natgillin/translations-raw huggingface dataset:
Table 3 Adverse drug reactions observed in the AML clinical study
Tablica 3 Nuspojave opažene u kliničkom ispitivanju AML-a
In a study with 36 healthy subjects, co-administration of the strong CYP3A4 inhibitor ketoconazole to steady state with a single dose of 50 mg midostaurin led to a significant increase in midostaurin exposure (1.8-fold Cmax increase and 10-fold AUCinf increase) and 3.5-fold increase in AUCinf of CGP62221, while the Cmax of the active metabolites (CGP62221 and CGP52421) decreased by half (see section 5.2).
U ispitivanju s 36 zdravih ispitanika, istodobna primjena snažnog CYP3A4 inhibitora ketokonazola do stanja dinamičke ravnoteže s jednokratnom dozom midostaurina od 50 mg dovela je do značajnog povećanja izloženosti midostaurinu (povećanje Cmax od 1,8 puta i povećanje AUCinf od 10 puta) i povećanja AUCinf za CGP62221 od 3,5 puta, dok se Cmax aktivnih metabolita (CGP62221 i CGP52421) smanjio za pola (vidjeti dio 5.2).
Table 3 presents the frequency category of ADRs reported in the phase III study in patients with newly diagnosed FLT3-mutated AML.
Tablici 3 navedena je kategorija učestalosti nuspojava zabilježenih u ispitivanju faze III u bolesnika s novodijagnosticiranim AML-om s FLT3 mutacijom.
Similarly, for CGP52421 and CGP62221 AUC increased to 19000 and 29200 ng*h/ml and Cmax decreased to 172 and 455 ng/ml, respectively.
Slično tome, za CGP52421, odnosno CGP62221, AUC se povećao na 19 000, odnosno 29 200 ng*h/ml, a Cmax se smanjio na 172, odnosno 455 ng/ml.
Other possible side effects in patients with ASM, SM-AHN and MCL Other side effects include those listed below.
Druge moguće nuspojave u oboljelih od ASM-a, SM-AHN-a i MCL-a Ostale nuspojave uključuju one navedene u nastavku.
Packs containing 56 (2 packs of 28) or 112 (4 packs of 28) soft capsules.
Pakiranja koja sadrže 56 (2 pakiranja po 28) ili 112 (4 pakiranja po 28) mekih kapsula.
On day 1, the AUC0-12 and Cmax were 8130 ng*h/ml and 1206 ng/ml, respectively, for healthy subjects.
Prvog dana AUC0-12 je bio 8130 ng*h/ml, a Cmax 1206 ng/ml za zdrave ispitanike.
In AML and ASM, SM-AHN and MCL patients, population pharmacokinetic estimates for clearance of midostaurin at steady state were 5.9 l/h and 4.4 l/h, respectively.
U bolesnika s AML-om, odnosno ASM-om, SM-AHN-om i MCL-om, populacijske farmakokinetičke procjene za klirens midostaurina u stanju dinamičke ravnoteže bile su 5,9 l/h, odnosno 4,4 l/h.
In a pre- and post-natal developmental study, maternal dystocia and reduced litter size, lower pup body weights, accelerated complete eye opening and delayed auricular startle ontogeny were noted.
U ispitivanju pred i postnatalnog razvoja, primijećene su maternalna distocija i smanjena veličina okota, niže tjelesne težine mladunčadi, ubrzano potpuno otvaranje očij i odgođeni razvoj odgovora na iznenadni zvuk.
Missed doses If a dose is missed, the patient should take the next dose at the scheduled time.
Ako propusti dozu, bolesnik treba uzeti sljedeću dozu prema rasporedu.
How Rydapt works
Kako Rydapt djeluje
The overall rate of SCT was 59.4% (214/360) of patients in the midostaurin plus standard chemotherapy arm versus 55.2% (197/357) in the placebo plus standard chemotherapy arm. All patients were followed for survival.
Ukupna stopa TMS-a bila je 59,4% (214/360) bolesnika u skupini koja je primala midostaurin plus standardnu kemoterapiju u usporedbi s 55,2% (197/357) u skupini koja je primala placebo plus standardnu kemoterapiju.
