natgillin/translations-raw huggingface dataset:
Det primære effektendepunkt var andelen, der udviste major molekylært respons (MMR) efter 12 måneder (48 uger) i bosutinib-behandlingsgruppen, sammenlignet med andelen i imatinibbehandlingsgruppen i mITT-populationen.
The primary efficacy endpoint was the proportion demonstrating a major molecular response (MMR) at 12 months (48 weeks) in the bosutinib treatment group compared with that in the imatinib treatment group in the mITT population.
Nydiagnosticeret CP Ph+ CML Den anbefalede dosis er 400 mg bosutinib 1 gang dagligt.
Newly-diagnosed CP Ph+ CML The recommended dose is 400 mg bosutinib once daily.
Mindst 1 mutation Dasatinib-resistente mutationer E255K/V
Mutation assessed No mutation At least 1 mutation Dasatinib resistant mutations E255K/V F317L Nilotinib resistant mutations c
Myelosuppression Behandling med bosutinib er forbundet med myelosuppression, defineret som anæmi, neutropeni og trombocytopeni.
Treatment with bosutinib is associated with myelosuppression, defined as anaemia, neutropenia, and thrombocytopenia.
Hvis du har glemt at tage Bosulif
If you forget to take Bosulif
Kaplan-Meier-estimaterne af OS efter 48 uger for bosutinib- og imatinib-patienter i mITTpopulationen var henholdsvis 99,6 % (95 % CI: 97,1 %-99,9 %) og 97,9 % (95 % CI: 95,0 %-99,1 %).
The Kaplan-Meier estimates of OS at 48 weeks for bosutinib and imatinib patients in the mITT population were 99.6% (95% CI: 97.1%, 99.9%) and 97.9% (95% CI: 95.0%, 99.1%), respectively.
Samlet, % (95 % CI) Major, % (95 % CI) Komplet, % (95 % CI)
Overall, % (95% CI) Major, % (95% CI) Complete, % (95% CI)
Det frarådes at anvende bosutinib under graviditeten og hos kvinder i den fertile alder, der ikke anvender kontraception.
Bosutinib is not recommended for use during pregnancy, or in women of childbearing potential not using contraception.
Kontakt lægen, hvis du har spørgsmål om, hvordan Bosulif virker, eller hvorfor du har fået ordineret dette lægemiddel.
If you have any questions about how Bosulif works or why this medicine has been prescribed for you, ask your doctor.
Mediantiden til MMR for respondenter var 24,7 uger over for 36,3 uger for henholdsvis bosutinib-behandlingsgruppen og imatinib-behandlingsgruppen i mITT-populationen.
The median time to MMR for responders was 24.7 weeks versus 36.3 weeks for the bosutinib treatment and imatinib treatment groups, respectively, in the mITT population.
Cmax af bosutinib i plasma var 2,4 gange, 2 gange og 1,5 gange højere ved hhv. Child-Pugh-klasse A, B og C, mens AUC af bosutinib var hhv. 2,3 gange, 2 gange og 1,9 gange højere.
Cmax of bosutinib in plasma increased 2.4-fold, 2-fold, and 1.5-fold, respectively, in Child-Pugh classes A, B, and C; and bosutinib AUC in plasma increased 2.3-fold, 2-fold, and 1.9-fold, respectively.
Baseret på den store reduktion i bosutinib-eksponeringen når det blev administreret sammen med rifampicin, er det sandsynligvis ikke tilstrækkeligt at øge bosutinibdosis for at kompensere for den reducerede eksponering ved administration sammen med potente eller moderate CYP3A-induktorer.
Based on the large reduction in bosutinib exposure that occurred when bosutinib was co-administered with rifampicin, increasing the dose of bosutinib when co-administering with strong or moderate CYP3A inducers is unlikely to sufficiently compensate for the loss of exposure.
Medbring om muligt pakningen eller denne indlægsseddel.
If possible, show the doctor the pack, or this leaflet.
I nogle tilfælde har dette medført akut leversvigt eller fulminant hepatitis, førende til levertransplantation eller fatalt udfald.
Some cases resulted in acute hepatic failure or fulminant hepatitis leading to liver transplantation or a fatal outcome.
Det primære effektmål i dette studie var major cytogenetisk respons (MCyR)-rate i uge 24 hos patienter med imatinibresistent CP CML, som forinden kun var blevet behandlet med 1 TKI (imatinib).
