natgillin/translations-raw huggingface dataset:
Hos patienter med svært (Child-Pugh C) nedsat leverfunktion er den anbefalede startdosis 10 mg lenvatinib én gang dagligt med den dosis af everolimus, der anbefales til patienter med svært nedsat leverfunktion i produktresuméet for everolimus.
In patients with severe (Child-Pugh C) hepatic impairment, the recommended starting dose of lenvatinib is 10 mg taken once daily in combination with the dose of everolimus recommended for patients with severe hepatic impairment in the everolimus SmPC.
De vigtigste alvorlige bivirkninger var nyresvigt og nedsat nyrefunktion (11,3 %), arteriel tromboemboli (3,9 %)*, hjertesvigt (1,6 %), cerebral blødning (1,6 %), intrakranial tumorblødning (0,7 %)*, PRES/RPLS (0,2 %)* og leversvigt (0,2 %)*.
The most important serious adverse reactions were renal failure and impairment (11.3%), arterial thromboembolisms (3.9%)*, cardiac failure (1.6%), cerebral haemorrhage (1.6%), intracranial tumour haemorrhage (0.7%)*, PRES / RPLS (0.2%)*, and hepatic failure (0.2%)* (the asterisked frequencies are from the DTC patient population).
Mediantiden til første forekomst hos patienter i lenvatinib-gruppen var 10,1 uger.
The median time to first onset in lenvatinib-treated patients was 10.1 weeks.
Mediantiden til start af leverrelaterede reaktioner i lenvatinib-gruppen var 12,1 uger.
The median time to onset of liver reactions in lenvatinib-treated patients was 12.1 weeks.
Patienter med DTC og nedsat leverfunktion ved baseline havde imidlertid en højere forekomst af hypertension og PPE og højere forekomst af grad 3 eller 4 hypertension, asteni, træthed og hypokalcæmi sammenlignet med patienter med normal leverfunktion.
However in DTC, patients with baseline hepatic impairment had a higher incidence of hypertension and PPE, and a higher incidence of Grade 3 or 4 hypertension, asthenia, fatigue, and hypocalcaemia compared with patients with normal hepatic function.
Gastrointestinal perforation eller fisteldannelse er blevet rapporteret hos patienter i behandling med lenvatinib (se pkt.
Gastrointestinal perforation or fistulae have been reported in patients treated with lenvatinib (see section 4.8).
På samme måde postuleres det, at virkningsmekanismen i forbindelse med proteinuri medieres via nedregulering af VEGFR1 og VEGFR2 i podocytterne i glomerulus, selvom det ikke er blevet undersøgt direkte.
Similarly, although not studied directly, the MOA for proteinuria is postulated to be mediated by downregulation of VEGFR1 and VEGFR2 in the podocytes of the glomerulus.
Forlængelse af QT/QTc-intervallet er blevet rapporteret med en højere forekomst hos patienter i behandling med lenvatinib end hos patienter i placebogruppen (se pkt.
QT/QTc interval prolongation has been reported at a higher incidence in patients treated with lenvatinib than in patients treated with placebo (see section 4.8, Description of selected adverse reactions).
Hvis proteinuri ≥ 2+ detekteres med urinstix, kan doseringsafbrydelse, dosisjustering eller seponering være nødvendig (se pkt.
If urine dipstick proteinuria ≥2+ is detected, dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
Sådan virker Kisplyx
How Kisplyx works
Patienter med DTC og nedsat nyrefunktion ved baseline havde en højere forekomst af grad 3 eller 4 hypertension, proteinuri, træthed, stomatitis, perifert ødem, trombocytopeni, dehydrering, QTforlængelse på elektrokardiogram, hypotyreoidisme, hyponatriæmi, forhøjet TSH i blodet og pneumoni sammenlignet med personer med normal nyrefunktion.