Musculoskeletal and connective tissue disorders Back pain
Poremećaji mišićno-koštanog sustava i vezivnog tkiva Bol u leđima
Carmine (E120) Hypromellose Propylene glycol
Tinta za označavanje boja karmin (E120) hipromeloza propilenglikol
Severe neutropenia (ANC <0.5 x 10
Teška neutropenija (ABN < 0,5 x 10
Neutropenic sepsis
Neutropenijska sepsa manje često
74.7 (31.5, NE) 25.6 (18.6, 42.9) 0.77 (0.63, 0.95) 0.0078
74,7 (31,5; NP) 25,6 (18,6; 42,9) 0,77 (0,63; 0,95) 0,0078
Amylase increased*
Povišena amilaza*
Pain in extremity
Bol u ekstremitetu često
Approximately one third (36%) received prior anti-neoplastic therapy for ASM, SM-AHN or MCL.At baseline in the primary efficacy population, 65% of the patients had >1 measurable C finding (thrombocytopenia, hypoalbuminaemia, anaemia, high total bilirubin, transfusion-dependent anaemia, weight loss, neutropenia, high ALT or high AST).
U populaciji za utvrđivanje primarne djelotvornosti je 65% bolesnika imalo > 1 mjerljivi C nalaz na početku (trombocitopenija, hipoalbuminemija, anemija, povišen ukupni bilirubin, anemija ovisna o transfuziji, gubitak tjelesne težine, neutropenija, povišen ALT ili povišen AST).
AST increased*
Povišeni AST*
Concomitant use of Rydapt with strong inducers of CYP3A4 (e.g. carbamazepine, rifampicin, enzalutamide, phenytoin, St. John's Wort [Hypericum perforatum]) is contraindicated (see section 4.3).
Istodobna primjena Rydapta sa snažnim CYP3A4 induktorima (npr. karbamazepin, rifampicin, enzalutamid, fenitoin, gospina trava [Hypericum perforatum]) je kontraindicirana (vidjeti dio 4.3).
Other possible side effects in patients with AML Other side effects include those listed below.
Druge moguće nuspojave u oboljelih od AML-a Ostale nuspojave uključuju one navedene u nastavku.
(signs of sepsis or neutropenic sepsis) - vomiting of blood, black or bloody stools (signs of gastrointestinal bleeding)
(znakovi sepse ili neutropenijske sepse). - povraćanje krvi, crna ili krvava stolica (znakovi krvarenja u probavnom sustavu).
ADRs occurring more often in the midostaurin arm versus placebo during maintenance included: nausea (46.4% versus 17.9%), hyperglycaemia (20.2% versus 12.5%), vomiting (19% versus 5.4%) and QT prolongation (11.9% versus 5.4%).
Nuspojave koje su se javljale češće u skupini koja je primala midostaurin u odnosu na onu koja je primala placebo tijekom održavanja uključivale su: mučninu (46,4% u odnosu na 17,9%), hiperglikemiju (20,2% u odnosu na 12,5%), povraćanje (19% u odnosu na 5,4%) i produljenje QT intervala (11,9% u odnosu na
The most frequent Grade 3/4 haematological abnormalities reported in patients during the maintenance phase with Rydapt were ANC decrease (20.8% versus 18.8%) and leukopenia (7.5% versus 5.9%).
Najučestalije hematološke abnormalnosti 3./4. stupnja zabilježene u bolesnika tijekom faze održavanja s Rydaptom bile su smanjenje ABN-a (20,8% u usporedbi s 18,8%) i leukopenija (7,5% u usporedbi s 5,9%).
Rydapt contains macrogolglycerol hydroxystearate, which may cause stomach discomfort and diarrhoea.
Rydapt sadrži makrogolglicerolhidroksistearat, koji može uzrokovati nelagodu u želucu i proljev.
If any of these side effects become severe, tell your doctor or pharmacist.
Ako bilo koja od tih nuspojava postane teška, obratite se liječniku ili ljekarniku.