The primary efficacy endpoint of the study was the major cytogenetic response (MCyR) rate at Week 24 in patients with imatinib-resistant CP CML previously treated with only 1 prior TKI (imatinib).
Tid til OHR hos respondenter alene, uger (95 % CI)
Time to OHR for responders only, weeks (95% CI)
Efter administration af en enkelt dosis bosutinib (500 mg) sammen med føde, var biotilgængeligheden 34% hos raske frivillige.
Following administration of a single dose of bosutinib (500 mg) with food in healthy subjects, the absolute bioavailability was 34%.
Der blev påvist føtal eksponering for bosutinib-deriveret radioaktivitet under drægtigheden i et placentapassagestudie med drægtige Sprague-Dawley-rotter.
Foetal exposure to bosutinib-derived radioactivity during pregnancy was demonstrated in a placental transfer study in gravid Sprague-Dawley rats.
Andre effektmål omfattede den kumulative MCyR-rate, tid til og varighed af MCyR og tid til og varighed af CHR hos patienter med CP CML, der forinden kun var blevet behandlet med 1 TKI (imatinib).
Other efficacy endpoints include the cumulative MCyR rate, time to and duration of MCyR, and time to and duration of CHR, in patients with CP CML previously treated with only 1 prior TKI (imatinib).
In vitro-studier med humane levermikrosomer tyder på, at det CYP-isoenzym, der primært er involveret i bosutinibs metabolisering, er CYP3A4, og interaktionsstudier har vist, at ketoconazol og rifampicin har udtalt effekt på bosutinibs farmakokinetik (se pkt.
In vitro studies with human liver microsomes indicated that the major cytochrome P450 isozyme involved in the metabolism of bosutinib is CYP3A4 and drug interaction studies have shown that ketoconazole and rifampicin had marked effect on the pharmacokinetics of bosutinib (see section 4.5).
Ingen evidens for leukæmi (NEL): opfylder alle kriterier for CHR, men kan eventuelt have trombocytopeni (trombocyttal over eller lig med 20.000/mm 3 og under 100.000/mm 3) og/eller neutropeni (ANC over eller lige med 0,5 x 10
No evidence of leukaemia (NEL): Meets all other criteria for CHR except may have thrombocytopenia (platelets greater than or equal to 20,000/mm and less than 100,000/mm 3) and/or neutropenia (ANC greater than or equal to 0.5×10
Det er vigtigt at vurdere nyrefunktionen, inden behandling indledes, og at monitorere den tæt under bosutinib-behandlingen med særlig opmærksomhed hos patienter med eksisterende nyreproblemer, og hos patienter med risiko for renal dysfunktion, herunder samtidig anvendelse af potentielt nefrotoksiske lægemidler, såsom diuretika, ACE-hæmmere, angiotensin receptor-antagonister og non-steroide anti-inflammatoriske lægemidler (NSAID'er).
It is important that renal function is assessed prior to treatment initiation and closely monitored during therapy with bosutinib, with particular attention in those patients who have pre-existing renal compromise or in those patients exhibiting risk factors for renal dysfunction, including concomitant use of medicinal products with potential for nephrotoxicity, such as diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers, and nonsteroidal anti-inflammatory drugs (NSAIDs).
Den mediane behandlingsvarighed var henholdsvis 14,1 måneder (interval: 0,3-24,7 måneder), 61,6 måneder (0,0399,6 måneder), 11,1 måneder (interval: 0,03-123,3 måneder), 30,2 måneder (interval: 0,385,6 måneder) og 5,7 måneder (interval: 0,07-17,8 måneder).
The median duration of therapy was 14.1 months (range: 0.3 to 24.7 months), 61.6 months (0.03 to 99.6 months), 11.1 months (range: 0.03 to 123.3 months), 30.2 months (range: 0.3 to 85.6 months), and 5.7 months (range: 0.07 to 17.8 months), respectively.
Hos CML-patienter i steady state var Cmax (geometrisk middelværdi, variationskoefficient (CV)%) 145 (14) ng/ml og AUCss (geometrisk middelværdi, CV%) var 2.700 (16) ng•t/ml efter daglig administration af bosutinib på 400 mg sammen med føde.
