natgillin/translations-raw huggingface dataset:
I et klinisk dosis-respons studie med axitinib observerede man hos forsøgspersoner, der modtog startdoser på 10 mg eller 20 mg 2 gange dagligt, bivirkninger omfattende hypertension, kramper i forbindelse med hypertension og dødelig hæmoptyse.
In a clinical dose finding study with axitinib, subjects who received starting doses of 10 mg twice daily or 20 mg twice daily experienced adverse reactions which included hypertension, seizures associated with hypertension, and fatal haemoptysis.
Stigning i hæmoglobin eller hæmatokrit
Elevation of haemoglobin or haematocrit
Det er blevet vist, at axitinib er en potent hæmmer af endotelcellers proliferation og -overlevelse, der medieres via VEGF.
Axitinib has been shown to potently inhibit VEGF-mediated endothelial cell proliferation and survival.
Lægen vil tage blodprøver før og under behandlingen med Inlyta.
Your doctor should do blood tests to check your liver function before and during treatment with Inlyta.
Samtidig administration af axitinib og CYP1A2-substrater kan medføre en stigning i koncentrationen af CYP1A2-substrater (f.eks. teofyllin).
Therefore, coadministration of axitinib with CYP1A2 substrates may result in increased plasma concentrations of CYP1A2 substrates (e.g. theophylline).
• Blødninger.
• Bleeding.
• Du må ikke amme, mens du er i behandling med Inlyta.
• Do not breast-feed during treatment with Inlyta.
In vitro studier af CYP- og UGT-hæmning og -induktion In vitro studier antyder, at axitinib ikke hæmmer CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5 eller UGT1A1 ved terapeutiske plasmakoncentrationer.
In vitro studies of CYP and UGT inhibition and induction In vitro studies indicated that axitinib does not inhibit CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5, or UGT1A1 at therapeutic plasma concentrations.
• Åndenød, hoste, hæshed
• Shortness of breath, cough, hoarseness
Ved doseringen 5 mg 2 dagligt til ikke-fastende patienter med RCC er den gennemsnitlige peak-plasmakoncentration og 24-timers AUC henholdsvis 27,8 ng/ml og 265 ng.time/ml.
At the 5 mg twice daily dose in the fed state, the geometric mean peak plasma concentration and 24-hour AUC were 27.8 ng/mL and 265 ng.h/mL, respectively, in patients with advanced RCC.
In vitro studier antyder, at axitinib hæmmer P-glykoprotein.
In vitro studies indicated that axitinib inhibits P-glycoprotein.
Forsigtighed bør udvises, hos patienter der tager potente hæmmere af disse isoenzymer, på grund af risikoen for stigning i plasmakoncentrationen af axitinib.
Caution should be exercised due to the risk of increased axitinib plasma concentrations in patients taking strong inhibitors of these isozymes.
Én-sidet p-værdi fra en log-rank test af behandling stratificeret efter ECOG performance status i.
h One-sided p-value from a log-rank test of treatment stratified by ECOG performance status.
CI = Confidence interval; HR=Hazard ratio (axitinib/sorafenib); IE: Ikke estimerbart; IS: Ikke significant; ITT: Intent-to-treat; ORR: Objective response rate; OS: Overall survival; PFS: Progression-free survival a.
CI = Confidence interval, HR = Hazard ratio (axitinib/sorafenib); ITT: Intent-to-treat; NE: not estimable; NS:
Delvis reversibel dentalcaries ses hos mus behandlet i mere end 1 måned med doser svarende til human-terapeutiske doser.
Partially reversible dental caries were observed in mice treated for more than 1 month at exposure levels similar to the expected human exposure.
De hyppigste bivirkninger (>20%), som ses ved behandling med axitinib er diarré, hypertension, træthed, nedsat appetit, kvalme, vægttab, dysfoni, palmo-plantar erytrodysæstesi (hånd- og fodsyndrom), blødning, hypotyreose, opkastning, proteinuri, hoste og obstipation.
The most common (≥ 20%) adverse reactions observed following treatment with axitinib were diarrhoea, hypertension, fatigue, decreased appetite, nausea, weight decreased, dysphonia, palmar-plantar erythrodysaesthesia (hand-foot) syndrome, haemorrhage, hypothyroidism, vomiting, proteinuria, cough, and constipation.