In DTC, patients with baseline renal impairment had a higher incidence of Grade 3 or 4 hypertension, proteinuria, fatigue, stomatitis, oedema peripheral, thrombocytopenia, dehydration, prolonged electrocardiogram QT, hypothyroidism, hyponatraemia, blood thyroid stimulating hormone increased, pneumonia compared with subjects with normal renal function.
I DTC-studiet (se produktresuméet for Lenvima) blev forlængelse af QT/QTc-intervallet rapporteret hos 8,8 % af patienterne i lenvatinib-gruppen og hos 1,5 % i placebogruppen.
In the DTC study (see Lenvima SmPC), QT/QTc interval prolongation was reported in 8.8% of lenvatinibtreated patients and 1.5% of patients in the placebo group.
I everolimus-gruppen udviklede 2,0 % af patienterne nyresvigt (2,0 % var grad 3).
In the everolimus monotherapy group 2.0% of patients developed renal failure (2.0% were Grade 3).
Arteriel tromboemboli (apopleksi, transitorisk cerebral iskæmi og myokardieinfarkt) er blevet rapporteret hos patienter i behandling med lenvatinib (se pkt.
Arterial thromboembolisms (cerebrovascular accident, transient ischaemic attack, and myocardial infarction) have been reported in patients treated with lenvatinib (see section 4.8, Description of selected adverse reactions).
Der er begrænsede data for asiatiske patienter med RCC. Asiatiske patienter med DTC havde imidlertid en højere forekomst end kaukasiske patienter af perifert ødem, hypertension, træthed, PPE, proteinuri, trombocytopeni og forhøjet TSH i blodet.
However, in DTC Asian patients had a higher incidence than Caucasian patients of peripheral oedema, hypertension, fatigue, PPE, proteinuria, thrombocytopenia, and blood thyroid stimulating hormone increased.
10 mg oralt én gang dagligt
10 mg orally once daily One 10 mg capsule
Der foreligger kun begrænsede data for doser under 8 mg.
8 mg orally once daily Two 4 mg capsules a Limited data are available for doses below 8 mg
LÆGEMIDLETS NAVN Kisplyx 4 mg hårde kapsler Kisplyx 10 mg hårde kapsler
NAME OF THE MEDICINAL PRODUCT Kisplyx 4 mg hard capsules Kisplyx 10 mg hard capsules
I lyset af den reducerede tolerabilitet af lenvatinib hos asiatiske og ældre patienter bør lenvatinib anvendes med forsigtighed hos sådanne patienter (se pkt.
Lenvatinib should be used with caution in such patients, given the reduced tolerability of lenvatinib in Asian and elderly patients (see section 4.8, Other special populations).
Arteriel tromboemboli
Arterial thromboembolisms
5.1) var de hyppigst rapporterede leverrelaterede bivirkninger i lenvatinib plus everolimus-gruppen forhøjede leverenzymer, herunder forhøjet alanin-aminotransferase (9,7 %), aspartat-aminotransferase (4,8 %), basisk fosfatase (4,8 %) og blod-bilirubin (3,2 %).
In the RCC study (see section 5.1), the most commonly reported liver-related adverse reactions in the lenvatinib plus everolimus-treated group were elevations of liver enzyme levels, including increases in alanine aminotransferase (9.7%), aspartate aminotransferase (4.8%), alkaline phosphatase (4.8%), and blood bilirubin (3.2%).
Grad 3 leverrelaterede reaktioner forekom hos 3,2 % af patienterne i lenvatinib plus everolimus-gruppen.
Grade 3 liver-related reactions occurred in 3.2% of lenvatinib plus everolimus-treated patients.
