natgillin/translations-raw huggingface dataset:
Kontakt straks lægen, hvis du får nye eller forværrede tegn på muskelproblemer, også uforklarlige muskelsmerter eller muskelsmerter, der ikke forsvinder, ømhed eller svaghed.
Tell your doctor straight away if you get new or worsening signs of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness.
Dette lægemiddel indeholder 48 mg natrium (hovedingrediens i almindelig madsalt af den anbefalede daglige dosis (1200 mg).
This medicine contains 48 mg sodium (main component of cooking/table salt) per recommended daily dose (1200 mg).
Fordele mht. progressionsfri overlevelse var ensartet for patienter med CNS-metastaser ved baseline (hazardratio = 0,40; 95% konfidensinterval : 0,25-0,64, median progressionsfri overlevelse for Alecensa = NE, 95% konfidensinterval: 9,2-NE, median progressionsfri overlevelse for crizotinib = 7,4 måneder, 95% konfidensinterval: 6,6-9,6) og uden CNS-metastaser ved baseline (hazardratio = 0,51; 95% konfidensinterval: 0,33-0,80; median progressionsfri overlevelse for Alecensa = NE, 95% konfidensinterval: NE, NE, median progressionsfri overlevelse for crizotinib = 14,8 måneder, 95% konfidensinterval:10,8-20,3), hvilket indikerer, at Alecensa i begge subgrupper er forbundet med større fordele end crizotinib.
The PFS benefit was consistent for patients with CNS metastases at baseline (HR = 0.40, 95% CI: 0.25-0.64, median PFS for Alecensa = NE, 95% CI: 9.2-NE, median PFS for crizotinib = 7.4 months, 95%CI: 6.6-9.6) and without CNS metastases at baseline (HR = 0.51, 95% CI: 0.33-0.80, median PFS for Alecensa = NE, 95% CI: NE, NE, median PFS for crizotinib = 14.8 months, 95% CI:10.8-20.3), indicating benefit of Alecensa over crizotinib in both subgroups.
Alecensa er indiceret som monoterapi til første-linje-behandling af voksne patienter med anaplastisk lymfomkinase (ALK)-positiv, fremskreden ikke-småcellet lungekræft (NSCLC).
Alecensa as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
● træthed, svækkelse eller åndenød på grund af nedsat antal røde blodlegemer (anæmi)
● you may feel tired, weak or short of breath due to a reduction in the number of red blood cells,
Forhøjet bilirubin forårsagede dosisændringer hos 5,2% af patienterne og forhøjet bilirubin forårsagede seponering af Alecensa behandling hos 1,5% af patienterne.
In 5.2% of patients, bilirubin elevations led to dose modifications and in 1.5% of patients, bilirubin elevations led to withdrawal from Alecensa treatment.
Du skal straks kontakte lægen, hvis du oplever et eller flere af følgende symptomer: gulfarvning af huden eller det hvide i øjnene, smerter i højre side af maven, mørk urin, kløende hud, manglende appetit, kvalme eller opkastning, træthed, at du lettere bløder eller får flere blå mærker, end du plejer.
Tell your doctor straight away if you get any of the following signs: 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.
● nye eller forværrede tegn på muskelproblemer, fx uforklarlige muskelsmerter eller muskelsmerter, der ikke forsvinder, ømhed eller svaghed (kan være tegn på muskelproblemer)
● New or worsening signs of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness (potential signs of muscle problems).
ALK-positiv ikke-småcellet lungekræft Tidligere ubehandlede patienter
ALK positive non-small cell lung cancer
Objektiv responsrate (investigator)*, *** Respondere n (%) [95% konfdensinterval]
ORR (INV)*, *** Responders n (%) [95% CI]
Fertile kvindelige patienter, som får Alecensa, skal anvende højeffektiv prævention under behandlingen og i mindst 3 måneder efter sidste dosis Alecensa.
Female patients of child-bearing potential receiving Alecensa must use highly effective contraceptive methods during treatment and for at least 3 months following the last dose of Alecensa.
Ved inklusion i studiet var 99% af patienterne i stadie IV, 61% havde hjernemetastaser, og 96% af patienterne havde tumorer klassificeret som adenokarcinomer.
