natgillin/translations-raw huggingface dataset:
5.1) blev hypertension (herunder hypertension, hypertensiv krise, forhøjet diastolisk blodtryk og forhøjet blodtryk) rapporteret hos 72,8 % af de lenvatinibbehandlede patienter og hos 16,0 % af patienterne i gruppen, der fik placebo.
In the pivotal Phase 3 SELECT trial (see section 5.1), hypertension (including hypertension, hypertensive crisis, increased diastolic blood pressure , and increased blood pressure) was reported in 72.8% of lenvatinib-treated patients and 16.0% of patients in the placebo-treated group.
• hovedpine og rygsmerter
• headache and back pain
PRES, kaldes også 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).
Prægeblækket indeholder: shellac, sort jernoxid (172), kaliumhydroxid, propylenglycol.
The printing ink contains shellac, black iron oxide (E172), potassium hydroxide, propylene glycol.
Den mediane tid til start hos lenvatinibbehandlede patienter var 16 dage.
The median time to onset in lenvatinib-treated patients was 16 days.
• tidligere har haft hjerteproblemer eller slagtilfælde
• have a history of heart problems or stroke
5.1) blev hypocalcæmi rapporteret hos 1,1 % af patienterne, hvor grad 3 reaktioner forekom hos 0,4 %.
In the Phase 3 REFLECT trial (see section 5.1), hypocalcaemia was reported in 1.1% of patients, with grade 3 reactions occurring in 0.4%.
Behandling af visse bivirkninger kan kræve dosisafbrydelse, justering eller seponering af lenvatinibbehandlingen.
Management of some adverse reactions may require dose interruption, adjustment, or discontinuation of lenvatinib therapy.
Trombocytopeni omfatter trombocytopeni og et nedsat antal trombocytter.
Thrombocytopenia includes thrombocytopenia and decreased platelet count.
Patienter, som har fået 1 tidligere VEGF/VEGFR-målrettet behandling (%) Antal progressioner eller dødsfald Median PFS i måneder (95 % CI)
Patients who had received 1 prior VEGF/VEGFR-targeted therapy (%) Number of progressions or deaths Median PFS in months (95% CI)
Asiatiske patienter havde en større forekomst end kaukasiske patienter af perifert ødem, hypertension, træthed, PPE, proteinuri, trombocytopeni og forhøjet niveau af tyreoideastimulerende hormon i blodet.
Asian patients had a higher incidence than Caucasian patients of peripheral oedema, hypertension, fatigue, PPE, proteinuria, thrombocytopenia, and increased blood thyroid stimulating hormone.
Tabel 5 Bivirkninger rapporteret hos patienter i behandling med lenvatinib Systemorganklasse (MedDRAterminologi*)
Table 5 Adverse reactions reported in patients treated with lenvatinib System Organ
Det anbefales at overvåge den overordnede sikkerhed hos patienter med let til moderat nedsat leversfunktion nøje (se også pkt.
Close monitoring of the overall safety is recommended in patients with mild or moderate hepatic impairment (see also sections 4.2 and 5.2).
Dosisjustering er ikke nødvendig på basis af nyrefunktion hos patienter med let eller moderat nedsat nyrefunktion.
No dose adjustments are required on the basis of renal function in patients with mild or moderate renal impairment.
5.1) havde 89,6 % af patienterne et baseline niveau af TSH, der var under den øvre grænse for det normale.
In the Phase 3 REFLECT trial (see section 5.1), 89.6% of patients had a baseline TSH level of less than the upper limit of normal.
5.1) blev forlængelse af QT/QTc-intervallet rapporteret hos 6,9 % af de lenvatinib-behandlede patienter.
In the Phase 3 REFLECT trial (see section 5.1), QT/QTc interval prolongation was reported in 6.9% of lenvatinib-treated patients.
