natgillin/translations-raw huggingface dataset:
Selvom patienter med forskellige AML-relaterede cytogenetiske anomalier blev inkluderet i studiet, blev patienter med akut promyelocyt leukæmi (M3) eller behandlingsrelateret AML udelukket. 
While the study included patients with various AML-related cytogenetic abnormalities, patients with acute promyelocytic leukaemia (M3) or therapy-related AML were excluded.
Medianen af de terminale halveringstider af midostaurin, CGP62221 og CGP52421 i plasma er ca. 20,9, 32,3 og 471 timer. 
The median terminal half-lives of midostaurin, CGP62221 and CGP52421 in plasma are approximately 20.9, 32.3 and 471 hours.
Patienter, der gik videre med hæmatopoietisk stamcelletransplantation (SCT), ophørte med at modtage forsøgsbehandling forud for opstart på konditioneringsregimet for SCT. 
Patients who proceeded to haematopoietic stem cell transplant (SCT) stopped receiving study treatment prior to the start of the SCT conditioning regimen.
Seponering som følge af en hvilken som helst bivirkning forekom hos 3,1 % af patienterne i Rydaptarmen versus 1,3 % i placebo-armen. 
Discontinuation due to any adverse reaction occurred in 3.1% of patients in the Rydapt arm versus 1.3% in the placebo arm.
Tyve (76,9 %) patienter havde ASM (17 [85 %] med AHN), og 6 patienter (23,1 %) havde mastcelleleukæmi (2 [33,3 %] med AHN). 
Twenty (76.9%) patients had ASM (17 [85%] with AHN) and 6 patients (23.1%) had MCL (2 [33.3%] with AHN).
Samlet set var der ingen klinisk relevant øgning i eksponering (AUC) for plasma-midostaurin hos forsøgspersoner med let eller moderat nedsat leverfunktion sammenlignet med forsøgspersoner med normal leverfunktion. 
Overall, there was no clinically relevant increase in exposure (AUC) to plasma midostaurin in subjects with mild or moderate hepatic impairment compared to subjects with normal hepatic function.
EFS (CR induktion) (HR) 
EFS (CR induction) (HR)
På basis af de populationsfarmakokinetiske analyser blev clearancen af midostaurin ikke signifikant påvirket af nedsat nyrefunktion, og derfor er det ikke nødvendigt at justere dosis hos patienter med let eller moderat nedsat nyrefunktion. 
Based on the population pharmacokinetic analyses, midostaurin clearance was not significantly impacted by renal impairment and therefore no dosage adjustment is necessary for patients with mild or moderate renal impairment.
Andre lægemidlers indvirkning på Rydapt 
Effect of other medicinal products on Rydapt
Hos voksne patienter med ASM, SM-AHN og mastcelleleukæmi eller AML er det ikke påkrævet at justere midostaurin-dosis på basis af alder. 
In adult patients with ASM, SM-AHN and MCL or AML, no midostaurin dose adjustment is required based on age.
Kateter-relateret trombose 
Catheter-related thrombosis
Afbryd doseringen af Rydapt i den resterende del af cyklus. 
Interrupt Rydapt for the remainder of the cycle.
De hyppigste bivirkninger, der førte til dosisændring (incidens ≥5 %), var kvalme og opkastning. 
The most frequent ADRs that led to dose modification (incidence ≥5%) were nausea and vomiting.
Rydapt bør ikke anvendes under graviditeten eller til kvinder i den fertile alder, som ikke anvender sikker kontraception. 
Rydapt is not recommended during pregnancy or in women of childbearing potential not using contraception.
I et fertilitetsstudie med rotter, blev midostaurin associeret med nedsat fertilitet, degeneration og atrofi af testiklerne, reduceret sædmotilitet, oligo- og aspermi, øget forekomst af resorptioner, nedsat graviditetsrate og nedsat antal implanteringer og levende fostre. 
In a fertility study in rats, midostaurin was associated with reduced fertility, testicular degeneration and atrophy, reduced sperm motility, oligo- and aspermia, increased resorptions, decreased pregnancy rate, number of implants and live embryos.
En 100 mg dosis Rydapt indeholder ca. 14 vol. % ethanol, vandfri, hvilket svarer til 333 mg alkohol. 
A 100 mg dose of Rydapt contains approximately 14 vol. % ethanol anhydrous, which corresponds to 333 mg alcohol.
Der blev set en reduktion i legemsvægten, blødning og blandet-celle-infiltration i lungerne og erytrocytose/erytrofagocytose i de mesenteriale lymfeknuder. 
A reduction in body weight, haemorrhage and mixed cell infiltration in the lungs, and erythrocytosis/erythrophagocytosis in the mesenteric lymph nodes were seen.
