natgillin/translations-raw huggingface dataset:
Som følge af neutropeni kan der opstå feber (febril neutropeni) og infektion i blodet (septisk shock)
(febrile neutropenia) and blood infection (septic shock) may occur
• virusinfektion
• viral infection
Lonsurf er indiceret som monoterapi til behandling af metastatisk kolorektal cancer hos voksne patienter, som tidligere er blevet behandlet med, eller som ikke anses som kandidater til, tilgængelige behandlinger, herunder fluorpyrimidin-, oxaliplatin- og irinotecan-baseret kemoterapi, anti-VEGFmidler, og anti-EGFR-midler.
Lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.
Tabel 5 - Bivirkninger rapporteret i kliniske studier hos patienter behandlet med Lonsurf Systemorganklasse (MedDRA)
Table 5 - Adverse drug reactions reported in clinical trials in patients treated with Lonsurf System Organ Class (MedDRA)a
Der blev udført en toksikologisk vurdering af trifluridin/tipiracilhydrochlorid hos rotter, hunde og aber.
Toxicology assessment of trifluridine/tipiracil hydrochloride was performed in rats, dogs and monkeys.
Udslæt Alopeci Pruritus Tør hud
Rash Alopecia Pruritus Dry skin
Anbefalede dosis modifikationer
Recommended dose adjustments
Lonsurfs overlevelsesfordel blev opretholdt efter justering for alle væsentlige prognostiske faktorer, tid siden diagnosticering af den første metastase, ECOG-PS og antal metastatiske steder (hazard ratio: 0,69; 95 % CI [0,58 til 0,81]).
The Lonsurf survival benefit was maintained after adjusting for all significant prognostic factors, namely, time since diagnosis of first metastasis, ECOG PS and number of metastatic sites (hazard ratio: 0.69; 95% CI [0.58 to 0.81]).
Tipiracilhydrochlorid var en hæmmer af OCT2 og MATE1 in vitro, men ved koncentrationer væsentligt højere end human plasmaCmax ved steady state.
Tipiracil hydrochloride was an inhibitor of OCT2 and MATE1 in vitro, but at concentrations substantially higher than human plasma Cmax at steady state.
0,0003 (1-sidet), 0,0006 (2-sidet)
0.0003 (1-sided), 0.0006 (2-sided)
Hvis ovenstående gælder for dig (eller hvis du er i tvivl), så tal med din læge eller apotekspersonalet, før du tager Lonsurf.
If the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking Lonsurf.
• hævet kløende udslæt, rød hud, blister, huden falder af, nældefeber, acne
• raised itchy rash, red skin, blisters, skin sloughing off, hives, acne
De alvorligste observerede bivirkninger hos patienter, der fik Lonsurf, er knoglemarvssuppression og gastrointestinal toksicitet (se pkt.
The most serious observed adverse drug reactions in patients receiving Lonsurf are bone marrow suppression and gastrointestinal toxicity (see section 4.4).
Vertigo Ubehag i øret
Vertigo Ear discomfort
Brug af anden medicin sammen med Lonsurf
Other medicines and Lonsurf
Lonsurf består af en antineoplastisk thymidin-baseret nukleosidanalog, trifluridin, og thymidinfosforylase- (TPase-) hæmmeren tipiracilhydrochlorid i et molforhold 1:0,5 (vægtforhold,
Lonsurf is comprised of an antineoplastic thymidine-based nucleoside analogue, trifluridine, and the thymidine phosphorylase (TPase) inhibitor, tipiracil hydrochloride, at a molar ratio 1:0.5 (weight ratio,
Ved en total daglig dosis på 50 mg skal patienten tage en 20 mg/8,19 mg tablet om morgenen og to 15 mg/6,14 mg tabletter om aftenen.
50a a At a total daily dose of 50 mg, patients should take 1 x 20 mg/8.19 mg tablet in the morning and 2 x 15 mg/6.14 mg tablets in the evening.
In vitro evaluering af trifluridin og tipiracilhydrochlorid blev udført under anvendelse af humane optagelses- og effluxtransportører (trifluridin med MDR1, OATP1B1, OATP1B3 og BCRP; tipiracilhydrochlorid med OAT1, OAT3, OCT2, MATE1, MDR1 og BCRP).