På tværs af kliniske studier, i hvilke 1.327 patienter fik lenvatinib som monoterapi til andre indikationer end HCC, blev blødning af grad 3 eller derover rapporteret hos 2 % af patienterne, 3 patienter (0,32 %) havde en grad 4 blødning, og 8 patienter (0,4 %) havde en grad 5 reaktion, herunder arteriel blødning, hjerneblødning, intrakanial blødning, intrakranial tumorblødning, hæmatemese, melæna, hæmoptyse og tumorblødning.
Across clinical studies in which 1,327 patients received lenvatinib monotherapy in indications other than HCC, Grade ≥ 3 or greater haemorrhage was reported in 2% of patients, 3 patients (0.2%) had a Grade 4 haemorrhage and 8 patients (0.6%) had a Grade 5 reaction including arterial haemorrhage, haemorrhagic stroke, intracranial haemorrhage, intracranial tumour haemorrhage, haematemesis, melaena, haemoptysis and tumour haemorrhage.
Bivirkninger, der mest almindeligt førte til dosisreduktioner (hos ≥ 5 % af patienterne), var hypertension, proteinuri, diarré, træthed, PPE, vægttab og nedsat appetit.
Adverse reactions that most commonly led to dose reductions (in ≥5% of patients) were hypertension, proteinuria, diarrhoea, fatigue, PPE, decreased weight, and decreased appetite.
Patienter med hypertension ved baseline havde en større forekomst af grad 3 eller 4 hypertension, proteinuri, diarré og dehydrering og oplevede mere alvorlige tilfælde af dehydrering, hypotension, lungeemboli, malign pleuraeffusion, atrieflimmer og mave-tarm-symptomer (abdominalsmerter, diarré, opkastning).
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).
≥60 kg kropsvægt 12 mg (tre 4 mg kapsler oralt en gang dagligt)
≥60 kg BW 12 mg (three 4 mg capsules orally once daily)
Arteriel tromboemboli (cerebrovaskulært anfald, transitorisk iskæmisk anfald 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).
Asiatiske patienter havde en højere forekomst end kaukasiske patienter af proteinuri, nedsat neutrocyttal, nedsat trombocyttal, nedsat antal hvide blodlegemer og PPE syndrom, mens kaukasiske patienter havde en højere forekomst af træthed, hepatisk encefalopati, akut nyreskade, angst, asteni, kvalme, trombocytopeni, og opkastning.
Asian patients had a higher incidence than Caucasian patients of proteinuria, decreased neutrophil count, decreased platelet count, decreased white blood count and PPE syndrome, while Caucasian patients had a higher incidence of fatigue, hepatic encephalopathy, acute kidney injury, anxiety, asthenia, nausea, thrombocytopenia and vomiting.
Patienter med nedsat nyrefunktion ved baseline havde en højere forekomst af træthed, hypotyreoidisme, dehydrering, diarré, nedsat appetit, proteinuri og hepatisk encefalopati.
Patients with baseline renal impairment had a higher incidence of fatigue, hypothyroidism, dehydration, diarrhoea, decreased appetite, proteinuria and hepatic encephalopathy.
5.1) blev der rapporteret hjertedysfunktion (inklusive kongestivt hjertesvigt, kardiogent shock og hjerte-lunge-svigt) hos 0,6 % af patienterne (0,4 % var grad ≥ 3) i den lenvatinib-behandlede gruppe.
In the Phase 3 REFLECT trial (see section 5.1), cardiac dysfunction (including congestive cardiac failure, cardiogenic shock, and cardiopulmonary failure) was reported in 0.6% of patients (0.4% were Grade ≥ 3) in the lenvatinib-treated group.
Nedsat nyrefunktion Forhøjet niveau af kreatinin i blodet Forhøjet niveau af urinstof i blodet
Renal impairment Increased blood creatinine Increased blood urea
5.1) blev proteinuri rapporteret hos 26,3 % af lenvatinibbehandlede patienter og grad 3 reaktioner forekom hos 5,9 %.
In the Phase 3 REFLECT trial (see section 5.1), proteinuria was reported in 26.3% of lenvatinibtreated patients and Grade 3 reactions occurred in 5.9%.
