natgillin/translations-raw huggingface dataset:
This allowed measurable concentrations of radioactivity to appear in the plasma of nursing pups.
To je omogućilo pojavu mjerljivih koncentracija radioaktivnosti u plazmi okota tijekom dojenja.
Hepatic impairment (see sections 5.1 and 5.2).
Oštećenje funkcije jetre (vidjeti dijelove 5.1 i 5.2).
This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Uredbe (EZ) br. 726/2004, nositelj odobrenja dužan je unutar navedenog vremenskog roka provesti sljedeće mjere:
The systemic exposure of N-desmethylated metabolite was 25% of the parent compound, while the oxydechlorinated metabolite was 19% of the parent compound.
Sistemska izloženost Ndesmetiliranog metabolita bila je 25% ishodišnog lijeka, dok je oksidekloriniran metabolit bio 19% ishodišnog lijeka.
Grapefruit products, including grapefruit juice and other foods that are known to inhibit CYP3A should be avoided (see section 4.5).
Moraju se izbjegavati proizvodi od grejpa, uključujući sok od grejpa i drugu hranu za koju se zna da inhibira CYP3A (vidjeti dio 4.5).
The study results indicate that bosutinib does not exhibit clinically relevant P-gp inhibitory effects.
Rezultati ispitivanja upućuju na to da bosutinib ne pokazuje klinički značajne učinke inhibicije P-gp-a.
A delayed increase in heart rate was observed.
Opažen je odgođeni porast srčane frekvencije.
There is a risk that treatment with Bosulif will lead to decreased fertility and you may wish to seek advice about sperm storage before the treatment starts.
Postoji rizik da liječenje lijekom Bosulif može uzrokovati smanjenu plodnost i možda ćete htjeti potražiti savjet oko pohranjivanja sperme prijepočetka liječenja.
Other efficacy endpoints include transformation to AP/BP, progression free survival and OS for all cohorts.
Druge mjere ishoda djelotvornosti uključuju transformaciju u AP/BP, preživljenje bez progresije (engl. progression free survival, PFS) i ukupno preživljenje u svim kohortama.
The recommended dose is 500 mg once daily for patients whose previous medicines to treat CML have either not worked or are not suitable.
Preporučena doza je 500 mg jedanput dnevno u bolesnika u kojih prethodni lijekovi za liječenje KMLa nisu bili učinkoviti ili nisu prikladni.
Four patients (0.3%) experienced QTcF interval prolongation (greater than 500 ms).
Četiri bolesnika (0,3%) imala su produljenje QTcF intervala (više od 500 ms).
White opaque 3-ply PVC/Polychlorotrifluoroethene/PVC blister sealed with push-through foil backing containing either 14 or 15 tablets.
Bijeli, neprozirni, troslojni PVC/poliklorotrifluoroeten/PVC blister zatvoren folijom kroz koju se protisnu tablete, koji sadrži 14 ili 15 tableta.
Cytogenetic Response criteria: Major Cytogenetic Response included Complete [0% Ph+ metaphases from bone marrow or < 1% positive cells from fluorescent in situ hybridisation (FISH)] or partial (1%-35%) cytogenetic responses.
Kriteriji citogenetskog odgovora: veliki citogenetski odgovor uključivao je potpune [0% Ph+ metafaza u koštanoj srži ili < 1% pozitivnih stanica u fluorescentnoj in situ hibridizaciji (FISH)] ili parcijalne (1%-35%) citogenetske odgovore.
- if you have, or have had in the past, liver problems.
- ako imate, ili ste u prošlosti imali probleme s jetrom.
Safety pharmacology
Sigurnosna farmakologija
Severe skin reactions.
Teške kožne reakcije.
Bosutinib has demonstrated the ability to absorb light in the UV-B and UV-A range and is distributed into the skin and uveal tract of pigmented rats.
Bosutinib je pokazao sposobnost apsorpcije svjetlosti u rasponima UV-B i UV-A te se distribuirao u kožu i srednju očnu ovojnicu pigmentiranih štakora.