In vitro evaluation of trifluridine and tipiracil hydrochloride was conducted using human uptake and efflux transporters (trifluridine with MDR1, OATP1B1, OATP1B3 and BCRP; tipiracil hydrochloride with OAT1, OAT3, OCT2, MATE1, MDR1 and BCRP).
ORR (komplet respons + partielt respons) var ikke signifikant højere hos patienter, som blev behandlet med Lonsurf (4,5 % versus 2,1 %, p-værdi = 0,2833), men DCR (komplet respons, partielt respons eller stabil sygdom) var signifikant højere hos patienter, som blev behandlet med Lonsurf (44,1 % versus 14,5 %, p < 0,0001).
The ORR (complete response + partial response) was not significantly higher in patients treated with Lonsurf (4.5% vs 2.1 %, p-value = 0.2833) but the DCR (complete response or partial response or stable disease) was significantly higher in patients treated with Lonsurf (44.1% vs 14.5%, p < 0.0001).
40 filmovertrukne tabletter
40 film-coated tablets
I RECOURSE var der en lidt højere samlet forekomst af hæmatologiske og myelosuppressionsrelaterede bivirkninger hos patienter, der tidligere havde fået strålebehandling, sammenlignet med patienter uden forudgående strålebehandling (henholdsvis 54,6 % versus 49,2 %,), hvor det skal bemærkes, at febril neutropeni var hyppigere hos Lonsurf-behandlede patienter, som tidligere havde fået strålebehandling, end hos patienter, som ikke havde.
There was a slightly higher incidence of overall haematological and myelosuppression-related adverse reactions for patients who received prior radiotherapy compared to patients without prior radiotherapy in RECOURSE (54.6% versus 49.2%, respectively), of note febrile neutropenia was higher in Lonsurf-treated patients who received prior radiotherapy vs. those that did not.
Pancytopeni Granulocytopeni Monocytopeni Erytropeni Leukocytose Monocytose
Pancytopenia Granulocytopenia Monocytopenia Erythropenia Leukocytosis Monocytosis
• besvimelse (synkope)
• passing out (syncope)
Absorberet trifluridin blev metaboliseret og udskilt i urinen som FTY og trifluridinglukuronidisomere.
The absorbed trifluridine was metabolised, and excreted into urine as FTY and trifluridine glucuronide isomers.
Cirka halvdelen (55,4 %) af patienterne havde tidligere fået behandling med irinotecan, 33,3 % havde tidligere fået behandling med ramucisumab og 16,6 % havde tidligere fået HER2-målrettet behandling.
Approximately half (55.4%) of patients received prior irinotecan, 33.3% received prior ramucirumab, and 16.6% received prior HER2-targeted therapy.
Hos de 800 randomiserede patienter var medianalderen 63 år, 61 % var mænd, 58 % var kaukasere/hvide, 35 % var asiater/orientalske, og 1 % var sorte/afroamerikanere, og alle patienter havde Eastern Cooperative Oncology Group (ECOG) performance status (PS) på 0 eller 1 ved baseline.
Of the 800 randomised patients, the median age was 63 years, 61% were male, 58% were Caucasian/White, 35% were Asian/Oriental, and 1% were Black/African American, and all patients had baseline Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
Baseret på den farmakokinetiske populationsanalyse var der ingen klinisk relevant effekt af alder, køn eller race på trifluridins og tipiracilhydrochlorids farmakokinetik.
Based on the population PK analysis, there is no clinically relevant effect of age, gender or race on the PK of trifluridine or tipiracil hydrochloride.
• øget antal hvide blodlegemer
• increased white blood cells
Lonsurf forårsagede en stigning i forekomsten af myelosuppression, herunder anæmi, neutropeni, leukopeni og trombocytopeni.
Lonsurf caused an increase in the incidence of myelosuppression including anaemia, neutropenia, leukopenia, and thrombocytopenia.
De bivirkninger, som hyppigst (≥ 2 %) resulterede i seponering af Lonsurf, dosisreduktion, dosisudskydelse, eller doseringsafbrydelse, var neutropeni, anæmi, leukopeni, træthed, trombocytopeni, kvalme og diarré.
The most common adverse drug reactions (≥ 2%) in patients receiving Lonsurf that resulted in treatment discontinuation, dose reduction, dose delay, or dose interruption were neutropenia, anaemia, leukopenia, fatigue, thrombocytopenia, nausea and diarrhoea.
