natgillin/translations-raw huggingface dataset:
Gentagne doser af esomeprazol 40 mg én gang dagligt, en protonpumpehæmmer, har ikke vist klinisk relevant indvirkning på den samlede eksponering af alectinib og M4.
Multiple doses of esomeprazole, a proton pump inhibitor, 40 mg once daily, demonstrated no clinically relevant effect on the combined exposure of alectinib and M4.
● Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
Ask your pharmacist how to throw away medicines you no longer use.
En ubetydelig del af alectinib og den aktive metabolit M4 udskilles uomdannet i urinen (<0,2% af dosis).
Negligible amounts of alectinib and the active metabolite M4 are excreted unchanged in urine (< 0.2%
Studiet opfyldte det primære endepunkt ved den primære analyse, hvor der påvistes en statistisk signifikant forbedring i progressionsfri overlevelse, vurderet af investigator.
The trial met its primary endpoint at the primary analysis, demonstrating a statistically significant improvement in PFS by investigator.
● Kapselindhold: lactosemonohydrat (se afsnit 2 ‘Alecensa indeholder lactose'), hydroxypropylcellulose, natriumlaurilsulfat (se afsnit 2 ”Alecensa indeholder natrium”, magnesiumstearat og carmellosecalcium
● Capsule content: lactose monohydrate (see section 2 ‘Alecensa contains lactose'), hydroxypropylcellulose, sodium laurilsulfate (see section 2 ‘Alecensa contains sodium'), magnesium stearate and carmellose calcium
Henholdsvis 84% og 5,8% af dosis udskiltes som uomdannet alectinib og M4.
In faeces, 84% and 5.8% of the dose was excreted as unchanged alectinib or M4, respectively.
● Hvis der er mere end 6 timer til din næste dosis, skal du tage den manglende dosis straks, du kommer i tanker om det.
● If it is more than 6 hours until your next dose, take the missed dose as soon as you remember.
Forekomst af grad 3-stigning i kreatinkinase var 3,7%.
The incidence of Grade 3 elevations of CPK was 3.7%.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1169/002
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1169/002
● betændelse i slimhinderne i munden
● inflammation of the mucous membrane of the mouth
[95% konfidensinterval]
[95% CI]
Du vil få taget blodprøver mindst hver 2. uge i den første måned og derefter efter behov under resten af behandlingen med Alecensa.
Your doctor will do blood tests at least every 2 weeks for the first month and as needed during treatment with Alecensa.
I de pivotale kliniske studier med Alecensa er der rapporteret 3 patienter med grad 3-4 ASAT/ALAT-stigning som havde lægemiddelinduceret leverskade.
In the pivotal Alecensa clinical trials it was reported that three patients with Grade 3-4 AST/ALT elevations had drug induced liver injury.
Hos drægtige kaniner forårsagede alectinib embryo-føtalt tab, små fostre og øget forekomst af skeletale variationer ved eksponeringer 2,9 gange den humane eksponering (AUC) ved den anbefalede dosis.
In pregnant rabbits, alectinib caused embryo-foetal loss, small fetuses and increased incidence of skeletal variations at exposures 2.9-fold of the human AUC exposure at the recommended dose.
CTCAE-grad
CTCAE grade
Alecensa indeholder
What Alecensa contains
240 hårde kapsler
240 hard capsules
● Det betyder, at du skal tage 6 kapsler (900 mg) hver dag.
● This means you take a total of 6 capsules (900 mg) each day.
Der er observeret tilfælde af svær interstitiel lungesygdom/pneumonitis hos patienter behandlet med Alecensa.
Severe ILD/pneumonitis occurred in patients treated with Alecensa.
Hos drægtige rotter forårsagede alectinib totalt embryo-føtalt tab (abort) ved eksponeringer 4,5 gange den humane eksponering (AUC) samt små fostre med forsinket ossifikation og mindre organmisdannelser ved eksponeringer 2,7 gange den humane eksponering (AUC).
In pregnant rats, alectinib caused total embryo-foetal loss (miscarriage) at exposures 4.5-fold of the human AUC exposure and small foetuses with retarded ossification and minor abnormalities of the organs at exposures 2.7-fold of the human AUC exposure.
Hvis Alecensa administreres sammen med BCRP-substrater (fx methotrexat, mitoxantron, topotecan og lapatinib) anbefales passende monitorering.
