behandlingsrelaterede bivirkninger indberettet hos > 2% af patienter med solide tumorer er anført nedenfor efter organklasse, hyppighed og sværhedsgrad.
Treatment-related adverse reactions that were reported in > 2% of solid tumour patients are listed below, by system organ class, frequency and grade of severity.
Hyppighederne er defineret som:
Frequencies are defined as:
Meget almindelig (≥1/ 10), almindelig (≥1/ 100 og < 1/ 10), ikke almindelig (≥1/ 1. 000 og < 1/ 100), sjælden (≥1/ 10. 000 og > 1/ 1. 000), meget sjælden (< 1/ 10. 000).
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).
8 Behandlingsrelaterede bivirkninger rapporteret i GIST- undersøgelserne
Treatment-Related Adverse Reactions reported in GIST studies
Bivirkning
Adverse Reactions
Alle Grader n (%)
All Grades n (%)
Meget almindelig Meget almindelig Meget almindelig Almindelig Almindelig
Very common Very common Very common Common Common
Anæmi Neutropeni Trombocytopeni Leukopeni Lymfocytopeni
Anaemia Neutropoenia Thrombocytopoenia Leukopoenia Lymphopoenia
86 (19, 5) 81 (18, 4%) 67 (15, 2%) 26 (5, 9%) 10 (2, 3%)
86 (19.5%) 81 (18.4%) 67 (15.2%) 26 (5.9%) 10 (2.3%)
3 (0, 7%) 5 (1, 1%) 6 1, 4%) 1 (0, 2%) 1 (0, 2%)
3 (0.7%) 5 (1.1%) 6 (1.4%) 1 (0.2%) 1 (0.2%)
8 (1, 8%)
8
0 (0, 0%)
System Organ Class
Nervesystemet
Frequency
Meget almindelig
Adverse Reactions
Smagsforstyrrelser b
All Grades n (%)
105 (23, 9%)
Grade 3 n (%)
1 (0, 2%)
Grade 4 n (%)
0 (0, 0%)
Nervous system disorders
Meget almindelig Almindelig Almindelig Almindelig Almindelig
Very common Common Common Common Common
Hovedpine Paræstesi Svimmelhed Perifer neuropati Hypæstesi
Headache Paraesthesia Dizziness Neuropathy peripheral Hypoaesthesia
76 (17, 3%) 27 (6, 1%) 18 (4, 1%) 11 (2, 5%) 10 (2, 3%)
76 (17.3%) 27 (6.1%) 18 (4.1%) 11 (2.5%) 10 (2.3%)
5 (1, 1%) 1 (0, 2%) 1 (0, 2%) 0 (0, 0%) 0 (0, 0%)
5 (1.1%) 1 (0.2%) 1 (0.2%) 0 (0.0%) 0 (0.0%)
0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%)
0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
28 (6, 4%) 16 (3, 6%) 18 (4, 1%) 187 (42, 5%) 161 (36, 6%) 98 (22, 2%) 90 (20, 5%) 80 (18, 2%) 77 (17, 5%)
0 (0.0%)
1 (0, 2%) 2 (0, 5%) 0 (0, 0%) 24 (5, 5%) 15 (3, 4%) 7 (1, 6%) 7 (1, 6%) 4 (0, 9%) 15 (4, 3%)
Respiratory, thoracic and mediastinal disorders
0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 2 (0, 5%)
Common Common
Meget almindelig Meget almindelig Almindelig Almindelig Almindelig Almindelig
Epistaxis Dyspnoea
Flatulens Oral smerte Obstipation Glossalgi Mundtørhed Gastro- øsofageal refluks
28 (6.4%) 16 (3.6%)
46 (10, 5%) 44 (10, 0%) 37 (8, 4%) 37 (8, 4%) 31 (7, 0%) 12 (2, 7%)
1 (0.2%) 2 (0.5%)
0 (0, 0%) 2 (0, 5%) 2 (0, 5%) 0 (0, 0%) 0 (0, 0%) 1 (0, 2%)
0 (0.0%) 0 (0.0%)
Sår i munden
Chromaturia
Almindelig
Gastrointestinal disorders
Ubehag i munden
Very common Very common Very common Very common Very common Very common
11 (2, 5%)
Diarrhoea Nausea Vomiting Stomatitis Dyspepsia Abdominal pain C / distension
0 (0, 0%)
187 (42.5%) 161 (36.6%) 98 (22.2%) 90 (20.5%) 80 (18.2%) 77 (17.5%)
0 (0, 0%)