Fund hos hunner omfatter tegn på forsinket seksuel modning, reduceret eller manglende corpora lutea, nedsat uterusvægt og uterinatrofi ved doser svarende til human-terapeutiske doser.
Findings in females included signs of delayed sexual maturity, reduced or absent corpora lutea, decreased uterine weights and uterine atrophy at exposures approximately equivalent to the expected human exposure.
Det anbefales at nedsætte dosis ved behandling af patienter med moderat nedsat leverfunktion (ChildPugh klasse B) (f.eks. fra startdosis på 5 mg 2 gange dagligt til 2 mg 2 gange dagligt).
A dose decrease is recommended when administering axitinib to patients with moderate hepatic impairment (Child-Pugh class B) (e.g. the starting dose should be reduced from 5 mg twice daily to 2 mg twice daily).
Drægtige mus eksponeret for axitinib udviste stigning i ganespalte og skeletforandringer, herunder forsinket ossifikation ved doser under human-terapeutiske doser.
Pregnant mice exposed to axitinib showed an increased occurrence of cleft palate malformations and skeletal variations, including delayed ossification, at exposure levels below the expected human exposure.
I et klinisk dosis-respons studie sås en samtidig stigning af ALAT (12 gange [ULN]) og bilirubin (2,3 gange ULN), vurderet til at være lægemiddelrelateret levertoksicitet, hos 1 patient ved en startdosis på 20 mg 2 gange dagligt (4 gangeden anbefalede daglige dosis).
In a clinical dose-finding study, concurrent elevations of ALT (12 times the ULN) and bilirubin (2.3 times the ULN), considered to be drug-related hepatotoxicity, were observed in 1 patient who received axitinib at a starting dose of 20 mg twice daily (4 times the recommended starting dose).
Arterielle emboliske og trombotiske hændelser
Arterial embolic and thrombotic events
Hvis du har glemt at tage Inlyta
If you forget to take Inlyta
Medicin nævnt herunder kan muligvis nedsætte virkningen af Inlyta:
The following medicines may reduce the effectiveness of Inlyta:
Fortæl lægen, hvis du får voldsomme mavesmerter.
Tell your doctor if you have severe abdominal pain.
Figur 1 Kaplan-Meier kurve over progressionsfri overlevelse udfra uafhængig vurdering i den samlede population.
Kaplan-Meier curve of progression-free survival by independent assessment for the overall population
Dosisjustering på grund af alder eller race er ikke nødvendig (se pkt.
No dosage adjustment is required on the basis of patient age or race (see sections 4.2 and 5.2).
Fortæl det til lægen, hvis du hurtigt bliver træt, føler dig kuldskær eller hvis din stemme bliver dybere, mens du tager Inlyta.
Tell your doctor if you get tired more easily, generally feel colder than other people, or your voice deepens whilst taking this medicine.
Hvis du holder op med at tage Inlyta
If you stop taking Inlyta
Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Dosering Den anbefalede dosis er 5 mg axitinib 2 gange dagligt.
The recommended dose of axitinib is 5 mg twice daily.
- Aktivt stof: axitinib.
• The active substance is axitinib.
Hvis du kaster op, mens du tager Inlyta
If you vomit while taking Inlyta
Samtidig administration af axitinib forventes ikke at reducere plasmakoncentrationen af CYP1A1, CYP1A2 eller CYP3A4/5 substrater in vivo.
Therefore co-administration of axitinib is not expected to reduce the plasma concentration of co-administered CYP1A1, CYP1A2, or CYP3A4/5 substrates in vivo.
• Hul i mavesæk eller tarm eller fistel-dannelse (unormal rør-lignende passage fra et hulrum i kroppen til et andet eller til huden).
• Hole in the stomach or intestine or formation of fistula (abnormal tube-like passage from one normal body cavity to another body cavity or the skin).
Skema 2.
Figure 2.
60 tabletter
56 tablets
Beslutning om at genoptage behandlingen bør baseres på klinisk vurdering af tilfredsstillende sårheling.
The decision to resume axitinib therapy after surgery should be based on clinical judgment of adequate wound healing.
