FrancophonIA/ELRC3.0 huggingface dataset:
English: In urine and faeces combined, 48%, 27%, and 9.1% of the radioactive dose was excreted as unchanged brigatinib, N-desmethyl brigatinib (AP26123), and brigatinib cysteine conjugate, respectively.
Danish: I urin og fæces kombineret blev henholdsvis 48 %, 27 % og 9,1 % af den radioaktive dosis udskilt som uændret brigatinib, N-desmethyl-brigatinib (AP26123) og brigatinib-cystein-konjugat.
English: Alunbrig is available as a treatment initiation pack.
Danish: Alunbrig fås som en pakning til behandlingsopstart.
English: In Study 101, the QT interval prolongation potential of Alunbrig was assessed in 123 patients with advanced malignancies following once daily brigatinib doses of 30 mg to 240 mg.
Danish: I Studie 101 blev Alunbrigs potentiale for forlængelse af QT-intervallet vurderet hos 123 patienter med fremskredne maligniteter efter doser af 30 mg til 240 mg brigatinib en gang daglig.
English: Alunbrig contains lactose
Danish: Alunbrig indeholder lactose
English: • rifabutin, rifampicin: medicines to treat tuberculosis or certain other infections
Danish: • rifabutin, rifampicin: lægemidler til behandling af tuberkulose eller visse andre infektioner
English: Coadministration of brigatinib with substrates of P-gp, (e.g., digoxin, dabigatran, colchicine, pravastatin), BCRP (e.g., methotrexate, rosuvastatin, sulfasalazine), organic cation transporter 1 (OCT1), multidrug and toxin extrusion protein 1 (MATE1), and 2K (MATE2K) may increase their plasma concentrations.
Danish: Samtidig administration af brigatinib og substrater af P-gp (f.eks. digoxin, dabigatran, colchicin, pravastatin), BCRP (f.eks. methotrexat, rosuvastatin, sulfasalazin), OCT1 (organic cation transporter 1), MATE1 (multidrug and toxin extrusion protein 1) og MATE2K kan øge deres plasmakoncentrationer.
English: Caution should be exercised when administering Alunbrig in combination with other agents known to cause bradycardia.
Danish: Der skal udvises forsigtighed ved administration af Alunbrig i kombination med andre stoffer, der vides at forårsage bradykardi.
English: Moderate CYP3A inducers may decrease the AUC of brigatinib by approximately 50% based on simulations from a physiologically-based pharmacokinetic model.
Danish: Moderate CYP3A-induktorer kan reducere brigatinibs AUC med ca. 50 % baseret på simuleringer fra en fysiologisk baseret farmakokinetisk model.
English: However, caution should be exercised when driving or operating machines as patients may experience visual disturbance, dizziness, or fatigue while taking Alunbrig.
Danish: Der skal dog udvises forsigtighed, hvis patienten fører motorkøretøj eller betjener maskiner, da der kan forekomme synsforstyrrelser, svimmelhed eller træthed under behandling med Alunbrig.
English: Population pharmacokinetic analyses showed that race and gender had no impact on the pharmacokinetics of brigatinib.
Danish: Farmakokinetiske populationsanalyser viste, at race og køn ikke har nogen indvirkning på brigatinibs farmakokinetik.
English: If concomitant use of strong CYP3A inhibitors cannot be avoided, the dose of Alunbrig should be reduced by approximately 50% (i.e. from 180 mg to 90 mg, or from 90 mg to 60 mg).
Danish: Hvis samtidig brug af kraftige CYP3A-hæmmere ikke kan undgås, skal dosis af Alunbrig reduceres med ca. 50 % (dvs. fra 180 mg til 90 mg eller fra 90 mg til 60 mg).
English: Brigatinib inhibited the in vitro and in vivo viability of cells expressing mutant forms of EML4-ALK associated with resistance to ALK inhibitors, including G1202R and L1196M.
Danish: Brigatinib hæmmede levedygtigheden in vitro og in vivo af celler, der udtrykker mutantformer af EML4-ALK forbundet med resistens over for ALK-hæmmere, herunder G1202R og L1196M.