24 (5.5%) 15 (3.4%) 7 (1.6%) 7 (1.6%) 4 (0.9%) 15 (3.4%)
Hud og subkutane væv
0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 2 (0.5%)
Meget almindelig
Very common Very common Common Common Common Common
Gulfarvning af hud/ misfarvning af huden
Flatulence Oral pain Constipation Glossodynia Dry mouth Gastro-oesophageal reflux disease
146 (33, 2%)
46 (10.5%) 44 (10.0%) 37 (8.4%) 37 (8.4%) 31 (7.0%) 12 (2.7%)
0 (0, 0%)
0 (0.0%) 2 (0.5%) 2 (0.5%) 0 (0.0%) 0 (0.0%) 1 (0.2%)
0 (0, 0%)
0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
Meget almindelig
Common Common
Palmar- plantar erythrodysaesthe - sia syndrom
Mouth ulceration Oral discomfort
106 (24, 1%)
11 (2.5%) 11 (2.5%)
27 (6, 1%)
0 (0.0%) 0 (0.0%)
Ændringer i hårfarve
Skin and subcutaneous
67 (15, 2%)
Very common
Meget almindelig Almindelig
Yellow skin/ Skin discolouration
Udslæt Tør hud
146 (33.2%)
3 (0, 7%) 0 (0, 0%)
0 (0.0%)
9 Organklasse
tissue disorders
Bivirkning
Palmar-plantar erythrodysaesthesia syndrome
Alle Grader n (%)
106 (24.1%)
Grad 3 n (%)
27 (6.1%)
Grad 4 n (%)
0 (0.0%)
Almindelig Almindelig Almindelig Almindelig Almindelig Almindelig Almindelig Almindelig
Very common Very common Common Common Common Common Common Common Common Common Common
Alopeci Dermatitis Periorbital ødem Hudreaktion Erytem Eksem Pruritus Hyperpigmentering af hud
Hair colour changes Rash Dry skin Alopecia Dermatitis Periorbital oedema Skin Reaction Erythema Eczema Pruritus Skin hyperpigmentation
33 (7, 5%) 29 (6, 6%) 20 (4, 5%) 20 (4, 5%) 18 (4, 1%) 16 (3, 6%) 16 (3, 6%) 15 (3, 4%)
67 (15.2%) 64 (14.5%) 41 (9.3%) 33 (7.5%) 29 (6.6%) 20 (4.5%) 20 (4.5%) 18 (4.1%) 16 (3.6%) 16 (3.6%) 15 (3.4%)
0 (0, 0%) 1 (0, 2%) 0 (0, 0%) 3 (0, 7%) 0 (0, 0%) 1 (0, 2%) 0 (0, 0%) 0 (0, 0%)
0 (0.0%) 3 (0.7%) 0 (0.0%) 0 (0.0%) 1 (0.2%) 0 (0.0%) 3 (0.7%) 0 (0.0%) 1 (0.2%) 0 (0.0%) 0 (0.0%)
0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%)
0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
Hudafskalning Blærer Hudlæsioner
Skin exfoliation Blister Skin lesion
Knogler, led, muskler og
Muscoloskeletal, connective tissue
Ekstremitets - smerter/ halten
Pain in extremity/ limb Arthralgia
3 (0, 7%) 0 (0, 0%) 1 (0, 2%) 2 (0, 5%) 1 (0, 2%)
5 (1.1%) 3 (0.7%)
0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%)
0 (0.0%) 0 (0.0%)
Almene symptomer og reaktioner på administrationssted
9
Meget almindelig Meget almindelig
System Organ Class
Træthed/ asteni Mucosa inflammation
Frequency
287 (65, 2%) 70 (15, 9%)
Adverse Reactions
64 (14, 5%) 6 (1, 4%)
All Grades n (%)
5 (1, 1%) 1 (0, 2%)
Grade 3 n (%)
et
Grade 4 n (%)
Meget almindelig Almindelig
Common Common Common Common
Ødem d Pyreksi
Myalgia Muscle spasm Back pain Muscular weakness
Psykiske forstyrrelser
General disorders and administration site conditions Psychiatric disorders
Almindelig
Very common Very common Very common Common Common
Insomni
Fatigue/ Asthenia Mucosal inflammation Oedema d Pyrexia Insomnia
Forhøjet lipase Nedsat antal hvide blodlegemer e
Lipase increase White blood cell count decreased e
Nedsat uddrivningsfraktion