At the time of entry in the study, 99% of patients had stage IV disease, 61% had brain metastases and in 96% of patients tumours were classified as adenocarcinoma.
Du må ikke opholde dig i solen i lang tid, mens du tager Alecensa og i 7 dage efter, behandlingen er slut.
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.
Akkumuleringsratio ved 600 mg 2 gange dagligt var ca. 6-fold.
The accumulation ratio for the twice-daily 600 mg regimen was approximately 6-fold.
Sekundære virkningsparametre
Secondary efficacy parameters
Ingen patienter havde tilfælde af grad ≥3.66 ud af 365 patienter (18%) behandlet med Alecensa havde en post-dosis hjertefrekvens på under 50 slag per minut.
There were 66 of 365 patients (18%) treated with Alecensa who had post-dose heart rate values below 50 beats per minutes (bpm).
I to af tilfældene medførte dette til en seponering af Alecensa.
Two of these cases led to withdrawal from Alecensa treatment.
● dabigatran-etexilat, medicin mod blodpropper
● dabigatran etexilate, a medicine used to treat blood clots
Tabel 5 Virkningsresultater fra studie NP28673 og NP28761
Table 5 Efficacy results from studies NP28673 and NP28761
I alt 87 patienter blev inkluderet i studiets fase II-del, hvor de fik Alecensa oralt i den anbefalede dosis på 600 mg to gange dagligt.
A total of 87 patients were included in the phase II part of the study and received Alecensa orally, at the recommended dose of 600 mg twice daily.
Fertile kvinder/prævention
Women of childbearing potential/contraception
Blandt de inkluderede patienter havde 26% oplevet progression under tidligere behandling med crizotinib alene og 74% progression under tidligere behandling med crizotinib og mindst én kemoterapibehandling.
Among the patients included in the study, 26% of the patients had previously progressed on crizotinib treatment only, and 74% had previously progressed on crizotinib and at least one chemotherapy treatment.
Alectinib og M4 kan derfor potentielt øge plasmakoncentrationen af samtidigt administrerede BCRP-substrater.
Therefore, alectinib and M4 may have the potential to increase plasma concentrations of co-administered substrates of BCRP.
Ved inklusion i studiet var 99% af patienterne i stadie IV, 60% havde hjernemetastaser og 94% af patienterne havde tumorer klassificeret som adenokarcinomer.
At the time of entry in the study, 99% of patients had stage IV disease, 60% had brain metastases and in 94% of patients tumours were classified as adenocarcinoma.
In vitro hæmmer alectinib og M4 efflux-transportøren BCRP (brystcancer-resistensprotein).
In vitro, alectinib and M4 are inhibitors of the efflux transporter Breast Cancer Resistance Protein (BCRP).
Hvis patienten oplever symptomatisk bradykardi eller livstruende hændelser, bør samtidig behandling med lægemidler, der vides at forårsage bradykardi, samt antihypertensiva vurderes, og behandlingen med Alecensa justeres som beskrevet i Tabel 2 (se pkt.
If patients experience symptomatic bradycardia or life-threatening events, concomitant medicinal products known to cause bradycardia, as well as anti-hypertensive medicinal products should be evaluated and Alecensa treatment should be adjusted as described in Table 2 (see sections 4.2 and 4.5, ‘P-gp substrates' and ‘BCRP substrates').
CNS-respondere n (%)
CNS responders n (%)
Tabel 6 Resumé af pooled analyse af CNS-endepunkter fra studie NP28673 og NP28761 CNS-parametre (NP28673 og NP28761)
Table 6 Summary of the pooled analysis of CNS endpoints from studies NP28673 and NP28761 CNS Parameters (NP28673 and NP28761)
I alt 138 patienter blev inkluderet i studiets fase II-del, hvor de fik Alecensa oralt i den anbefalede dosis på 600 mg to gange dagligt.
A total of 138 patients were included in the phase II part of the study and received Alecensa orally, at the recommended dose of 600 mg twice daily.
In vitro hæmmer alectinib og dets primære aktive metabolit, M4, efflux-transportøren P-glykoprotein (P-gp).
In vitro, alectinib and its major active metabolite M4 are inhibitors of the efflux transporter P-glycoprotein (P-gp).