The most frequent non-haematological laboratory abnormalities were hyperglycaemia (93.7%), total bilirubin increased (40.1%), lipase increased (39.4%), aspartate aminotransferase (AST) increased (33.8%), and alanine aminotransferase (ALT) increased (33.1%), while the most frequent haematological laboratory abnormalities were absolute lymphocyte count decreased (73.2%) and ANC decreased (58.5%).
Najučestalije nehematološke laboratorijske abnormalnosti bile su hiperglikemija (93,7%), povišeni ukupni bilirubin (40,1%), povišena lipaza (39,4%), povišena aspartat aminotransferaza (AST) (33,8%) i povišena alanin aminotransferaza (ALT) (33,1%), dok su najučestalije hematološke laboratorijske abnormalnosti bile sniženi apsolutni broj limfocita (73,2%) i sniženi ABN (58,5%).
Interrupt Rydapt until haemoglobin greater than or equal to 8 g/dl, then resume Rydapt at 50 mg twice daily and, if tolerated, increase to 100 mg twice daily.
Prekinuti primjenu Rydapta dok hemoglobin ne bude veći od ili jednak 8 g/dl, zatim nastaviti primjenu Rydapta u dozi od 50 mg dvaput na dan te, ako se podnosi, povećati na 100 mg dvaput na dan.
Absolute lymphocyte decreased*
Snižen apsolutni broj limfocita*
Table 2 Rydapt dose interruption, reduction and discontinuation recommendations in patients with ASM, SM-AHN or MCL
Tablica 2 Preporuke za privremeni prekid doziranja, smanjenje doze i obustavu primjene Rydapta u bolesnika s ASM-om, SM-AHN-om ili MCL-om
Table 4 presents the frequency category of ADRs based on pooled data from two studies in patients with ASM, SM-AHN and MCL.
Tablica 4 prikazuje kategorije učestalosti nuspojava na temelju zbirnih podataka iz dvaju ispitivanja u bolesnika s ASM-om, SM-AHN-om i MCL-om.
Ethanol anhydrous Maize oil mono-di-triglycerides All-rac-alpha-tocopherol
Sadržaj kapsule makrogolglicerolhidroksistearat makrogol etanol, bezvodni mono-, di- i trigliceridi kukuruznog ulja sav-rac-alfa-tokoferol
The following medicines must be avoided during treatment with Rydapt: - medicines used to treat tuberculosis, such as rifampicin; - medicines used to treat epilepsy, such as carbamazepine or phenytoin; - enzalutamide, a medicine used to treat prostate cancer; - St. John's Wort (also known as Hypericum perforatum), a herbal medicine used to treat depression.
Sljedeće lijekove morate izbjegavati tijekom liječenja Rydaptom: - lijekove koji se koriste za liječenje tuberkuloze, kao što je rifampicin; - lijekove koji se koriste za liječenje epilepsije, kao što je karbamazepin ili fenitoin; - enzalutamid, lijek koji se koristi za liječenje raka prostate; - gospinu travu (poznata i pod imenom Hypericum perforatum), biljni lijek koji se koristi za liječenje depresije.
The safety of Rydapt (100 mg twice daily) as a single agent in patients with ASM, SM-AHN and MCL was evaluated in 142 patients in two single-arm, open-label, multicentre studies.
Sigurnost monoterapije Rydaptom (100 mg dvaput na dan) u bolesnika s ASM-om, SM-AHN-om i MCL-om ocijenjena je u 142 bolesnika u dva multicentrična otvorena ispitivanja s po jednom skupinom.
ADRs are listed according to MedDRA system organ class.
Nuspojave su navedene prema klasifikaciji organskih sustava iz Medicinskog rječnika za regulatorne poslove (MedDRA).
Other Grade 3/4 non-haematological toxicities
Ostale nehematološke toksičnosti 3./4. stupnja
Rydapt contains the active substance midostaurin.
Rydapt sadrži djelatnu tvar midostaurin.
