natgillin/translations-raw huggingface dataset:
Der blev påvist en statistisk signifikant forbedring i EFS for midostaurin plus standardkemoterapi sammenlignet med placebo plus standardkemoterapi (HR: 0,78 [95 % Cl, 0,66 til 0,93] p = 0,0024) og en median EFS på henholdsvis 8,2 måneder og 3,0 måneder; se tabel 5.
The EFS showed a statistically significant improvement for midostaurin plus standard chemotherapy over placebo plus standard chemotherapy (HR: 0.78 [95% CI, 0.66 to 0.93] p = 0.0024), and a median EFS of 8.2 months and 3.0 months, respectively; see Table 5.
Så meget Rydapt skal du tage
How much Rydapt to take
Effekt og sikkerhed hos patienter i alderen 60-70 år blev undersøgt i et fase-II-, enkeltarmet studie, initieret af investigator, af midostaurin kombineret med intensiv induktion, konsolidering inklusive allogen SCT og vedligeholdelse med enkeltstof, hos patienter med FLT3-ITD-muteret AML.
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.
Rydapt anvendes også hos voksne til behandling af aggressiv systemisk mastocytose (ASM), systemisk mastocytose i kombination med hæmatologisk neoplasma (SM-AHN), eller mastcelleleukæmi (MCL).
Rydapt is also used in adults to treat aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN), or mast cell leukaemia (MCL).
I et studie af præ- og postnatal udvikling blev maternel dystoci og reduceret kuldstørrelse, lavere legemsvægt, accelereret komplet øjenåbning og forsinket startle-refleks på pludselige, skarpe lyde i ontogenesen bemærket.
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.
Potente CYP3A4-induktorer nedsætter eksponeringen for midostaurin og dets aktive metabolitter (CGP52421 og CGP62221).
Strong CYP3A4 inducers decrease exposure of midostaurin and its active metabolites (CGP52421 and CGP62221).
- hvis du har eller oplever smerter eller ubehag i brystkassen, ørhed, besvimelse, svimmelhed, blåfarvning af læber, hænder eller fødder, åndenød eller hævelse af ben (ødem) eller hud, da disse kan være tegn på hjerteproblemer.
- if you have or experience chest pain or discomfort, light-headedness, fainting, dizziness, blue discolouration of your lips, hands or feet, shortness of breath, or swelling of your lower limbs (oedema) or skin, because these may be signs of heart problems.
Induktion af cytochrom P450
Cytochrome P450 induction
Fortæl din læge eller apotekspersonalet, hvis du tager nogle af følgende lægemidler: - visse lægemidler til behandling af infektioner, fx ketoconazol eller clarithromycin; - visse lægemidler til behandling af HIV, fx ritonavir eller efavirenz; - nefazadon, et lægemiddel til behandling af depression; - visse lægemidler, der anvendes til at forebygge, at kroppen afstøder transplanterede organer, fx tacrolimus; - visse lægemidler til behandling af kræft, fx paclitaxel eller cyclophosphamid; - visse lægemidler, der anvendes til at kontrollere fedtindholdet i dit blod, fx atorvastatin; - digoxin, et lægemiddel til behandling af hjertesvigt; - warfarin, et lægemiddel, der anvendes til at behandle og forebygge blodpropper; - tizanidine, et lægemiddel, der anvendes til at få musklerne til at slappe af; - kodein, et lægemiddel, der anvendes til behandling af smerter; - omeprazol, et lægemiddel, der anvendes til behandling af for meget mavesyre, mavesår og halsbrand; - chlorzoxazon, et lægemiddel, der anvendes til behandling af ubehag forårsaget af muskelkramper.
Tell your doctor or pharmacist if you are taking any of the following medicines: - some medicines used to treat infections, such as ketoconazole or clarithromycin; - some medicines used to treat HIV, such as ritonavir or efavirenz; - nefazadone, a medicine used to treat depression; - some medicines used to stop the body from rejecting organ transplants, such as tacrolimus; - some medicines used to treat cancer, such as paclitaxel or cyclophosphamide; - some medicines used to control levels of fat in your blood, such as atorvastatin; - digoxin, a medicine used to treat heart failure; - warfarin, a medicine used to treat and prevent thrombosis; - tizanidine, a medicine used to relax muscles; - codeine, a medicine used to treat pain; - omeprazole, a medicine to treat excessive stomach acid, ulcers and heartburn; - chlorzoxazone, a medicine used for treating discomfort caused by muscle spasms.
Der forekom alvorlige bivirkninger i tilsvarende hyppigheder hos patienterne i Rydapt-armen versus placebo-armen.
