natgillin/translations-raw huggingface dataset:
Kvinder i den fertile alder skal anvende meget sikker kontraception, mens de tager lenvatinib og i 1 måned efter behandlingsophør (se pkt.
Women of childbearing potential must use highly effective contraception while taking lenvatinib and for one month after stopping treatment (see section 4.6).
De hyppigste bivirkninger (≥5 %), der medførte dosisreduktion i gruppen behandlet med lenvatinib plus everolimus, var diarré (21,0 %), trombocytopeni (6,5 %) og opkastning
The most common adverse reactions (≥5%) resulting in dose reductions in the lenvatinib plus everolimus treated group were diarrhoea (21.0%), thrombocytopenia (6.5%), and vomiting (6.5%).
Nogle tilfælde af blødning er opstået sekundært til tumorsvind og fisteldannelse, f.eks. trakeoøsofageale fistler.
Some cases of bleeding have occurred secondarily to tumour shrinkage and fistula formation, e.g. tracheooesophageal fistulae.
Der foreligger begrænsede data fra anvendelse til patienter af anden etnisk oprindelse end kaukasisk eller asiatisk (se også pkt.
Limited data are available on use in patients from ethnic origins other than Caucasian or Asian (see also section 4.8, Other special populations).
• har problemer med leveren eller nyrerne
• have liver or kidney problems
• lavt antal blodplader, hvilket kan medføre blå mærker og problemer med sårheling
• low levels of platelets in the blood which may lead to bruising and difficulty in wound healing
Kisplyx indeholder:
What Kisplyx contains
Lungeemboli†
Pulmonary embolism†,
Patienterne bør overvåges for kliniske symptomer eller tegn på hjertedekompensation, da doseringsafbrydelse, dosisjustering eller seponering kan være nødvendig (se pkt.
Patients should be monitored for clinical symptoms or signs of cardiac decompensation, as dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
Oral inflammation omfatter: aftøs ulcus, stomatitis, glossitis, mundsår og mucosainflammation.
Oral inflammation includes: aphthous ulcer, stomatitis, glossitis, mouth ulceration, and mucosal inflammation.
Behandlingen skal seponeres i tilfælde af livstruende reaktioner (f.eks. grad 4), med undtagelse af laboratorieanomalier, der bedømmes til ikke at være livstruende.
Treatment should be discontinued in case of life-threatening reactions (e.g., Grade 4) with the exception of laboratory abnormalities judged to be non-life-threatening, in which case they should be managed as severe reactions (e.g., Grade 3).
Der foreligger ingen data med kombinationen for patienter med nedsat leverfunktion.
No data with the combination is available in patients with hepatic impairment.
De hyppigst rapporterede bivirkninger hos patientpopulationerne med RCC og DTC (forekom hos ≥ 30 % af patienterne) var diarré (80,6 %), hypertension (70,1 %)*, træthed (59,7 %), nedsat appetit (53,7 %), vægttab (52,6 %)*, opkastning (48,4 %), kvalme (45,2 %), proteinuri (38,9 %)*, stomatitis (36,9 %)*, hovedpine (35,8 %)*, dysfoni (35,6 %)*, palmoplantar erytrodysæstesisyndrom (PPE) (34,1 %)*, perifert ødem (33,9 %) og hyperkolesterolæmi (30,6 %).
The most frequently reported adverse reactions in the RCC and DTC patient populations (occurring in ≥30% of patients) were diarrhoea (80.6%), hypertension (70.1%)*, fatigue (59.7%), decreased appetite (53.7%), weight decreased (52.6%)*, vomiting (48.4%), nausea (45.2%), proteinuria (38.9%)*, stomatitis (36.9%)*, headache (35.8%)*, dysphonia (35.6%)*, palmar-plantar erythrodysaesthesia syndrome (PPE) (34.1%)*, peripheral oedema (33.9%), and hypercholesterolemia (30.6%).
Sådan skal du tage Kisplyx
How to take Kisplyx
Lenvatinib plus everolimus-armen viste en statistisk signifikant og klinisk meningsfuld forbedring i PFS sammenlignet med everolimus-armen.
The lenvatinib plus everolimus arm showed a statistically significant and clinically meaningful improvement in PFS compared with the everolimus arm.
Forlængelse af QTinterval
QT interval prolongation
Det primære virkningsendepunkt, baseret på investigatorbedømt tumorrespons, var progressionsfri overlevelse (PFS), for lenvatinib plus everolimus-armen vs everolimus-armen og for lenvatinib-armen vs everolimus-armen.