- if you have fluid retention.
- ako imate zadržavanje tekućine.
Following administration of a single dose of bosutinib (500 mg) with food in healthy subjects, the absolute bioavailability was 34%.
Nakon primjene jedne doze bosutiniba (500 mg) s hranom u zdravih ispitanika, apsolutna bioraspoloživost je bila 34%.
Bosutinib is not recommended for use during pregnancy, or in women of childbearing potential not using contraception.
Ne preporučuje se koristiti bosutinib tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
Paediatric population Bosulif has not yet been studied in children and adolescents less than 18 years of age.
Pedijatrijska populacija Bosulif još nije ispitan u djece i adolescenata mlađe od 18 godina.
Age, gender and race
Dob, spol i rasa
In addition, 5.6% of patients in the bosutinib treatment group had further dose escalations to 600 mg.
Osim toga, u 5,6% bolesnika iz skupine liječene bosutinibom doza je dodatno postupno povećavana do 600 mg.
Maximal exposure Cmax increased by 28% and 34% in the moderate and severe groups, respectively.
Maksimalna izloženost Cmax porasla je u skupinama s umjerenim i teškim oštećenjem za 28%, odnosno 34%.
Patients should be tested for HBV infection before initiating treatment with bosutinib.
Bolesnike je potrebno testirati na infekciju HBV-om prije početka liječenja bosutinibom.
9/L, no blasts or promyelocytes in peripheral blood, less than 5% myelocytes + metamyelocytes in bone marrow, less than 20% basophils in peripheral blood, and no extramedullary involvement.
9/l, odsustvo blasta ili promijelocita u perifernoj krvi, manje od 5% mijelocita + metamijelocita u koštanoj srži, manje od 20% bazofila u perifernoj krvi i odsustvo ekstramedularne zahvaćenosti.
Table 4 - Comparison of MMR at Months 3, 6, and 9 by treatment in the mITT population
Tablica 4 - Usporedba značajnog molekularnog odgovora (MMR) u 3., 6. i 9. mjesecu prema liječenju u mITT populaciji
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMPa.
If bosutinib is used during pregnancy, or the patient becomes pregnant while taking bosutinib, she should be apprised of the potential hazard to the foetus.
Ako bolesnica koristi bosutinib tijekom trudnoće, ili zatrudni za vrijeme uzimanja bosutiniba, mora biti obaviještena o potencijalnom riziku za plod.
Snapshot date: 02Oct2015
Datum prikazanog stanja: 2. listopada 2015.
Pfizer Ελλάς Α.Ε.
Pfizer Ελλάς A.E.
After a minimum of 12 months of follow-up in the mITT population, 77.6% of patients treated with bosutinib (N=241) and 72.4% of patients treated with imatinib (N=239) were still receiving first-line treatment.
Nakon najmanje 12 mjeseci praćenja u mITT populaciji 77,6% bolesnika liječenih bosutinibom (N = 241) i 72,4% bolesnika liječenih imatinibom (N = 239) još su primali prvu liniju liječenja.
Blood creatinine increased, Amylase increased, Blood creatine phosphokinase increased
Porast kreatinina u krvi, porast amilaze u krvi, porast kreatin fosfokinaze u krvi
Patients with serum creatinine > 1.5 × ULN were excluded from the CML studies.
Bolesnici sa serumskim kreatininom > 1,5 × GGN bili su isključeni iz ispitivanja KML-a.
Effects of bosutinib on other medicinal products
Učinci bosutiniba na druge lijekove
Bosulif film-coated tablets come in different strengths.
Bosulif filmom obložene tablete isporučuju se u različitim jačinama.
Chest pain (including Chest discomfort), Pain
Bol u prsištu (uključujući nelagodu u prsištu), bol
- This medicine does not require any special storage conditions.
- Lijek ne zahtijeva posebne uvjete čuvanja.
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.
Toksičnosti su bile obilježene povećanjem težine jetre u korelaciji s hepatocelularnom hipertrofijom koja se pojavila u odsustvu povišenih jetrenih enzima ili mikroskopskih znakova hepatocelularne citotoksičnosti te je važnost u ljudi nepoznata.