Progressionsfri overlevelse (PFS)a efter investigators bedømmelse Median PFS i måneder (95 %
Progression-free survival (PFS)a by Investigator Assessment
Lenvatinib er en receptortyrosinkinase (RTK)-hæmmer, der selektivt hæmmer kinaseaktiviteten af vaskulær endotel-vækstfaktor (VEGF)-receptorerne VEGFR1 (FLT1), VEGFR2 (KDR) og VEGFR3 (FLT4) foruden andre proangiogene og onkogene reaktionsvejsrelaterede RTK'er, herunder fibroblastvækstfaktor (FGF)-receptorerne FGFR1, 2, 3 og 4, trombocytderiveret vækstfaktor (PDGF)receptor PDGFRα, KIT og RET. Kombinationen med lenvatinib og everolimus viste en øget antiangiogen og antitumor-aktivitet, vist ved reduceret human endotelcelleproliferation, rørdannelse og VEGF-signalering in vitro og et tumorvolumen hos muse-xenograftmodeller af human nyrecellecancer, der var større end for hvert af de enkelte lægemidler.
Lenvatinib is a receptor tyrosine kinase (RTK) inhibitor that selectively inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4), in addition to other proangiogenic and oncogenic pathway-related RTKs including fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4, the platelet derived growth factor (PDGF) receptor PDGFRα, KIT, and RET.
Alle patienter var tidligere blevet behandlet med 1 VEGF-hæmmer, 65 % med sunitinib, 23 % med pazopanib, 4 % med tivozanib, 3 % med bevacizumab og 2 % hver med sorafenib eller axitinib.
The median time from diagnosis to first dose was 32 months in the lenvatinib plus everolimus-treatment arm, 33 months in the lenvatinib arm and 26 months in the everolimus arm. All patients had been treated with 1 prior VEGF-inhibitor; 65% with sunitinib, 23% with pazopanib, 4% with tivozanib, 3% with bevacizumab, and 2% each with sorafenib or axitinib.
Patienter med RCC og hypertension ved baseline havde en højere forekomst af grad 3 eller 4 dehydrering, træthed og hypertension.
In RCC, patients with baseline hypertension had a higher incidence of Grade 3 or 4 dehydration, fatigue, and hypertension.
I DTC-studiet (se produktresuméet for Lenvima) udviklede 5,0 % af patienterne nyresvigt, og 1,9 % udviklede nedsat nyrefunktion (3,1 % af patienterne havde grad ≥ 3 nyresvigt eller nedsat nyrefunktion).
In the DTC study (see Lenvima SmPC), 5.0% of patients developed renal failure and 1.9% developed renal impairment, (3.1% of patients had a Grade ≥ 3 event of renal failure or impairment).
I DTC-studiet (se produktresuméet for Lenvima) blev diarré rapporteret hos 67,4 % af patienterne i lenvatinib-gruppen (9,2 % var grad ≥ 3) og hos 16,8 % i placebogruppen (ingen var grad ≥ 3).
In the DTC study (see Lenvima SmPC), diarrhoea was reported in 67.4% of patients in the lenvatinib-treated group (9.2% were Grade ≥ 3) and in 16.8% of patients in the placebo group (none were Grade ≥ 3).
Kardial dysfunktion (< 1 %) og nedsat venstre ventrikel uddrivningsfraktion er blevet rapporteret hos patienter i behandling med lenvatinib (se pkt.
Cardiac failure (<1%) and decreased left ventricular ejection fraction have been reported in patients treated with lenvatinib (see section 4.8, Description of selected adverse reactions).
Patienter med RCC og diabetes ved baseline havde en højere forekomst af grad 3 eller 4 hypertension, hypertriglyceridæmi og akut nyresvigt.
In RCC, patients with baseline diabetes had a higher incidence of Grade 3 or 4 hypertension, hypertriglyceridemia and acute renal failure.
Reaktioner af sværhedsgrad 3 eller 4 forekom hos 5,0 % af patienterne i lenvatinib-gruppen.
Reactions of Grade 3 or 4 severity occurred in 5.0% of lenvatinib-treated vs 0 placebo-treated patients.
Mediantiden til start i lenvatinibgruppen var 16 dage.
The median time to onset in lenvatinib-treated patients was 16 days.