Ejection fraction decreased
0 (0, 0%)
Common
Nedsat hæmoglobin Nedsat antal trombocytter
Platelet count decrease
27 (6, 1%) 25 (5, 7%)
25 (5.7%)
6 (1, 4%) 4 (0, 9%)
4 (0.9%)
0 (0, 0%) 1 (0, 2%)
1 (0.2%)
Almindelig Almindelig Almindelig
Common Common
Vægttab Stigning i amylase Forhøjet blod - kreatinin - fosfokinase
Weight decreased Blood creatinine phosphokinase increased
23 (5, 2%) 21 (4, 8%) 22 (5, 0%)
23 (5.2%) 22 (5.0%)
1 (0, 2%) 8 (1, 8%) 1 (0, 2%)
1 (0.2%) 1 (0.2%)
0 (0, 0%) 0 (0, 0%) 1 (0, 2%)
0 (0.0%) 1 (0.2%)
Aspartat - aminotransferase stigning
Amylase increased Aspartate aminotransferase increased
18 (4, 1%)
21 (4.8%) 18 (4.1%)
2 (0, 5%)
8 (1.8%) 2 (0.5%)
1 (0, 2%)
0 (0.0%) 1 (0.2%)
Alanin - aminotransferase stigning
Alanine aminotransferase increased
Enhver bivirkning
Any adverse event
Følgende betegnelser er kombineret: a Anoreksi og nedsat appetit b Dysgeusi, ageusi og smagsforstyrrelser c Abdominalsmerter og smerter i øvre abdomen d Ødem, perifert ødem og ødem i ansigt
The following terms have been combined: a Anorexia and decreased appetite b Dysgeusia, ageusia and taste disturbance c Abdominal pain and abdominal pain upper d Oedema, oedema peripheral and oedema face e White blood cell count decreased, neutrophil count decreased, and leukocyte count decreased
Behandlingsrelaterede bivirkninger rapporteret i cytokin- refraktære og behandlingsnaive mRCC- undersøgelser
Treatment-Related Adverse Reactions reported in cytokine-refractory and treatment-naïve MRCC studies
Meget almindelig
Very common Very common
Trombocytopeni
Neutropoenia Thrombocytopoenia
86 (15, 8%)
89 (16.4%) 86 (15.8%)
37 (6, 8%)
46 (8.5%) 37 (6.8%)
5 (0, 9%)
5 (0.9%) 5 (0.9%)
Meget almindelig
Very common Common Common
67 (12, 3%)
Anaemia Leukopoenia Lymphopenia
20 (3, 7% 9
67 (12.3%) 45 (8.3%) 21 (3.9%)
Almindelig Almindelig
20 (3.7%) 16 (2.9%) 12 (2.2%)
Leukopeni Lymfocytopeni
3 (0.6%) 0 (0%) 1 (0.2%)
45 (8, 3%) 21 (3, 9%)
Endocrine
16 (2, 9%) 12 (2, 2%)
Very common
0 (0%) 1 (0, 2%)
Hypothyroidism
Det endokrine system
67 (12.3%)
Meget Almindelig
7 (1.3%)
Hypotyreose
0 (0%)
67 (12, 3%)
10
Øget tåreflåd Hævede øjenlåg
System Organ Class disorders
0 (0%) 0 (0%)
Frequency
Meget Almindelig
Adverse Reactions
Nervesystemet
All Grades n (%)
3 (0, 6%)
Grade 3 n (%)
2 (0, 4%)
Grade 4 n (%)
Paræstesi
Eye disorders
0 (0%)
Common
Almindelig
Lacrimation increased
Perifer neuropati
39 (7.2%)
33 (6, 1%)
0 (0%)
1 (0, 2%)
0 (0%)
Hypæstesi
Eyelid oedema
0 (0%)
a
17 (3, 1%)
12 (2.2%)
Vaskulære sygdomme
Metabolism and nutrition disorders
Almindelig Almindelig
Decreased appetite Dehydration
Rødmen Hedeture
205 (37.7%) 33 (6.1%)
17 (3, 1%) 12 (2, 2%)
9 (1.7%) 7 (1.3%)
0 (0%) 0 (0%)
0 (0%) 1 (0.2%)
Meget almindelig
Very common Very common Common Common Common
Almindelig Almindelig
Taste disturbance b Headache Dizziness Paraesthesia Neuropathy peripheral
Dyspnø Faryngolaryngeal smerte
250 (46.0%) 82 (15.1%) 38 (7.0%) 36 (5.9%) 33 (6.1%)
45 (8, 3%) 29 (5, 3%)
1 (0.2%) 3 (0.6%) 2 (0.4%) 0 (0%) 1 (0.2%)
6 (1, 1%) 2 (0, 4%)