A dedicated hepatic impairment study assessed the systemic exposure of midostaurin after oral administration of 50 mg twice daily for 6 days in subjects with baseline mild or moderate hepatic impairment (Child-Pugh Class A or B, respectively) and control subjects with normal hepatic function.
Posebnim ispitivanjem za procjenu utjecaja oštećenja jetre procjenjivala se sistemska izloženost midostaurinu nakon peroralne primjene 50 mg dvaput na dan tijekom 6 dana u ispitanika s početnim blagim odnosno umjerenim oštećenjem jetre (Child-Pugh stadij A, odnosno B) i kontrolnih ispitanika s normalnom funkcijom jetre.
9/l attributed to Rydapt in patients without MCL, or ANC less than 0.5 x 10
9/l koji se pripisuje Rydaptu u bolesnika bez MCL-a, ili ABN manji od 0,5 x 10
Each soft capsule contains 25 mg midostaurin.
Jedna meka kapsula sadrži 25 mg midostaurina.
The CGP62221 Cmin, ss in the AML and the ASM, SM-AHN, MCL population were 1610 ng/ml and 2020 ng/ml, respectively.
Cmin, ss za CGP62221 u populaciji s AML-om, odnosno s ASM-om, SM-AHN-om, MCL-om iznosio je 1610 ng/ml, odnosno 2020 ng/ml.
Serious ADRs occurred at similar rates in patients in the Rydapt versus the placebo arm.
Ozbiljne nuspojave javile su se u sličnim stopama u bolesnika u skupini koja je primala Rydapt u odnosu na skupinu koja je primala placebo.
9/l attributed to Rydapt in patients with baseline platelet count of 25-75 x 10
9/l koji se pripisuje Rydaptu u bolesnika s početnim brojem trombocita od 25-75 x 10 9/l
If neutropenia (ANC <1.0 x 10
Ako neutropenija (ABN < 1,0 x 10
Cytochrome P450 inhibition
Inhibicija citokroma P450
Two major metabolites have been identified in murine models and humans, i.e. CGP62221 and CGP52421.
Utvrđena su dva glavna metabolita u mišjim modelima i u ljudi, tj. CGP62221 i CGP52421.
In a study in healthy subjects, co-administration of the strong CYP3A4 inducer rifampicin (600 mg daily) to steady state with a 50 mg single dose of midostaurin decreased midostaurin Cmax by 73% and AUCinf by 96% on average, respectively.
U jednom ispitivanju zdravih ispitanika, istodobnom primjenom snažnog CYP3A4 induktora rifampicina (600 mg na dan) do stanja dinamičke ravnoteže i jedne doze midostaurina od 50 mg, Cmax midostaurina se prosječno smanjio za 73%, a AUCinf za 96%.
No dose adjustment is required in patients with mild or moderate (Child-Pugh A or B) hepatic impairment (see section 5.2).
Za bolesnike s blagim ili umjerenim (Child-Pugh A ili B) oštećenjem jetre nije potrebna prilagodba doze (vidjeti dio 5.2).
The CGP52421, Cmin,ss in the AML and the ASM, SM-AHN, MCL population were 8630 ng/ml and 2860 ng/ml, respectively.
Cmin,ss za CGP52421 u populaciji s AML-om, odnosno s ASM-om, SM-AHN-om, MCL-om iznosio je 8630 ng/ml, odnosno 2860 ng/ml.
The most frequent ADRs were nausea (82%), vomiting (68%), diarrhoea (51%), peripheral oedema (35%) and fatigue (31%).
Najučestalije nuspojave bile su mučnina (82%), povraćanje (68%), proljev (51%), periferni edem (35%) i umor (31%).
9/l attributed to Rydapt in patients with baseline ANC value of 0.5-1.5 x 10
9/l koji se pripisuje Rydaptu u bolesnika s početnom vrijednošću ABN-a od 0,5-1,5 x 10
After oral administration of a single 100 mg dose of midostaurin under fed conditions in ASM, SM-AHN and MCL patients, AUCinf, Cmax and Tmax were 49600 ng*h/ml, 2940 ng/ml and 3 h, respectively, for midostaurin.