• oppustethed eller luft i tarmen
• feeling bloated or having gas in the bowel
Hazard ratio (95 % CI)b lenvatinib + everolimus vs everolimus
Median PFS in months (95% CI) Hazard Ratio (95% CI)b lenvatinib + everolimus vs everolimus
Mediantiden til første start i lenvatinibgruppen var 11,1 uger.
The median time to first onset in lenvatinib-treated patients was 11.1 weeks.
En MSKCC- (Memorial Sloan Kettering Cancer Center) risiko for dårlig prognose blev observeret hos 39 % af patienterne i lenvatinib plus everolimus-armen, hos 44 % i lenvatinib-armen og hos 38 % i everolimus-armen.
Memorial Sloan Kettering Cancer Centre (MSKCC) poor risk was observed in 39% of patients in the lenvatinib plus everolimus arm, 44% in the lenvatinib arm and 38% in the everolimus arm. International mRCC Database Consortium (IMDC) poor risk was observed in 20% of patients in the lenvatinib plus everolimus arm, 23% in the lenvatinib arm, and 24% in the everolimus arm.
Hæmning af suppression af thyreoideastimulerende hormon/thyreoideadysfunktion Der er blevet rapporteret hypotyreoidisme hos patienter i behandling med lenvatinib (se pkt.
Impairment of thyroid stimulating hormone suppression / Thyroid dysfunction Hypothyroidism has been reported in patients treated with lenvatinib (see section 4.8, Description of selected adverse reactions).
I DTC-studiet (se produktresuméet for Lenvima) blev arteriel tromboemboli rapporteret hos 5,4 % af patienterne i lenvatinib-gruppen og hos 2,3 % i placebogruppen.
In the DTC study (see Lenvima SmPC), arterial thromboembolic events were reported in 5.4% of lenvatinib-treated patients and 2.3% of patients in the placebo group.
I DTC-studiet (se produktresuméet for Lenvima) blev blødning rapporteret hos 34,9 % (1,9 % var grad ≥ 3) af patienterne i lenvatinib-gruppen versus 18,3 % (3,1 % var grad ≥ 3) i placebogruppen.
In the DTC study (see Lenvima SmPC), haemorrhage was reported in 34.9% (1.9% were Grade ≥ 3) of lenvatinib-treated patients versus 18.3% (3.1% were Grade ≥ 3) of placebo-treated patients.
5.1) blev hypertension rapporteret hos 41,9 % af patienterne i lenvatinib plus everolimus-gruppen (forekomsten af grad 3 eller grad 4 hypertension var 12,9 %) og hos 10,0 % i everolimus-gruppen (forekomsten af grad 3 eller grad 4 hypertension var 2,0 %).
In the RCC study (see section 5.1), hypertension was reported in 41.9% of patients in the lenvatinib plus everolimus-treated group (the incidence of Grade 3 or Grade 4 hypertension was 12.9%) and 10.0% of patients in the everolimus-treated group (the incidence of Grade 3 or Grade 4 hypertension was 2.0%).
5.1) medførte bivirkninger dosisreduktion hos 67,7 % af patienterne og seponering hos 18 (29,0 %).
In the RCC study (see section 5.1), adverse reactions led to dose reductions in 67.7% of patients and 18 (29.0%) patients discontinued the treatment.
Elektrolytforstyrrelser, såsom hypokaliæmi, hypokalcæmi eller hypomagnesiæmi, øger risikoen for QT-forlængelse.
Electrolyte disturbances such as hypokalaemia, hypocalcaemia, or hypomagnesaemia increase the risk of QT prolongation; therefore electrolyte abnormalities should be monitored and corrected in all patients before starting treatment.
I DTC-studiet (se produktresuméet for Lenvima) blev proteinuri rapporteret hos 33,7 % af patienterne i lenvatinib-gruppen og hos 3,1 % i placebogruppen.