Serious ADRs occurred at similar rates in patients in the Rydapt versus the placebo arm.
• som monoterapi til behandling af voksne patienter med aggressiv systemisk mastocytose (ASM), systemisk mastocytose associeret med hæmatologisk neoplasi (SM-AHN) eller mastcelleleukæmi (MCL).
• as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN), or mast cell leukaemia (MCL).
Ved baseline havde 65 % af patienterne i primær effektpopulationen >1 målbare C-fund (trombocytopeni, hypoalbuminæmi, anæmi, højt totalbilirubinniveau, transfusionsafhængig anæmi, vægttab, neutropeni, højt ALAT-niveau eller højt ASATniveau).
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).
De hyppigste hæmatologiske anomalier af grad 3/4 rapporteret hos patienter i vedligeholdelsesfasen med Rydapt var fald i ANC (20,8 % versus 18,8 %) og leukopeni (7,5 % versus 5,9 %).
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%).
9/l, og genoptag herefter med 50 mg to gange daglig.
9/l, then resume at 50 mg twice daily.
9/l som tilskrives Rydapt hos patienter med trombocyttal ved baseline på 25-75 x 10
9/l attributed to Rydapt in patients with baseline platelet count of 25-75 x 10
Psykiske forstyrrelser Insomni
Psychiatric disorders Insomnia
Hver blød kapsel indeholder 25 mg midostaurin.
Each soft capsule contains 25 mg midostaurin.
Giv ikke Rydapt i løbet af den næste cyklus, hvis QTc-intervallet ikke er forbedret i tide til at starte behandling i denne cyklus.
If QTc interval is not improved in time to start the next cycle do not administer Rydapt during that cycle.
Samtidig administration af potente CYP3A4-induktorer, fx rifampicin, prikbladet perikon (Hypericum perforatum), carbamazepin, enzalutamid, phenytoin (se pkt.
Concomitant administration of potent CYP3A4 inducers, e.g. rifampicin, St. John's Wort (Hypericum perforatum), carbamazepine, enzalutamide, phenytoin (see section 4.5).
Samlet overlevelse (OS) Median OS i måneder (95 % CI)
Overall Survival (OS) Median OS in months (95% CI)
Tabel 4 viser hyppighedskategorien af bivirkninger baseret på sammenlagte data fra to studier hos patienter med ASM, SM-AHN og mastcelleleukæmi.
Table 4 presents the frequency category of ADRs based on pooled data from two studies in patients with ASM, SM-AHN and MCL.
Rydapt + kemo n=345
Rydapt + chemo n=345
Dosisjustering er ikke nødvendig hos patienter med let eller moderat nedsat nyrefunktion.
No dose adjustment is required for patients with mild or moderate renal impairment.
Hvis neutropeni (ANC <1,0 x 10
If neutropenia (ANC <1.0 x 10
Kvalme, opkastning og diarré blev observeret hos patienter med AML, ASM, SM-AHN og mastcelleleukæmi.
Nausea, vomiting and diarrhoea were observed in AML, ASM, SM-AHN and MCL patients.
Andre bivirkninger omfatter dem, der er anført nedenfor.
Other possible side effects in patients with AML Other side effects include those listed below.
Kapslerne bør tages sammen med mad (se pkt.
The capsules should be taken with food (see sections 4.5 and 5.2).
Afbryd doseringen af Rydapt indtil ANC ≥1,0 x 10
Interrupt Rydapt until ANC ≥1.0 x 10
Dyrestudier med midostaurin har vist nedsat fertilitet (se pkt.
Animal studies with midostaurin have shown impaired fertility (see section 5.3).
Den hyppigste alvorlige bivirkning i begge behandlingsarme var febril neutropeni
The most frequent serious ADR in both arms was febrile neutropenia (16%).
Fald i absolut lymfocyttal*
Absolute lymphocyte decreased*
Hæmning af cytochrom P450
Cytochrome P450 inhibition
Lægemidler med smalt terapeutisk interval, der er substrater af CYP1A2 (fx tizanidin), CYP2D6 (fx kodein), CYP2C8 (fx paclitaxel), CYP2C9 (fx warfarin), CYP2C19 (fx omeprazol), CYP2E1 (fx chlorzoxazon), CYP3A4/5 (fx tacrolimus), CYP2B6 (fx efavirenz), P-Gp (fx paclitaxel), BCRP (fx atorvastatin) eller OATP1B1 (fx digoxin) skal anvendes med forsigtighed, når de administreres samtidigt med midostaurin.