Bosutinib inhibited 16 of 18 imatinib-resistant forms of BCR-ABL expressed in murine myeloid cell lines.
Bosutinib je inhibirao 16 od 18 oblika BCR-ABL-a rezistentnih na imatinib izraženih u mijeloidnim staničnim linijama miševa.
If clinically significant moderate or severe non-haematological toxicity develops, bosutinib should be interrupted, and may be resumed at a dose reduced by 100 mg taken once daily after the toxicity has resolved.
Ako se razvije klinički značajna umjerena ili teška nehematološka toksičnost, liječenje bosutinibom mora se prekinuti, a može se nastaviti dozom smanjenom za 100 mg uzetom jedanput dnevno nakon nestanka toksičnosti.
The p-values for endpoints other than MMR at 12 months and CCyR by 12 months have not been adjusted for multiple comparisons.
Za mjere ishoda koje nisu bile MMR nakon 12 mjeseci i CCyR do 12 mjeseci, p-vrijednosti nisu bile prilagođene za višestruke usporedbe.
The secondary efficacy endpoints included MMR by 18 months, duration of MMR, CCyR by 12 months, duration of CCyR, event-free survival (EFS), and overall survival (OS).
Sekundarne mjere ishoda djelotvornosti uključivale su MMR do 18 mjeseci, trajanje MMR-a, CCyR do 12 mjeseci, trajanje CCyR-a, preživljenje bez pojave događaja (engl. event-free survival, EFS) i ukupno preživljenje (engl. overall survival, OS).
Clinical data are very limited (n = 3) for CML patients with moderate renal impairment receiving an escalated dose of 600 mg bosutinib.
Klinički podaci su vrlo ograničeni (n = 3) u bolesnika s KML-om i umjerenim oštećenjem bubrega koji primaju povećanu dozu od 600 mg bosutiniba.
Bosutinib inhibits the abnormal BCR-ABL kinase that promotes CML.
Bosutinib inhibira abnormalnu BCR-ABL kinazu koja pospješuje KML.
Dose reduction is recommended for patients with moderate or severe renal impairment (see sections 4.2 and 5.2).
Preporučuje se smanjivanje doza u bolesnika s umjerenim ili teškim oštećenjem bubrega (vidjeti dijelove 4.2 i 5.2).
The following adverse reactions were reported in patients in bosutinib clinical studies (Table 2).
Sljedeće nuspojave prijavljene su u bolesnika tijekom kliničkih ispitivanja bosutiniba (Tablica 2).
Incidence at baseline n (%)
Incidencija na početku n (%)
If you stop taking Bosulif
Ako prestanete uzimati Bosulif
The antiemetic agent, domperidone, has the potential to increase QT interval (QTc) prolongation and to induce “torsade de pointes”- arrhythmias; therefore, co-administration with domperidone should be avoided.
Antiemetik domperidon ima potencijal produljiti QT interval (QTc) i izazvati aritmije "torsade de pointes", stoga je nužno izbjeći istodobnu primjenu domperidona.
One patient on bosutinib and 7 patients on imatinib died while on study.
Jedan bolesnik liječen bosutinibom i 7 bolesnika liječenih imatinibom umrli su tijekom sudjelovanja u ispitivanju.
- Do not use this medicine after the expiry date which is stated on the blister foil and carton after “EXP”.
- Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na foliji blistera i kutiji iza oznake „Rok valjanosti“ ili „EXP“.
If a dose is missed by more than 12 hours, take your next dose at your regular time on the following day.
Ako je od propuštene doze prošlo više od 12 sati, uzmite sljedeću dozu u predviđeno vrijeme sljedećeg dana.
At least 1 adverse reaction of any toxicity grade was reported for 1,240 (97.5%) patients.
Najmanje 1 nuspojava bilo kojeg stupnja toksičnosti bila je prijavljena u 1240 (97,5%) bolesnika.
Treatment with bosutinib may result in a clinically significant decline in renal function in CML patients.