In CML patients at steady state, Cmax (geometric mean, coefficient of variation [CV]%) was 145 (14) ng/mL, and AUCss (geometric mean, CV%) was 2,700 (16) ng•h/mL after daily administration of bosutinib at 400 mg with food.
I studierne blev der set øget eksponering (AUC - arealet under kurven) hos patienter med moderat eller svær nyreinsufficiens.
Increasing exposure (area under curve [AUC]) in patients with moderate and severe renal impairment during studies was observed.
Doser under 300 mg/dag har været anvendt, men virkningen er ikke klarlagt.
Doses less than 300 mg/day have been used; however, efficacy has not been established.
Cytogenetisk respons var baseret på procentdelen af Ph+ metafaser blandt ≥ 20 metafaseceller i hver knoglemarvsprøve.
Cytogenetic responses were based on the percentage of Ph+ metaphases among ≥ 20 metaphase cells in each bone marrow sample.
Infektioner Bosutinib kan gøre patienterne mere modtagelige for bakterie-, svampe- og protozoinfektioner.
Infections Bosutinib may predispose patients to bacterial, fungal, viral, or protozoan infections.
Doser under 300 mg/dag har været anvendt til patienter, men virkningen er ikke klarlagt.
Doses less than 300 mg/day have been used in patients; however, efficacy has not been established.
- markant nedsat antal af en særlig type hvide blodlegemer (granulocytter).
- a marked decrease in the number of granulocytes (a type of white blood cells).
I alt 1.272 patienter med leukæmi blev behandlet med mindst 1 dosis bosutinib som enkeltstofbehandling.
A total of 1,272 leukaemia patients received at least 1 dose of single-agent bosutinib.
Mandlige patienter i behandling med bosutinib bør søge råd vedrørende indsamling og opbevaring af sæd inden behandlingen, på grund af muligheden for nedsat fertilitet som følge af behandling med bosutinib.
Men being treated with bosutinib are advised to seek advice on conservation of sperm prior to treatment because of the possibility of decreased fertility due to therapy with bosutinib.
Du skal undgå disse lægemidler under behandlingen med Bosulif.
These medicines should be avoided during your treatment with Bosulif.
Efter administration af en enkelt eller gentagne doser af bosutinib (400 eller 500 mg) til mennesker, var de vigtigste cirkulerende metabolitter tilsyneladende oxydechlorineret (M2) og Ndemetyleret (M5) bosutinib, mens bosutinib-N-oxid (M6) var en minor cirkulerende metabolit.
Following administration of single or multiple doses of bosutinib (400 or 500 mg) to humans, the major circulating metabolites appeared to be oxydechlorinated (M2) and N-desmethylated (M5) bosutinib, with bosutinib N-oxide (M6) as a minor circulating metabolite.
Det skal du vide, før du begynder at tage Bosulif
What do you need to know before you take take Bosulif
Ni patienter (0,8%) fik QTcF-forlængelse i forhold til baseline på mere end 60 ms.
Nine (0.8%) patients experienced QTcF increase from baseline exceeding 60 ms.
Accelereret fase tidligere behandlet med imatinib som minimum
Accelerated phase with prior treatment of at least imatinib
I det kliniske fase 1/2-studie med patienter med CML, som var resistente eller intolerante over for tidligere behandling, og som påbegyndte behandling med ≤ 500 mg, fik 93 (93/558; 16,7 %) patienter dosis øget til 600 mg dagligt
In the Phase 1/2 clinical study in patients with CML who were resistant or intolerant to prior therapy who started treatment at ≤ 500 mg, 93 (93/558; 16.7%) patients had dose escalations to 600 mg daily.
Fortæl det til lægen, hvis du får mavesmerter, halsbrand, diarré, forstoppelse, kvalme og opkastning.
Tell your doctor if you develop stomach pain, heartburn, diarrhoea, constipation, nausea and vomiting.
Antiarytmika og andre substanser, der kan forlænge QT Bosutinib skal anvendes med forsigtighed hos patienter, der har eller kan udvikle QT-forlængelse, herunder patienter, der tager antiarytmika såsom amiodaron, disopyramid, procainamid, quinidin og sotalol eller andre lægemidler, der kan føre til QT-forlængelse, såsom chloroquin, halofantrin, clarithromycin, domperidon, haloperidol, methadon og moxifloxacin (se pkt.