● nilotinib, medicin mod bestemte typer kræft
● nilotinib, a medicine used to treat certain types of cancer
Dosisjustering af Alecensa på grund af disse bivirkninger var kun nødvendig hos to patienter (0,5%).
Dose modifications of Alecensa treatment due to these adverse events were only required for two patients (0.5%); Alecensa treatment was not withdrawn due to these events of myalgia.
I toksikologiske studier med gentagen dosering til rotter og aber omfattede målorganer ved klinisk relevant eksponering bl.a. det erytropoietiske system, gastrointestinalkanalen samt lever og galdeveje.
Target organs in both rat and monkey at clinically relevant exposures in the repeat-dose toxicology studies included, but were not limited to the erythroid system, gastrointestinal tract, and hepatobiliary system.
astenopi og diplopi inkluderer tilfælde af bradykardi og sinusbradykardi inkluderer tilfælde af stomatitis og mundsår 6) inkluderer tilfælde af forhøjet bilirubin i blod, hyperbilirubinæmi og forhøjet konjugeret bilirubin inkluderer to patienter med rapporteret lægemiddelinduceret leverskade (MedDRA-term) samt en patient med rapporteret grad 4 stigninger i ASAT og ALAT, som havde dokumenteret lægemiddelinduceret leverskade ved leverbiopsi 8) inkluderer tilfælde af udslæt, makulopapuløst udslæt, acneiform dermatitis, erytem,
1) includes cases of anaemia and haemoglobin decreased includes cases of dysgeusia and hypogeusia 3) includes cases of blurred vision, visual impairment, vitreous floaters, reduced visual acuity, asthenopia, and diplopia 4) includes cases of bradycardia and sinus bradycardia includes cases of stomatitis and mouth ulceration 6) includes cases of blood bilirubin increased, hyperbilirubinaemia and bilirubin conjugated increased includes two patients with reported MedDRA term of drug-induced liver injury as well as one patient with reported Grade 4 increased AST and ALT who had documented drug-induced liver injury by liver biopsy includes cases of rash, rash maculopapular, dermatitis acneiform, erythema, rash generalised, rash papular, rash pruritic, rash macular and exfoliative rash includes cases of myalgia and musculoskeletal pain includes cases of oedema peripheral, oedema, generalised oedema, eyelid oedema, periorbital oedema, face oedema and localised oedema
Alectinib og M4 kan derfor potentielt øge plasmakoncentrationen af samtidigt administrerede P-gp-substrater.
Therefore, alectinib and M4 may have the potential to increase plasma concentrations of co-administered substrates of P-gp.
Patienten skal udvise forsigtighed, når der føres motorkøretøj og betjenes maskiner, da symptomatisk bradykardi (fx synkope, svimmelhed, hypotension) eller synsforstyrrelser kan optræde under behandling med Alecensa (se pkt.
Caution should be exercised when driving or operating machines as patients may experience symptomatic bradycardia (e.g., syncope, dizziness, hypotension) or vision disorders while taking Alecensa (see section 4.8).
Samtidig administration af gentagne orale doser rifampicin 600 mg 1 gang dagligt, en potent CYP3Ainduktor, og en enkelt oral dosis alectinib på 600 mg reducerede alectinib-Cmax og -AUCinf med henholdsvis 51% og 73% og øgede M4-Cmax og -AUCinf henholdsvis 2,20- og 1,79-fold.
Co-administration of multiple oral doses of 600 mg rifampicin once daily, a strong CYP3A inducer, with a single oral dose of 600 mg alectinib reduced alectinib Cmax, and AUCinf by 51% and 73% respectively and increased M4 Cmax and AUCinf 2.20 and 1.79-fold respectively.
Alecensa hårde kapsler er hvide med ‘ALE' trykt med sort blæk på hætten og ‘150 mg' trykt med sort blæk på underdelen.
What Alecensa looks like and contents of the pack Alecensa hard capsule are white, with ‘ALE' printed in black ink on the cap and ‘150 mg' printed in black ink on the body.
Pakningsstørrelse: 224 (4 pakker a 56) hårde kapsler.
Pack size: 224 (4 packs of 56) hard capsules.