Liječenje bosutinibom može rezultirati klinički značajnim smanjenjem funkcije bubrega u bolesnika s KML-om.
Among the 994 patients with diarrhoea, 180 patients (18%) were managed with treatment interruption and of these 170 (94%) were rechallenged with bosutinib.
Među 994 bolesnika s proljevom, 180 bolesnika (18%) bilo je zbrinuto prekidom liječenja, a od toga je 170 (94%) ponovno izloženo bosutinibu.
The recommended dose is 400 mg once daily for patients with newly-diagnosed CML.
Preporučena doza je 400 mg jedanput dnevno u bolesnika s novodijagnosticiranim KML-om.
- if you notice any of these symptoms: pain in your side, blood in your urine or reduced amount of urine.
- ako primijetite bilo koji od sljedećih simptoma: bol u slabinama, krv u mokraći ili smanjenu količinu mokraće.
Your doctor should do blood tests to check your liver function prior to your starting treatment with Bosulif and for the first 3 months of treatment with Bosulif, and as clinically indicated.
Vaš liječnik mora zatražiti pretrage krvi kako bi provjerio funkcionira li Vaša jetra ispravno prije početka liječenja lijekom Bosulif, za vrijeme prva 3 mjeseca liječenja lijekom Bosulif i kad god je to klinički indicirano.
In vitro studies indicate that bosutinib has a low potential to inhibit breast cancer resistance protein (BCRP, systemically), organic anion transporting polypeptide (OATP)1B1, OATP1B3, organic anion transporter (OAT)1, OAT3, organic cation transporter (OCT)2 at clinically relevant concentrations, but may have the potential to inhibit BCRP in the gastrointestinal tract and OCT1.
In vitro ispitivanja pokazuju da bosutinib ima niski potencijal za inhibiciju proteina rezistencije raka dojke (BCRP, sistemski), polipeptida koji prenose organske anione (OATP)1B1, OATP1B3, transportera organskih aniona (OAT)1, OAT3, transportera organskih kationa (OCT)2 pri klinički značajnim koncentracijama, ali može imati potencijal inhibirati BCRP u gastrointestinalnom traktu i OCT1.
FISH analysis (≥ 200 cells) could be used for post-baseline cytogenetic assessments if ≥ 20 metaphases were not available.
FISH analiza (≥ 200 stanica) može se koristiti za citogenetske procjene nakon početka ako nije bilo dostupno ≥ 20 metafaza.
1-sided p-value
Jednostrana p-vrijednost
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.
Medijan trajanja terapije bio je 14,1 mjesec (raspon: 0,3 do 24,7 mjeseci), 61,6 mjeseci (0,03 do 99,6 mjeseci), 11,1 mjesec (raspon: 0,03 do 123,3 mjeseca), 30,2 mjeseca (raspon: 0,3 do 85,6 mjeseci), odnosno 5,7 mjeseci (raspon: 0,07 do 17,8 mjeseci).
In a rat pre- and postnatal development study, there were reduced number of pups born at ≥ 30 mg/kg/day, and increased incidence of total litter loss and decreased growth of offspring after birth occurred at 70 mg/kg/day.
U ispitivanju prenatalnog i postnatalnog razvoja štakora zabilježen je smanjen broj mladunčadi okoćene pri ≥ 30 mg/kg/dan te je došlo do povećane incidencije ukupnog gubitka okota i smanjenja rasta mladunčadi nakon okota pri 70 mg/kg/dan.
Hypokalaemia or hypomagnesaemia must be corrected prior to bosutinib administration and should be monitored periodically during therapy.
Hipokalijemiju ili hipomagnezijemiju se mora korigirati prije primjene bosutiniba te se povremeno mora pratiti tijekom terapije.
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).
Bolesnici koji su na početku ispitivanja imali nekontroliranu ili značajnu kardiovaskularnu bolest, uključujući produljeni QTc, nisu bili uključeni u klinička ispitivanja (vidjeti dijelove 5.1 i 5.3).
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.