The primary efficacy outcome measure, based on investigator assessed tumour response, was progression-free survival (PFS) of the lenvatinib plus everolimus arm vs the everolimus arm and of the lenvatinib arm vs the everolimus arm. Other efficacy outcome measures included overall survival (OS) and investigator-assessed objective response rate (ORR).
Leverrelaterede reaktioner medførte doseringsafbrydelse og dosisreduktion hos hhv. 4,6 % og 2,7 % af patienterne og permanent seponering hos 0,4 %.
Liver-related reactions led to dose interruptions and reductions in 4.6% and 2.7% of patients, respectively, and to permanent discontinuation in 0.4%.
Tabel 3 Anbefalet behandling af hypertension
Recommended management of hypertension
Leverrelaterede reaktioner medførte doseringsafbrydelse og dosisreduktion hos hhv. 1,6 % og 1,6 % af patienterne og permanent seponering hos 3,2 % af patienterne.
Liver-related reactions led to dose interruptions and reductions in 1.6% and 1.6% of patients, respectively, and to permanent discontinuation in 3.2% of patients.
• kvalme og opkastning, forstoppelse, diarré, mavesmerter, fordøjelsesbesvær
• feeling and being sick, constipation, diarrhoea, abdominal pain, indigestion
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Kisplyx 4 mg hårde kapsler
QUALITATIVE AND QUANTITATIVE COMPOSITION Kisplyx 4 mg hard capsules
Progressionsfri overlevelse (PFS)a efter en post-hoc, retrospektiv uafhængig gennemgang Median PFS i måneder (95 %
Progression-free survival (PFS)a by Post-hoc Retrospective Independent Review
Forlænget QT-interval (se pkt.
QT interval prolongation (see section 4.4)
Forekomsten af et længere QT-interval end 500 ms var 2 % i lenvatinib-gruppen sammenlignet med ingen rapporter i placebogruppen.
The incidence of QT interval prolongation of greater than 500 ms was 2% in the lenvatinib-treated patients compared to no reports in the placebo group.
Data-afskæringsdato = 13. juni 2014 Procenterne er baseret på det totale antal personer i det fuldstændige analysesæt i den relevante behandlingsgruppe.
Percentages are based on the total number of subjects in the Full Analysis Set within relevant treatment group.
Kvinder i den fertile alder skal undgå at blive gravide og anvende meget sikker kontraception, mens de er i behandling med lenvatinib og mindst en måned efter behandlingsophør.
Women of childbearing potential/ Contraception in females Women of childbearing potential should avoid becoming pregnant and use highly effective contraception while on treatment with lenvatinib and for at least one month after finishing treatment.
Hepatocellulær skade og hepatitis omfatter: lægemiddelinduceret leverskade, leversteatose og kolestatisk leverskade.
Hepatocellular damage and hepatitis includes: drug-induced liver injury, hepatic steatosis, and cholestatic liver injury.
QT-interval >500 ms
>500 ms
Selvom virkningsmekanismen i forbindelse med hypertension ikke blev undersøgt direkte med lenvatinib, postuleres det, at den er medieret via hæmning af VEGFR2 i vaskulære endotelceller.
Although not studied directly with lenvatinib, the mechanism of action (MOA) for hypertension is postulated to be mediated by the inhibition of VEGFR2 in vascular endothelial cells.
I DTC-studiet (se produktresuméet for Lenvima) blev hypertension (herunder hypertension, hypertensiv krise, forhøjet diastolisk blodtryk og forhøjet blodtryk) rapporteret hos 72,8 % af patienterne i lenvatinib-gruppen og hos 16,0 % i placebogruppen.
In the DTC study (see Lenvima SmPC), hypertension (including hypertension, hypertensive crisis, blood pressure diastolic increased, and blood pressure increased) was reported in 72.8% of lenvatinib-treated patients and 16.0% of patients in the placebo-treated group.
Posteriort reversibelt encefalopatisynd rom Monoparese Transitorisk cerebral iskæmi
Posterior reversible encephalopathy syndrome Monoparesis Transient ischaemic attack
5.1) var der 1 tilfælde af PRES (grad 3) i lenvatinib-gruppen, og dette opstod efter 18,4 ugers behandling.
In the RCC study (see section 5.1), there was 1 event of PRES (Grade 3) in the lenvatinib-treated group, occurring after 18.4 weeks of treatment.
