natgillin/translations-raw huggingface dataset:
A MCyR at the 3-month landmark correlated strongly and statistically significantly with PFS and OS (p<0.0001 and p=0.0006, respectively).
MCyR je na 3 mesečni kontrolni točki močno koreliran in statistično značilno povezan s PFS in OS (p <0,0001 oziroma p = 0,0006).
Iclusig should be interrupted and patients evaluated for serious or severe haemorrhage.
Zdravljenje z zdravilom Iclusig je treba prekiniti in bolnika oceniti glede pojava resne ali hude krvavitve.
In the phase 2 trial, 86 CP-CML patients achieved MCyR at a dose of 45 mg, 45 CP-CML patients achieved MCyR after a dose reduction to 30 mg, mostly for adverse events.
V preskušanju 2. faze je 86 bolnikov s CP-KML doseglo MCyR pri odmerku 45 mg, 45 bolnikov s CP-KML je doseglo MCyR po zmanjšanju odmerka na 30 mg, največkrat zaradi neželenih učinkov.
- increased levels of the serum proteins lipase or amylase.
- zvišane ravni serumskih beljakovin lipaze ali amilaze,
If decreased vision or blurred vision occurs, an ophthalmic examination (including fundoscopy) should be performed.
Če se pojavi poslabšanje vida ali zamegljen vid, je treba opraviti oftalmološki pregled (vključno s fundoskopijo).
Table 11 Maintenance of response in CP-CML patients who achieved MCyR or MMR at 45 mg dose (data extraction 6 February 2017) Achieved MCyR at 45 mg (N=86)
Preglednica 11 Vzdrževanje odgovora pri bolnikih s CP-KML, ki so dosegli MCyR ali MMR pri odmerku 45 mg (ekstrakcija podatkov 6. februarja 2017) Dosežen MCyR pri 45 mg (N=86)
For a dose of 30 mg or 15 mg once daily, 15 mg and 30 mg film-coated tablets are available.
Za odmerek 30 mg ali 15 mg enkrat na dan so na voljo 15 mg in 30 mg filmsko obložene tablete.
Iclusig has not been studied at doses above 30 mg in patients with hepatic impairment (Childs-Pugh Classes A, B & C).
Zdravilo Iclusig pri bolnikih z okvaro jeter ni bilo preskušeno pri odmerkih, višjih od 30 mg (razredi po lestvici Childs-Pugh A, B in C).
Inform your doctor immediately if you experience these symptoms.
O pojavu teh simptomov takoj obvestite svojega zdravnika.
BCR-ABL mutation detected at entry, n (%)b None a* of 427 patients reporting prior TKI therapy with dasatinib or nilotinib b Of the patients with one or more BCR-ABL kinase domain mutations detected at entry, 37 unique mutations were detected.
Mutacija BCR-ABL, odkrita ob vstopu, n (%)b Brez a* od 427 bolnikov, ki so prejeli predhodno zdravljenje s TKI z dasatinibom ali nilotinibom b Od bolnikov z eno ali več mutacij domene kinaze BCR-ABL, odkritih ob vstopu, je bilo 37 enkratnih mutacij.
At therapeutic serum concentrations, ponatinib did not inhibit OATP1B1 or OATP1B3, OCT1 or OCT2, organic anion transporters OAT1 or OAT3, or bile salt export pump (BSEP) in vitro.
V terapevtskih koncentracijah ponatinib in vitro ni zaviral OATP1B1 ali OATP1B3, OCT1 ali OCT2, organskih anionskih prenašalcev OAT1 ali OAT3 ali črpalke žolčnih soli (BSEP, bile salt export pump).
The trial enrolled 449 patients of which 444 were eligible for analysis: 267 CP-CML patients (R/I Cohort: n=203, T315I Cohort: n=64), 83 AP-CML patients (R/I Cohort: n=65, T315I Cohort: n=18), 62 BP-CML (R/I Cohort: n=38, T315I Cohort: n=24), and 32 Ph+ ALL patients (R/I Cohort: n=10, T315I Cohort: n=22).