Gentagne dosistoksicitetsforsøg
Repeat dose toxicity
• Hvis du under behandlingen med Inlyta får symptomer såsom hovedpine, forvirring, kramper (krampeanfald) eller synsforstyrrelser med eller uden højt blodtryk.
• If during treatment with this medicine, you get symptoms such as headache, confusion, seizures (fits), or changes in vision with or without high blood pressure.
Venøse emboliske og trombotiske hændelser
Venous embolic and thrombotic events
Axitinib må ikke anvendes under amning.
Axitinib should not be used during breast-feeding.
I et randomiseret overkrydsningsforsøg, fik 35 raske forsøgspersoner en enkeltdosis axitinib (5 mg) med og uden samtidig dosering af 400 mg ketokonazol i 7 dage.
In a randomised, 2-way crossover study, 35 healthy subjects were administered a single oral dose of axitinib (5 mg) in the absence and presence of 400 mg ketoconazole for 7 days.
Anæmia Trombocytopeni Polycytæmi
Thrombocytopenia Polycythaemiac
In vitro studier med humane hepatocytter viste, at axitinib ikke inducerede CYP1A1, CYP1A2 eller CYP3A4/5.
In vitro studies in human hepatocytes also indicated that axitinib does not induce CYP1A1, CYP1A2, or CYP3A4/5.
Bivirkningerne hos patienter i behandling med axitinib inkluderede epistaxis (7,8%), hæmaturi (3,6%), hæmoptyse (2,5%), rektalblødning (2,2%), gingival blødning (1,1%), gastrisk blødning (0,6%), hjerneblødning (0,3%) og nedre gastrointestinal blødning (0,3%).
The haemorrhagic adverse reactions in patients treated with axitinib included epistaxis (7.8%), haematuria (3.6%), haemoptysis (2.5%), rectal haemorrhage (2.2%), gingival bleeding (1.1%), gastric haemorrhage (0.6%), cerebral haemorrhage (0.3%) and lower gastrointestinal haemorrhage (0.3%).
Baseret på axitinibs farmakologiske egenskaber, kan axitinib være fosterskadende.
Based on the pharmacological properties of axitinib, it may cause foetal harm when administered to a pregnant woman.
Meget almindelig Hypotyreose Almindelig
Very common Hypothyroidismc Common
Ketoconazol, en potent hæmmer af CYP3A4/5, administreret i doser på 400 mg 1 gang dagligt i 7 dage, øgede middelarealet under kurven (AUC) 2 gange og Cmax 1,5 gange i forhold til 1 enkelt oral dosis på 5 mg hos raske forsøgspersoner.
Ketoconazole, a strong inhibitor of CYP3A4/5, administered at a dose of 400 mg once daily for 7 days, increased the mean area under the curve (AUC) 2-fold and Cmax 1.5-fold of a single 5-mg oral dose of axitinib in healthy volunteers.
Axitinib metaboliseres primært i leveren af CYP3A4/5 og i mindre grad af CYP1A2, CYP2C19 og UGT1A1.
Axitinib is metabolised primarily in the liver by CYP3A4/5 and to a lesser extent by CYP1A2, CYP2C19, and UGT1A1.
Det er vigtigt, at blodtrykket bliver målt inden behandlingen startes og regelmæssigt under behandlingen.
It is important to check your blood pressure before you take this medicine, and regularly while you are taking it.
Inlyta er medicin, der bruges til behandling af fremskreden nyrekræft (fremskreden renalcellekræft) hos voksne, når anden medicin mod kræft (sunitinib eller et cytokin) ikke virker længere.
Inlyta is indicated for the treatment of advanced kidney cancer (advanced renal cell carcinoma) in adults, when another medicine (called sunitinib or a cytokine) is no longer stopping disease from progressing.
Bivirkninger med samme hyppighed er angivet i faldende orden indenfor hver organklasse.
Within each system organ class, adverse reactions with the same frequency are presented in order of decreasing seriousness.
Farmakokinetiske populationsundersøgelser har vist, at axitinib-clearance ikke er påvirket hos patienter med nedsat nyrefunktion.
Population pharmacokinetic analyses have shown that axitinib clearance was not altered in subjects with renal impairment and no dose adjustment of axitinib is required.