When Alecensa is co-administered with BCRP substrates (e.g., methotrexate, mitoxantrone, topotecan and lapatinib), appropriate monitoring is recommended.
ALK-positiv ikke-småcellet lungekræft -status skal fastlægges inden påbegyndelse af Alecensa-behandling.
ALK-positive NSCLC status should be established prior to initiation of Alecensa therapy.
Det primære endepunkt i studiet var at påvise bedre effekt af Alecensa versus crizotinib på baggrund af progressionsfri overlevelse efter investigators vurdering baseret på RECIST 1.1.
The primary endpoint of the trial was to demonstrate superiority of Alecensa versus crizotinib based on Progression Free survival (PFS) as per investigator assessment using RECIST 1.1.
Dosisjustering er derfor ikke nødvendig for samtidigt administrerede CYP3Asubstrater.
Therefore, no dose adjustment is required for co-administered CYP3A substrates.
● hævelser på grund af væskeansamlinger i kroppen (ødem).
● swelling caused by fluid build-up in the body (oedema)
● medicin mod krampeanfald (antiepileptika såsom phenytoin, carbamazepin eller phenobarbital)
● medicines used to stop seizures or fits (anti-epileptics such as phenytoin, carbamazepine, or phenobarbital)
Det primære endepunkt var at evaluere virkningen af Alecensa ved objektiv responsrate, bedømt af en central uafhængig bedømmelseskomité ved anvendelse af RECIST (Response Evaluation Criteria in Solid Tumors), version 1.1, i hele populationen (med og uden tidligere behandling med cytotoksisk kemoterapi).
The primary endpoint was to evaluate the efficacy of Alecensa by Objective Response Rate (ORR) as per central Independent Review Committee (IRC) assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 in the overall population (with and without prior exposure of cytotoxic chemotherapy treatments).
Alecensa indeholder lactose
Alecensa contains lactose
● Alecensa skal tages i forbindelse med et måltid.
● You must take Alecensa with food.
Da alectinib primært metaboliseres i leveren kan nedsat leverfunktion øge plasmakoncentrationen af alectinib og/eller den primære metabolit M4.
As elimination of alectinib is predominantly through metabolism in the liver, hepatic impairment may increase the plasma concentration of alectinib and/or its major metabolite M4.
Studiet vedrørende nedsat leverfunktion inkluderede også en gruppe med moderat (Child-Pugh B) nedsat leverfunktion og viste begrænset højere eksponering af alectinib hos denne gruppe sammenlignet med eksponeringen hos tilsvarende raske forsøgspersoner.
The hepatic impairment study also included a group with moderate (Child-Pugh B) hepatic impairment, and a modestly higher alectinib exposure was observed in this group compared with matched healthy subjects.
Hvid hård kapsel, 19,2 mm i længden, med “ALE” præget i sort blæk på hætten og “150 mg” præget i sort blæk på bunden.
White hard capsule of 19.2 mm length, with “ALE” printed in black ink on the cap and “150 mg” printed in black ink on the body.
(interval 1-29)
(range 1 - 29)
In vitro hæmmede alectinib ikke OATP1B1/OATP1B3, OAT1, OAT3 eller OCT2 ved klinisk relevante koncentrationer.
Alectinib did not inhibit OATP1B1/OATP1B3, OAT1, OAT3 or OCT2 at clinically relevant concentrations in vitro.
Størstedelen af tilfældene var af grad 1 og 2; grad 3-tilfælde blev rapporteret hos 3,2% af patienterne.
The majority of the events were of Grade 1 and 2 intensity; Grade 3 events were reported in 3.2% of the patients.
● sirolimus, medicin, der forebygger, at kroppens immunsystem afstøder en transplanteret nyre,
● sirolimus, a medicine used to prevent the body's immune system from rejecting a transplanted kidney, heart or liver
Du skal bruge solcreme og læbepomade med faktor 50 eller højere beskyttelse for at undgå at blive skoldet.
You need to apply sunscreen and lip balm with a Sun Protection Factor of 50 or higher to help prevent sunburn.
● Den anbefalede dosis er 3 kapsler (450 mg) 2 gange dagligt.
● The recommended dose is 3 capsules (450 mg) twice a day.