V preskušanje je bilo vključenih 449 bolnikov, med katerimi jih je bilo 444 primernih za analizo: 267 bolnikov s CP-KML (kohorta O/N: n = 203, kohorta T315I: n = 64), 83 bolnikov z AP-KML (kohorta O/N: n = 65, kohorta T315I: n = 18), 62 bolnikov z BP-KML (kohorta O/N: n = 38, kohorta T315I: n = 24) in 32 bolnikov s Ph+ ALL (kohorta O/N: n = 10, kohorta T315I: n = 22).
Patients were assigned to one of six cohorts based on disease phase (CP-CML; AP-CML; or BPCML/Ph+ ALL), resistance or intolerance (R/I) to dasatinib or nilotinib, and the presence of the T315I mutation.
Bolnike so dodelili v eno od šestih kohort na podlagi faze bolezni (CP-KML; AP-KML ali BP-KML/Ph+ ALL), odpornost ali neprenašanje (O/N) dasatiniba ali nilotiniba in prisotnost mutacije T315I.
In juvenile rats, mortality related to inflammatory effects was observed in animals treated with 3 mg/kg/day, and reductions in body weight gain were observed at doses of 0.75, 1.5 and 3 mg/kg/day during the pre-weaning and early post-weaning treatment phases.
Pri juvenilnih podganah so pri živalih, ki so dobivale 3 mg/kg/dan, opazili smrtnost, povezano z vnetnimi učinki, in zmanjšanje pridobivanja telesne mase pri odmerkih 0,75, 1,5 in 3 mg/kg/dan v obdobju zdravljenja pred odstavitvijo in v zgodnjem obdobju po odstavitvi.
A statistically significant increased incidence of squamous cell carcinoma of the clitoral gland was observed at that dose.
Pri tem odmerku je bilo opaziti statistično značilno povečano pojavnost ploščatoceličnega karcinomoma v žlezah klitorisa.
Anaemia (Hgb decreased)
Anemija (znižana raven Hgb) Limfopenija
The median dose intensity was 28 mg/day in CP-CML patients or, 63% of the expected 45 mg dose; median dose intensity was greater in advanced disease states (32 mg/day in the AP-CML patients and 44 mg/day in the BP CML/Ph+ ALL patients).
Mediana intenzivnosti odmerka je bila 28 mg/dan pri bolnikih s CP-KML ali 63 % pričakovanega 45 mg odmerka; mediana intenzivnosti odmerka je bila večja pri napredovalih bolezenskih stanjih (32 mg/dan pri bolnikih z AP KML in 44 mg/dan pri bolnikih z BPKML/Ph+ ALL.
(95% CI) Completeb (CHR)
(95-% IZ) Celovitb (CHR)
Iclusig is associated with severe (National Cancer Institute Common Terminology Criteria for Adverse Events grade 3 or 4) thrombocytopenia, neutropenia, and anaemia.
Zdravilo Iclusig je povezano s hudo (3. ali 4. stopnje po Poenotenih kriterijih za neželene učinke Nacionalnega inštituta za rak) trombocitopenijo, nevtropenijo in anemijo.
• or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall
• ali ste imeli anevrizmo (razširitev in oslabitev stene krvne žile) ali raztrganino v steni krvne žile.
• troubling skin rashes involving blisters or peeling and spread across the body, and involving tiredness.
• neprijetni kožni izpuščaji, ki vključujejo mehurje ali luščenje kože, in so razširjeni po telesu ter vključujejo utrujenost.
Within the range of clinically relevant doses evaluated in patients (15 mg to 60 mg), ponatinib exhibited dose proportional increases in both Cmax and AUC.
V klinično pomembnem razponu odmerkov, ki so ga ocenili pri bolnikih (15 mg do 60 mg), je ponatinib pokazal zvišanja Cmax in AUC, sorazmerno z odmerkom.