5.1) blev blødning rapporteret hos 34,9 % (1,9 % var grad ≥ 3) af de lenvatinibbehandlede patienter versus 18,3 % (3,1 % var grad ≥ 3) af de placebobehandlede patienter.
In the pivotal Phase 3 SELECT trial (see section 5.1), 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.
Hvis proteinuri ≥ 2+ detekteres med urinstix, kan det være nødvendigt med dosisafbrydelser, -justeringer eller -seponering (se pkt.
If urine dipstick proteinuria ≥2+ is detected, dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
Patienter, som har fået 0 tidligere VEGF/VEGFR-målrettede behandlinger (%) Antal progressioner eller dødsfald Median PFS i måneder (95 % CI)
Patients who had received 0 prior VEGF/VEGFR-targeted therapy (%) Number of progressions or deaths Median PFS in months (95% CI)
5.1) blev diarré rapporteret hos 38,7 % af patienterne, der blev behandlet med lenvatinib (4,2% var grad ≥ 3).
In the Phase 3 REFLECT trial (see section 5.1), diarrhoea was reported in 38.7% of patients treated with lenvatinib (4.2% were Grade ≥ 3).
Mave-tarmperforation eller fistel
GI perforation or fistula
Hos patienter med tegn eller symptomer på PRES kan det være nødvendigt med dosisafbrydelser, -justeringer eller seponering (se pkt.
In patients with signs or symptoms of PRES, dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
Hæmning af undertrykkelse af tyreoideastimulerende hormon/tyreoideadysfunktion
Impairment of thyroid stimulating hormone suppression/ Thyroid dysfunction
Patienter med nedsat nyrefunktion ved baseline havde en større forekomst af grad 3 eller 4 hypertension, proteinuri, træthed, stomatitis, perifert ødem, trombocytopeni, dehydrering, QTforlængelse, hypotyreoidisme, hyponatriæmi, forhøjet niveau af tyreoideastimulerende hormon i blodet, pneumoni sammenlignet med personer med normal nyrefunktion.
Patients with baseline renal impairment had a higher incidence of Grade 3 or 4 hypertension, proteinuria, fatigue, stomatitis, oedema peripheral, thrombocytopenia, dehydration, prolonged QT, hypothyroidism, hyponatraemia, increased blood thyroid stimulating hormone, pneumonia compared with subjects with normal renal function.
Patienter i alderen ≥ 75 år havde en større tendens til hypertension, proteinuri, nedsat appetit, asteni, dehydrering, svimmelhed, utilpashed, perifert ødem, pruritus og hepatisk encefalopati.
Patients of age ≥75 years were more likely to experience hypertension, proteinuria, decreased appetite, asthenia, dehydration, dizziness, malaise, peripheral oedema, pruritus and hepatic encephalopathy.
5.1) var der en hændelse med PRES (grad 2) i den lenvatinibbehandlede gruppe.
In the Phase 3 REFLECT trial (see section 5.1), there was 1 event of PRES (Grade 2) in the lenvatinib-treated group.
Arteriel tromboemboli (se pkt.
Arterial thromboembolisms (see section 4.4)
Leverrelaterede reaktioner af grad 3 eller derover (herunder 1 grad 5 tilfælde af leversvigt) forekom hos 5,4 % af de lenvatinibbehandlede patienter sammenlignet med 0,8 % af de placebobehandlede patienter.
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.
Mave-tarm-perforation og fisteldannelse (se pkt.
Gastrointestinal perforation and fistula formation (see section 4.4)
Hazard ratio (95 % CI)b, e P-værdib,e
Hazard ratio (95% CI)b, e P-value b, e
Hazard ratio (99 % CI)b,c P-værdib
Hazard ratio (99% CI)b,c P-valueb
Hos 496 patienter med HCC var dosisreduktion (afbrydelse eller reduktion) og seponering de udførte handlinger for en bivirkning hos henholdsvis.
In 496 patients with HCC, dose modification (interruption or reduction) and discontinuation were the actions taken for an adverse reaction in 62.3% and 20.2% of patients, respectively.