Alecensa bruges til at behandle voksne med en type lungekræft, der kaldes ikke-småcellet lungekræft.
Alecensa is used to treat adults with a type of lung cancer called ‘non-small cell lung cancer' (‘NSCLC').
In vitro viser Alectinib og M4 svag tidsafhængig hæmning af CYP3A4, og alectinib viser svagt induktionspotentiale for CYP3A4 og CYP2B6 ved kliniske koncentrationer.
In vitro, alectinib and M4 show weak time-dependent inhibition of CYP3A4, and alectinib exhibits a weak induction potential of CYP3A4 and CYP2B6 at clinical concentrations.
Hvis en planlagt Alecensa-dosis springes over, kan patienten tage den manglende dosis, medmindre der er mindre end 6 timer til næste planlagte dosis.
If a planned dose of Alecensa is missed, patients can make up that dose unless the next dose is due within 6 hours.
De fleste af tilfældene var af grad 1 eller 2; tre patienter (0,7%) havde en grad 3bivirkning.
The majority of events were Grades 1 or 2 and three patients (0.7%) had a Grade 3 event.
● øget følsomhed for sollys - du må ikke opholde dig i solen i længere tid, mens du er i behandling med Alecensa og i 7 dage efter, du er stoppet med behandlingen.
● sensitivity to sunlight - do not expose yourself to the sun for any long period of time while you are taking Alecensa and for 7 days after you stop.
Ialt blev 303 patienter inkluderet i fase III-studiet; 151 patienter blev randomiseret til crizotinib-armen og 152 patienter til Alecensa-armen, hvor de fik Alecensa oralt, i den anbefalede dosis på 600 mg, 2 gange dagligt.
A total of 303 patients were included in the Phase III trial, 151 patients randomised to the crizotinib arm and 152 patients randomised to the Alecensa arm receiving Alecensa orally, at the recommended dose of 600 mg twice daily.
Baseret på in vitro-data er CYP3A4 det primære enzym, der indgår i metaboliseringen af såvel alectinib og den primære aktive metabolit M4, og CYP3A bidrager til 40-50% af den totale levermetabolisme.
Based on in vitro data, CYP3A4 is the primary enzyme mediating the metabolism of both alectinib and its major active metabolite M4, and CYP3A contributes to 40% − 50% of total hepatic metabolism.
Anbefalet Alecensa-dosis er 600 mg (4 kapsler a 150 mg) 2 gange dagligt i forbindelse med et måltid (daglig dosis i alt er 1200 mg).
The recommended dose of Alecensa is 600 mg (four 150 mg capsules) taken twice daily with food (total daily dose of 1200 mg).
● opkastning - hvis du kaster op efter at have taget en dosis Alecensa, skal du ikke tage en ekstra dosis; du tager bare næste dosis til sædvanlig tid
● vomiting - if you vomit after taking a dose of Alecensa, do not take an extra dose, just take your next dose at the usual time
* Sekundære nøgle-endepunkter i det hierakiske testforløb ** Konkurrerende risikoanalyse af CNS-progression, systemisk progression og død som konkurrerende hændelser *** 2 patienter i crizotinib-armen og 6 patienter i alectinib-armen havde komplet respons CNS = centralnervesystem, NE = ikke-estimérbar;
* Key secondary endpoints part of the hierarchical testing ** Competing risk analysis of CNS progression, systemic progression and death as competing events *** 2 patients in the crizotinib arm and 6 patients in the alectinib arm had CR CI = confidence interval; CNS = central nervous system; CR = complete response; DOR = duration of response; HR = hazard ratio; IRC = Independent Review Committee; INV = investigator; NE = not estimable; ORR = objective response rate; PFS = progression free survival
Fertile kvinder skal informeres om, at de skal undgå at blive gravide under behandling med Alecensa.
Women of childbearing potential must be advised to avoid pregnancy while on Alecensa.
Det er for at kontrollere, at du ikke får leverproblemer, mens du tager Alecensa.
This is to check you do not have any liver problems while taking Alecensa.
De geometrisk gennemsnitlige Cmax, Cmin og AUC0-12t for M4 ved steady state var henholdsvis ca. 246 ng/ml (45,4%), 222 ng/ml (46,6%) og 2.810 ng∙time/ml (45,9%).