Anti-arrhythmic medicinal products and other substances that may prolong QT Bosutinib should be used with caution in patients who have or may develop prolongation of QT, including those patients taking anti-arrhythmic medicinal products such as amiodarone, disopyramide, procainamide, quinidine and sotalol or other medicinal products that may lead to QT prolongation such as chloroquine, halofantrine, clarithromycin, domperidone, haloperidol, methadone, and moxifloxacin (see section 4.4).
I hele udviklingsprogrammet sås samtidig stigning i aminotransferaser ≥ 3 × ULN og bilirubin > 2 × ULN med basisk fosfatase < 2 × ULN uden alternative årsager hos 1 studiedeltager ud af 1.611 behandlet med bosutinib (≤ 0,1%).
In the entire development program, concurrent elevation in transaminases ≥ 3 × ULN and bilirubin > 2 × ULN with alkaline phosphatase < 2 × ULN occurred without alternative causes in 1/1,611 (< 0.1%) subjects treated with bosutinib.
CP, AP eller BP Ph+ CML med resistens eller intolerance over for tidligere behandling Den anbefalede dosis er 500 mg bosutinib 1 gang dagligt.
CP, AP, or BP Ph+ CML with resistance or intolerance to prior therapy The recommended dose is 500 mg bosutinib once daily.
Toksiciteterne var kendetegnet ved en øget levervægt i korrelation med hepatocellulær hypertrofi, der indtrådte under fravær af forhøjede leverenzymer eller mikroskopiske tegn på hepatocullær cytotoksicitet.
Toxicities were characterised by an increase in liver weights in correlation with hepatocellular hypertrophy which occurred in the absence of elevated liver enzymes or microscopic signs of hepatocellular cytotoxicity, and is of unknown relevance to humans.
Patienter med ukontrolleret eller signifikant kardiovaskulær sygdom, inklusive forlænget QT-interval, ved baseline blev ikke inkluderet i kliniske studier (se pkt.
Patients with uncontrolled or significant cardiovascular disease including QTc prolongation, at baseline, were not included in clinical studies (see sections 5.1 and 5.3).
På grund af den mulige forekomst af tumorlysesyndrom (TLS), anbefales det at korrigereklinisk signifikant dehydrering samt at behandle høje urinsyreniveauer inden behandling med bosutinib (se pkt.
Due to the possible occurrence of tumour lysis syndrome (TLS), correction of clinically significant dehydration and treatment of high uric acid levels are recommended prior to initiation of bosutinib (see section 4.8).
Ph+ CP CML tidligere behandlet med imatinib alene
Ph+ CP CML with prior imatinib treatment only
Forhøjede leveraminotransferaser: Ved stigning i leveraminotransferaser til > 5 x øvre normalgrænse (ULN) skal behandlingen med bosutinib afbrydes indtil bedring til ≤ 2,5 x ULN, hvorefter behandlingen kan genoptages med 400 mg 1 gang dagligt.
Elevated liver transaminases: If elevations in liver transaminases > 5 × institutional upper limit of normal (ULN) occur, bosutinib should be interrupted until recovery to ≤ 2.5 × ULN and may be resumed at 400 mg once daily thereafter.
- clarithromycin, telithromycin, erythromycin og ciprofloxacin, der er antibiotika til behandling af bakterieinfektioner.
- clarithromycin, telithromycin, erythromycin, and ciprofloxacin, used to treat bacterial infections.
Amning bør afbrydes under behandlingen med bosutinib.
Breast-feeding should be discontinued during treatment with bosutinib.
I et studie med studiedeltagere med nyreinsufficiens blev en enkelt dosis på 200 mg bosutinib administreret med føde hos 26 deltagere med let, moderat eller svær nyreinsufficiens og hos 8 tilsvarende raske frivillige.
In a renal impairment study, a single dose of 200 mg bosutinib was administered with food to 26 subjects with mild, moderate, or severe renal impairment and to 8 matching healthy volunteers.
Magnesiumstearat (E470b)
Povidone (E1201) Magnesium stearate (E470b)
Efter 1 enkelt intravenøs dosis på 120 mg til raske forsøgspersoner var den gennemsnitlige (% CV) eliminationshalveringstid 35,5 (24) timer, og den gennemsnitlige (% CV) clearance var 61,9 (26) l/time.