De vigtigste alvorlige bivirkninger var nyresvigt og nedsat nyrefunktion (2,4 %), arteriel tromboemboli (3,9 %), hjertesvigt (0,7 %), intrakranial tumorblødning (0,7 %), PRES/RPLS (0,2 %), leversvigt (0,2 %) og arteriel tromboemboli (cerebrovaskulært anfald (1,1 %), transitorisk iskæmisk anfald (0,7 %) og myokardieinfarkt (0,9 %).
The most important serious adverse reactions were renal failure and impairment (2.4%), arterial thromboembolisms (3.9%), cardiac failure (0.7%), intracranial tumour haemorrhage (0.7%), PRES / RPLS (0.2%), hepatic failure (0.2%), and arterial thromboembolisms (cerebrovascular accident (1.1%), transient ischaemic attack (0.7%), and myocardial infarction (0.9%).
Bivirkninger, der mest almindeligt førte til seponering af lenvatinib var hepatisk encefalopati, træthed, øget bilirubin i blodet, proteinuri og leversvigt.
Adverse reactions that most commonly led to discontinuation of lenvatinib were hepatic encephalopathy, fatigue, increased blood bilirubin, proteinuria and hepatic failure.
1 kapsel med 4 mg).
(1 capsule of 10 mg and 1 capsule of 4 mg).
• oppustet følelse eller luft i tarmen
• feeling bloated or having excess wind
De vigtigste alvorlige bivirkninger var leversvigt (2,8 %), hepatisk encefalopati (4,6), øsofageal åreknudeblødning (1,4 %), cerebral blødning (0,6%), arteriel tromboembolisk hændelse (2,0 %) inklusive myokardieinfarkt (0,8 %), cerebralt infarkt (0,4 %) og cerebrovaskulært anfald (0,4 %) og hændelser med nyresvigt/-forringelser (1,4 %).
The most important serious adverse reactions were hepatic failure (2.8%), hepatic encephalopathy (4.6%), oesophageal varices haemorrhage (1.4%), cerebral haemorrhage (0.6%), arterial thromboembolic events (2.0%) including myocardial infarction (0.8%), cerebral infarction (0.4%) and cerebrovascular accident (0.4%) and renal failure/impairment events (1.4%).
5.1) blev der rapporteret en nedsat uddrivningsfraktion/hjertesvigt hos 6,5 % af patienterne (1,5 % var grad ≥ 3) i gruppen behandlet med lenvatinib og hos 2,3 % i placebogruppen (ingen var grad ≥ 3).
In the pivotal Phase 3 SELECT trial (see section 5.1), 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).
5.1) blev diarré rapporteret hos 67,4 % af patienterne i gruppen behandlet med lenvatinib (9,2 % var grad ≥ 3) og hos 16,8 % af patienterne i placebogruppen (ingen var grad ≥ 3).
In the pivotal Phase 3 SELECT trial (see section 5.1), 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).
5.1) var de mest almindeligt rapporterede leverrelaterede bivirkninger hypoalbuminæmi (9,6 % lenvatinib versus 1,5 % placebo) og forhøjelser af leverenzymniveauerne, herunder forhøjelser i alaninaminotransferase (7,7 % lenvatinib versus 0 placebo), aspartataminotransferase (6,9 % lenvatinib versus 1,5 % placebo) og bilirubin i blodet (1,9 % lenvatinib versus 0 placebo).
In the pivotal Phase 3 SELECT trial (see section 5.1), 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).
Den anbefalede daglige dosis af lenvatinib er 8 mg (to 4 mg kapsler) én gang dagligt for patienter med en kropsvægt på < 60 kg og 12 mg (tre 4 mg kapsler) én gang dagligt for patienter med en kropsvægt på ≥ 60 kg. Dosisjustering baseres kun på observerede toksciteter og ikke på ændringer i kropsvægt i løbet af behandlingen.