Nakon peroralne primjene jednokratne doze midostaurina od 100 mg nakon obroka u bolesnika s ASM-om, SM-AHN-om i MCL-om, AUCinf, Cmax, odnosno Tmax, za midostaurin iznosili su 49 600 ng*h/ml, 2940 ng/ml, odnosno 3 h.
NE (27.0, NE)
NP (27,0; NP)
AUC0-12h and Cmax for CGP62221 were 8700 ng*h/ml and 931 ng/ml, respectively.
AUC0-12h, odnosno Cmax, za CGP62221 iznosili su 8700 ng*h/ml, odnosno 931 ng/ml.
Partial response, n
Ukupna stopa odgovora, n
Breast-feeding should be discontinued during treatment with Rydapt and for at least 4 months after stopping treatment.
Dojenje treba prekinuti tijekom liječenja Rydaptom te najmanje 4 mjeseca nakon prestanka liječenja.
known as hyperglycaemia) - muscle weakness, drowsiness, confusion, convulsions, impaired consciousness (signs of high level of sodium in the blood, known as hypernatraemia) - muscle weakness, muscle spasms, abnormal heart rhythm (signs of low levels of potassium in the blood, known as hypokalaemia) - bruising and bleeding (defect in blood clotting) - abnormal blood test results which can indicate to your doctor how well certain parts of your body are functioning: high levels of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) (indicative of liver function)
- slabost mišića, omamljenost, smetenost, konvulzije, smanjena svijest (znakovi visokih razina natrija u krvi, što se naziva hipernatrijemijom) - slabost mišića, grčevi mišića, poremećeni srčani ritam (znakovi niskih razina kalija u krvi, što se naziva hipokalijemija) - stvaranje podljeva i krvarenje (poremećeno zgrušavanje krvi) - odstupanja u rezultatima krvnih pretraga koje Vašem liječniku mogu ukazivati na to koliko dobro funkcioniraju određeni dijelovi Vašeg tijela: visoke razine alanin aminotransferaze (ALT) i/ili aspartat aminotransferaze (AST) (ukazuju na funkciju jetre)
The most frequent Grade 3/4 ADRs were fatigue (8.5%), sepsis (7.7%), pneumonia (7%), febrile neutropenia (7%), and diarrhoea (6.3%).
Najučestalije nuspojave 3./4. stupnja bile su umor (8,5%), sepsa (7,7%), pneumonija (7%), febrilna neutropenija (7%) i proljev (6,3%).
Interrupt Rydapt until ANC ≥1.0 x 10
Prekinuti primjenu Rydapta dok ABN ne bude ≥ 1,0 x 10
How much Rydapt to take
Koliko Rydapta uzimati
Median overall survival, months (95% CI)
Medijan ukupnog preživljenja, mjeseci (95% CI)
Efficacy and safety in patients 60-70 years old were evaluated in a phase II, single- arm, investigator- initiated study of midostaurin in combination with intensive induction, consolidation including allogenic SCT and single-agent maintenance in patients with FLT3-ITD mutated AML.
Djelotvornost i sigurnost u bolesnika u dobi od 60-70 godina ocjenjivane su u ispitivanju faze II s jednom skupinom koje su pokrenuli ispitivači u svrhu ispitivanja midostaurina u kombinaciji s intenzivnom indukcijom i konsolidacijom, uključujući alogeni TMS, kao i u monoterapiji održavanja u bolesnika s FLT3-ITD-mutiranim AML-om.
Rydapt 25 mg capsules midostaurin
Rydapt 25 mg kapsule midostaurin
Animal studies with midostaurin have shown impaired fertility (see section 5.3).
Ispitivanja midostaurina na životinjama pokazala su smanjenje plodnosti (vidjeti dio 5.3).
For CGP52421, AUC0-12h and Cmax were 2770 ng*h/ml and 299 ng/ml, respectively.
Za CGP52421, AUC0-12h, odnosno Cmax, iznosili su 2770 ng*h/ml, odnosno 299 ng/ml.