Beskrivelse af udvalgte lægemiddelbivirkninger
Description of selected adverse drug reactions
Afhængigt af sværhedsgraden af stigningen i kreatinkinase bør behandlingen med Alecensa afbrydes og derefter genoptages, eller dosis bør reduceres (se pkt.
Based on the severity of the CPK elevation, Alecensa should be withheld, then resumed or dose reduced (see section 4.2).
● Prægeblæk: rød jernoxid (E172), gul jernoxid (E172), indigocarmin aluminium lake (E132), carnaubavoks, hvid shellac og glycerylmonooleat.
● Printing ink: red iron oxide (E172), yellow iron oxide (E172), indigo carmine aluminium lake (E132), carnauba wax, white shellac and glyceryl monooleate.
Forhøjet kreatinkinase i Blodet
Increased blood creatine phosphokinase
Til patienter med svært nedsat leverfunktion (Child-Pugh C) skal startdosis være 450 mg 2 gange dagligt i forbindelse med et måltid (daglig dosis i alt er 900 mg).
Patients with underlying severe hepatic impairment (Child-Pugh C) should receive a starting dose of 450 mg taken twice daily with food (total daily dose of 900 mg).
Kontakt lægen, sundhedspersonalet eller apotekspersonalet, hvis du bemærker en eller flere af følgende bivirkninger:
Other side effects Tell your doctor, pharmacist or nurse if you notice any of the following side effects:
Kapselskal Hypromellose Carrageenan Kaliumchlorid Titandioxid (E171) Majsstivelse Carnaubavoks
Capsule shell Hypromellose Carrageenan Potassium chloride Titanium dioxide (E171) Maize starch Carnauba wax
Det skal du vide, før du begynder at tage Alecensa
What you need to know before you take Alecensa
Sikkerhed og virkning af Alecensa er undersøgt i et globalt, randomiseret, åbent, klinisk fase III-studie (BO28984, ALEX) med tidligere ubehandlede, ALK-positive patienter med ikke-småcellet lungekræft.
The safety and efficacy of Alecensa were studied in a global randomised Phase III open label clinical trial (BO28984, ALEX) in ALK-positive NSCLC patients who were treatment naïve.
Øjne Synsforstyrrelser3)
Eye disorders Vision disorders3)
itraconazol, voriconazol, posaconazol) og medicin mod bestemte bakterielle infektioner
These include medicines that treat fungal infections (antifungals such as ketoconazole, itraconazole, voriconazole, posaconazole) and medicines that treat certain types of bacterial infection (antibiotics such as telithromycin)
CNS-objektiv responsrate for patienter med målbare og ikke-målbare CNSmetastaser ved baseline (uafhængig bedømmelseskomité)
CNS-ORR in patients with measurable and non-measurable CNS metastases at baseline (IRC)
Alecensa kan give alvorlige og livstruende hævelser i lungerne (inflammation).
Alecensa may cause severe or life-threatening swelling (inflammation) of the lungs during treatment.
79639 Grenzach-Whylen
79639 Grenzach-Wyhlen
På baggrund af virkningen på den samlede eksponering af alectinib og M4 er dosisjustering ikke nødvendig, når Alecensa administreres samtidig med CYP3A-induktorer.
Based on the effects on the combined exposure of alectinib and M4, no dose adjustments are required when Alecensa is co-administered with CYP3A inducers.
Startdosis til patienter med svært nedsat leverfunktion (Child-Pugh C) er 450 mg 2 gange dagligt (dosis i alt er 900 mg) (se pkt.
Patients with underlying severe hepatic impairment (Child-Pugh C) should receive a starting dose of 450 mg taken twice daily (total dose of 900 mg) (see section 5.2).
På baggrund af virkningen på den samlede eksponering af alectinib og M4 er dosisjustering ikke nødvendig, når Alecensa administreres sammen med CYP3A-hæmmere.
Based on the effects on the combined exposure of alectinib and M4, no dose adjustments are required when Alecensa is co-administered with CYP3A inhibitors.
Hvis du kaster op, efter du har taget Alecensa
If you vomit after taking Alecensa
De patientdemografiske data svarede til data for en ikke-småcellet lungekræft ALK-positiv population.
Patient demographics were consistent with that of a NSCLC ALK positive population.