In healthy subjects given a single intravenous dose of 120 mg bosutinib, the mean (%CV) terminal elimination half-life was 35.5 (24) hours, and the mean (%CV) clearance was 61.9 (26) L/h.
Der blev udført et åbent 2-arms fase 3 multi-center superiority-forsøg for at undersøgevirkning og sikkerhed af bosutinib 400 mg 1 gang dagligt alene sammenlignet med imatinib 400 mg 1 gang dagligt alene hos voksne patienter med nydiagnosticeret Ph+ CP CML.
A 2-arm, Phase 3, open-label, multicentre superiority trial was conducted to investigate the efficacy and safety of bosutinib 400 mg once daily alone compared with imatinib 400 mg once daily alone in adult patients with newly-diagnosed Ph+ CP CML.
Baseret på prækliniske fund har bosutinib potentiale til at nedsætte forplantningsevnen og fertiliteten hos mennesker (se pkt.
Based on non-clinical findings, bosutinib has the potential to impair reproductive function and fertility in humans (see section 5.3).
Skema 2 - Bivirkninger ved bosutinib
Table 2 - Adverse reactions for bosutinib
Behandling med bosutinib kan være forbundet med væskeretention, inklusive perikardie-effusion, pleuraeffusion, lungeødem og/eller perifert ødem.
Treatment with bosutinib may be associated with fluid retention including pericardial effusion, pleural effusion, pulmonary oedema and/or peripheral oedema.
I nogle tilfælde har dette medført akut leversvigt eller fulminant hepatitis, resulterende i levertransplantation eller fatalt udfald (se pkt.
Some cases resulted in acute hepatic failure or fulminant hepatitis leading to liver transplantation or a fatal outcome (see section 4.4).
Nedenstående beskrivelser er baseret på en sikkerhedspopulation på 1.272 patienter, der fik mindst 1 dosis bosutinib for nydiagnosticeret CML i kronisk fase, eller som var resistente eller intolerante over for tidligere behandling med CP, AP eller BP CML eller Ph+ ALL.
The descriptions included below are based on the safety population of 1,272 patients who received at least 1 dose of bosutinib for either newly-diagnosed CP CML or were resistant or intolerant to prior therapy with CP, AP, or BP CML, or Ph+ ALL.
- hvis du nogensinde har været eller måske er smittet med hepatitis B. Dette er fordi Bosulif kan forårsage, at hepatitis B bliver aktiv igen, hvilket undertiden kan være dødeligt.
This is because Bosulif could cause hepatitis B to become active again, which can be fatal in some cases.
I kliniske studier er der observeret en nedsættelse over tid i den estimerede glomerulære filtrationshastighed (eGFR) hos patienter, der blev behandlet med bosutinib.
A decline over time in estimated glomerular filtration rate (eGFR) has been observed in patients treated with bosutinib in clinical studies.
• nydiagnosticeret Philadelphiakromosompositiv kronisk myeloid leukæmi (Ph+ CML) i kronisk fase (CP).
• newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).
Efter indgivelse af en enkelt intravenøs dosis bosutinib på 120 mg til raske forsøgspersoner var det gennemsnitlige distributionsvolumen (%variationskoefficient (CV)) af bosutinib på 2,331 (32) l, hvilket tyder på, at bosutinib fordeles til ekstravaskulært væv i omfattende grad.
Following administration of a single intravenous dose of 120 mg bosutinib to healthy subjects, bosutinib had a mean (% coefficient of variation [CV]) volume of distribution of 2,331 (32) L, suggesting that bosutinib is extensively distributed to extra vascular tissue.
Der er foretaget en vurdering af en dosis på 200 mg bosutinib administreret sammen med føde i en kohorte med 18 forsøgsdeltagere med leverinsufficiens (Child-Pugh-klasse A, B og C) og 9 tilsvarende raske frivillige.
A 200 mg dose of bosutinib administered with food was evaluated in a cohort of 18 hepatically impaired subjects (Child-Pugh classes A, B, and C) and 9 matched healthy subjects.
I fase 3-studiet med patienter med nydiagnosticeret CP CML, som påbegyndte bosutinib-behandlingen med 400 mg, fik i alt 46 patienter (17,2 %) dosis øget til 500 mg.