The overall median duration of exposure was 42 days (range 2 to 576 days) for patients in the Rydapt plus standard chemotherapy arm versus 34 days (range 1 to 465 days) for patients in the placebo plus standard chemotherapy arm. For the 205 patients (120 in Rydapt arm and 85 in placebo arm) who entered the maintenance phase, the median duration of exposure in maintenance was 11 months for both arms (16 to 520 days for patients in the Rydapt arm and 22 to 381 days in the placebo arm).
Za 205 bolesnika (120 u Rydapt skupini i 85 u placebo skupini) koji su ušli u fazu održavanja, medijan trajanja izloženosti kod održavanja bio je 11 mjeseci za obje ispitivane skupine (16 do 520 dana za bolesnike u Rydapt skupini i 22 do 381 dan u placebo skupini).
Caution is warranted when considering the administration of midostaurin in patients with severe hepatic impairment and patients should be carefully monitored for toxicity (see section 5.2).
Potreban je oprez kad se razmatra primjena midostaurina u bolesnika s teškim oštećenjem jetre, a bolesnike je potrebno pažljivo nadzirati zbog moguće toksičnosti (vidjeti dio 5.2).
No impact of hepatic impairment could be identified in patients with mild or moderate hepatic impairment in the ASM, SM-AHN, MCL and AML populations.
U bolesnika s blagim ili umjerenim oštećenjem jetre nije utvrđen nikakav utjecaj oštećenja jetre u populaciji s ASM-om, SM-AHN-om, MCL-om i AML-om.
However, there was a less than dose-proportional increase in exposure after multiple doses within the dose range of 50 mg to 225 mg daily.
Međutim, nakon višestrukih doza unutar raspona doze od 50 mg do 225 mg na dan došlo je do povećanja izloženosti koje je manje od proporcionalnog s dozom.
No dose adjustment is required for patients with mild or moderate renal impairment.
Nije potrebna prilagodba doze za bolesnike s blagim ili umjerenim oštećenjem jetre na početku.
56 (2 packs of 28) capsules
56 (2 pakiranja po 28) kapsula
112 (4 packs of 28) capsules
112 (4 pakiranja po 28) kapsula
You should not breast-feed during treatment with Rydapt and for at least 4 months after stopping the treatment.
Ne smijete dojiti tijekom liječenja Rydaptom te najmanje 4 mjeseca nakon prestanka liječenja.
PAES: In order to investigate the efficacy in elderly patients, the MAH should conduct and submit the results of a randomised, double-blind E2301 study of midostaurin versus placebo in combination with chemotherapy during induction and consolidation, followed by 12 months of midostaurin monotherapy in adult patients (aged ≥18 years) with newly diagnosed AML, without FLT3 mutation.
PAES: Da bi se ispitala djelotvornost u starijih bolesnika, nositelj odobrenja treba provesti i dostaviti rezultate randomiziranog, dvostruko-slijepog E2301 ispitivanja midostaurina u usporedbi s placebom u kombinaciji s kemoterapijom tijekom indukcije i konsolidacije, nakon čega slijedi 12 mjeseci monoterapije midostaurinom u odraslih bolesnika (u dobi od ≥ 18 godina) s novodijagnosticiranim AML-om, bez FLT3 mutacije.
The most frequent laboratory abnormalities were haemoglobin decreased (97.3%), ANC decreased (86.7%), ALT increased (84.2%), AST increased (73.9%) and hypokalaemia (61.7%).
Najučestalije laboratorijske abnormalnosti bile su sniženi hemoglobin (97,3%), sniženi ABN (86,7%), povišeni ALT (84,2%), povišeni AST (73,9%) i hipokalijemija (61,7%).
Caution is warranted when considering the administration of midostaurin in patients with severe renal impairment or end-stage renal disease and patients should be carefully monitored for toxicity (see section 5.2).
Potreban je oprez kad se razmatra primjena midostaurina u bolesnika s teškim oštećenjem bubrega ili završnim stadijem bolesti bubrega, a bolesnike je potrebno pažljivo nadzirati zbog moguće toksičnosti (vidjeti dio 5.2).