In the DTC study (see Lenvima SmPC), proteinuria was reported in 33.7% of lenvatinib-treated patients and 3.1% of patients in the placebo-treated group.
Kolecystitis
Cholecystitis
Kisplyx 10 mg hårde kapsler
Kisplyx 10 mg hard capsules
I DTC-studiet (se produktresuméet for Lenvima) blev der rapporteret nedsat uddrivningsfraktion/hjertesvigt hos 6,5 % af patienterne (1,5 % var grad ≥ 3) i lenvatinib-gruppen og hos 2,3 % i placebogruppen (ingen var grad ≥ 3).
In the DTC study (see Lenvima SmPC), decreased ejection fraction/cardiac failure was reported in 6.5% of patients (1.5% were Grade ≥ 3) in the lenvatinib treated group, and 2.3% in the placebo group (none were Grade ≥ 3).
Hos patienter med symptomer på PRES kan doseringsafbrydelse, dosisjustering eller seponering være nødvendig (se pkt.
In patients with signs or symptoms of PRES, dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
Kisplyx 4 mg hårde kapsler Kisplyx 10 mg hårde kapsler lenvatinib
Kisplyx 4 mg hard capsules Kisplyx 10 mg hard capsules lenvatinib
Kisplyx 4 mg hårde kapsler
Kisplyx 4 mg hard capsules
Mediantiden til første symptomer på hypokalcæmi var 28,3 uger (alle grader) og 45,9 uger (grad ≥ 3) i lenvatinib plus everolimus-gruppen.
The median time to onset of hypocalcaemia was 28.3 weeks (any grade) and 45.9 weeks (Grade ≥ 3) in the lenvatinib plus everolimus-treated group.
Lenvatinib hæmmer eksogen thyreoideasuppression (se pkt.
Lenvatinib impairs exogenous thyroid suppression (see section 4.8, Description of selected adverse reactions).
I tilfælde af gastrointestinal perforation eller fisteldannelse kan doseringsafbrydelse, dosisjustering eller seponering være nødvendig (se pkt.
In the case of a gastrointestinal perforation or fistula, dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
De fleste reaktioner fortog sig efter understøttende behandling uden doseringsafbrydelse eller dosisreduktion, hvilket forekom hos hhv. 1,5 % og 1,1 % af patienterne.
Most reactions resolved following supportive treatment, without dose interruption or reduction, which occurred in 1.5% and 1.1% of patients, respectively; 1 patient with Grade 4 hypocalcaemia discontinued treatment permanently.
Kisplyx 10 mg hårde kapsler: - Hver hård kapsel indeholder 10 mg lenvatinib (som mesilat).
Kisplyx 10 mg hard capsules: - Each hard capsule contains 10 mg of lenvatinib (as mesylate).
Der er begrænsede data for patienter med nedsat leverfunktion og RCC.
There are limited data on patients with hepatic impairment in RCC.
Hver hård kapsel indeholder 10 mg lenvatinib (som mesilat).
Each hard capsule contains 10 mg of lenvatinib (as mesylate).
Nyrer og urinveje
nausea and vomiting
Blodtryksniveau
Blood pressure (BP) level
Kisplyx 10 mg
INFORMATION IN BRAILLE Kisplyx 10 mg
Kisplyx 4 mg hårde kapsler: - Hver hård kapsel indeholder 4 mg lenvatinib (som mesilat).
Kisplyx 4 mg hard capsules: - Each hard capsule contains 4 mg of lenvatinib (as mesylate).
Forhøjet basisk fosfatase i blodet Unormal leverfunktion Forhøjet gammaglutamyltransferasek
Blood alkaline phosphatase increased Hepatic function abnormal Gamma-glutamyltransferase increasedk Blood bilirubin increased‡
Behandling af bivirkninger kan kræve doseringsafbrydelse, dosisjustering eller seponering af kombinationsbehandlingen (se pkt.