English: Lactose monohydrate Microcrystalline cellulose Sodium starch glycolate (type A) Silica colloidal hydrophobic Magnesium stearate
Danish: Lactosemonohydrat Mikrokrystallinsk cellulose Natriumstivelsesglykolat (type A) Kolloid hydrofob silica Magnesiumstearat
English: Following Grade 1-2 pulmonary adverse reactions, treatment with Alunbrig was either interrupted and then restarted or the dose was reduced.
Danish: Efter pulmonale bivirkninger af Grad 1-2 blev behandling med Alunbrig enten afbrudt og derefter genopstartet, eller dosis blev reduceret.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Alunbrig in all subsets of the paediatric population in lung carcinoma (small cell and non-small cell carcinoma) (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af forsøg med Alunbrig i alle undergrupper af den pædiatriske population med lungekarcinom (småcellet og ikke-småcellet karcinom) (se pkt.
English: In patients with any brain metastases at baseline, intracranial disease control rate was 77.8% (95% CI 67.2-86.3) in the 90 mg arm (N = 81) and 85.1% (95% CI 75-92.3) in the 180 mg arm (N=74).
Danish: Hos patienter med hjernemetastaser uanset type ved baseline var kontrolraten for intrakraniel sygdom 77,8 % (95 % CI 67,2-86,3) i 90 mg-armen (N = 81) og 85,1 % (95 % CI 75-92,3) i 180 mg-armen (N = 74).
English: Alunbrig is used to treat adults with advanced stages of a lung cancer called non-small cell lung cancer.
Danish: Alunbrig bruges til behandling af voksne med fremskredne stadier af lungekræft af typen ikke-småcellet lungekræft.
English: Additionally, 2.3% of patients in ALTA experienced pneumonitis later in treatment, with 2 patients having Grade 3 pneumonitis (see sections 4.2 and 4.4).
Danish: Desuden fik 2,3 % af patienterne i ALTA pneumonitis senere i behandlingen, og 2 patienter fik Grad 3-pneumonitis (se pkt.
English: Brigatinib is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) in vitro.
Danish: Brigatinib er et substrat af P-glykoprotein (P-gp) og brystcancer-resistensprotein (BCRP) in vitro.
English: Each bottle contains one canister of a desiccant and is packed in a carton with:
Danish: Hver flaske indeholder en kapsel med tørremiddel og er pakket i en ydre karton med:
English: The recommended dose is
Danish: Anbefalet dosis
English: • cold-like symptoms (upper respiratory tract infection)
Danish: • forkølelsessymptomer (infektion i de øvre luftveje)
English: For elevations to Grade 3 and 4, the incidences for ALT and AST were 5.5% and 3.6%, respectively.
Danish: Forekomsten af forhøjede ALAT- og ASAT-værdier af Grad 3 og 4 var henholdsvis 5,5 % og 3,6 %.
English: Blood pressure should be monitored regularly during treatment with Alunbrig.
Danish: Blodtrykket skal overvåges regelmæssigt under behandling med Alunbrig.
English: The median time to onset for CPK elevations was 27 days.
Danish: Mediantiden til debut af forhøjet CK var 27 dage.
English: Alunbrig may cause visual disturbances, dizziness or tiredness.
Danish: Alunbrig kan give synsforstyrrelser, svimmelhed eller træthed.
English: Common Pneumonitisi
Danish: Almindelig Pneumonitisi
English: Moderate CYP3A inhibitors (e.g., diltiazem and verapamil) may increase the AUC of brigatinib by approximately 40% based on simulations from a physiologically-based pharmacokinetic model.
Danish: Moderate CYP3A-hæmmere (f.eks. diltiazem og verapamil) kan øge AUC for brigatinib med ca. 40 % baseret på simuleringer fra en fysiologisk baseret farmakokinetisk model.
English: If pneumonitis is suspected, the dose of Alunbrig should be withheld, and the patient evaluated for other causes of symptoms (e.g., pulmonary embolism, tumour progression, and infectious pneumonia).
Danish: Ved mistanke om pneumonitis skal behandling med Alunbrig tilbageholdes og patienten skal evalueres for andre årsager til symptomer (for eksempel lungeemboli, tumorprogression og infektiøs pneumoni).
English: Common Pain in extremity Musculoskeletal stiffness
Danish: Almindelig Smerter i ekstremitet Muskel- og knoglestivhed
English: Efficacy results from ALTA analysis are summarised in Table 4. and the Kaplan-Meier (KM) curve for investigator-assessed PFS is shown in Figure 1.