De farmakokinetiske parametre for alectinib og den vigtigste aktive metabolit (M4) er karakteriseret hos patienter med ALK-positiv ikke-småcellet lungekræft og raske frivillige.
The pharmacokinetic parameters for alectinib and its major active metabolite (M4) have been characterised in ALK-positive NSCLC patients and healthy subjects.
● Kapselskal: hypromellose, carrageenan, kaliumchlorid, titandioxid (E171), majsstivelse og carnaubavoks
● Capsule shell: hypromellose, carrageenan, potassium chloride, titanium dioxide (E171), maize starch and carnauba wax
Brug af anden medicin sammen med Alecensa
Other medicines and Alecensa
En valideret ALK-test er nødvendig for at udvælge patienter med ALK-positiv ikke-småcellet lungekræft.
A validated ALK assay is necessary for the selection of ALK-positive NSCLC patients.
Lægen vil tage blodprøver, inden du begynder behandlingen med Alecensa, hver 2. uge i de første 3 måneder af behandlingen og derefter med længere mellemrum.
When you take Alecensa your doctor will do blood tests before you start treatment, then every 2 weeks for the first 3 months of your treatment and then less often.
● Hvis Alecensa er pakket i beholder, skal det opbevares i den original pakning og hold beholderen tæt lukket for at beskytte mod fugt.
● If Alecensa is packed in bottles, store in the original package and keep the bottle tightly closed to protect from moisture.
Der er rapporteret tilfælde af interstitiel lungesygdom/pneumonitis i kliniske studier med Alecensa (se pkt.
Cases of ILD/pneumonitis have been reported in clinical trials with Alecensa (see section 4.8).
Hvis du har flere spørgsmål til brugen af denne medicin, skal du kontakte lægen, sundhedspersonalet eller apotekspersonalet.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING En hård kapsel indeholder alectinibhydrochlorid svarende til 150 mg alectinib.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains alectinib hydrochloride equivalent to 150 mg alectinib.
Henholdsvis 1,2% og 1,5% af patienterne seponerede Alecensa på grund af forhøjet ASAT og ALAT.
In 1.2% and 1.5% of the patients, AST and ALT elevations, respectively, led to withdrawal from Alecensa treatment.
Der blev rapporteret grad 3-tilfælde af diarré (0,7%), kvalme (0,5%) og opkastning (0,2%).
Most of these events were of mild or moderate severity; Grade 3 events were reported for diarrhea (0.7%), nausea (0.5%), and vomiting (0.2%).
Kontakt straks lægen, hvis du oplever nye eller forværrede symptomer, for eksempel vejrtrækningsbesvær, åndenød eller hoste med eller uden slim, eller hvis du får feber.
Tell your doctor straight away if you have any new or worsening signs including difficulty in breathing, shortness of breath, or cough with or without mucous, or fever.
Alecensa 600 mg, 2 gange dagligt
Alecensa 600 mg twice daily
Selvom farmakokinetiske simulationer for Alecensa ikke indikerer lav eksponering hos patienter med ekstrem kropsvægt (dvs. >130 kg), har alectinib et stort fordelingsvolumen.
Although PK simulations for Alecensa do not indicate a low exposure in patients with extreme body weight (i.e. >130 kg), alectinib is widely distributed and clinical studies for alectinib enrolled patients within a range of body weights of 36.9−123 kg.
LÆGEMIDLETS NAVN Alecensa 150 mg hårde kapsler
NAME OF THE MEDICINAL PRODUCT Alecensa 150 mg hard capsules
Sådan virker Alecensa
How Alecensa works
Ved vedvarende dosering af alectinib 600 mg 2 gange dagligt nås steady state inden for 7 dage.
Alectinib steady-state is reached within 7 days with continuous 600 mg twice daily dosing.
● unormale værdier af en blodprøve til kontrol af leversygdomme eller knoglesygdomme (høje værdier af alkalisk fosfatase)
● abnormal results of blood tests to check for liver disease or bone disorders (high level of alkaline phosphatase)
Afbryd behandlingen indtil bedring til grad ≤1 (asymptomatisk) bradykardi eller til en hjertefrekvens på ≥60 slag per minut.