Medicinal products with a narrow therapeutic range that are substrates of CYP1A2 (e.g. tizanidine), CYP2D6 (e.g. codeine), CYP2C8 (e.g. paclitaxel), CYP2C9 (e.g. warfarin), CYP2C19 (e.g. omeprazole), CYP2E1 (e.g. chlorzoxazone), CYP3A4/5 (e.g. tacrolimus), CYP2B6 (e.g. efavirenz), P-gp (e.g. paclitaxel), BCRP (e.g. atorvastatin) or OATP1B1 (e.g. digoxin) should be used with caution when administered concomitantly with midostaurin and may need dose adjustment to maintain optimal exposure (see section 5.2).
Hypercalcæmi*
Hypercalcaemia*
Rydapt 25 mg bløde kapsler er lys orange, aflange kapsler påtrykt “PKC NVR” med rødt.
What Rydapt looks like and contents of the pack Rydapt 25 mg soft capsules are pale orange, oblong capsules with red imprint “PKC NVR”.
9/l som tilskrives Rydapt hos patienter uden mastcelleleukæmi, eller ANC på under 0,5 x 10
9/l attributed to Rydapt in patients without MCL, or ANC less than 0.5 x 10
De hyppigste bivirkninger af grad 3/4 var træthed (8,5 %), sepsis (7,7 %), pneumoni (7 %), febril neutropeni (7 %) og diarré (6,3 %).
The most frequent Grade 3/4 ADRs were fatigue (8.5%), sepsis (7.7%), pneumonia (7%), febrile neutropenia (7%), and diarrhoea (6.3%).
Der skal udvises forsigtighed, når det overvejes, om midostaurin skal administreres til patienter med alvorlig nedsat leverfunktion, og patienterne bør overvåges nøje for tegn på toksicitet (se pkt.
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).
De hyppigste ikke-hæmatologiske laboratorieanomalier var hyperglykæmi (93,7 %), forhøjet totalbilirubin-niveau (40,1 %), forhøjet lipase-niveau (39,4 %), forhøjet aspartataminotransferase (ASAT)-niveau (33,8 %) og forhøjet alaninaminotransferase (ALAT)-niveau (33,1 %), mens den hyppigste hæmatologiske laboratorieanomali var fald i absolut lymfocyttal (73,2 %) og fald i ANC (58,5 %).
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%).
Amning bør stoppe under behandling med Rydapt og i mindst 4 måneder efter behandlingsophør.
Breast-feeding should be discontinued during treatment with Rydapt and for at least 4 months after stopping treatment.
Det skal være bekræftet ved brug af en valideret test, at AML-patienter har en FLT3-mutation (intern tandemduplikation [ITD] eller tyrosinkinasedomæne [TKD]), inden patienten begynder at tage midostaurin.
Before taking midostaurin, AML patients must have confirmation of FLT3 mutation (internal tandem duplication [ITD] or tyrosine kinase domain [TKD]) using a validated test.
Generelt viste midostaurin og dets metabolitter ingen større afvigelse fra dosisproportionalitet efter en enkelt dosis i intervallet 25 mg til 100 mg. Der var imidlertid en mindre end dosisproportional øgning i eksponering efter flere doser inden for dosisintervallet 50 mg til 225 mg daglig.
In general, midostaurin and its metabolites showed no major deviation from dose-proportionality after a single dose in the range of 25 mg to 100 mg.
48 % af patienterne i midostaurinarmen og 41 % i placeboarmen var mænd.
Forty-eight per cent were male in the midostaurin arm and 41% in the placebo arm.
26,8 (17,6, 34,7) 51,1 (28,7, NE) 20,7 (16,3, 33,9) 9,4 (7,5, NE)
26.8 (17.6, 34.7) 51.1 (28.7, NE) 20.7 (16.3, 33.9)
Antal patienter fortsat i risiko
Patients at risk
CGP62221 Cmin,ss i populationen af AML- og ASM-, SM-AHN-, mastcelleleukæmi var henholdsvis 1610 ng/ml og 2020 ng/ml.
The CGP62221 Cmin, ss in the AML and the ASM, SM-AHN, MCL population were 1610 ng/ml and 2020 ng/ml, respectively.
I et studie med 36 raske forsøgspersoner førte samtidig administration af den potente CYP3A4-hæmmer ketoconazol indtil steady state samt en enkelt dosis midostaurin på 50 mg til en signifikant øgning i eksponeringen for midostaurin (stigning til 1,8 gange Cmax og 10 gange AUCinf) og 3,5 gange stigning i AUCinf for CGP62221, mens Cmax af de aktive metabolitter (CGP62221 og CGP52421) blev halveret (se pkt.
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).