Danish: Tabel 4 viser en oversigt over effektresultater fra ALTA-analyser, og figur 1 viser Kaplan-Meier-kurven (KM) for investigator-bedømt PFS.
English: 90 mg regimen* (N = 26)
Danish: 90 mg regime* (N = 26)
English: Overall, these effects on the male reproductive organs in rats and monkeys occurred at exposures ≥ 0.2-times the AUC observed in patients at the 180 mg once daily dose.
Danish: Samlet set forekom disse virkninger på handyrs forplantningsorganer hos rotter og aber ved eksponeringer ≥ 0,2 gange det AUC, der er observeret hos patienter, som fik en dosis på 180 mg en gang daglig.
English: In in vitro kinase and cellular assays, the metabolite, AP26123, inhibited ALK with approximately 3-fold lower potency than brigatinib.
Danish: I in vitro- kinase og cellebaserede analyse hæmmede metabolitten AP26123 ALK med ca. 3 gange lavere potens end brigatinib.
English: Brigatinib was not mutagenic in vitro in the bacterial reverse mutation (Ames) or the mammalian cell chromosomal aberration assays, but slightly increased the number of micronuclei in a rat bone marrow micronucleus test.
Danish: Brigatinib var ikke mutagent in vitro i analyserne af bakteriel revers mutation (Ames) eller kromosomforandringer af pattedyrsceller, men øgede antallet af mikrokerner i en test af mikrokerner i rotteknoglemarv.
English: If you forget to take Alunbrig
Danish: Hvis du har glemt at tage Alunbrig
English: If you stop taking Alunbrig
Danish: Hvis du holder op med at tage Alunbrig
English: Tell your doctor if you have pain on the right side of your stomach area, yellowing of your skin or the whites of your eyes, or dark urine.
Danish: hvis du får smerter i højre side af maven, hvis din hud eller det hvide i dine øjne bliver gulfarvet, eller hvis din urin er mørk.
English: In six healthy male subjects given a single 180 mg oral dose of [14C]brigatinib, 65% of the administered dose was recovered in faeces and 25% of the administered dose was recovered in urine.
Danish: Hos seks raske mandlige forsøgspersoner, som fik en enkelt oral dosis på 180 mg [14C]brigatinib, blev 65 % af den administrerede dosis genfundet i fæces, og 25 % af den administrerede dosis blev genfundet i urin.
English: A validated ALK assay is necessary for the selection of ALK-positive NSCLC patients (see section 5.1).
Danish: Der kræves en valideret ALK-analysemetode som grundlag for udvælgelse af ALK-positive NSCLC-patienter (se pkt.
English: Brigatinib is a substrate of the transporter proteins P-gp and BCRP.
Danish: Brigatinib er et substrat af transportørproteinerne P-gp og BCRP.
English: • mibefradil: a medicine to treat irregular heart rhythm and high blood pressure
Danish: • mibefradil: et lægemiddel til behandling af uregelmæssig hjerterytme og for højt blodtryk
English: The population pharmacokinetic analyses showed that body weight, age, and albumin concentration had no clinically relevant impact on the pharmacokinetics of brigatinib.
Danish: De farmakokinetiske populationsanalyser viste, at legemsvægt, alder og albuminkoncentration ikke havde klinisk relevant indvirkning på brigatinibs farmakokinetik.
English: Patients with a history of pulmonary interstitial disease or drug-related pneumonitis were excluded.
Danish: Patienter med interstitiel lungesygdom eller lægemiddel-relateret pneumonitis blev udelukket.
English: 180 mg once daily reduce to 120 mg once daily reduce to 90 mg once daily reduce to 60 mg once daily
Danish: 180 mg en gang daglig reducer til 120 mg en gang daglig reducer til 90 mg en gang daglig reducer til 60 mg en gang daglig
English: Grapefruit or grapefruit juice may also increase plasma concentrations of brigatinib and should be avoided (see section 4.2).
Danish: Grapefrugt eller grapefrugtjuice kan også øge plasmakoncentrationen for brigatinib og bør undgås (se pkt.
English: Lipase and amylase should be monitored regularly during treatment with Alunbrig.