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
0 (0%) 0 (0%)
Common Common
Almindelig Almindelig Almindelig Almindelig
Hypoaesthesia Hyperaesthesia
Hoste Dysfoni Tørhed i næsen Anstrengelsesudløst dyspnø
20 (3.7%) 17 (3.1%)
23 (4, 2%) 16 (2, 9%) 14 (2, 6%) 12 (2, 2%)
0 (0%) 0 (0%)
0 (0%) 0 (0%) 0 (0%) 0 (0%)
0 (0%) 0 (0%)
0 (0%) 0 (0%) 0 (0%) 0 (0%)
Vascular disorders
Almindelig Almindelig
Very common Common Common
Nasal tilstoppethed Pleuraeffusion
Hypertension Flushing Hot flush
12 (2, 2%) 12 (2, 2%)
143 (26.3%) 17 (3.1%) 12 (2.2%)
0 (0%) 3 (0, 6%)
55 (10.1%) 0 (0%) 0 (0%)
11 Organklasse
Respiratory, thoracic and
Bivirkning
Epistaxis
Alle Grader n (%)
86 (15.8%)
Grad 3 n (%)
3 (0.6%)
Grad 4 n (%)
0 (0%)
Mave - tarmkanalen
mediastinal
326 (59, 9%)
45 (8.3%)
38 (7, 0%)
6 (1.1%)
290 (53, 3%)
disorders
Meget almindelig
Pharyngolaryngeal pain
Dyspepsi
29 (5.3%)
8 (1, 5%)
2 (0.4%)
Meget almindelig
Common Common Common Common Common Common
Stomatitis
Cough Dysphonia Nasal dryness Dyspnoea exertional Nasal congestion Pleural effusion
185 (34, 0%)
23 (4.2%) 16 (2.9%) 14 (2.6%) 12 (2.2%) 12 (2.2%) 12 (2.2%)
Meget almindelig
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 3 (0.6%)
Opkastning
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
178 (32, 7%)
Gastrointestinal disorders
Meget almindelig
Very common Very common Very common Very common Very common Very common
Abdominalsmerterc / distension
Diarrhoea Nausea Dyspepsia Stomatitis Vomiting Abdominal pain c / distension
106 (19, 5%)
326 (59.9%) 290 (53.3%) 189 (34.7%) 185 (34.0%) 178 (32.7%) 106 (19.5%)
10 (1, 8%)
38 (7.0%) 19 (3.5%) 8 (1.5%) 13 (2.4%) 17 (3.1%) 10 (1.8%)
Meget almindelig
Very common Very common Very common Very common Very common Common
Obstipation
Constipation Glossodynia Flatulence Oral pain Dry mouth Gastroesophageal reflux disease
83 (15, 3%)
83 (15.3%) 63 (11.6%) 60 (11.0%) 60 (11.0%) 56 (10.3%) 50 (9.2%)
Meget almindelig
1 (0.2%) 0 (0%) 0 (0%) 2 (0.4%) 0 (0%) 2 (0.4%)
63 (11, 6%)
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
Meget almindelig
Common Common Common Common Common Common Common Common
Flatulens
Dysphagia Cheilitis Gingival bleeding Haemorrhoids Proctalgia Mouth ulceration Stomach discomfort Rectal haemorrhage
60 (11, 0%)
20 (3.7%) 19 (3.5%) 18 (3.3%) 18 (3.3%) 17 (3.1%) 16 (2.9%) 15 (2.8%) 13 (2.4%)
Meget almindelig
1 (0.2%) 1 (0.2%) 0 (0%) 0 (0%) 0 (0%) 1 (0.2%) 0 (0%) 0 (0%)
0 (0%)
11
Meget almindelig
System Organ Class
Mundtørhed
Frequency
56 (10, 3%)
Adverse Reactions
Almindelig
All Grades n (%)
50 (9, 2%)
Grade 3 n (%)
1 (0, 2%) 1 (0, 2%) 0 (0%) 0 (0%) 0 (0%) 1 (0, 2%) 0 (0%) 0 (0%)
Skin and subcutaneous tissue disorders
Palmar- plantar erytrodysæsthesi syndrom
Palmar-plantar erythrodysaesthesia syndrome
Gulfarvning af hud/ misfarvning af huden
Yellow discolouration/ Skin discolouration
Meget almindelig
Very common Very common Very common Very common Common Common Common Common Common Common Common
Udslæt
Rash Dry skin Hair colour changes Alopecia Erythema Skin exfoliation Pruritus Periorbital oedema Dermatitis Skin lesion Nail disorder/ discolouration