The geometric mean steady-state Cmax, Cmin and AUC0-12hr for M4 were approximately 246 ng/mL (45.4%), 222 ng/mL (46.6%) and 2810 ng*h/mL (45.9%), respectively.
Cmax og AUCinf for M4 var henholdsvis 39% og 34 % lavere og resulterede i at den samlede eksponering af alectinib og M4 (AUCinf) var 1,8 gange højere hos patienter med svært nedsat leverfunktion sammenlignet med eksponeringen hos tilsvarende raske forsøgspersoner.
M4 Cmax and AUCinf was 39% and 34% lower respectively, resulting in a combined exposure of alectinib and M4 (AUCinf) 1.8-fold higher in patients with severe hepatic impairment compared with matched healthy subjects.
Der er observeret abnorm erytrocytmorfologi ved eksponeringer svarende til eller højere end 10-60% af den humane eksponering (AUC) ved den anbefalede dosis.
Abnormal erythrocyte morphology was observed at exposures equal or greater than 10-60% the human exposure by AUC at the recommended dose.
Da alectinib hæmmer P-gp, forventes det ikke, at samtidig administration af P-gp-hæmmere har relevant effekt på eksponeringen af M4.
As alectinib inhibits P-gp, it is not expected that co-medication with P-gp inhibitors has a relevant effect on M4 exposure.
De hyppigste bivirkninger (≥20%) var obstipation (35%), ødem (30%, inklusive perifert ødem, ødem, generaliseret ødem, øjenlågsødem, periorbitalt ødem, ansigtsødem og lokaliseret ødem) og myalgi (28%, inklusive myalgi og muskuloskeletale smerter).
The most common adverse drug reactions (ADRs) (≥ 20%) were constipation (35%), oedema (30%, including oedema peripheral, oedema, generalised oedema, eyelid oedema, periorbital oedema, face oedema and localised oedema), and myalgia (28%, including myalgia and musculoskeletal pain).
Da alectinib kun i ubetydelig grad elimineres gennem nyrerne, er dosisjustering ikke nødvendig hos patienter med svært nedsat nyrefunktion (se pkt.
However, since alectinib elimination via the kidney is negligible, no dose adjustment is required in patients with severe renal impairment (see section 5.2).
Relevant monitorering anbefales hos patienter i samtidig behandling med potente CYP3A-hæmmere (inklusive, men ikke begrænset til ritonavir, saquinavir, telithromycin, ketoconazol, itraconazol, voriconazol, posaconazol, nefazodon, grapefrugt og pomerans).
Appropriate monitoring is recommended for patients taking concomitant strong CYP3A inhibitors (including, but not limited to, ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole nefazodone, grapefruit or Seville oranges).
Ved recidiv skal behandlingen seponeres permanent.
Permanently discontinue in case of recurrence.
Primære virkningsparametre
Primary efficacy parameter
CNS-objektiv responsrate for patienter med målbare CNS- metastaser ved baseline
CNS-ORR in patients with measurable CNS metastases at baseline
Efter oral administration af 600 mg 2 gange dagligt til patienter med ALK-positiv ikke småcellet lungekræft i forbindelse med et måltid absorberes alectinib, og Tmax nås efter 4-6 timer.
Following oral administration of 600 mg twice daily under fed conditions in ALK-positive NSCLC patients, alectinib was absorbed reaching Tmax after approximately 4 to 6 hours.
Hvis Alecensa administreres samtidig med P-gp-substrater (fx digoxin, dabigatranetexilat, topotecan, sirolimus, everolimus, nilotinib og lapatinib) anbefales passende monitorering.
When Alecensa is co-administered with P-gp substrates (e.g., digoxin, dabigatran etexilate, topotecan, sirolimus, everolimus, nilotinib and lapatinib), appropriate monitoring is recommended.
Symptomatisk bradykardi kan forekomme i forbindelse med behandling med Alecensa (se pkt.
Symptomatic bradycardia can occur with Alecensa (see section 4.8).
● medicin mod AIDS/HIV (fx ritonavir, saquinavir)
● medicines used to treat AIDS/HIV (e.g. ritonavir, saquinavir)
● betændelse i lungerne (pneumonitis).
● lung inflammation (pneumonitis).
I BO28984 (ALEX; n=152) var medianvarigheden af crizotinib-eksponering 10,7 måneder.