OS- og PFS-fordelen blev observeret i alle relevante præspecificerede undergrupper, herunder race, geografisk område, alder (< 65; ≥ 65), køn, ECOG-PS, KRAS-status, tid siden diagnosticering af den første metastase, antal metastatiske steder og fokus for primær tumor.
The OS and PFS benefit was observed consistently, in all relevant pre-specified subgroups, including race, geographic region, age (< 65; ≥ 65), sex, ECOG PS, KRAS status, time since diagnosis of first metastasis, number of metastatic sites, and primary tumour site.
• hævede slimhinder - det kan være i næsen, munden, halsen, øjnene, vagina, lunger eller tarme
• swelling of mucous membranes - this could be inside the nose, mouth, throat, eyes, vagina, lungs or gut
Tabel 3 - Anbefalede dosisjusteringer for Lonsurf ved hæmatologiske og ikke-hæmatologiske bivirkninger
Table 3 - Recommended dose modifications for Lonsurf in case of haematological and non-haematological adverse reactions
Almindelig: Kan forekomme hos op til 1 ud af 10 personer
Common: may affect up to 1 in 10 people:
Næsten alle (99,8 %) patienter havde tidligere fået behandling med fluorpyrimidin, 100 % havde tidligere fået behandling med platin og 90,5 % havde tidligere fået behandling med taxan.
Nearly all (99.8%) patients received prior fluoropyrimidine, 100% received prior platinum therapy and 90.5% received prior taxane therapy.
• du har nyreproblemer
• you have kidney problems
Resultater af dyrestudier indikerede ikke indvirkning af trifluridin og tipiracilhydrochlorid på hanlig og hunlig fertilitet hos rotter.
Results of animal studies did not indicate an effect of trifluridine and tipiracil hydrochloride on male and female fertility in rats.
• Øvrige indholdsstoffer er: - Tabletkerne: Lactosemonohydrat, pregelatineret stivelse (majs) og stearinsyre.
• The other ingredients are: - Tablet core: lactose monohydrate, starch pregelatinised (Maize) and stearic acid.
• blodpropper, f.eks. i hjernen eller benene
• blood clots, e.g. in the brain or legs
Kriterierne for doseringsgenoptagelse er gældende for alle patienter ved starten af næste cyklus, uanset om kriterierne for doseringsafbrydelse blev mødt eller ej.
≥ 75 × 109/L a Resumption criteria applied to the start of the next cycle for all patients regardless of whether or not the interruption criteria were met.
Periodontal sygdom Tandlidelse
Periodontal disease Tooth disorder
Lonsurf er indiceret som monoterapi til behandling af metastatisk gastrisk cancer hos voksne patienter, herunder adenokarcinom i den gastroøsofageale overgang, som tidligere er blevet behandlet med mindst to forudgående systemiske behandlingsregimer for fremskreden sygdom (se pkt.
Lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease (see section 5.1).
• Uge 1 - tag dosis 2 gange daglig i 5 dage - derefter 2 dage uden medicin
• Week 1 - take the dose 2 times a day for 5 days - then have 2 days off - no medicine
Dyrestudier har vist, at trifluridin, tipiracilhydrochlorid og/eller deres metabolitter udskilles i mælk (se pkt.
Studies in animals have shown excretion of trifluridine, tipiracil hydrochloride and/or their metabolites in milk (see section 5.3).
Angst Insomni
Anxiety Insomnia
Lonsurfs kliniske effekt og sikkerhed blev evalueret i et internationalt, randomiseret, dobbeltblindt, placebokontrolleret fase III-studie (TAGS) hos patienter, som tidligere var behandlet for metastatisk gastrisk cancer (herunder adenokarcinom i den gastroøsofageale overgang), og som tidligere var blevet behandlet med mindst to forudgående systemiske behandlingsregimer for fremskreden sygdom, herunder fluorpyrimidin-, platin- og enten taxan- eller irinotecan-baseret kemoterapi samt, hvis relevant, human epidermal vækstfaktor-receptor 2 (HER2)-målrettet behandling.
The clinical efficacy and safety of Lonsurf were evaluated in an international, randomised, doubleblind, placebo-controlled Phase III study (TAGS) in patients with previously treated metastatic gastric cancer (including adenocarcinoma of the gastroesophageal junction), who had been previously treated with at least two prior systemic treatment regimens for advanced disease, including fluoropyrimidine-, platinum-, and either taxane- or irinotecan-based chemotherapy, plus if appropriate human epidermal growth factor receptor 2 (HER2) -targeted therapy.