I DTC-studiet (se produktresuméet for Lenvima) var der 1 tilfælde af PRES (grad 2) i lenvatinibgruppen, og ingen rapporter for placebogruppen.
In the DTC study (see Lenvima SmPC), there was 1 event of PRES (Grade 2) in the lenvatinib-treated group and no reports in the placebo group.
Blandt disse patienter med normal TSH ved baseline blev der observeret et forhøjet niveau af TSH over 0,5 mE/l efter baseline hos 57 % i lenvatinib-gruppen sammenlignet med 14 % i placebogruppen.
In those patients with a normal TSH at baseline, elevation of TSH level above 0.5 mU/L was observed post baseline in 57% of lenvatinib-treated patients as compared with 14% of placebo-treated patients.
Blandt 1.166 patienter i behandling med lenvatinib blev blødning af grad 3 eller højere rapporteret hos 2 % af patienterne, 3 patienter (0,3 %) havde en grad 4 blødning, og 5 patienter (0,4 %) havde en grad 5 reaktion, herunder arteriel blødning, hjerneblødning, intrakranial tumorblødning, hæmoptyse og tumorblødning.
Amongst 1,166 patients treated with lenvatinib, Grade 3 or greater haemorrhage was reported in 2% of patients, 3 patients (0.3%) had a Grade 4 haemorrhage and 5 patients (0.4%) had a Grade 5 reaction including arterial haemorrhage, haemorrhagic stroke, intracranial tumour haemorrhage, haemoptysis and tumour haemorrhage.
Gastrointestinal perforation og fisteldannelse
Gastrointestinal perforation and fistula formation
Blandt 1.166 patienter behandlet med lenvatinib var der 5 tilfælde (0,4 %) af arteriel tromboemboli (3 tilfælde af myokardieinfarkt og 2 cerebrovaskulære tilfælde) med dødelig udgang.
Amongst 1,166 patients treated with lenvatinib, there were 5 cases (0.4%) of arterial thromboembolisms (3 cases of myocardial infarction and 2 cases of cerebrovascular accident) with a fatal outcome.
Forekomsten af QTc-interval på over 500 ms var 6 % i lenvatinib plus everolimus-gruppen.
The incidence of QTc interval greater than 500 ms was 6% in the lenvatinib plus everolimus-treated group.
Den anbefalede daglige dosis af lenvatinib er 18 mg (én 10 mg kapsel og to 4 mg kapsler) én gang dagligt i kombination med 5 mg everolimus én gang dagligt.
The recommended daily dose of lenvatinib is 18 mg (one 10 mg capsule and two 4 mg capsules) once daily in combination with 5 mg of everolimus once daily.
Der var ingen rapporter i grupperne med lenvatinib plus everolimus eller everolimus-monoterapi.
There were no reports in the lenvatinib plus everolimus or everolimus monotherapy groups.
Prævention, graviditet og amning
Contraception, pregnancy and breast-feeding
Kisplyx kan startes igen, når det vurderes,
Kisplyx may be restarted once adequate wound healing is established.
Hvis du har taget for meget Kisplyx
If you take more Kisplyx than you should
Reaktioner, der opstod med en forekomst på ≥ 2,0 %, var: epistaxis (22,6 %), hæmaturi (4,8 %), hæmatom (3,2 %) og gastrisk blødning (3,2 %).
Reactions that occurred at an incidence of ≥2.0% were: epistaxis (22.6%), haematuria (4.8%), haematoma (3.2%), and gastric haemorrhage (3.2%).
Grad 3 reaktioner forekom hos 10,7 % af patienterne i lenvatinib-gruppen og hos ingen i placebogruppen.
Grade 3 reactions occurred in 10.7% of lenvatinib-treated patients and none in placebo-treated patients.
Patienter med DTC og lav legemsvægt (< 60 kg) havde imidlertid en højere forekomst af PPE, proteinuri, grad 3 eller 4 hypokalcæmi og hyponatriæmi og en tendens til højere forekomst af grad 3 eller 4 appetitløshed.
However in DTC patients with low body weight (<60 kg) had a higher incidence of PPE, proteinuria, of Grade 3 or 4 hypocalcaemia and hyponatraemia, and a trend towards a higher incidence of Grade 3 or 4 decreased appetite.
Hvis du har taget for meget Kisplyx, skal du straks kontakte lægen eller apotekspersonalet.
If you take more Kisplyx than you should, talk to a doctor or pharmacist straight away.