Muškarcima koji su liječeni bosutinibom savjetuje se da potraže savjet oko pohranjivanja sperme prije početka liječenja zbog mogućeg smanjenja plodnosti uslijed terapije bosutinibom.
Some cases resulted in acute hepatic failure or fulminant hepatitis leading to liver transplantation or a fatal outcome (see section 4.4).
U nekim je slučajevima došlo do akutnog zatajenja jetre ili fulminantnog hepatitisa što je dovelo do transplantacije jetre ili smrtnog ishoda (vidjeti dio 4.4).
There are limited amount of data in pregnant women from the use of bosutinib.
Ograničeni su podaci o primjeni bosutiniba u trudnica.
- if you have or have had pancreas problems.
- ako imate ili ste imali probleme s gušteračom.
Treatment with bosutinib may be associated with fluid retention including pericardial effusion, pleural effusion, pulmonary oedema and/or peripheral oedema.
Liječenje bosutinibom može biti povezano sa zadržavanjem tekućine, uključujući perikardijalni izljev, pleuralni izljev, plućni edem i/ili periferni edem.
Cytochrome P-450 (CYP)3A inhibitors
Inhibitori citokroma P450 (CYP)3A
Statistically significant comparison at the pre-specified significance level; based on CMH test stratified by geographical region and Sokal score at randomisation.
Statistički značajna usporedba na unaprijed određenoj razini značajnosti; na temelju CMH testa raslojenog prema geografskom području i rezultatu prema Sokalu pri randomizaciji.
Ph+ CP CML with prior imatinib treatment only
Ph+ CP KML s prethodnim liječenjem samo imatinibom
Carcinogenicity Bosutinib was not carcinogenic in the 2-year rat carcinogenicity study.
Bosutinib nije bio kancerogen u dvogodišnjem ispitivanju kancerogenosti provedenom na štakorima.
Ph+ CP CML with prior treatment with imatinib and dasatinib or nilotinib
Ph+ CP KML s prethodnim liječenjem imatinibom i dasatinibom ili nilotinibom
In the event that you have moderate or severe kidney problems, your doctor will reduce your dose by 100 mg once daily for moderate kidney problems and by an additional 100 mg once daily for severe kidney problems.
U slučaju umjerenih ili teških problema s bubrezima, Vaš liječnik će Vam smanjiti dozu uzetu jednom dnevno za 100 mg kod umjerenih problema s bubrezima i za dodatnih 100 mg jednom dnevno kod teških problema s bubrezima.
At least 1 Grade 3 or Grade 4 adverse reaction was reported for 814 (63.9%) patients.
Najmanje jedna nuspojava 3. stupnja ili 4. stupnja prijavljena je u 814 (63,9%) bolesnika.
No metabolism of bosutinib was observed with CYPs 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A5.
Metabolizam bosutiniba nije zapažen s enzimima CYP 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 ili 3A5.
Rare side effects (may affect up to 1 in 1,000 people): - severe skin disorder (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) due to an allergic reaction, exfoliative (scaly, peeling) rash.
Rijetke nuspojave (mogu se javiti u manje od 1 na 1000 osoba): - teški kožni poremećaji (multiformni eritem, Stevens-Johnsonov sindrom, toksična epidermalna nekroliza) nastali zbog alergijske reakcije, eksfolijativni (ljuskav, koji se ljušti) osip
These medicines should be avoided during your treatment with Bosulif.
Te lijekove treba izbjegavati za vrijeme Vašeg liječenja lijekom Bosulif.
This finding was in a study of bosutinib in combination with letrozole in a patient with metastatic breast cancer.
Ti su nalazi dobiveni u ispitivanju bosutiniba u kombinaciji s letrozolom u bolesnice s metastatskim rakom dojke.
A total of 1,272 leukaemia patients received at least 1 dose of single-agent bosutinib.
Ukupno 1272 bolesnika s leukemijom primilo je najmanje jednu dozu bosutiniba kao jedinog lijeka.
If cytopoenia recurs, reduce dose by an additional 100 mg upon recovery and resume treatment.