Det primære effektmål var samlet overlevelse (overall survival, OS), og støttende effektmål var progressionsfri overlevelse (progression-free survival, PFS), samlet responsrate (overall response rate, ORR) og sygdomskontrolrate (disease control rate, DCR).
The primary efficacy endpoint was overall survival (OS), and supportive efficacy endpoints were progression-free survival (PFS), overall response rate (ORR) and disease control rate (DCR).
Patienter på 65 år og ældre, som fik Lonsurf, havde, sammenlignet med patienter under 65 år, en højere incidens af følgende bivirkninger: - metastatisk kolorektal cancer (RECOURSE): Grad 3 og 4 neutropeni (48 % versus 30 %), grad 3 anæmi (26 % versus 12 %), grad 3 og 4 leukopeni (26 % versus 18 %) og grad 3 og 4 trombocytopeni (9 % versus 2 %), - metastatisk gastrisk cancer (TAGS): Grad 3 og 4 nedsat neutrofiltal (17,0 % versus 6,6 %), nedsat appetit (37,3 % versus 31,9 %), asteni (22,2 % versus 17,0 %) og stomatitis (7,2 % versus 2,2 %).
Patients 65 years of age or older who received Lonsurf had a higher incidence of the following events compared to patients younger than 65 years: - metastatic colorectal cancer (RECOURSE): Grade 3 or 4 neutropenia (48% vs 30%), Grade 3 anaemia (26% vs 12%), Grade 3 or 4 leukopenia (26% vs 18%) and Grade 3 or 4 thrombocytopenia (9% vs 2%), - metastatic gastric cancer (TAGS): Grade 3 or 4 neutrophil count decrease (17.0% vs 6.6%), decreased appetite (37.3% vs 31.9%), asthenia (22.2% vs 17.0%) and stomatitis (7.2% vs 2.2%).
• Uge 2 - tag dosis 2 gange daglig i 5 dage - derefter 2 dage uden medicin
• Week 2 - take the dose 2 times a day for 5 days - then have 2 days off - no medicine
Ud af de 533 patientser i RECOURSE-studiet, som fik Lonsurf, havde 306 (57 %) patienter normal nyrefunktion (CrCl ≥ 90 ml/min), 178 (33 %) patienter havde let nedsat nyrefunktion (CrCl 60 til 89 ml/min), og 47 (9 %) havde moderat nedsat nyrefunktion (CrCl 30 til 59 ml/min).
Of the 533 patients in the RECOURSE study who received Lonsurf, 306 (57%) patients had normal renal function (CrCl ≥ 90 mL/min), 178 (33%) patients had mild renal impairment (CrCl 60 to 89 mL/min), and 47 (9%) had moderate renal impairment (CrCl 30 to 59 mL/min), with data missing for 2 patients.
Det skal du vide, før du begynder at tage Lonsurf
What you need to know before you take Lonsurf
Median OS var 5,7 måneder (95 % CI: 4,8; 6,2) for Lonsurf-gruppen versus 3,6 måneder (95 % CI: 3,1; 4,1) for placebo-gruppen, med 1-årige overlevelsesrater på henholdsvis 21,2 % og 13,0 %.
The median OS was 5.7 months (95% CI: 4.8, 6.2) for the Lonsurf group versus 3.6 months (95% CI: 3.1, 4.1) for the placebo group; with 1-year survival rates of 21.2% and 13.0%, respectively.
Angina pectoris Arytmi
Angina pectoris Arrhythmia Palpitations
• inflammation eller øget mængde syre i maven eller spiserøret, halsbrand
• inflammation or increased acid in your stomach or gullet, reflux
I alt blev 507 patienter randomiseret 2:1 til at få Lonsurf (N = 337) plus den bedste understøttende behandling (BSC) eller placebo (N = 170) plus BSC. Lonsurf-dosis blev administreret på basis af BSA med en startdosis på 35 mg/m2/dosis.
In total, 507 patients were randomised 2:1 to receive Lonsurf (N = 337) plus best supportive care (BSC) or placebo (N = 170) plus BSC. Lonsurf dosing was based on BSA with a starting dose of 35 mg/m2/dose.
Patienter med moderat nedsat nyrefunktion bør overvåges oftere for hæmatologisk toksicitet.
Patients with renal impairment should be monitored closely when being treated with Lonsurf; patients with moderate renal impairment should be more frequently monitored for haematological toxicities.
Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}
This leaflet was last revised in
Baseret på en farmakokinetisk populationsanalyse var eksponeringen af Lonsurf hos patienter med let nedsat nyrefunktion (CrCl = 60 til 89 ml/min) den samme som hos patienter med normal nyrefunktion (CrCl ≥ 90 ml/min).
Based on a population PK analysis, the exposure of Lonsurf in patients with mild renal impairment (CrCl = 60 to 89 mL/min) was similar to those in patients with normal renal function (CrCl ≥ 90 mL/min).
4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Knoglemarvssuppression
4.4 Special warnings and precautions for use
Lonsurf anbefales ikke til patienter med svært nedsat nyrefunktion (kreatininclearance [CrCl] < 30 ml/min) eller terminal nyresygdom (som kræver dialyse), da Lonsurf ikke er undersøgt hos denne patientgruppe (se pkt.
Lonsurf is not recommended for use in patients with severe renal impairment or end-stage renal disease (creatinine clearance [CrCl] < 30 mL/min or requiring dialysis, respectively), as Lonsurf has not been studied in these patients (see section 5.2).
• dårlig ånde, huller i tænderne, problemer i tænder eller gummer, blødende gummer, infektioner i gummerne
• bad breath, tooth decay, tooth or gum problems, bleeding gums, gum infections
C]-tipiracilhydrochlorid blev mindst 27 % af det administrerede tipiracilhydrochlorid absorberet, og 50 % af den totale radioaktive dosis blev målt i fæces, hvilket indikerer moderat gastrointestinal absorption af tipiracilhydrochlorid.
After oral administration of Lonsurf with [14C]-tipiracil hydrochloride, at least 27% of the administered tipiracil hydrochloride was absorbed and 50% of the total radioactivity dose measured into faeces, suggestive of moderate gastrointestinal absorption of tipiracil hydrochloride.
In vitro studier indikerede, at trifluridin, tipiracilhydrochlorid og FTY (inaktiv metabolit af trifluridin) ikke hæmmer de testede CYP-isoformer (CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 og CYP3A4/5).
In vitro studies indicated that trifluridine, tipiracil hydrochloride and FTY (inactive metabolite of trifluridine) did not inhibit the CYP isoforms tested (CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4/5).
• rødme, hævelse og smerte i dine håndflader og fodsåler (hånd-fod syndrom)
• redness, swelling, pain on the palms of your hands and soles of your feet (hand-foot syndrome)
• smerte eller betændelse i øvre eller nedre del af fordøjelseskanalen
• pain or inflammation in upper or lower part of digestive tract
• unormal stigning eller fald i hjertefrekvensen (pulsen)
• abnormal increase or decrease in heart rate
Anbefalede dosisjusteringer
Recommended dose modifications
De identificerede målorganer var lymfesystemet og det hæmatopoietiske system samt mavetarm-kanalen.
The target organs identified were the lymphatic and haematopoietic systems and the gastrointestinal tract.
Symptomerne omfatter vejrtrækningsbesvær og kortåndethed med hoste eller feber.
The signs include difficulty in breathing, shortness of breath, with cough or fever.
Trifluridins og tipiracilhydrochlorids farmakokinetik blev evalueret i et specifikt studie hos cancerpatienter med let eller moderat nedsat leverfunktion (National Cancer Institute [NCI] Criteria gruppe B og C) og patienter med normal leverfunktion.
In a dedicated study the PK of trifluridine and tipiracil hydrochloride were evaluated in cancer patients with mild or moderate hepatic impairment (National Cancer Institute [NCI] Criteria Group B and C, respectively) and in patients with normal hepatic function.
Efter gentagne doser af Lonsurf i det anbefalede doseringsregime var den gennemsnitlige halveringstid (t1/2) af trifluridin på henholdsvis dag 1 og dag 12 i cyklus 1 1,4 timer og 2,1 timer.
Following the multiple-dose administration of Lonsurf at the recommended dose and regimen, the mean elimination half-life (t1/2) for trifluridine on Day 1 of Cycle 1 and on Day 12 of Cycle 1 were 1.4 hours and 2.1 hours, respectively.
Efter godkendelse har der været rapporter om interstitiel lungesygdom hos patienter i behandling med Lonsurf.
There have been reports of interstitial lung disease in patients receiving Lonsurf post approval.