En risiko-ratio >1 indikerer større sandsynlighed for response i axitinib-armen; En risiko-ratio <1 indikerer større sandsynlighed for response i sorafenib-armen.
A risk ratio > 1 indicated a higher likelihood of responding in the axitinib arm; a risk ratio < 1 indicated a higher likelihood of responding in the sorafenib arm. g One-sided p-value from Cochran-Mantel-Haenszel test of treatment stratified by ECOG performance status and prior therapy.
Én-sidet p-værdi fra en log-rank test af behandling stratificeret efter ECOG performance status og tidligere behandling.
c One-sided p-value from a log-rank test of treatment stratified by ECOG performance status and prior therapy.
HDPE beholder med silicagel tørrekapsel og polypropylenlåg indeholdende 180 filmovertrukne tabletter.
HDPE bottle with a silica gel desiccant and a polypropylene closure containing 180 film-coated tablets.
Akkumuleringen var mindre end det dobbelte ved indgift af 5 mg axitinib 2 gange dagligt sammenlignet med administration af 1 enkelt dosis.
Dosing of axitinib at 5 mg twice daily resulted in less than two-fold accumulation compared to administration of a single dose.
Bivirkningerne er anført efter behandlingsrelateret hyppighed uanset årsag National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0 Se beskrivelse af udvalgte bivirkninger i punktet herunder Dødelige tilfælde (Grad 5) er set
b National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 c See Description of selected adverse reactions section.
Tidligere sunitinibbehandling
Prior sunitinib treatment
Håndtering af hjertesvigt kan kræve midlertidig eller permanent afbrydelse af behandlingen og/eller dosisnedsættelse af axitinib.
Management of cardiac failure events may require temporary interruption or permanent discontinuation and/or dose reduction of axitinib therapy.
Stigning i thyreoidea-stimulerende hormon (TSH) blev set som bivirkning hos 5,3% af patienterne i behandling med axitinib.
Thyroid stimulating hormone (TSH) increased was reported as an adverse reaction in 5.3% of patients receiving axitinib.
I kliniske studier var den systemiske exposure for axitinib ca. 2 gange højere hos patienter med moderat nedsat leverfunktion (Child-Pugh klasse B) end hos patienter med normal leverfunktion.
In clinical studies with axitinib, the systemic exposure to axitinib was approximately two-fold higher in subjects with moderate hepatic impairment (Child-Pugh class B) compared to subjects with normal hepatic function.
Inklusive akut myokardieinfarkt, emboli, myokardieinfarkt, retinalarterieokklusion og transitorisk cerebral iskæmi
j Including acute myocardial infarction, embolism, myocardial infarction, retinal artery occlusion and transient ischaemic attack.
Disse fund blev set hos mus ved doser ca. 12 gange human-terapeutiske doser og hos hunde ved doser lavere end human-terapeutiske doser.
These findings were observed in mice at exposure levels approximately 12-fold the expected human exposure, and in dogs at exposure levels below the expected human exposure.
Én-sidet p-værdi fra Cochran-Mantel-Haenszel test af behandling stratificeret efter ECOG performance status og tidligere behandling.
One-sided p-value from Cochran-Mantel-Haenszel test of treatment stratified by ECOG performance status.
Axitinib er ikke undersøgt hos patienter, som har haft arterielle tromboemboliske hændelser inden for de sidste 12 måneder.
Axitinib has not been studied in patients who had an arterial embolic or thrombotic event within the previous 12 months.
Ved rutinemæssige laboratorieundersøgelser sås stigninger i TSH til ≥10 µU/ml hos 32,2% af de axitinib-behandlede patienter, som havde TSH <5 µU/ml før behandlingsstart.
During routine laboratory assessments, in patients who had TSH < 5 μU/mL before treatment, elevations of TSH to ≥ 10 μU/mL occurred in 32.2% of patients receiving axitinib.
Inklusive Budd-Chiari's syndrom, dyb venetrombose, vena jugularis trombose, bækkenvenetrombose, lungeemboli, retinalveneokklusion, retinalvenetrombose, vena subclavia trombose, venøs trombose og trombose i ekstremitetvene
i Including Budd-Chiari syndrome, deep vein thrombosis, jugular vein thrombosis, pelvic venous thrombosis, pulmonary embolism, retinal vein occlusion, retinal vein thrombosis, subclavian vein thrombosis, venous thrombosis, and venous thrombosis limb.