In BO28984 (ALEX; N=152) the median duration of exposure to Alecensa was 17.9 months, whereas the median duration of exposure to crizotinib was 10.7 months.
Efter administration af en enkelt oral dosis af 300 mg alectinib til forsøgspersoner med svært (ChildPugh C) nedsat leverfunktion var alectinibs Cmax det samme og AUCinf var 2,2 gange højere sammenlignet med disse parametre hos tilsvarende raske forsøgspersoner.
Following administration of a single oral dose of 300 mg alectinib in subjects with severe (Child-Pugh C) hepatic impairment, alectinib Cmax was the same and AUCinf was 2.2-fold higher compared with the same parameters in matched healthy subjects.
CYP-substrater
CYP substrates
Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Tyskland
Manufacturer Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Germany
Pakningsstørrelse: 240 hårde kapsler.
Pack size: 240 hard capsules.
Proliferativ zoneudvidelse i den gastrointestinale mucosa sås hos begge arter ved eksponeringer svarende til eller højere end 20-120% af den humane eksponering (AUC) ved den anbefalede dosis.
Proliferative zone extension in GI mucosa in both species was observed at exposures equal to or greater than 20-120% of the human AUC exposure at the recommended dose.
Alecensa tages oralt.
Alecensa is for oral use.
Hold øje med disse symptomer, mens du tager Alecensa.
Look out for these while you are taking Alecensa.
Hvis du ikke er sikker, skal du spørge lægen, sundhedspersonalet eller apotekspersonalet, før du tager Alecensa.
If you are not sure, talk to your doctor, pharmacist or nurse before taking Alecensa.
SÆRLIGE OPBEVARINGSBETINGELSER Opbevar i den originale pakning for at beskytte mod fugt
SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from moisture
Alectinibs farmakokinetik er ikke undersøgt hos patienter med svært nedsat nyrefunktion.
The pharmacokinetics of alectinib has not been studied in patients with severe renal impairment.
Behandlingen skal straks afbrydes hos patienter, hvor interstitiel lungesygdom/pneumonitis diagnosticeres, og Alecensa skal seponeres permanent, hvis der ikke identificeres andre potentielle årsager til interstitiel lungesygdom/pneumonitis (se pkt.
Alecensa should be immediately interrupted in patients diagnosed with ILD/pneumonitis and should be permanently discontinued if no other potential causes of ILD/pneumonitis have been identified (see section 4.2).
Alecensa er ikke undersøgt hos patienter med svært nedsat nyrefunktion.
Alecensa has not been studied in patients with severe renal impairment.
Relevant monitorering anbefales hos patienter i samtidig behandling med potente CYP3A-induktorer (inklusive, men ikke begrænset til carbamazepin, phenobarbital, phenytoin, rifabutin, rifampicin og perikon (Hypericum perforatum)).
Appropriate monitoring is recommended for patients taking concomitant strong CYP3A inducers (including, but not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin and St. John's Wort (Hypericum perforatum)).
I fase II studierne (NP28761, NP28673; n=253) var medianvarigheden af Alecensa-eksponering 11 måneder.
In the phase II clinical trials (NP28761, NP28673; N=253), the median duration of exposure to Alecensa was 11 months.
Hvis du holder op med at tage Alecensa
If you stop taking Alecensa
Hvis patienten kaster op efter at have taget en dosis Alecensa, skal patienten tage næste dosis på det planlagte tidspunkt.
If vomiting occurs after taking a dose of Alecensa, patients should take the next dose at the scheduled time.
Kapselindhold Lactosemonohydrat Hydroxypropylcellulose Natriumlaurilsulfat Magnesiumstearat Carmellosecalcium
Capsule content Lactose monohydrate Hydroxypropylcellulose Sodium laurilsulfate Magnesium stearate Carmellose calcium
● Den anbefalede dosis er 4 kapsler (600 mg) 2 gange dagligt.
● The recommended dose is 4 capsules (600 mg) twice a day.
b20 patienter havde ikke målbar sygdom ved baseline vurderet af uafhængig bedømmelseskomité og kunne ikke inkluderes i populationen, der evalueredes for respons.
20 patients did not have measurable disease at baseline according to the IRC and were not included in the IRC response evaluable population
Patienter, som udvikler symptomatisk bradykardi, skal behandles som anbefalet i pkt.