Table 10 Vascular occlusive first adverse events in CP-CML patients who achieved MCyR at 45 mg or 30 mg (data extraction 7 April 2014) Most recent dose at onset of first vascular occlusive Event 45 mg
Preglednica 10 Vaskularni okluzivni prvi neželeni učinki pri bolnikih s CP-KML, ki so dosegli MCyR pri 45 mg ali 30 mg (ekstrakcija podatkov 7. aprila 2014) Zadnji odmerek pri začetku prvega vaskularnega okluzivnega dogodka
• Iclusig should be interrupted and hepatic function should be monitored
• Jemanje zdravila Iclusig je treba prekiniti in spremljati delovanje jeter.
Of the CP-CML patients previously treated with one, two, three or four prior TKIs, 75% (12/16), 68% (66/97), 44% (63/142), and 58% (7/12)) achieved a MCyR while on Iclusig, respectively.
Med bolniki s CP-KML, predhodno zdravljenimi z enim, dvema, tremi ali štirimi TKI, jih je med uporabo zdravila Iclusig MCyR doseglo 75 % (12/16), 68 % (66/97), 44 % (63/142) oz. 58 % (7/12).
c MCyR combines both complete (No detectable Ph+ cells) and partial (1% to 35% Ph+ cells)
c MCyR združuje celovite (brez zaznavnih celic Ph+) in delne (1 % do 35 % celic Ph+) citogenetske odgovore.
*Reported using National Cancer Institute Common Terminology Criteria for Adverse Events version
*Poročilo v skladu s Poenotenimi kriteriji za neželene učinke Nacionalnega inštituta za rak, različica
Ponatinib is not a substrate for the human organic anion transporting polypeptides OATP1B1, OATP1B3 and the organic cation transporter OCT-1.
Ponatinib ni substrat za humana organska anionska prenašalska polipeptida OATP1B1 in OATP1B3 niti za organski kationski prenašalec OCT-1.
The median duration of treatment with Iclusig was 32.2 months in CP-CML patients, 19.4 months in AP-CML patients, and 2.9 months in BP-CML/Ph+ ALL patients.
Mediana trajanja zdravljenja z zdravilom Iclusig je bila 32,2 meseca pri bolnikih s CP-KML, 19,4 meseca pri bolnikih z AP-KML in 2,9 meseca pri bolnikih z BP-KML/Ph+ ALL.
There were no effects on male rat fertility parameters.
Pri samcih podgan ni bilo nobenih učinkov na parametre plodnosti.
Table 4 Adverse reactions observed in CML and Ph+ ALL patients - frequency reported by incidence of treatment emergent events System organ class
Preglednica 4 Neželeni učinki, ki so jih opazili pri bolnikih s KML in Ph+ ALL - pogostnost incidenc glede na poročila o dogodkih Organski sistem
(95% CI) Complete (CCyR)
(95-% IZ) Celovit (CCyR)
In vitro data showed no difference in plasma protein binding in plasma samples of healthy subjects and hepatically impaired (mild, moderate and severe) subjects.
Podatki študije in vitro v plazemskih vzorcih niso prikazali razlik pri vezavi na beljakovine v plazmi med skupino zdravih oseb in skupino bolnikov z okvaro jeter (blago, zmerno, hudo).
For CP-CML patients overall (N=267), as well as for CP-CML R/I Cohort A patients (N=203) and T315I Cohort B patients (N=64), the median OS has not yet been reached.
Pri vseh bolnikih s CP-KML (N = 267) in pri bolnikih s CP-KML v kohorti O/N (N = 203) in bolnikih s T315I v kohorti B (N = 64) mediana celokupnega preživetja še ni bila dosežena.
In CP-CML patients who achieved MCyR, the median time to MCyR was 2.8 months (range: 1.6 to 11.3 months) and in patients who achieved MMR, the median time to MMR was 5.5 months (range: 1.8 to 55.5 months).