In the Phase 3 study in patients with newly-diagnosed CP CML who started bosutinib treatment at 400 mg, a total of 46 patients (17.2%) received dose escalations to 500 mg.
Der blev ikke set nogen indvirkning på bosutinibs metabolisering af CYP1A2, -2A6, -2B6, -2C8, -2C9, -2C19,2D6, -2E1, eller -3A5.
No metabolism of bosutinib was observed with CYPs 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A5.
Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter): - feber forbundet med lavt antal hvide blodlegemer (febril neutropeni).
Uncommon side effects (may affect up to 1 in 100 people): - fever associated with low white blood cell count (febrile neutropenia).
Hos patienter med aminotransferasestigninger skal bosutinib midlertidigt afbrydes (og det skal overvejes at reducere dosis efter bedring til grad 1 eller baseline) og/eller seponeres.
Patients with transaminase elevations should be managed by withholding bosutinib temporarily (with consideration given to dose reduction after recovery to Grade 1 or baseline), and/or discontinuation of bosutinib.
- mavegener (mavekatar), blødning fra mave eller tarm.
- stomach irritation (gastritis), bleeding from the stomach or intestine.
C]-radioaktivt mærket bosutinib hos rotter blev der påvist udskillelse af bosutinibafledt radioaktivitet i mælken (se pkt.
A study of [14C] radiolabelled bosutinib in rats demonstrated excretion of bosutinib-derived radioactivity in breast milk (see section 5.3).
Samtidig brug af bosutinib og potente CYP3A-hæmmere (inklusive men ikke begrænset til itraconazol, ketoconazol, posaconazol, voriconazol, clarithromycin, telithromycin, nefazodon, mibefradil, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir, boceprevir, telaprevir, grapefrugt-produkter inklusive grapefrugtjuice) eller moderate CYP3A-hæmmere (inklusiv men ikke begrænset til fluconazol, ciprofloxacin, erythromycin, diltiazem, verapamil, amprenavir, atazanavir, darunavir/ritonavir, fosamprenavir, aprepitant, crizotinib, imatinib) bør undgås, da det vil medføre højere bosutinib-plasmakoncentration.
The concomitant use of bosutinib with strong CYP3A inhibitors (including, but not limited to itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, telithromycin, nefazodone, mibefradil, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir, boceprevir, telaprevir, grapefruit products including grapefruit juice) or moderate CYP3A inhibitors (including, but not limited to fluconazole, ciprofloxacin, erythromycin, diltiazem, verapamil, amprenavir, atazanavir, darunavir/ritonavir, fosamprenavir, aprepitant, crizotinib, imatinib) should be avoided, as an increase in bosutinib plasma concentration will occur.
Fortæl det straks til lægen, hvis du får et eller flere af disse symptomer: blødning, feber eller tendens til blå mærker (det kan være du har forstyrrelser i blod- eller lymfesystemet).
Tell your doctor right away if you have any of these symptoms: bleeding, fever or easy bruising (you might have blood or lymphatic system disorder).
Nyreinsufficiens blev baseret på kreatinin-clearance (beregnet ved hjælp af Cockcroft-Gault-formlen) < 30 ml/min (svær nyreinsufficiens), kreatinin-clearance 30-50 ml/min (moderat nyreinsufficiens) eller kreatinin-clearance 50-80 ml/min (let nyreinsufficiens).
Renal impairment was based on CLCr (calculated by the Cockcroft-Gault formula) of < 30 mL/min (severe renal impairment), 30  CLCr  50 mL/min (moderate renal impairment), or 50 < CLCr  80 mL/min (mild renal impairment).
Transformation til AP/BP
Transformation to AP/BPf On--treatment transformation, n
Hvis det er nødvendigt at administrere en potent eller moderat CYP3A-hæmmer under behandlingen med bosutinib, skal det overvejes at afbryde behandlingen med bosutinib eller at reducere bosutinibdosis.
If a strong or moderate CYP3A inhibitor must be administered during bosutinib treatment, an interruption of bosutinib therapy or a dose reduction in bosutinib should be considered.
I et studie med studiedeltagere med nedsat leverfunktion blev der set en stigende hyppighed af QTcforlængelse > 450 msek.
In a study in liver impaired subjects, an increasing frequency of QTc prolongation > 450 ms with declining hepatic function was observed.