Patients who develop symptomatic bradycardia should be managed as recommended in sections 4.2 and 4.4.
● gulfarvning af huden eller det hvide i øjnene, smerter i højre side af maven, mørkfarvet urin, kløende hud, mindre appetit end sædvanligt, kvalme eller opkastning, træthed, blødning eller tendens til at få blå mærker (kan være tegn på leverproblemer)
● Yellowing of your skin or the whites of your eyes, pain on the right side of your stomach area, dark urine, itchy skin, feeling less hungry than usual, nausea or vomiting, feeling tired, bleeding or bruising more easily than normal (potential signs of liver problems)
NP28761 Alecensa 600 mg 2 gange dagligt
NP28761 Alecensa 600 mg twice daily
Patienterne bør informeres om at undgå at opholde sig i solen i længere tid, mens de er i behandling med Alecensa og i mindst 7 dage efter behandlingsophør.
Patients should be advised to avoid prolonged sun exposure while taking Alecensa, and for at least 7 days after discontinuation of treatment.
I det fase-III kliniske studie BO28984 oplevede en patient (0,2%) kvalme af grad 4 i Alecensa-armen og forekomsten af kvalme, opkastning og diarré af grad 3-4 var henholdvis 3,3%, 3,3% og 2.0% i crizotinib-armen.
In the phase III clinical trial BO28984, one patient (0.2%) experienced a Grade 4 event of nausea in the Alecensa arm and the incidence of Grade 3 and 4 events for nausea, vomiting, and diarrhoea was 3.3%, 3.3%, and 2.0%, respectively, in the crizotinib arm.
Lever Forhøjet bilirubin7)
Hepatobiliary disorders Increased bilirubin6)
Hvad bruges Alecensa til?
What Alecensa is used for
NP28673 Alecensa 600 mg 2 gange dagligt
NP28673 Alecensa 600 mg twice daily
Afhængigt af bivirkningens sværhedsgrad bør behandlingen med Alecensa afbrydes og genoptages med reduceret dosis eller Alecensa seponeres permanent som beskrevet i Tabel 2 (se pkt.
Based on the severity of the adverse drug reaction, Alecensa should be withheld and resumed at a reduced dose, or permanently discontinued as described in Table 2 (see section 4.2).
Baseret på en farmakokinetisk populationsanalyse var de geometrisk gennemsnitlige (variationskoefficient %) Cmax, Cmin og AUC0-12t for alectinib ved steady state henholdsvis ca. 665 ng/ml (44,3%), 572 ng/ml (47,8%) og 7.430 ng∙time/ml (45,7%).
Based on population pharmacokinetic analysis, the geometric mean (coefficient of variation %) steady-state Cmax, Cmin and AUC0-12hr for alectinib were approximately 665 ng/mL (44.3%), 572 ng/mL (47.8%) and 7430 ng*h/mL (45.7%), respectively.
De primære virkningsresultater fra studie NP28673 og NP28761 præsenteres i Tabel 5.
The main efficacy results from studies NP28673 and NP28761 are summarised in Table 5.
Mødre bør frarådes at amme, mens de er i behandling med Alecensa.
Mothers should be advised against breast-feeding while receiving Alecensa.
● Hvis Alecensa er pakket i blisterpakning, skal det opbevares i den originale pakning for at beskytte mod fugt.
● If Alecensa is packed in blisters, store in the original package in order to protect from moisture.
● digoxin, hjertemedicin
● digoxin, a medicine used to treat heart problems
Hvis du har glemt at tage Alecensa
If you forget to take Alecensa
Efter administration af en enkelt oral dosis på 600 mg sammen med et fedt- og kalorierigt måltid steg alectinib- og M4-eksponeringen ca. 3-fold i forhold til ved fastende tilstand (se pkt.
Following a single oral administration of 600 mg with a high-fat, high-calorie meal, alectinib and M4 exposure was increased by around 3-fold relative to fasted conditions (see section 4.2).
Blandt de inkluderede patienter havde 20% oplevet progression under tidligere behandling med crizotinib alene, og 80% havde oplevet progression under tidligere behandling med crizotinib og mindst én kemoterapibehandling.
Among patients included in the study, 20% of the patients had previously progressed on crizotinib treatment only, and 80% had previously progressed on crizotinib and at least one chemotherapy treatment.