Management of adverse reactions may require dose interruption, adjustment, or discontinuation of the combination therapy (see section 4.4).
Diarré er blevet hyppigt rapporteret hos patienter i behandling med lenvatinib og opstår normalt tidligt i behandlingsforløbet (se pkt.
Diarrhoea has been reported frequently in patients treated with lenvatinib, usually occurring early in the course of treatment (see section 4.8, Description of selected adverse reactions).
Træthed Asteni Perifert ødem
Fatigue Asthenia Oedema peripheral
Mediantiden til fremkomst af nedsat uddrivningsfraktion eller hjertesvigt var 15,7 uger (alle grader) og 32,8 uger (grad ≥ 3) i lenvatinib plus everolimus-gruppen.
The median time to onset of decreased ejection fraction and cardiac failure was 15.7 weeks (any grade) and 32.8 weeks (Grade ≥ 3) in the lenvatinib plus everolimus-treated group.
I tilfælde af hepatotoksicitet kan doseringsafbrydelse, dosisjustering eller seponering være nødvendig (se pkt.
In the case of hepatotoxicity, dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
LÆGEMIDLETS NAVN Kisplyx 4 mg hårde kapsler lenvatinib ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 4 mg lenvatinib (som mesilat).
NAME OF THE MEDICINAL PRODUCT Kisplyx 4 mg hard capsules lenvatinib STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 4 mg lenvatinib (as mesilate).
Tabel 1 Bivirkninger, hvor justering af lenvatinibdosis er nødvendig Bivirkning
Adverse reactions requiring dose modification of lenvatinib
For at undgå forværring bør lenvatinibbehandling ikke påbegyndes hos patienter med fistel, og lenvatinib bør seponeres permanent hos patienter med øsofageal eller trakeobronkial involvering og ved enhver grad 4 fistel (se pkt.
Lenvatinib should not be started in patients with fistulae to avoid worsening and lenvatinib should be permanently discontinued in patients with oesophageal or tracheobronchial tract involvement and any Grade 4 fistula (see section 4.2); limited information is available on the use of dose interruption or reduction in management of other events, but worsening was observed in some cases and caution should be taken.
Blod og lymfesystem Trombocytopenia
Blood and lymphatic disorders
Mediantiden til start var 4,9 uger (alle grader) og 6,9 uger (grad ≥3) i lenvatinib plus everolimus-gruppen.
The median time to onset was 4.9 weeks (any grade) and 6.9 weeks (Grade ≥ 3) in the lenvatinib plus everolimus-treated group.
5.1) blev der rapporteret forlængelse af QTc-intervallet på over 60 ms hos 11 % af patienterne i lenvatinib plus everolimus-gruppen.
In the RCC study (see section 5.1), QTc interval increases greater than 60 ms were reported in 11% of patients in the lenvatinib plus everolimus-treated group.
Mediantiden til forekomst var 4,1 uger (alle grader) og 8,1 uger (grad ≥ 3) i lenvatinib plus everolimus-gruppen.
The median time to onset was 4.1 weeks (any grade) and 8.1 weeks (Grade ≥ 3) in the lenvatinib plus everolimus-treated group.
5.1) udviklede 8,1 % af patienterne i lenvatinib plus everolimus-gruppen nyresvigt, og 3,2 % udviklede nedsat nyrefunktion (9,7 % af patienterne havde grad 3 nyresvigt eller nedsat nyrefunktion).
In the RCC study (see section 5.1), 8.1% of patients in the lenvatinib plus everolimus treated group developed renal failure and 3.2% developed renal impairment, (9.7% of patients had a Grade 3 event of renal failure or impairment).
• smerter i led eller muskler
• joint or muscle pain
5.1) forekom hypotyreoidisme hos 24 % af patienterne i lenvatinib plus everolimus-gruppen og hos 2 % i everolimus-gruppen.
In the RCC study (see section 5.1), hypothyroidism occurred in 24% of patients in the lenvatinib plus everolimus-treated group and 2% of patients in the everolimus-treated group.