Tabel 4 Bivirkninger observeret i de kliniske studier af ASM, SM-AHN og mastcelleleukæmi
Table 4 Adverse drug reactions observed in the ASM, SM-AHN and MCL clinical studies
Undersøgelser Fald i hæmoglobin-niveau*
Investigations Haemoglobin decreased*
Tabel 2 Anbefalinger til doseringsafbrydelse, reduktion og seponering af Rydapt hos patienter med ASM, SM-AHN eller mastcelleleukæmi
Table 2 Rydapt dose interruption, reduction and discontinuation recommendations in patients with ASM, SM-AHN or MCL
Titandioxid (E 171) Jernoxid, gul (E 172) Jernoxid, rød (E 172) Vand, renset
Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172) Purified water
Embryoføtal toksicitet og amning
Embryofoetal toxicity and breast-feeding
Transportør-lægemiddel-lægemiddel-interaktioner In vitro-eksperimenter viste, at midostaurin, CGP52421 og CPG62221 potentielt kan hæmme P-gp, BCRP, OATP1B1 og BSEP.
In vitro experiments demonstrated that midostaurin, CGP52421 and CPG62221 can potentially inhibit P-gp, BCRP, OATP1B1 and BSEP.
- Hvis du bliver behandlet for AML, vil du få Rydapt alene i op til 12 måneder efter det tidspunkt,
you will receive Rydapt alone for up to 12 months.
Tilsvarende steg AUC for CGP52421 og CGP62221 til 19000 og 29200 ng*t/ml, og Cmax faldt til henholdsvis 172 og 455 ng/ml.
Similarly, for CGP52421 and CGP62221 AUC increased to 19000 and 29200 ng*h/ml and Cmax decreased to 172 and 455 ng/ml, respectively.
Efter administration af en enkelt dosis på 50 mg midostaurin sammen med mad hos raske forsøgspersoner, blev AUC af midostaurin øget til 20800 ng*t/ml og Cmax blev nedsat til 963 ng/ml (se pkt.
In healthy subjects, after administration of a single dose of 50 mg midostaurin with food, AUC of midostaurin was increased to 20800 ng*h/ml and Cmax was decreased to 963 ng/ml (see section 4.5).
Svær neutropeni (ANC <0,5 x 10
Severe neutropenia (ANC <0.5 x 10
Infektioner og parasitære sygdomme Urinvejsinfektion
Infections and infestations Urinary tract infection
Median-samlet overlevelse, måneder (95 % CI)
Median overall survival, months (95% CI)
Rydapt indeholder ricinusolie, polyoxyleret, hydrogeneret, hvilket kan give mavebesvær og diarré.
Rydapt contains macrogolglycerol hydroxystearate, which may cause stomach discomfort and diarrhoea.
AUC0-12t og Cmax for CGP62221 var henholdsvis 8700 ng*t/ml og 931 ng/ml.
AUC0-12h and Cmax for CGP62221 were 8700 ng*h/ml and 931 ng/ml, respectively.
Ricinusolie, polyoxyleret, hydrogeneret Macrogol
Macrogolglycerol hydroxystearate Macrogol
PAES: For at undersøge effekten hos ældre patienter, skal indehaveren af markedsføringstilladelsen udføre og indsende resultaterne af et randomiseret, dobbeltblindet studie, E2301, af midostaurin versus placebo i kombination med kemoterapi under induktion og konsolidering, efterfulgt af 12 måneders midostaurin monoterapi hos voksne patienter (≥18 år) med nydiagnosticeret AML uden FL3-mutation.
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.
Hazard ratio (HR) estimeret ved brug af Cox' regressionsmodel stratificeret i henhold til FLT3-mutationrandomiseringsfaktoren.
2key secondary endpoint; NE: Not Estimated Hazard ratio (HR) estimated using Cox regression model stratified according to the randomisation FLT3 mutation factor.
CGP52421, Cmin,ss i populationen af AML- og ASM-, SM-AHN-, mastcelleleukæmi var henholdsvis 8630 ng/ml og 2860 ng/ml.
The CGP52421, Cmin,ss in the AML and the ASM, SM-AHN, MCL population were 8630 ng/ml and 2860 ng/ml, respectively.
- hvis du allerede tager nogle af følgende lægemidler: lægemidler til behandling af tuberkulose, fx rifampicin; lægemidler til behandling af epilepsi, fx carbamazepin eller phenytoin; enzalutamid, et lægemiddel til behandling af prostatakræft; prikbladet perikon (også kendt som Hypericum perforatum), et naturpræparat til behandling af depression.
- if you are already taking any of the following medicines: 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.