Pri bolnikih s CP-KML, ki so dosegli MCyR, je bila mediana časa do MCyR 2,8 meseca (razpon: 1,6 do 11,3 mesecev ), pri bolnikih, ki so dosegli MMR, pa je bila mediana časa do MMR 5,5 meseca (razpon: 1,8 do 55,5 mesecev).
• changes in blood levels: decreased number of red blood cells (symptoms include: weakness, dizziness, fatigue) decreased number of blood platelets (symptoms include: increased tendency to bleed or bruise) decreased number of white blood cells called neutrophilis (symptoms include: increase tendency of infection) increased level of the serum protein known as lipase
• srčni napad (simptomi vključujejo: nenaden občutek zvišanega srčnega utripa, bolčine v prsnem košu, zasoplost)spremembe v krvi: - zmanjšano število rdečih krvnih celic (simptomi vključujejo šibkost, omotico, utrujenost) - zmanjšano število trombocitov (simptomi vključujejo povečano nagnjenost h krvavitvam ali nastanku podplutb) - zmanjšano število belih krvnih celic, imenovanih nevtrofilci (simptomi vključujejo povečano nagnjenost k okužbam)
Based on the Kaplan-Meier estimates, 82% (95% CI: [74%-88%]) of CP-CML (median duration of treatment: 32.2 months) patients who achieved a MCyR are projected to maintain that response at 48 months and 61% (95% CI: [51%- 70%]) of CP-CML patients who achieved a MMR are projected to maintain that response at 36 months.
Na podlagi ocene Kaplan-Meier se projicira, da bo 82 % (95-% IZ: [74 %-88 %]) bolnikov s CP-KML (mediana trajanja zdravljenja: 32,2 meseca), ki so dosegli MCyR ohranilo ta odziv za obdobje 48 mesecev in 61 % (95-% IZ: [51 %-70 %]) bolnikov s CP-KML, ki so dosegli MMR, ohranilo odgovor še v 36 mesecu.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, silica (colloidal anhydrous), magnesium stearate, talc, macrogol 4000, polyvinyl alcohol, titanium dioxide (E171).
Druge sestavine zdravila so laktoza monohidrat, mikrokristalna celuloza, natrijev karboksimetilškrob, brezvodni koloidni silicijev dioksid, magnezijev stearat, smukec, makrogol 4000, polivinilalkohol, titanov dioksid (E171).
alanine aminotransferase aspartate aminotransferase
- alanin-aminotransferaze
The median time to MaHR in patients with AP-CML, BP-CML, and Ph+ ALL was 0.7 months (range: 0.4 to 5.8 months), 1.0 months (range: 0.4 to 3.7 months), and 0.7 months (range: 0.4 to 5.5 months),
Mediana časa do MaHR pri bolnikih z AP-KML, BP-KML in Ph+ ALL je bila 0,7 meseca (razpon: 0,4 do 5,8 meseca), 1,0 meseca (razpon: 0,4 do 3,7 meseca) oz. 0,7 meseca (razpon: 0,4 do 5,5 meseca).
Alkaline phosphatase increased
- alkalne fosfataze
Table 7 Efficacy of Iclusig in resistant or intolerant chronic phase CML patients Overall (N=267)
Preglednica 7 Učinkovitost zdravila Iclusig pri bolnikih s kronično fazo KML, ki so na zdravljenje odporni ali ga ne prenašajo Skupaj (N = 267)
• you develop heart or blood vessel problems.
• se pojavijo težave s srcem ali krvnimi žilami;
Database cutoff date 06 February 2017.
Upoštevajo se podatki v podatkovni zbirki, vneseni do 6. februarja 2017.
After a minimum follow-up of 64 months, the rates of adverse reactions resulting in discontinuation were 20% in CP-CML, 11% in AP-CML, 15% in BP-CML and 9% in Ph+ ALL.
Po najmanj 64 mesecih spremljanja so bile stopnje pojavnosti neželenih učinkov, zaradi katerih je bilo treba zdravljenje prekiniti, 20 % za CP-KML, 11 % za AP-KML, 15 % za BP-KML in 9 % za Ph+ ALL.