Mediantiden til første symptom var 10,2 uger (alle grader) og 7,6 uger (grad ≥ 3) i lenvatinib plus everolimusgruppen.
The median time to first onset of was 10.2 weeks (any grade) and 7.6 weeks (Grade ≥ 3) in the lenvatinib plus everolimus-treated group.
• Hvis du har alvorlige problemer med leveren eller nyrerne, er den anbefalede dosis Kisplyx 10 mg én gang dagligt (en 10 mg kapsel) sammen med en 5 mg tablet everolimus én gang dagligt.
• If you have severe liver or kidney problems the recommended dose of Kisplyx is 10 mg once a day
• Kisplyx 10 mg hård kapsel: gul underdel og en gullig-rød hætte, ca. 14,3 mm lang med ”Є” præget med sort blæk på hætten og ”LENV 10 mg” på underdelen.
• Kisplyx 10 mg hard capsule: yellow body and yellowish red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 10 mg” on the body.
LÆGEMIDLETS NAVN Kisplyx10 mg hårde kapsler lenvatinib ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 10 mg lenvatinib (som mesilat).
NAME OF THE MEDICINAL PRODUCT Kisplyx 10 mg hard capsules lenvatinib STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 10 mg lenvatinib (as mesyilate).
I DTC-studiet (se produktresuméet for Lenvima) blev hypokalcæmi rapporteret hos 12,6 % af patienterne i lenvatinib-gruppen og hos 0 % i placebogruppen.
In the DTC study (see Lenvima SmPC), hypocalcaemia was reported in 12.6% of lenvatinib-treated patients vs. no cases in the placebo arm.
• Kisplyx 4 mg hård kapsel: gullig-rød underdel og en gullig-rød hætte, ca. 14,3 mm lang med ”Є” præget med sort blæk på hætten og ”LENV 4 mg” på underdelen.
• Kisplyx 4 mg hard capsule: yellowish red body and yellowish red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 4 mg” on the body.
Nedsat nyrefunktion
Nongastrointestinal fistulak
Vægttab
Malaise
Derfor anbefales lenvatinib ikke til disse patienter.
Patients with end-stage renal disease were not studied, therefore the use of lenvatinib in these patients is not recommended.
Mediantiden til start af proteinuri var 6,1 uger (alle grader) og 20,1 uger (grad ≥ 3) i lenvatinib plus everolimus-gruppen.
The median time to onset of proteinuria was 6.1 weeks (any grade) and 20.1 weeks (Grade ≥ 3) in the lenvatinib plus everolimus-treated group.
Mediantiden til start af leverrelaterede reaktioner var 6,7 uger (alle grader) og 14,2 uger (grad ≥ 3) i lenvatinib plus everolimus-gruppen.
The median time to onset of liver events was 6.7 weeks (any grade) and 14.2 weeks (Grade ≥ 3) in the lenvatinib plus everolimus-treated group.
Hjertesvigt QT-forlængelse i ekg Nedsat uddrivningsfraktion
Cardiac failure Electrocardiogram QT prolonged Ejection fraction decreased
Én 10 mg kapsel plus to 4 mg kapsler
14 mg orally once daily One 10 mg capsule plus one 4 mg capsule
Kardial dysfunktion (se pkt.
Cardiac dysfunction (see section 4.4)
Palmoplantar erytrodysæstesisynd rom Erytem i håndfladen Udslæt Alopeci
Palmar-plantar erythrodysaesthesia syndrome Palmar erythema Rash Alopecia
5.1) blev blødning rapporteret hos 38,7 % (8,1 % var grad ≥ 3) af patienterne i lenvatinib plus everolimus-gruppen.
In the RCC study (see section 5.1), haemorrhage was reported in 38.7% (8.1% were Grade ≥ 3) of patients in the lenvatinib plus everolimus-treated group.