Danish: Niveauerne af lipase og amylase skal overvåges regelmæssigt under behandling med Alunbrig.
English: For new or worsening severe visual symptoms, an ophthalmologic evaluation and dose reduction should be considered (see section 4.2).
Danish: Ved nye eller forværrede svære synsrelaterede symptomer skal det overvejes at foretage en oftalmologisk evaluering og reduktion af dosis skal overvejes (se pkt.
English: • The other excipients are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), silica colloidal hydrophobic, magnesium stearate, talc, macrogol, polyvinyl alcohol, and titanium dioxide.
Danish: • Øvrige indholdsstoffer: lactosemonohydrat, mikrokrystallinsk cellulose, natriumstivelsesglykolat (type A), kolloid hydrofob silica, magnesiumstearat, talkum, macrogol, polyvinylalkohol og titandioxid.
English: Pneumoniaa
Danish: Pneumonia
English: Therefore, coadministration of Alunbrig with CYP3A substrates with a narrow therapeutic index (e.g., alfentanil, fentanyl, quinidine, cyclosporine, sirolimus, tacrolimus) should be avoided as their effectiveness may be reduced.
Danish: Derfor skal samtidig administration af Alunbrig og CYP3A-substrater med et smalt terapeutisk indeks (f.eks. alfentanil, fentanyl, quinidin, ciclosporin, sirolimus, tacrolimus) undgås, da deres virkning kan blive hæmmet.
English: Investigator assessment
Danish: Investigatorbedømmelse
English: Based on repeat-dose toxicity studies in male animals, Alunbrig may cause reduced fertility in males (see section 5.3).
Danish: På baggrund af toksicitetsundersøgelser med flere doser hos handyr kan Alunbrig medføre nedsat fertilitet hos handyr (se pkt.
English: Grade 1-2 pulmonary adverse reactions resolved with interruption of treatment or dose modification.
Danish: Pulmonale bivirkninger af Grad 1-2 forsvandt med afbrydelse af behandling eller en dosisjustering.
English: The geometric mean steady state Cmax of brigatinib at doses of 90 mg and 180 mg once daily was 552 and 1,452 ng/mL, respectively, and the corresponding AUC0-τ was 8,165 and 20,276 h∙ng/mL, respectively.
Danish: Geometrisk middelværdi for steady state Cmax for brigatinib ved doser på 90 mg og 180 mg en gang daglig var henholdsvis 552 og 1452 ng/ml, og det tilhørende AUC0- var henholdsvis 8.165 og 20.276 t∙ng/ml.
English: Alunbrig should be resumed at next lower dose level as described in Table 1.
Danish: Behandling med Alunbrig skal genoptages med det nærmeste lavere dosistrin, som beskrevet i tabel 1.
English: If symptomatic bradycardia occurs, treatment with Alunbrig should be withheld and concomitant medicinal products known to cause bradycardia should be evaluated.
Danish: Hvis der opstår symptomatisk bradykardi, skal behandling med Alunbrig afbrydes, og samtidig brug af lægemidler, der vides at forårsage bradykardi, skal reevalueres.
English: • increased blood levels of liver enzymes (aspartate aminotransferase, alanine aminotransferase) in tests -may indicate liver cell damage.
Danish: • forhøjede niveauer af leverenzymer i blodet (aspartataminotransferase, alaninaminotransferase) (set i test) - kan være tegn på levercelleskader.
English: Brigatinib inhibited autophosphorylation of ALK and ALK-mediated phosphorylation of the downstream signalling protein STAT3 in in vitro and in vivo assays.
Danish: Brigatinib hæmmede autophosphorylering af ALK og ALK-medieret phosphorylering af det nedstrøms-signalerings protein STAT3 i in vitro- og in vivo-analyser.
English: • digoxin: a medicine to treat heart problems
Danish: • digoxin: et lægemiddel til behandling af hjerteproblemer
English: • The patient alert card shall contain the following key messages: o A warning message for health care professionals treating the patient at any time, including in conditions of emergency, that the patient is using Alunbrig o That Alunbrig treatment may increase the risk of early onset pulmonary events (including interstitial lung disease and pneumonitis) o Signs or symptoms of the safety concern and when to seek attention from a HCP o Contact details of the Alunbrig prescriber
Danish: • Patientkortet skal indeholde følgende nøglebudskaber: o En advarsel/information til sundhedsprofessionelle, der på et hvilket som helst tidspunkt behandler en patient inklusive under en akut nødsituation, om behandling med Alunbrig, o At behandling med Alunbrig kan øge risikoen for lungelidelser efter kort tids behandling (inklusive interstitiel lungesygdom og pneumonitis).