Arterial occlusion and venous thromboembolism
Arterijska okluzija in venska trombembolija
What you need to know before you take Iclusig Do not take Iclusig
Kaj morate vedeti, preden boste vzeli zdravilo Iclusig Ne jemljite zdravila Iclusig
• inflammation of hair follicles, swollen, red area of skin or underneath skin that feels hot and tender
• vnetje lasnih foliklov, otekel ali rdeč predel kože ali območja pod njo, na katerem se pojavi občutek toplote in nežne kože
Defined as a ≤ 0.1% ratio of BCR-ABL to ABL transcripts on the International Scale (IS) (ie, ≤ 0.1% BCR-ABLIS; patients must have the b2a2/b3a2 (p210) transcript),
Opredeljeno kot ≤ 0,1 % razmerje BCR-ABL glede na transkripte ABL na mednarodni lestvici (IS, International Scale) (tj. ≤ 0,1 % BCR-ABLIS; bolniki morajo imeti transkript b2a2/b3a2 (p210)), v periferni krvi, izmerjeno s pomočjo kvantitativne reakcije verižne polimerizacije reverzne transkriptaze (qRT PCR, quantitative reverse transcriptase polymerase chain reaction).
Concomitant use of ponatinib with anti-clotting agents should be approached with caution in patients who may be at risk of bleeding events (see “Myelosuppression” and “Haemorrhage”).
Pri sočasni uporabi ponatiniba z zdravili proti strjevanju krvi je pri bolnikih, pri katerih obstaja tveganje za krvavitev, potrebna previdnost (glejte "Mielosupresija" in "Krvavitev").
No human data on the effect of ponatinib on fertility are available.
Pri ljudeh ni podatkov o vplivu ponatiniba na plodnost.
Lactose monohydrate Microcrystalline cellulose Sodium starch glycolate Colloidal anhydrous silica Magnesium stearate
Jedro tablete laktoza monohidrat mikrokristalna celuloza natrijev karboksimetilškrob brezvodni koloidni silicijev dioksid magnezijev stearat
• a 15 mg film-coated tablet and a 30 mg film-coated tablet to allow for dose adjustments.
• 15 mg filmsko obložene tablete in 30 mg filmsko obložene tablete za prilagajanje odmerka.
Statistical significance was achieved in the correlation of PFS and OS with a MCyR at the 12-month landmark (p=<0.0001 and p=0.0012, respectively).
Korelacija med PFS in OS z MCyR je bila statistično značilna na 12-mesečni kontrolni točki (p =< 0,0001 oziroma p = 0,0012).
Achieved MCyR at 45 mg (N=86)
Dosežen MCyR pri 45 mg (N=86)
Serious venous thromboembolic adverse reactions occurred in 5% of patients (treatment-emergent frequencies) (see section 4.8).
Resni venski trombembolični neželeni učinki so se pojavili pri 5 % bolnikov (pogostnosti v povezavi z zdravljenjem) (glejte poglavje 4.8).
Evidence for pre- and post-implantation loss of embryos was reported in female rats and ponatinib may therefore impair female fertility.
Pri samicah podgan so poročali o izgubi zarodkov pred vgnezditvijo in po njej in zato lahko ponatinib zmanjša plodnost žensk.
In the phase 2 trial, serious arterial occlusive adverse reactions occurred in 20% of patients (treatment-emergent frequencies).
V preskušanjih 2. faze so se resni arterijski okluzivni neželeni učinki pojavili pri 20 % bolnikov (pogostnosti v povezavi z zdravljenjem).
Dose reduction to 30 mg only ≥ 3 month reduction at 30 mg
Brez zmanjšanja odmerka Zmanjšanje odmerka le na 30 mg 15
For all patients in the phase 2 trial, the dose intensity-safety relationship indicated that there are significant increases in grade ≥ 3 adverse events (cardiac failure, arterial thrombosis, hypertension, thrombocytopenia, pancreatitis, neutropenia, rash, ALT increase, AST increase, lipase increase, myelosuppression, arthralgia) over the dose range of 15 to 45 mg once-daily.