Temporarily withhold until recovery to ≤ Grade 1 (asymptomatic) bradycardia or to a heart rate of ≥ 60 bpm.
● lapatinib, medicin mod bestemte typer brystkræft
● lapatinib, a medicine used to treat certain types of breast cancer
Afbryd behandlingen indtil bedring til baselineniveau eller ≤2,5 gange øvre referencegrænse; herefter genoptages behandlingen med reduceret dosis i overensstemmelse med Tabel 1.
Temporarily withhold until recovery to baseline or to ≤ 2.5 times ULN, then resume at reduced dose as per Table 1.
Baseret på en farmakokinetisk populationsanalyse svarer eksponeringen af alectinib og M4 hos patienter med let og moderat nedsat nyrefunktion til eksponeringen hos patienter med normal nyrefunktion.
Based on a population pharmacokinetic analysis alectinib and M4 exposures were similar in patients with mild and moderate renal impairment and normal renal function.
SÆRLIGE OPBEVARINGSBETINGELSER Opbevar i den originale pakning og hold beholderen tæt lukket for at beskytte mod fugt
SPECIAL STORAGE CONDITIONS Store in the original package and keep the bottle tightly closed in order to protect from moisture
Sikkerhedsprofilen af Alecensa var generelt tilsvarende i det pivotale fase III kliniske studie BO28984 (ALEX) og i fase II-studier (NP28761, NP28673).
The safety profile of Alecensa was generally consistent across the pivotal phase III clinical trial BO28984 (ALEX) and phase II trials (NP28761, NP28673).
Der anbefales passende monitorering (fx markører for leverfunktionen) for alle patienter med nedsat leverfunktion, se pkt.
For all patients with hepatic impairment, appropriate monitoring (e.g. markers of liver function) is advised, see section 4.4.
Hvis anden samtidig lægemiddelbehandling identificeres som bidragende til tilstanden, og denne seponeres, eller dosis heraf justeres, kan behandling med Alecensa genoptages med reduceret dosis (se Tabel 1), når bradykardien er af grad ≤1 (asymptomatisk) eller ved en hjertefrekvens på ≥60 slag per minut, med hyppig monitorering som klinisk indiceret.
If a contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, resume at reduced dose (see Table 1) upon recovery to ≤ Grade 1 (asymptomatic) bradycardia or to a heart rate of ≥ 60 bpm, with frequent monitoring as clinically indicated.
● unormale resultater af blodprøver til vurdering af muskelskader (højt niveau af kreatinkinase)
● abnormal results of blood tests to check for muscle damage (high level of creatine phosphokinase)
Patienterne skal monitoreres for pulmonale symptomer indikative for pneumonitis (se pkt.
Patients should be monitored for pulmonary symptoms indicative of pneumonitis (see sections 4.2 and 4.4).
Studie NP28761 var et enkeltarmet fase I/II-multicenterstudie med patienter med ALK-positiv fremskreden ikke-småcellet lungekræft, der har oplevet progression under behandling med crizotinib.
Study NP28761 was a Phase I/II single arm multicentre study conducted in patients with ALK positive advanced NSCLC who have previously progressed on crizotinib treatment.
● vægtstigning
● weight gain.
Alecensa 150 mg hårde kapsler alectinib
Alecensa 150 mg hard capsules alectinib
I de generelle toksicitetsstudier er der ikke observeret negative virkninger på reproduktionsorganer hos hanner eller hunner (se pkt.
No adverse effects on male and female reproductive organs were observed in general toxicology studies (see section 5.3).
Rød jernoxid (E172) Gul jernoxid (E172) Indigocarminaluminium lake (E132) Carnaubavoks
Red iron oxide (E172) Yellow iron oxide (E172) Indigo carmine aluminum lake (E132) Carnauba wax
Studie NP28673 var et enkeltarmet fase I/II-multicenterstudie med patienter med ALK-positiv fremskreden ikke-småcellet lungekræft, der har oplevet progression under tidligere crizotinibbehandling.
Study NP28673 was a Phase I/II single arm, multicentre study conducted in patients with ALK-positive advanced NSCLC who have previously progressed on crizotinib treatment.
Alecensa indeholder natrium
Alecensa contains sodium