English: • Alunbrig should be permanently discontinued if no contributing concomitant medicinal product is identified.
Danish: • Behandling med Alunbrig skal seponeres, hvis der ikke er identificeret andre bidragende samtidigt anvendte lægemidler.
English: In a separate dose finding study, 25 patients with ALK-positive NSCLC that progressed on crizotinib were administered Alunbrig at 180 mg once daily with 7-day lead-in at 90 mg once daily regimen.
Danish: I et separat forsøg til dosisfastlæggelse fik 25 patienter med ALK-positiv NSCLC, som progredierede med crizotinib, administreret 180 mg Alunbrig en gang daglig med 7-dages opstartsperiode med 90 mg en gang daglig.
English: In a pharmacokinetic study, unbound AUC0-INF was 94% higher in patients with severe renal impairment (eGFR < 30 mL/min, N = 6) as compared to patients with normal renal function (eGFR ≥ 90 mL/min, N = 8) (see section 4.2).
Danish: I et farmakokinetisk forsøg var ubundet AUC0-INF 94 % højere hos patienter med svært nedsat nyrefunktion (eGFR < 30 ml/min, N = 6) sammenlignet med patienter med normal nyrefunktion (eGFR ≥ 90 ml/min, N = 8) (se pkt.
English: • methotrexate: a medicine to treat severe joint inflammation, cancer and the skin disease psoriasis
Danish: • methotrexat: et lægemiddel til behandling af svær ledbetændelse, kræft og hudsygdommen psoriasis
English: Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.
Danish: Alunbrig er indiceret som monoterapi til behandling af voksne patienter med fremskreden anaplastisk lymfom-kinase(ALK)-positiv, ikke-småcellet lungecancer (NSCLC), som tidligere har fået behandling med crizotinib.
English: if you are allergic to brigatinib or any of the other ingredients of this medicine (listed in section 6).
Danish: Det skal du vide, før du begynder at tage Alunbrig Tag ikke Alunbrig: hvis du er allergisk over for brigatinib eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
English: For elevations to Grade 3 and 4, the incidences for amylase and lipase were 8.2% and 10%, respectively.
Danish: Forhøjelser i amylase- og lipaseværdier af Grad 3 og 4 var henholdsvis 8,2 % og 10 %.
English: Heart rates of less than 50 beats per minute (bpm) were reported in 8.2% of patients at the 180 mg regimen.
Danish: Hjertefrekvenser på under 50 slag i minuttet (bpm) blev rapporteret hos 8,2 % af patienterne behandlet med 180 mg-regimet.
English: • cyclosporine, sirolimus, tacrolimus: medicines to suppress the immune system
Danish: • ciclosporin, sirolimus, tacrolimus: lægemidler, der undertrykker immunsystemet
English: The safety and efficacy of Alunbrig was evaluated in a randomised (1:1), open-label, multicenter trial (ALTA) in 222 adult patients with locally advanced or metastatic ALK-positive NSCLC who had progressed on crizotinib.
Danish: Alunbrigs sikkerhed og virkning blev vurderet i et randomiseret (1:1), åbent multicenterforsøg (ALTA) med 222 voksne patienter med lokalt fremskreden eller metastatisk ALK-positiv NSCLC, som havde progredieret på crizotinib.
English: In vitro studies demonstrated that brigatinib is primarily metabolised by CYP2C8 and CYP3A4, and to a much lesser extent by CYP3A5.
Danish: In vitro-forsøg påviste, at brigatinib primært omsættes af CYP2C8 og CYP3A4 og i langt mindre udstrækning af CYP3A5.
English: No dose adjustment of Alunbrig is required for patients with mild or moderate renal impairment (estimated glomerular filtration rate (eGFR) ≥ 30 mL/min).