Ako se citopenija ponovno pojavi, smanjiti dozu za dodatnih 100 mg kad dođe do oporavka i nastaviti liječenje.
Seventy-five percent of the dose was recovered within 96 hours.
U roku od 96 sati nađeno je sedamdesetpet posto doze.
After 500 mg bosutinib daily with food, Cmax was 200 (6) ng/mL and AUCss was 3,640 (12) ng•h/mL.
Nakon svakodnevne primjene 500 mg bosutiniba s hranom, Cmax je iznosio 200 (6) ng/ml, a AUCss je iznosio 3640 (12) ng•h/ml.
In a mass-balance study with oral bosutinib, an average of 94.6% of the total dose was recovered in 9 days; faeces (91.3%) was the major route of excretion, with 3.29% of the dose recovered in urine.
U ispitivanju masene bilance nakon peroralne primjene bosutiniba, prosječno 94,6% od ukupne doze nađeno je u roku od 9 dana, glavni put ekskrecije bio je feces (91,3%), a 3,29% doze nađeno je u urinu.
Table 6 - Response by baseline BCR-ABL mutation status in CP CML evaluable population: prior imatinib and dasatinib and/or nilotinib (third-line)
Tablica 6 - Odgovor prema statusu mutacije BCR-ABL-a na početku u procjenjivoj populaciji s CP KML-om: prije toga liječeni imatinibom i dasatinibom i /ili nilotinibom (treća linija)
Discontinuations due to suboptimal response or treatment failure as assessed by the investigator occurred for 2.0% of patients in the bosutinib-treated group compared to 6.3% of patients in the imatinib-treated group.
Do prekida primjene lijeka zbog suboptimalnog odgovora ili neuspješnog liječenja prema procjeni ispitivača došlo je u 2,0% bolesnika u skupini liječenoj bosutinibom, u usporedbi sa 6,3% bolesnika u skupini liječenoj imatinibom.
Monitoring for an effect on the QTc is advisable and a baseline electrocardiogram (ECG) is recommended prior to initiating therapy with bosutinib and as clinically indicated.
Preporučuje se praćenje učinka na QTc i preporučeno je snimanje ishodišnog elektrokardiograma (EKG-a) prije početka terapije bosutinibom te kad god je to klinički indicirano.
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).
In vitro ispitivanja na mikrosomima ljudske jetre pokazuju da je CYP3A4 bio glavni izoenzim citokroma P450 uključen u metabolizam bosutiniba, a ispitivanja interakcije lijekova pokazala su da ketokonazol i rifampicin imaju značajni učinak na farmakokinetiku bosutiniba (vidjeti dio 4.5).
- if you have diarrhoea and vomiting.
- ako imate proljev i povraćate.
In a study in liver impaired subjects, an increasing frequency of QTc prolongation > 450 ms with declining hepatic function was observed.
U ispitivanju na ispitanicima s oštećenjem jetre zapaženo je povećavanje učestalosti produljenja QTc-a > 450 ms s pogoršavanjem jetrene funkcije.
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.
Doza od 200 mg bosutiniba primijenjena s hranom procijenjena je u kohorti od 18 ispitanika s oštećenjem jetre (Child-Pugh stadiji A, B i C) i 9 odgovarajućih zdravih ispitanika.
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.
Porast jetrenih transaminaza: ako se javi porast jetrenih transaminaza > 5 × institucionalne gornje granice normale (GGN), liječenje bosutinibom mora se prekinuti do oporavka na ≤ 2,5 × GGN, a može se nastaviti nakon toga s 400 mg jedanput dnevno.
Infections Bosutinib may predispose patients to bacterial, fungal, viral, or protozoan infections.
Bosutinib može uzrokovati povećanu sklonost bolesnika bakterijskim, gljivičnim, virusnim ili protozoalnim infekcijama.
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.
Ako se tijekom liječenja bosutinibom mora primijeniti snažni ili umjereni inhibitor CYP3A, mora se razmotriti prekid terapije bosutinibom ili smanjenje doze bosutiniba.