Soft capsule
Meka kapsula
The most frequent adverse drug reactions (ADRs) in the Rydapt arm were febrile neutropenia (83.4%), nausea (83.4%), exfoliative dermatitis (61.6%), vomiting (60.7%), headache (45.9%), petechiae (35.8%) and pyrexia (34.5%).
Najučestalije nuspojave u skupini koja je primala Rydapt bile su febrilna neutropenija (83,4%), mučnina (83,4%), eksfolijativni dermatitis (61,6%), povraćanje (60,7%), glavobolja (45,9%), petehije (35,8%) i pireksija (34,5%).
Grades 3/4
3./4. stupanj
Dose modifications in ASM, SM-AHN and MCL
Prilagodbe doze kod ASM-a, SM-AHN-a i MCL-a
Table 4 Adverse drug reactions observed in the ASM, SM-AHN and MCL clinical studies
Tablica 4 Nuspojave opažene u kliničkim ispitivanjima ASM-a, SM-AHN-a i MCL-a
PAES: In order to investigate the efficacy in elderly patients, the MAH should conduct and submit the results of A2408, a study to assess the efficacy and safety of midostaurin in combination with standard chemotherapy during induction and consolidation, followed by 12 months of midostaurin monotherapy in adult patients (aged ≥18 years) with newly diagnosed FLT3-mutated AML.
PAES: Da bi se ispitala djelotvornost u starijih bolesnika, nositelj odobrenja treba provesti i dostaviti rezultate A2408, ispitivanja kojim se ocjenjuje djelotvornost i sigurnost midostaurina u kombinaciji sa standardnom kemoterapijom tijekom indukcije i konsolidacije, nakon čega slijedi 12 mjeseci monoterapije midostaurinom u odraslih bolesnika (u dobi od ≥ 18 godina) s novodijagnosticiranim FLT3 mutiranim AML-om.
Sinus tachycardia
Sinusna tahikardija često
After 100 mg bid multiple oral doses of midostaurin the Cmin,ss plasma midostaurin in AML and ASM, SMAHN, MCL patients were 919 and 1060 ng/ml, respectively.
Nakon višestrukih peroralnih doza midostaurina od 100 mg dvaput na dan, Cmin,ss midostaurina u plazmi u bolesnika s AML-om, odnosno s ASM-om, SM-AHN-om, MCL-om bio je 919, odnosno 1060 ng/ml.
Interrupt Rydapt for 3 days (6 doses), then resume at 50 mg twice daily and, if tolerated, gradually increase to 100 mg twice daily.
Prekinuti primjenu Rydapta na 3 dana (6 doza), zatim nastaviti u dozi od 50 mg dvaput na dan te, ako se podnosi, postupno povećati na 100 mg dvaput na dan.
The most frequent Grade 3/4 ADRs were febrile neutropenia (83.5%), lymphopenia (20.0%), device-related infection (15.7%), exfoliative dermatitis (13.6%), hyperglycaemia (7.0%) and nausea (5.8%).
Najučestalije nuspojave 3./4. stupnja bile su febrilna neutropenija (83,5%), limfopenija (20,0%), infekcija povezana s uređajem (15,7%), eksfolijativni dermatitis (13,6%), hiperglikemija (7,0%) i mučnina (5,8%).
Hypercalcaemia*
Hiperkalcijemija*
The most frequent Grade 3/4 laboratory abnormalities were absolute lymphocyte count decreased (45.8%), ANC decreased (26.8%), hyperglycaemia (19%), and lipase increased (17.6%).
Najučestalije laboratorijske abnormalnosti 3./4. stupnja bile su sniženi apsolutni broj limfocita (45,8%), sniženi ABN (26,8%), hiperglikemija (19%) i povišena lipaza (17,6%).
primary endpoint;
Mjera primarnog ishoda;
Infections and infestations Device-related infection
Infekcije i infestacije Infekcija povezana s uređajem
56 (2 packs of 28) capsules 112 (4 packs of 28) capsules
56 (2 pakiranja po 28) kapsula 112 (4 pakiranja po 28) kapsula
Hypernatraemia*
Hipernatrijemija*