Danish: Der kræves ingen dosisjustering af Alunbrig hos patienter med let til moderat nedsat nyrefunktion (estimeret glomerulær filtrationsrate (eGFR) ≥ 30 ml/min.).
English: • increased blood clotting time shown by test of activated partial thromboplastin time
Danish: • blodet er længere tid om at størkne (set i test ved aktiveret partiel protrombintid)
English: • increased blood level of insulin
Danish: • forhøjet niveau af insulin i blodet
English: In an embryo-foetal development study in which pregnant rats were administered daily doses of brigatinib during organogenesis; dose-related skeletal anomalies were observed at doses as low as approximately 0.7-times the human exposure by AUC at the 180 mg once daily dose.
Danish: I et forsøg af embryo-føtal udvikling med administration af daglige doser af brigatinib til drægtige rotter under organogenese blev der observeret dosisrelaterede knogleanomalier ved doser ned til ca. 0,7 gange human eksponering efter AUC med dosen på 180 mg en gang daglig.
English: Each pack consists of an outer carton with two inner cartons containing:
Danish: Hver pakning består af en udvendig æske med to indvendige æsker med:
English: • bosentan: a medicine to treat pulmonary hypertension
Danish: • bosentan: et lægemiddel til behandling af pulmonal hypertension
English: • increased blood level of bilirubin
Danish: • forhøjet niveau af bilirubin i blodet
English: Thirty percent of patients had resolution of all peripheral neuropathy adverse reactions.
Danish: Hos tredive procent af patienterne gik alle bivirkninger med perifer neuropati over igen.
English: Heart rate should be monitored more frequently in patients if concomitant use of a medicinal product known to cause bradycardia cannot be avoided.
Danish: Hjertefrekvensen skal overvåges hyppigere hos patienter, der samtidigt behandles med lægemidler, som vides at forårsage bradykardi, hvis brugen af disse lægemidler ikke kan undgås.
English: The concomitant use of Alunbrig with strong and moderate CYP3A inducers should be avoided (see section 4.5).
Danish: Samtidig brug af Alunbrig og kraftige og moderate CYP3A-induktorer bør undgås (se pkt.
English: The most common adverse reactions (≥ 25%) reported in patients treated with Alunbrig at the recommended dosing regimen were increased AST, hyperglycaemia, hyperinsulinaemia, anaemia, increased CPK, nausea, increased lipase, decreased lymphocyte count, increased ALT, diarrhoea, increased amylase, fatigue, cough, headache, increased alkaline phosphatase, hypophosphataemia,
Danish: De mest almindelige bivirkninger (≥ 25 %), som blev rapporteret hos patienter i behandling med det anbefalede doseringregime for Alunbrig, var forhøjet ASAT, hyperglykæmi, hyperinsulinæmi, anæmi, forhøjet CK, kvalme, forhøjet lipase, nedsat lymfocyttal, forhøjet ALAT, diarré, forhøjet amylase, træthed, hoste, hovedpine, forhøjet alkalisk phosphatase, hypophosphatæmi, forhøjet APTT, udslæt, opkastning, dyspnø, hypertension, nedsat leukocyttal, myalgi og perifer neuropati.
English: In patients given brigatinib 180 mg once daily, the geometric mean apparent volume of distribution (Vz/F) of brigatinib at steady state was 153 L, indicating moderate distribution into tissues.
Danish: Hos patienter, der fik 180 mg brigatinib en gang daglig, var den tilsyneladende geometriske middelværdi for distributionsvolumen (Vz/F) for brigatinib ved steady state 153 l, hvilket indikerer moderat fordeling til væv.
English: Common Dry skin Photosensitivity reaction
Danish: Almindelig Tør hud Lysfølsomhed
English: Outer Carton PC:
Danish: Ydre karton PC:
English: In healthy subjects, compared to overnight fasting, a high fat meal reduced brigatinib Cmax by 13% with no effect on AUC.
Danish: Hos raske forsøgspersoner reducerede et måltid med højt fedtindhold brigatinib Cmax med 13 % sammenlignet med faste natten over, mens der ikke var nogen virkning på AUC.
English: Fasting serum glucose should be assessed prior to initiation of Alunbrig and monitored periodically thereafter.
Danish: Inden indledning af behandling med Alunbrig skal serumglukose under faste evalueres og derefter overvåges regelmæssigt.