121 (22, 2%)
121 (22.2%) 108 (19.9%) 103 (18.9%) 64 (11.8%) 51 (9.4%) 47 (8.6%) 40 (7.4%) 31 (5.7%) 27 (5.0%) 26 (4.8%) 25 (4.6%)
2 (0, 4%)
2 (0.4%) 1 (0.2%) 0 (0%) 0 (0%) 2 (0.4%) 4 (0.7%) 1 (0.2%) 1 (0.2%) 4 (0.7%) 1 (0.2%) 0 (0%)
1 (0, 2%)
1 (0.2%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
Meget almindelig
Common Common Common Common
108 (19, 9%)
Blister Skin reaction Hyperkeratosis Acne
0 (0%)
23 (4.2%) 23 (4.2%) 22 (4.0%) 19 (3.5%)
Meget almindelig
1 (0.2%) 6 (1.1%) 4 (0.7%) 0 (0%)
Ændringer i hårfarve
0 (0%) 0 (0%) 0 (0%) 0 (0%)
103 (18, 9%)
Musculoskeletal and connective tissue disorders
Meget almindelig
Very common Common Common Common Common
Almindelig Almindelig Almindelig Almindelig Almindelig Almindelig
Pain in extremity Arthralgia Myalgia Muscle Spasm Back pain
Erytem Hudeksfoliation Kløe Periorbitalt ødem Dermatitis Hudlæsioner
96 (17.6%) 49 (9.0%) 48 (8.8%) 26 (4.8%) 17 (3.1%)
51 (9, 4%) 47 (8, 6%) 40 (7, 4%) 31 (5, 7%) 27 (5, 0%) 26 (4, 8%)
6 (1.1%) 1 (0.2%) 2 (0.4%) 0 (0%) 2 (0.4%)
2 0, 4%) 4 (0, 7%) 1 (0, 2%) 1 (0, 2%) 4 0, 7%) 1 (0, 2%)
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
General disorders and administration
12 Organklasse
Very common Very common
Bivirkning
Fatigue/ asthenia Mucosal inflammation
Alle Grader n (%)
397 (73.0%) 127 (23.3%)
Grad 3 n (%)
95 (17.5%) 8 (1.5%)
Grad 4 n (%)
1 (0.2%) 0 (0%)
Almindelig
site conditions
Blærer Hudreaktioner Hyperkeratose Acne
Oedema d Pyrexia Chills Pain Chest pain
23 (4, 2%) 23 (4, 2%) 22 (4, 0%) 19 (3, 5%)
99 (18.2%) 37 (6.8%) 35 (6.4%) 20 (3.7%) 13 (2.4%)
1 (0, 2%) 6 (1, 1%) 4 (0, 7%) 0 (0%)
5 (0.9%) 3 (0.6%) 2 (0.4%) 0 (0%) 2 (0.4%)
Knogler, led, muskler og
Psychiatric disorders Investigations
Meget almindelig
Common Common Very common
Ekstremitetssmerter
Insomnia Depression Ejection fraction decreased
96 (9, 0%)
22 (4.0%) 15 (2.8%) 84 (15.4%)
6 (1, 1%)
0 (0%) 1 (0.2%) 16 (2.9%)
bindevæv
Very common Common
Almindelig Almindelig Almindelig Almindelig
Weight decreased Platelet count decreased
Artralgi Myalgi Muskelkramper Rygsmerter
57 (10.5%) 41 (7.5%)
49 (9, 0%) 48 (8, 8%) 26 (4, 8%) 17 (3, 1%)
1 (0.2%) 15 (2.8%)
1 (0, 2%) 2 (0, 4%) 0 (0%) 2 (0, 4%)
0 (0%) 2 (0.4%)
0 (0%) 0 (0%) 0 (0%) 0 (0%)
Common
Almene symptomer og
White blood cell count decreased e
Træthed/ asteni
37 (6.8%)
397 (73, 0%)
16 (2.9%)
95 (17, 5%)
0 (0%)
1 (0, 2%)
Common Common
reaktioner på administrationss
Lipase increased Haemoglobin decreased
Meget almindelig
36 (6.6%) 25 (4.6%)
Mucosa inflammation
19 (3.5%) 8 (1.5%)
127 (23, 3%)
11 (2%) 0 (0%)
8 (1, 5%)
Common
0 (0%)
Blood creatine phosphokinase increased
tedet
19 (3.5%)
Meget almindelig
7 (1.3%)
Ødem d
2 (0.4%)
99 (18, 2%)
Common
5 (0, 9%)
Aspartate aminotransferase
0 (0%)
18 (3.3%)
Almindelig Almindelig Almindelig Almindelig
7 (1.3%)
37 (6, 8%) 35 (6, 4%) 20 (3, 7%) 13 (2, 4%)
0 (0%)
3 (0, 6%) 2 (0, 4%) 0 (0%) 2 (0, 4%)
12
0 (0%) 1 (0, 2%) 16 (2, 9%)
System Organ Class
0 (0%) 0 (0%) 0 (0%)
Frequency
Meget almindelig