Lenvatinibs farmakokinetik efter en enkelt dosis på 10 mg blev evalueret hos 6 personer med let og 6 personer med moderat nedsat leverfunktion (Child-Pugh A hhv. Child-Pugh B).
The pharmacokinetics of lenvatinib following a single 10-mg dose were evaluated in 6 subjects each with mild and moderate hepatic impairment (Child-Pugh A and Child-Pugh B, respectively).
Patienter ≥ 75 år med DTC havde imidlertid en større tendens til grad 3 eller 4 hypertension, proteinuri, nedsat appetit og dehydrering.
However, in DTC, patients of age ≥75 years were more likely to experience Grade 3 or 4 hypertension, proteinuria, decreased appetite, and dehydration.
Alvorlige tumorrelaterede blødninger, herunder blødning med dødelig udgang, er forekommet i kliniske studier og er blevet rapporteret efter markedsføring (se pkt.
Serious tumour related bleeds, including fatal haemorrhagic events have occurred in clinical trials and have been reported in post-marketing experience (see section 4.8, Description of selected adverse reactions).
I everolimus-gruppen blev der rapporteret arteriel tromboemboli hos 6,0 % af patienterne (4,0 % var grad ≥ 3).
In the everolimus group, 6.0% of patients reported an arterial thromboembolism (4.0% were Grade ≥ 3).
Blandt 1.166 patienter behandlet med lenvatinib var der 4 tilfælde (0,3 %) af PRES (alle var grad 3 eller 4), som alle fortog sig efter behandling og/eller doseringsafbrydelse eller permanent seponering.
Amongst 1,166 patients treated with lenvatinib, there were 4 cases (0.3%) of PRES (0.3% were Grade 3 or 4), all of which resolved after treatment and/or dose interruption, or permanent discontinuation.
• Den anbefalede daglige dosis af Kisplyx er 18 mg én gang dagligt (en 10 mg kapsel og to 4 mg kapsler) sammen med en 5 mg tablet everolimus én gang dagligt.
• The recommended daily dose of Kisplyx is 18 mg once a day (one 10 mg capsule and two 4 mg capsules) in combination with one 5 mg tablet of everolimus once a day.
De fleste tilfælde blev bedre eller fortog sig efter doseringsafbrydelse eller dosisreduktion, hos hhv. 13,0 % og 13,4 % af patienterne.
The majority of cases recovered or resolved following dose interruption or reduction, which occurred in 13.0% and 13.4% of patients, respectively.
Rygsmerter Artralgi Myalgi Ekstremitetssmerter Muskuloskeletale smerter
Back pain Arthralgia Myalgia Pain in extremity Musculoskeletal pain
Hos patienter med en normal TSH ved baseline blev der observeret forhøjet TSH efter baseline hos 60,5 % af patienterne i lenvatinib plus everolimus-gruppen sammenlignet med ingen i everolimus-gruppen.
In patients with a normal TSH at baseline, an elevation of TSH level was observed post baseline in 60.5% of lenvatinib plus everolimus-treated patients as compared with none in patients receiving everolimus alone.
Reaktioner af grad 3 eller derover (herunder 1 grad 4 reaktion) forekom hos 44,4 % af patienterne i lenvatinib-gruppen sammenlignet med 3,8 % i placebogruppen.
Reactions of Grade 3 or higher (including 1 reaction of Grade 4) occurred in 44.4% of lenvatinib-treated patients compared with 3.8% of placebo-treated patients.
Resultater for ORR var i overensstemmelse med investigatorernes bedømmelser, 35,3 % i lenvatinib plus everolimus-armen med et fuldstændigt respons og 17 med delvist respons.
Results for ORR were consistent with that of the investigators' assessments, 35.3% in the lenvatinib plus everolimus arm, with one complete response and 17 partial responses; no subject had an objective response in the everolimus arm (P < 0.0001) in favour of the lenvatinib plus everolimus arm.
For toksiciteter, der menes at være forbundet med lenvatinib (se tabel 1), kan behandlingen genoptages med en reduceret dosis lenvatinib, som foreslået i tabel 2, når bivirkningen har fortaget sig eller er bedret til grad 0-1 eller baseline-niveau.
For toxicities thought to be related to lenvatinib (see Table 1), upon resolution/improvement of an adverse reaction to Grade 0-1 or baseline, treatment should be resumed at a reduced dose of lenvatinib as suggested in Table 2.