Pakninger med 56 (2 pakninger med 28) eller 112 (4 pakninger med 28) bløde kapsler.
Packs containing 56 (2 packs of 28) or 112 (4 packs of 28) soft capsules.
På dag 1 var AUC0-12 og Cmax henholdsvis 8130 ng*t/ml og 1206 ng/ml for raske forsøgspersoner.
On day 1, the AUC0-12 and Cmax were 8130 ng*h/ml and 1206 ng/ml, respectively, for healthy subjects.
De hyppigste bivirkninger var kvalme (82 %), opkastning (68 %), diarré (51 %), perifert ødem (35 %) og træthed (31 %).
The most frequent ADRs were nausea (82%), vomiting (68%), diarrhoea (51%), peripheral oedema (35%) and fatigue (31%).
Medianvarigheden af eksponering ved vedligeholdelse hos de 205 patienter (120 i Rydapt-armen og 85 i placebo-armen), der indgik i vedligeholdelsesfasen, var 11 måneder for begge behandlingsarme (16-520 dage for patienter i Rydapt-armen og 22-381 dage i placebo-armen).
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).
For CGP52421 var AUC0-12t og Cmax henholdsvis 2770 ng*t/ml og 299 ng/ml.
For CGP52421, AUC0-12h and Cmax were 2770 ng*h/ml and 299 ng/ml, respectively.
Følgende lægemidler skal undgås under behandling med Rydapt: - lægemidler til behandling af tuberkulose, fx rifampicin; - lægemidler til behandling af epilepsi, fx carbamazepin eller phenytoin; - enzalutamid, et lægemiddel til behandling af prostatakræft; - prikbladet perikon (også kendt som Hypericum perforatum), et naturpræparat til behandling af depression.
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.
Efter oral administration af en enkelt 100 mg dosis midostaurin efter et måltid hos ASM-, SM-AHN- og mastcelleleukæmipatienter, var AUCinf, Cmax og Tmax henholdsvis 49600 ng*t/ml, 2940 ng/ml og 3 t for midostaurin.
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.
I et studie med raske forsøgspersoner førte samtidig administration af den potente CYP3A4-induktor rifampicin (600 mg daglig) indtil steady state samt en enkelt dosis af midostaurin på 50 mg til nedættelse af Cmax og AUCinf for midostaurin med henholdsvis 73 % og 96 % i gennemsnit.
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.
Samtidig anvendelse af Rydapt og potente CYP3A4-induktorer (fx carbamazepin, rifampicin, enzalutamid, phenytoin, prikbladet perikon [Hypericum perforatum]) er kontraindiceret (se pkt.
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).
Samlet responsrate, n (%) (95 % CI)
Overall response rate, n (%) (95% CI)
Infektioner og parasitære sygdomme Infektion relateret til administrationssystem
Infections and infestations Device-related infection
Andre bivirkninger hos patienter med AML
Some side effects in patients with AML could be serious.
PAES: For at undersøge effekten hos ældre patienter, skal indehaveren af markedsføringstilladelsen udføre og indsende resultaterne af A2408; et studie, der evaluerer effekten og sikkerheden af midostaurin i kombination med standard kemoterapi under induktion og konsolidering, efterfulgt af 12 måneders midostaurin monoterapi hos voksne patienter (≥18 år) med nydiagnosticeret, FLT3muteret AML.
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.
112 (4 pakninger med 28) kapsler
112 (4 packs of 28) capsules
Forhøjet ALAT-niveau*
AST increased*
Der er ikke gennemført studier hos patienter med svært nedsat (Child-Pugh C) leverfunktion (se pkt.
No study has been completed in patients with severe (Child-Pugh C) hepatic impairment (see section 4.4).
Det er ikke nødvendigt at justere dosis hos patienter med let eller moderat nedsat leverfunktion ved baseline.
No dosage adjustment is necessary for patients with baseline mild or moderate hepatic impairment.
Du bør ikke amme under behandling med Rydapt og i mindst 4 måneder efter behandlingsophør.
You should not breast-feed during treatment with Rydapt and for at least 4 months after stopping the treatment.
Brug af anden medicin sammen med Rydapt
Other medicines and Rydapt
Kvinder 95% CI
Females 95% CI
56 (2 pakninger med 28) kapsler
56 (2 packs of 28) capsules
De hyppigste bivirkninger i Rydapt-armen var febril neutropeni (83,4 %), kvalme (83,4 %), eksfoliativ dermatitis (61,6 %), opkastning (60,7 %), hovedpine (45,9 %), petekkier (35,8 %) og pyreksi (34,5 %).
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%).