Adverse Reactions increased
57 (10, 5%)
All Grades n (%)
Almindelig
Grade 3 n (%)
Nedsat antal trombocytter
Grade 4 n (%)
2 (0, 4%)
Common
Nedsat antal hvide blodlegemer e
Blood amylase increased
16 (2, 9%)
11 (2.0%)
0 (0%)
2 (0.4%)
Aspartat - aminotransferase stigning
Blood creatinine increased
18 (3, 3%)
15 (2.8%)
7 (1, 3%)
2 (0.4%)
Stigning i amylase Forhøjet blod - kreatinin
Blood pressure increased
18 (3, 3%) 15 (2, 8%)
15 (2.8%)
11 (2, 0%) 2 (0, 4%)
2 (0.4%)
2 (0, 4%) 0 (0%)
0 (0%)
Blodtryksstigning Alanin - aminotransferase stigning
Alanine aminotransferase increased
15 (2, 8%) 14 (2, 6%)
14 (2.6%)
2 (0, 4%) 7 (1, 3%)
7 (1.3%)
0 (0%) 2 (0, 4%)
2 (0.4%)
Følgende betegnelser er kombineret: a Anoreksi og nedsat appetit b Dysgeusi, ageusi og smagsforstyrrelser c Abdominalsmerter og smerter i øvre abdomen
The following terms have been combined: a Anorexia and decreased appetite b Dysgeusia, ageusia and taste disturbance c Abdominal pain and abdominal pain upper d Oedema, oedema peripheral and oedema face e White blood cell count decreased, neutrophil count decreased, and leukocyte count decreased
Bivirkninger efter markedsføring
Adverse reactions from post-marketing experience
Følgende typer af bivirkninger er rapporteret efter markedsføring af SUTENT.
The following adverse reactions have been identified during post-approval use of SUTENT.
Disse omfatter spontane tilfælde såvel som alvorlige bivirkninger fra igangværende undersøgelser, ” the expanded access programmes ”, kliniske- farmakologiske forsøg og eksplorative undersøgelser med ikke godkendte indikationer.
This includes spontaneous case reports as well as serious adverse events from ongoing studies, the expanded access programmes, clinical pharmacology studies and exploratory studies in unapproved indications.
Mave- tarmkanalen:
Rare:
Hjertesvigt, kronisk venstresidigt hjerteinsufficiens, venstre ventrikelsvigt Forlænget QT- interval, torsade de pointes
Cardiac failure, cardiac failure congestive, left ventricular failure Prolonged QT interval, Torsade de pointes
Lever og galdeveje:
Rare:
Pancreatitis Gastrointestinal perforation
Pancreatitis Gastrointestinal perforation
Ikke almindelig:
Hepatobiliary disorders:
Leversvigt
Hepatic failure
Stigning i thyroideastimulerende hormon (TSH)
Elevated thyroid stimulating hormone (TSH)
Infektioner og parasitære sygdomme Hyppighed ikke kendt
Infections and Infestations Non known:
Infektioner (med eller uden neutropeni)
Muscoloskeletal and Not known:
Myopati og/ eller rhabdomyolyse
Pulmonary disorders
Luftveje, thorax og Hyppighed ikke kendt:
Infections (with or without neutropoenia) connective tissue disorders Myopathy and/ or rhabdomyolysis
mediastinum Pleuraeffusion
Not known:
Hyppighed ikke kendt:
Not known:
Lungeemboli og respirationssvigt
Pleural effusion Pulmonary embolism and respiratory failure
Tromboemboliske hændelser:
Thromboembolic events:
Der er rapporteret tilfælde af lungeemboli, og i nogle tilfælde fatale.
Cases of pulmonary embolism, in some cases with fatal outcome, have been reported.