The recommended daily dose of lenvatinib is 8 mg (two 4 mg capsules) once daily for patients with a body weight of < 60 kg and 12 mg (three 4 mg capsules) once daily for patients with a body weight of ≥ 60 kg.
5.1) udviklede 5,0 % af patienterne nyresvigt, og 1,9 % udviklede nedsat nyrefunktion (3,1 % af patienterne havde en grad ≥ 3 hændelse med nyresvigt eller nedsat nyrefunktion).
In the pivotal Phase 3 SELECT trial (see section 5.1), 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).
Lenvatinib må ikke startes hos patienter med fistel for at undgå forværring, og lenvatinib skal seponeres permanent hos patienter med øsofageal eller trakeobronkial involvering og alle grad 4 fistler (se pkt.
Lenvatinib should not be started in patients with fistula 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.
Reaktioner, der opstod med en forekomst på ≥ 0,75 % mere end placebo var: epistakse (11,9 %), hæmaturi (6,5 %), kontusion (4,6 %), blødning fra tandkød (2,3 %), hæmatochezi (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%).
Oral inflammation omfatter: aftøs stomatitis, aftøs mavesår, erosion i tandkødet, sår i tandkødet, blærer i mundslimhinden, stomatitis, glossitis, mundulcus og mukosal inflammation.
Oral inflammation includes: aphthous stomatitis, aphthous ulcer, gingival erosion, gingival ulceration, oral mucosal blistering, stomatitis, glossitis, mouth ulceration, and mucosal inflammation.
Forhøjet niveau af tyreoideastimulerende hormon i blodet‡
Hypothyroidism Increased blood thyroid stimulating hormone ‡
Flertallet af tilfælde kom sig efter afbrydelse eller reduktion af dosis, som forekom hos henholdsvis 6,9 % og 2,5 % af patienterne.
The majority of cases recovered following dose interruption or reduction, which occurred in 6.9% and 2.5% of patients respectively.
Otte raske, demografisk matchede personer var kontroller og fik en dosis på 10 mg. Lenvatinib-eksponeringen baseret på dosisjusterede data for AUC0-t og AUC0-inf var 119 %, 107 % og 180 % af normalen for personer med hhv. let, moderat og svært nedsat leverfunktion.
Lenvatinib exposure, based on dose-adjusted AUC0-t and AUC0-inf data, was 119%, 107%, and 180% of normal for subjects with mild, moderate, and severe hepatic impairment, respectively.
Handling Dosisreduktion og genstart af lenvatinib
Dose reduce and resume lenvatinib
5.1) var de mest almindeligt rapporterede bivirkninger med hepatotoksisitet bivirkninger forhøjelser af bilirubin i blodet (14,9 %), forhøjet aspartataminotransferase (13,7%), forhøjet alaninaminotransferase (11,1%), hypoalbuminæmi (9,2 %), hepatisk encefalopati (8 %), forhøjet gamma-glutamyltransferase (7,8 %) og forhøjet alkalisk fosfatase i blodet (6,7 %).
In the Phase 3 REFLECT trial (see section 5.1), the most commonly reported hepatotoxicity adverse reactions were increased blood bilirubin (14.9%), increased aspartate aminotransferase (13.7%), increased alanine aminotransferase (11.1%), hypoalbuminaemia (9.2%), hepatic encephalopathy (8.0%), increased gamma-glutamyltransferase (7.8%) and increased blood alkaline phosphatase (6.7%).
Flertallet af tilfælde kom sig efter afbrydelse eller reduktion af dosis, som forekom hos henholdsvis 3,6 % og 3,4 % af patienterne.
The majority of cases recovered following dose interruption or reduction, which occurred in 3.6% and 3.4% of patients respectively.
5.1) blev hypocalcæmi rapporteret hos 12,6 % af de lenvatinibbehandlede patienter versus ingen tilfælde i placeboarmen.
In the pivotal Phase 3 SELECT trial (see section 5.1), hypocalcaemia was reported in 12.6% of lenvatinib-treated patients vs. no cases in the placebo arm.
Hver hård kapsel indeholder 4 mg lenvatinib (som mesilat).