Selvom dosisjustering af axitinib ikke er undersøgt hos patienter i behandling med potente CYP3A4/5induktorer, anbefales det at øge axititinib dosis gradvist.
Although axitinib dose adjustment has not been studied in patients receiving strong CYP3A4/5 inducers, if a strong CYP3A4/5 inducer must be co-administered, a gradual dose increase of axitinib is recommended.
Fortæl altid lægen, apoteket eller sundhedspersonalet, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin.
Please tell your doctor, pharmacist or nurse about all the medicines you have recently taken, are currently taking, or plan to take, including medicines obtained without a prescription, vitamins, and herbal medicines.
Systemisk eksposure efter enkeltdosis axitinib var sammenlignelig hos patienter med normal leverfunktion og patienter med let nedsat leverfunktion (Child-Pugh class A) og højere (ca. to gange) hos patienter med moderat nedsat leverfunktion (Child-Pugh class B).
Compared to subjects with normal hepatic function, systemic exposure following a single dose of axitinib was similar in subjects with mild hepatic impairment (Child-Pugh class A) and higher (approximately two-fold) in subjects with moderate hepatic impairment (Child-Pugh class B).
I studier med axitinib givet som monoterapi (N = 850) så man hæmoptyse hos 3,9% af patienterne; hæmoptyse af grad ≥3 blev rapporteret hos 0,5 % af patienterne.
In monotherapy studies with axitinib (N = 850), haemoptysis was reported in 3.9% of patients; Grade > 3 haemoptysis was reported in 0.5% of patients.
Reversibel epifysedysplasi ses hos mus og hunde efter indgift af axitinib i mindst 1 måned med doser ca. seks gange human-terapeutiske doser.
Reversible physeal dysplasia was observed in mice and dogs given axitinib for at least 1 month at exposure levels approximately six-fold higher than the expected human exposure.
Kontakt omgående læge eller skadestue.
Get emergency help right away and call your doctor.
Skema 1 viser bivirkninger set i et poolet datasæt for 672 patienter med RCC behandlet med axitinib i kliniske studier (se pkt.
Table 1 presents adverse reactions reported in a pooled dataset of 672 patients who received axitinib in clinical studies for the treatment of patients with RCC (see section 5.1).
Figur 2 Kaplan-Meier kurve over progressionsfri overlevelse udfra uafhængig vurdering i undergruppen med tidligere sunitinib-behandling.
Kaplan-Meier curve of progression-free survival by independent assessment for the prior sunitinib subgroup
Virkning og anvendelse Det skal du vide, før du begynder at tage Inlyta Sådan skal du tage Inlyta Bivirkninger
What Inlyta is and what it is used for What you need to know before you take Inlyta How to take Inlyta
Axitinib er ikke undersøgt hos patienter, som har haft venøse tromboemboliske hændelser inden for de sidste 6 måneder.
Axitinib has not been studied in patients who had a venous embolic or thrombotic event within the previous 6 months.
• Ændringer i stoffer/enzymer i blodet.
• Changes in the levels of different chemicals/enzymes in the blood (may show in your blood tests)
• Hvis du for nylig har haft problemer med blodpropper, inklusive slagtilfælde og hjertetilfælde.
• If you have had a recent problem with blood clots in your veins and arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis.
HDPE beholder med silicagel tørrekapsel og polypropylenlåg indeholdende 60 filmovertrukne tabletter.
HDPE bottle with a silica gel desiccant and a polypropylene closure containing 60 film-coated tablets.
Bivirkninger set i RCC-studier hos patienter behandlet med axitinib (N = 672) Systemorganklasse Hyppighed
Adverse reactions reported in RCC studies in patients who received axitinib (N = 672)
Sådan skal du tage Inlyta
How to take Inlyta
• Røde blodlegemer i urinen (ses i urinprøver)
• Presence of red blood cells in the urine (may show in your urine tests)
In vitro data antyder, at axitinib primært metaboliseres via CYP3A4/5 og i mindre udstrækning via CYP1A2, CYP2C19 og uridindiphosphat-glucuronosyltranferase (UGT) 1A1.