Za vse bolnike v preskušanju 2. faze razmerje med intenzivnostjo odmerjanja in varnostjo kaže, da v razponu odmerkov od 15 do 45 mg enkrat na dan obstaja značilno povečanje neželenih učinkov stopnje ≥ 3 (srčno popuščanje, arterijska tromboza, hipertenzija, trombocitopenija, pankreatitis, nevtropenija, izpuščaj, povečanje vrednosti ALT, povečanje vrednosti AST, povečanje vrednosti lipaze, mielosupresija, artralgija).
• bleeding in the brain
• krvavitev v možganih
Bottles of Iclusig 15 mg contain either 30, 60 or 180 film-coated tablets.
Plastenke zdravila Iclusig 15 mg vsebujejo 30, 60 ali 180 filmsko obloženih tablet.
With a minimum follow-up of 64 months, 3.4% (9/267) of CP-CML patients experienced transformation of their disease to AP-CML or BP-CML.
Z najkrajšim časom spremljanja 64 mesecev, se je pri 3,4 % (9/267) bolnikih s CP-KML dosegel prehod bolezni na AP-KML ali BP-KML.
6.6 Special precautions for disposal and other handling Disposal
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
• heart problems, left sided chest pain, dysfunction of the left heart chamber
• težave s srcem, bolečine na levi strani prsnega koša, nepravilno delovanje levega srčnega prekata
Adverse reactions reported in all CML and Ph+ ALL patients are presented in Table 4.
Neželeni učinki, o katerih so poročali za vse bolnike s KML in Ph+ ALL, so predstavljeni v preglednici 4.
amylase alkaline phosphatase gamma-glutamyltransferase
- gama-glutamiltransferaze
Arterial occlusions, including fatal myocardial infarction, stroke, retinal arterial occlusions associated in some cases with permanent visual impairment or vision loss, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, renal artery stenosis (associated with worsening, labile or treatment-resistant hypertension), and the need for urgent revascularization procedures have occurred in Iclusig-treated patients.
Pri bolnikih, zdravljenih z zdravilom Iclusig, so se pojavili arterijska okluzija, vključno s smrtnim miokardnim infarktom, možgansko kapjo, retinalna arterijska okluzija, v nekaterih primerih povezana s trajno okvaro vida ali slepoto, stenozo velikih arterijskih žil v možganih, hudo periferno žilno boleznijo, stenozo ledvične arterije (povezano s poslabšanjem hipertenzije, labilno hipertenzijo ali na zdravljenje odporno hipertenzijo) in potrebo po nujnem postopku revaskularizacije.
Table 8 Efficacy of Iclusig in resistant or intolerant advanced phase CML patients Accelerated Phase CML
Preglednica 8 Učinkovitost zdravila Iclusig pri bolnikih s KML z napredovalo fazo, ki so na zdravljenje odporni ali ga ne prenašajo KML v pospešeni fazi
• you have a liver disorder.
• imate motnje v delovanju jeter.
Co-administration of a single 15 mg oral dose of Iclusig in the presence of ketoconazole (400 mg daily), a strong CYP3A inhibitor, resulted in modest increases in ponatinib systemic exposure, with ponatinib AUC0-∞ and Cmax values that were 78% and 47% higher, respectively, than those seen when ponatinib was administered alone.
Sočasna uporaba enega 15 mg peroralnega odmerka zdravila Iclusig v prisotnosti ketokonazola (400 mg na dan), močnega zaviralca CYP3A, je povzročila blago zvišanje sistemske izpostavljenosti ponatinibu, z vrednostima AUC0-∞ in Cmax, ki sta bili za 78 % oz. 47 % višji kot pri dajanju samega ponatiniba.
(95% CI) a Primary endpoint for AP-CML and BP-CML/Ph+ ALL Cohorts was MaHR, which combines complete haematological responses and no evidence of leukaemia.