Reaktioner, der opstod med en forekomst på ≥ 0,75 % over placebo, var: epistaxis (11,9 %), hæmaturi (6,5 %), kontusion (4,6 %), gingivalblødning (2,3 %), hæmatokeksi (2,3 %), rektalblødning (1,5 %), hæmatom (1,1 %), blødende hæmorroider (1,1 %), laryngeal blødning (1,1 %), petekkier (1,1 %) og intrakranial tumorblødning (0,8 %).
Reactions that occurred at an incidence of ≥0.75% above placebo were: epistaxis (11.9%), haematuria (6.5%), contusion (4.6%), gingival bleeding (2.3%), haematochezia (2.3%), rectal haemorrhage (1.5%), haematoma (1.1%), haemorrhoidal haemorrhage (1.1%), laryngeal haemorrhage (1.1%), petechiae (1.1%), and intracranial tumour haemorrhage (0.8%).
Der er begrænsede data for patienter med legemsvægt under 60 kg med RCC (se også pkt.
Limited data are available on patients with a body weight below 60 kg with RCC (see also section 4.8, Other special populations).
De observerede bivirkninger i kliniske studier med RCC og DTC var sammenlignelige.
Tabulated list of adverse reactions for RCC and DTC studies Similar adverse reactions were observed in clinical trials in RCC and DTC.
PRES (også kaldet RPLS) er blevet rapporteret hos patienter i behandling med lenvatinib (< 1 %, se pkt.
PRES, also known as RPLS, has been reported in patients treated with lenvatinib (<1%; see section 4.8, Description of selected adverse reactions).
Lenvatinib hæmmede ikke aldehydoxidase-aktiviteten i human lever-cytosol.
In human liver cytosol, lenvatinib did not inhibit aldehyde oxidase activity.
Seponer lenvatinib og påbegynd passende behandling.
Discontinue lenvatinib and institute appropriate medical management.
Patienter med RCC og nedsat nyrefunktion ved baseline havde en højere forekomst af grad 3 træthed.
In RCC, patients with baseline renal impairment had a higher incidence of Grade 3 fatigue.
Hos patienter med DTC havde kvinder en højere forekomst af hypertension (herunder grad 3 eller 4 hypertension), proteinuri og palmoplantar erytrodysæstesisyndrom (PPE), og mænd havde en højere forekomst af nedsat uddrivningsfraktion samt gastrointestinal perforation og fisteldannelse.
In patients with DTC, females had a higher incidence of hypertension (including Grade 3 or 4 hypertension), proteinuria, and PPE, while males had a higher incidence of decreased ejection fraction and gastrointestinal perforation and fistula formation.
Fistel uden for mave-tarm-kanalen omfatter tilfælde af fistler uden for mave og tarme, såsom trakeal, trakeoøsofageal, øsofageal fistel samt fistel i de kvindelige kønsorganer og kutan fistel.
Non-gastrointestinal fistula includes cases of fistula occurring outside of the stomach and intestines such as tracheal, tracheo-oesophageal, oesophageal, female genital tract fistula, and cutaneous fistula.
Gastrointestinal perforation og fisteldannelse (se pkt.
Gastrointestinal perforation and fistula formation (see section 4.4)
I DTC-studiet (se produktresuméet for Lenvima) havde 88 % af alle patienter et baseline-niveau af TSH ≤ 0,5 mE/l.
In the DTC study (see Lenvima SmPC), 88% of all patients had a baseline TSH level less than or equal to 0.5 mU/L.
I DTC-studiet blev hændelser med gastrointestinal perforation eller fisteldannelse rapporteret hos 1,9 % af patienterne i lenvatinib-gruppen og hos 0,8 % i placebogruppen.
In the DTC study, events of gastrointestinal perforation or fistula were reported in 1.9% of lenvatinib-treated patients and 0.8% of patients in the placebo group.
Hver karton indeholder 30, 60 eller 90 hårde kapsler.
Each carton contains 30, 60, or 90hard capsules.Not all pack sizes may be marketed.
Det endokrine system Hypotyroidisme** Forhøjet niveau af thyreoideastimulere nde hormon i blodet‡**
Hypothyroidism** Blood thyroid stimulating hormone increased‡**
I DTC-studiet (se produktresuméet for Lenvima) var de hyppigst rapporterede leverrelaterede bivirkninger hypoalbuminæmi (9,6 % lenvatinib versus 1,5 % placebo) og forhøjede leverenzymer, herunder forhøjet alanin-aminotransferase (7,7 % lenvatinib versus 0 placebo), aspartataminotransferase (6,9 % lenvatinib versus 1,5 % placebo) og blod-bilirubin (1,9 % lenvatinib versus 0 placebo).