In vitro data indicate that axitinib is metabolised primarily by CYP3A4/5 and, to a lesser extent, CYP1A2, CYP2C19, and uridine diphosphate-glucuronosyltransferase (UGT) 1A1.
Alle grader
All Gradesb
Dosisreduktion anbefales til patienter med moderat nedsat leverfunktion (Child-Pugh klasse B) (se pkt.
A dose decrease is recommended when administering axitinib to patients with moderate hepatic impairment (Child-Pugh class B) (see section 4.2).
Selvom dosisjustering af axitinib ikke er undersøgt hos patienter i behandling med potente CYP3A4/5hæmmere, anbefales det at reducere axitinib-dosis til ca. halvdelen (f.eks bør startdosis nedsættes fra 5 mg 2 gange dagligt til 2 mg 2 gange dagligt), hvis axitinib skal administreres sammen med en kraftig CYP/3A4/5-hæmmer.
Although axitinib dose adjustment has not been studied in patients receiving strong CYP3A4/5 inhibitors, if a strong CYP3A4/5 inhibitor must be co-administered, a dose decrease of axitinib to approximately half the dose (e.g. the starting dose should be reduced from 5 mg twice daily to 2 mg twice daily) is recommended.
Vurderet ved uafhængig radiologisk gennemgang i henhold til Response Evaluation Criteria in Solid Tumours (RECIST).
Cutoff date: 03 June 2011. b Assessed by independent radiology review according to Response Evaluation Criteria in Solid
• Fistel-dannelse (unormal rør-lignende passage fra et hulrum i kroppen til et andet eller til huden)
• Fistula (abnormal tube like passage from one normal body cavity to another body cavity or the skin)
Hjertesvigt c, d, f
Cardiac failure eventsc,d,f
I et klinisk studie med axitinib til behandling af patienter med RCC, så man hypotyreose hos 20,9% af patienterne og hypertyreose hos 1,1% af patienterne.
In a controlled clinical study with axitinib for the treatment of patients with RCC, hypothyroidism was reported in 20.9% of patients and hyperthyroidism was reported in 1.1% of patients.
I et kontrolleret klinisk studie med axitinib til behandling af patienter med RCC var 34% af patienterne over 65 år gamle.
In a controlled clinical study with axitinib for the treatment of patients with RCC, 34% of patients treated with axitinib were ≥ 65 years of age.
Ring straks til lægen, hvis du får symptomer såsom hovedpine, forvirring, kramper og synsforstyrrelser, med eller uden for højt blodtryk.
Get emergency help right away and call your doctor if you get symptoms such as headache, confusion, seizures (fits), or changes in vision with or without high blood pressure.
Inlyta 1 mg filmovertrukne tabletter Inlyta 3 mg filmovertrukne tabletter Inlyta 5 mg filmovertrukne tabletter Inlyta 7 mg filmovertrukne tabletter
Inlyta 1 mg film-coated tablets Inlyta 3 mg film-coated tablets Inlyta 5 mg film-coated tablets Inlyta 7 mg film-coated tablets
Arterielle tromboemboliske hændelser c, d, j
Arterial embolic and thrombotic eventsc,d,j
Bivirkninger, hvor hyppigheden ikke er kendt
Not known: frequency cannot be estimated from the available data
Der skal monitoreres for symptomer på gastrointestinal perforation og fistler under hele behandlingen med axitinib.
Symptoms of gastrointestinal perforation or fistula should be periodically monitored for throughout treatment with axitinib.
Nedsat nyrefunktion Uomdannet axitinib genfindes ikke i urin.
Unchanged axitinib is not detected in the urine.
Inlyta indeholder:
What Inlyta contains
Effekt Endepunkt/ studiepopulation axitinib sorafenib
Efficacy results Endpoint / study population axitinib sorafenib HR (95% CI) p-value
Håndteringen af nogle af bivirkningerne kan kræve midlertidig eller permanent afbrydelse af behandlingen og/eller dosisnedsættelse af axitinib (se pkt.
Management of some adverse reactions may require temporary or permanent discontinuation and/or dose reduction of axitinib therapy (see section 4.4).