(95-% IZ) a Primarni opazovani dogodek za kohorti AP-KML in BP-KML/Ph+ ALL je bil MaHR, ki združuje celovit hematološki odgovor in odsotnost dokazov o levkemiji.
• chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation
• s kronično mieloidno levkemijo (KML) v kronični fazi, pospešeni fazi ali blastni fazi, ki so odporni na dasatinib ali nilotinib; ki ne prenašajo dasatiniba ali nilotiniba in pri katerih nadaljnje zdravljenje z imatinibom ni klinično ustrezno; ali ki imajo mutacijo T315I
Iclusig is available in plastic bottles, each containing one canister of a molecular sieve desiccant.
Zdravilo Iclusig je na voljo v plastenkah, od katerih vsaka vsebuje eno posodo s sušilnim sredstvom z molekulskim sitom.
The secondary efficacy endpoints in CP-CML were complete haematological response (CHR) and major molecular response (MMR).
Sekundarni opazovani dogodek učinkovitosti pri bolnikih s CP-KML je bil celovit hematološki odgovor (CHR, complete haematological response) in bistven molekularni odgovor (MMR, major molecular response).
The incidence of severe bleeding events was higher in patients with AP-CML, BP-CML and Ph+ ALL.
Incidenca težkih krvavitev je bila večja pri bolnikih z AP-KML, BP-KML in Ph+ ALL.
Occurrence at 30 mg:
Pojav pri 30 mg:
Arterial occlusive adverse events were more frequent with increasing age and in patients with history of ischaemia, hypertension, diabetes, or hyperlipidaemia.
Neželeni učinki arterijske okluzije so bili pogostejši pri starejših bolnikih in pri bolnikih z ishemijo, hipertenzijo, sladkorno boleznijo ali hiperlipidemijo v anamnezi.
Serious venous occlusive reactions (treatment-emergent frequencies) occurred in 5% of patients.
Resne venske okluzivne reakcije (pogostnosti v povezavi z zdravljenjem) so se pojavile pri 5 % bolnikov.
• pain in bones, joints, pain in muscles, back, arms or legs, muscle spasms
• bolečina v kosteh, sklepih, bolečina v mišicah, hrbtu, rokah ali nogah, mišični krči
Resistant or Intolerant R/I Cohort (N=203)
Odporni ali ne prenašajo O/N kohorta (N = 203)
• Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
• z akutno limfoblastno levkemijo s prisotnim kromosomom Philadelphia (Ph+ ALL), ki so odporni na dasatinib; ki ne prenašajo dasatiniba in pri katerih nadaljnje zdravljenje z imatinibom ni klinično ustrezno; ali ki imajo mutacijo T315I.
In the phase 2 trial (with a minimum of 64 months follow-up), venous thromboembolic adverse reactions have occurred in 6% of patients (treatment-emergent frequencies).
V preskušanju 2. faze (z najmanj 64 mesecev spremljanja), so se venski trombembolični neželeni učinki pojavili pri 6 % bolnikov (pogostnosti v povezavi z zdravljenjem).
• stroke (symptoms include: difficulty to speak or move, sleepiness, migraine, abnormal sensations)
• možganska kap (simptomi vključujejo težave z govorom ali premikanjem, zaspanost, migreno,
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Venous thromboembolic reactions (treatment-emergent frequencies) occurred in 6% of patients.
Venski trombembolični dogodki (pogostnosti v povezavi z zdravljenjem) so se pojavili pri 6 % bolnikov.
In the phase 2 trial (with a minimum of 64 months follow-up), arterial occlusive adverse reactions have occurred in 25% of patients (treatment-emergent frequencies).
V preskušanju 2. faze (z najmanj 64 mesecev spremljanja) so se arterijski okluzivni neželeni učinki pojavili pri 25 % bolnikov (pogostnosti v povezavi z zdravljenjem).
• sodium decrease in the blood
• znižanje ravni natrija v krvi
• lung infection (may cause breathing difficulty)
• okužba pljuč (lahko povzroči težave z dihanjem)