In the DTC study (see Lenvima SmPC), the most commonly reported liver-related adverse reactions were hypoalbuminaemia (9.6% lenvatinib vs. 1.5% placebo) and elevations of liver enzyme levels, including increases in alanine aminotransferase (7.7% lenvatinib vs. 0 placebo), aspartate aminotransferase (6.9% lenvatinib vs. 1.5% placebo), and blood bilirubin (1.9% lenvatinib vs. 0 placebo).
Bivirkningerne opstillet i dette afsnit er baseret på de kombinerede sikkerhedsdata fra 62 RCCpatienter (se pkt.
The adverse reactions presented in this section are based on the combined safety data of 62 RCC patients (see section 5.1) and 458 DTC patients (see Lenvima SmPC).
Hovedparten af tilfælden blev bedre eller fortog sig efter doseringsafbrydelse eller dosisreduktion, hos hhv. 16,9 % og 10,7 % af patienterne.
The majority of cases had an outcome of recovered or resolved following dose interruption or reduction, which occurred in 16.9% and 10.7% of patients, respectively.
Lenvatinib kan som andre stoffer i den samme klasse have negativ indvirkning på sårhelingsprocessen.
Lenvatinib may adversely affect the wound healing process as do other agents of the same class.
Efter du har drukket den, hælder du samme mængde vand eller æblejuice i glasset, hvirvler væsken rundt og drikker den.
After drinking, add the same amount of water or apple juice, swirl and swallow.
Hos patienter med svært nedsat nyrefunktion er den anbefalede startdosis 10 mg lenvatinib med 5 mg everolimus én gang dagligt.
In patients with severe renal impairment, the recommended starting dose is 10 mg of lenvatinib with 5 mg of everolimus taken once daily.
Der skal udvises forsigtighed hos patienter, der får lægemidler med virkning på renin-angiotension-aldosteron systemet, da der er en potentielt højere risiko for akut nyresvigt med denne kombinationsbehandling.Doseringsafbrydelse, dosisjustering eller seponering kan være nødvendig (se pkt.
Caution should be taken in patients receiving agents acting on the renin-angiotensin aldosterone system given a potentially higher risk for acute renal failure with the combination treatment.
Hos patienter lå medianen for det tilsyneladende fordelingsvolumen (Vz/F) for den første dosis i intervallet fra 50,5 l til 92 l, og det var generelt konsistent i dosisgrupper fra 3,2 mg til 32 mg. Analogt hermed var det mediane tilsyneladende fordelingsvolumen ved steady state (Vz/Fss) også generelt konsistent og i intervallet fra 43,2 l til 121 l.
In patients, the median apparent volume of distribution (Vz/F) of the first dose ranged from 50.5 L to 92 L and was generally consistent across the dose groups from 3.2 mg to 32 mg.
Tabel 2 Dosisjustering i forhold til den anbefalede daglige dosis lenvatiniba Dosisniveau
Table 2 Dose modifications from recommended lenvatinib daily dose a
Patienter med DTC og hypertension ved baseline havde en højere forekomst af grad 3 eller 4 hypertension, proteinuri, diarré og dehydrering og oplevede mere alvorlige tilfælde af dehydrering, hypotension, lungeemboli, malign pleuraeffusion, atrieflimmer og gastrointestinale symptomer (abdominalsmerter, diarré, opkastning).
In DTC, patients with baseline hypertension had a higher incidence of Grade 3 or 4 hypertension, proteinuria, diarrhoea, and dehydration, and experienced more serious cases of dehydration, hypotension, pulmonary embolism, malignant pleural effusion, atrial fibrillation, and GI symptoms (abdominal pain, diarrhoea, vomiting).
For at undgå gentagen eksponering for indholdet må omsorgspersoner ikke åbne kapslerne.
Caregivers should not open the capsule, in order to avoid repeated exposure to the contents of the capsule.
Leverrelaterede reaktioner af grad 3 eller derover (herunder 1 grad 5 tilfælde af leversvigt) forekom hos 5,4 % af patienterne i lenvatinib-gruppen sammenlignet med 0,8 % i placebogruppen.
Liver-related reactions of Grade 3 or higher (including 1 Grade 5 case of hepatic failure) occurred in 5.4% of lenvatinib-treated patients compared with 0.8% in placebo-treated patients.