Each hard capsule contains 4 mg of lenvatinib (as mesylate).
20 mg oralt én gang dagligt To 10mg kapsler Anden dosisreduktion 14 mg oralt én gang dagligt En 10mg kapsel plus en 4 mg kapsel Tredje dosisreduktion 10 mg oralt én gang dagligta En 10mg kapsel a:
Second dose reduction 14 mg orally once daily One 10mg capsuleplus one 4 mg capsule Third dose reduction
Forlængelse af QTintervallet
QT interval prolongation
(1/1.000 til <1/100)
• Uncommon (≥1/1,000 to <1/100)
Den mediane tid til start af leverreaktioner hos lenvatinibbehandlede patienter var 12,1 uger.
The median time to onset of liver reactions in lenvatinib-treated patients was 12.1 weeks.
Hjertesvigt (< 1 %) og nedsat venstre ventrikulær 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).
5.1) blev forlængelse af QT/QTc-intervallet rapporteret hos 8,8 % af de lenvatinibbehandlede patienter og hos 1,5 % af patienterne i gruppen, der fik placebo.
In the pivotal Phase 3 SELECT trial (see section 5.1), QT/QTc interval prolongation was reported in 8.8% of lenvatinib-treated patients and 1.5% of patients in the placebo group.
<60 kg kropsvægt 8 mg (to 4 mg kapsler oralt en gang dagligt)
<60 kg BW 8 mg (two 4 mg capsules orally once daily)
Arterie tromboembolier
Arterial thromboembolisms
Leversvigt omfatter:leversvigt, akut leversvigt og kronisk leversvigt.
Hepatic failure includes: hepatic failure, acute hepatic failure and chronic hepatic failure.
Bivirkninger, der mest almindeligt førte til dosisreduktioner (hos ≥ 5 % af patienterne), var nedsat appetit, diarré, proteinuri, hypertension, træthed, PPE og nedsat trombocyttal.
Adverse reactions that most commonly led to dose modifications (in ≥5% of patients) were decreased appetite, diarrhoea, proteinuria, hypertension, fatigue, PPE and decreased platelet count.
(kan ikke estimeres ud fra forhåndenværende data) Inden for hver enkelt frekvenskategori er bivirkningerne opstillet efter, hvor alvorlige de er.
Within each frequency category, undesirable effects are presented in order of decreasing seriousness.
Diarré Mave-tarm- og abdominalsmerterf
Diarrhoea Gastrointestinal and abdominal painsf
Perianal absces
Perineal abscess
De fleste tilfælde havde et udfald med bedring, eller reaktionen gik væk efter dosisafbrydelse eller -reduktion, hvilket forekom 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.
Rygsmerter Artralgi Myalgi Smerter i ekstremiteter Smerter i knogler, led og muskler
Back pain Arthralgia Myalgia Pain in extremity Musculoskeletal pain
Bivirkninger, der mest almindeligt førte til seponering af lenvatinib, var proteinuri, asteni, hypertension, cerebrovaskulært anfald, diarré og lungeemboli.
Adverse reactions that most commonly led to discontinuation of lenvatinib were proteinuria, asthenia, hypertension, cerebrovascular accident, diarrhoea, and pulmonary embolism.
De fleste reaktioner gik væk efter støttebehandling uden dosisafbrydelse eller -reduktion, 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.
Den mediane tid til første symptom hos lenvatinibbehandlede patienter var 11,1 uger.
The median time to first onset in lenvatinibtreated patients was 11.1 weeks.
Dosis er normalt 12 mg én gang dagligt (3 kapsler med 4 mg), hvis du vejer 60 kg og derover og
The dose is usually 12 mg once a day (3 capsules of 4 mg) if you weigh 60 kg or more and 8 mg once a day (2 capsules of 4 mg) if you weigh less than 60kg.
Den mediane tid til første symptom hos lenvatinibbehandlede patienter var 10,1 uger.
The median time to first onset in lenvatinib-treated patients was 10.1 weeks.