• ophobning af væske i lungerne
• accumulation of fluid in the lungs
Når en enkelt dosis af Lonsurf på 35 mg/m blev administreret til 14 patienter med solide tumorer efter et standardiseret fedtholdigt og kalorierigt måltid, ændrede trifluridin-AUC sig ikke, men trifluridinCmax og tipiracilhydrochlorid-Cmax og AUC faldt med cirka 40 % sammenlignet med ved faste.
When Lonsurf at a single dose of 35 mg/m2 was administered to 14 patients with solid tumours after a standardised high-fat, high-calorie meal, trifluridine area under the concentration-time curve (AUC) did not change, but trifluridine Cmax, tipiracil hydrochloride Cmax and AUC decreased by approximately 40% compared to those in a fasting state.
Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Les Laboratoires Servier Industrie
Name and address of the manufacturer responsible for batch release
Med hensyn til de øvrige eksponeringsparametre for trifluridin og dosisintervallet 20 til 35 mg/m tipiracilhydrochlorid syntes de at være dosisproportionale.
As for the other exposure parameters of trifluridine and tipiracil hydrochloride, those appeared to be dose proportional.
Hæmoragisk enterocolitis Gastrointestinal blødning Akut pankreatitis Ascites
Enterocolitis haemorrhagic Gastrointestinal haemorrhage Pancreatitis acute Ascites
Resultater af dyrestudier indikerede ikke en effekt af Lonsurf på hanlig eller hunlig fertilitet (se pkt.
Results of animal studies did not indicate an effect of Lonsurf on male or female fertility (see section 5.3).
Der blev ikke set korrelation mellem hverken trifluridins eller tipiracilhydrochloids farmakokinetiske parametre og ASAT og/eller total-bilirubin.
No correlation was seen for trifluridine nor tipiracil hydrochloride between PK parameters and AST or/and total blood bilirubin.
Hazard ratio [95 % CI]
Hazard ratio [95% CI] P-valuec
Effekten blev også opretholdt hos regorafenib-naive patienter (hazard ratio: 0,69, 95 % CI [0,57 til 0,83]).
The effect was also maintained in regorafenib-naive patients (hazard ratio: 0.69, 95% CI [0.57 to 0.83]).
Hver filmovertrukket tablet indeholder 90,735 mg lactosemonohydrat.
Each film-coated tablet contains 90.735 mg of lactose monohydrate.
Stratificeret log-rank test (strata: region, ECOG-status ved baseline, tidligere behandling med ramucirumab)
a Kaplan-Meier estimates b Methodology of Brookmeyer and Crowley c Stratified log-rank test (strata: region, ECOG status at baseline, prior ramucirumab treatment)
In vitro evaluering viste, at trifluridin, tipiracilhydrochlorid og FTY ikke havde induktiv effekt på human CYP1A2, CYP2B6 eller CYP3A4/5.
In vitro evaluation indicated that trifluridine, tipiracil hydrochloride and FTY had no inductive effect on human CYP1A2, CYP2B6 or CYP3A4/5.
Niveau 2-dosisreduktion: Fra 30 mg/m til 25 mg/m25 mg/m a
Level 2 dose reduction: From 30 mg/m2 to 25 mg/m2 25 mg/m2
Mediantiden til forværring af ECOG PS til ≥ 2 var 4,3 måneder for Lonsurf-gruppen versus 2,3 måneder for placebo-gruppen med HR på 0,69 (95 % CI: 0,562; 0,854), p-værdi = 0,0005.
The median time to deterioration of ECOG performance status to ≥2 was 4.3 months for the Lonsurf group versus 2.3 months for the placebo group with HR of 0.69 (95% CI: 0.562, 0.854), p-value = 0.0005.
• Let nedsat nyrefunktion (CrCl 60 til 89 ml/min) og moderat nedsat nyrefunktion (CrCl 30 til
• Mild renal impairment (CrCl 60 to 89 mL/min) or moderate renal impairment (CrCl 30 to
Tipiracilhydrochlorid blev ikke metaboliseret i en human lever S9-fraktion eller i kryopræserverede humane hepatocytter.
Tipiracil hydrochloride was not metabolised in human liver S9 or in cryopreserved human hepatocytes.
INFORMATION I BRAILLESKRIFT Lonsurf 20 mg/8,19 mg
INFORMATION IN BRAILLE Lonsurf 20 mg/8.19 mg