Rydapt bør seponeres hos patienter, der udvikler tilbagevendende eller længerevarende svær neutropeni, som formodes at være relateret til Rydapt (se pkt. 
Rydapt should be discontinued in patients who develop recurrent or prolonged severe neutropenia that is suspected to be related to Rydapt (see section 4.2).
Forlængelse af aktiveret partiel tromboplastintid 
Activated partial thromboplastin time prolonged
Metabolisme og ernæring Hyperurikæmi 
Metabolism and nutrition disorders Hyperuricaemia
Reproduktionsstudier hos rotter og kaniner viste, at midostaurin inducerede føtotoksicitet (se pkt. 
Reproductive studies in rats and rabbits demonstrated that midostaurin induced foetotoxicity (see section 5.3).
I proliferationsanalyser med FLT3-ITD-udtrykkende celler viste CGP62221 en potens, der var omtrent den samme sammenlignet med det oprindelige stof; men CGP52421 var ca. 10 gange mindre potent. 
In proliferation assays with FLT3-ITD expressing cells, CGP62221 showed similar potency compared to the parent compound, however CGP52421 was approximately 10-fold less potent.
Det anbefales ikke at anvende Rydapt til børn og unge (se pkt. 
Rydapt is not recommended to be used in children and adolescents (see section 4.2).
Øre og labyrint Vertigo 
Ear and labyrinth disorders Vertigo
Kapslerne fås i blistre og er tilgængelige i pakninger med 56 kapsler (2 pakninger med 28 kapsler) eller 112 kapsler (4 pakninger med 28 kapsler). 
The capsules are provided in blisters and are available in packs containing 56 capsules (2 packs of 28 capsules) or 112 capsules (4 packs of 28 capsules).
Rydapt doseres på dag 8-21 i induktions- og konsolideringskemoterapi serierne og for patienter med komplet respons herefter hver dag som monoterapi vedligeholdelsesbehandling indtil tilbagefald i op til 12 serier af 28 dages varighed (se pkt. 
Rydapt is dosed on days 8-21 of induction and consolidation chemotherapy cycles, and then for patients in complete response every day as single agent maintenance therapy until relapse for up to 12 cycles of 28 days each (see section 4.1).
Carminer (E 120) Hypromellose Propylenglycol 
Carmine (E120) Hypromellose Propylene glycol
Hæmoglobinværdier på mindre end 8 g/dl som tilskrives Rydapt hos patienter uden mastcelleleukæmi, eller livstruende anæmi som tilskrives Rydapt hos patienter med hæmoglobinværdier ved baseline på 8-10 g/dl 
Haemoglobin less than 8 g/dl attributed to Rydapt in patients without MCL, or life-threatening anaemia attributed to Rydapt in patients with baseline haemoglobin value of 8-10 g/dl
Rydapt + kemo n=229 
Rydapt + chemo n=229
Farmakokinetikken af midostaurin hos pædiatriske patienter blev undersøgt i et fase I-monoterapistudie med dosisøgning, der omfattede 22 patienter (12 i alderen 0-2 år og 10 i alderen 10-17 år) med AML eller MLL-omlejret ALL, ved brug af en populationsfarmakokinetisk tilgang. 
The pharmacokinetics of midostaurin in paediatric patients were explored in a phase I dose escalation monotherapy study with 22 patients (12 aged 0-2 years and 10 aged 10-17 years) with AML or MLL-rearranged ALL using a population pharmacokinetic approach.
Det er ikke påkrævet at justere midostaurin-dosis på basis af køn. 
No midostaurin dose adjustment is required based on gender.
Bløde kapsler 
Soft capsule
Seksuelt aktive kvinder i den fertile alder rådes til at få foretaget en graviditetstest, inden for 7 dage før behandling med Rydapt påbegyndes, og at de bør anvende sikker kontraception (metoder, der resulterer i graviditetsrater på mindre end 1 %), mens de bruger Rydapt og i mindst 4 måneder efter ophør af behandling med Rydapt. 
Sexually active women of childbearing potential are advised to have a pregnancy test within 7 days prior to starting treatment with Rydapt and that they should use effective contraception (methods that result in less than 1% pregnancy rates) when using Rydapt and for at least 4 months after stopping treatment with Rydapt.
Tmax blev forsinket for alle enheder, midostaurin medianTmaxvar 3 t, og for CGP52421 og CGP62221 blev Tmax forsinket til henholdsvis 6 og 7 timer. 
Tmax was delayed for all entities, midostaurin median Tmax was 3 h, and for CGP52421 and CGP62221 Tmax was delayed to 6 and 7 hours respectively.
Koncentrationen af CGP52421 synes ikke at falde så signifikant som koncentrationerne af midostaurin og CGP62221. 
CGP52421 concentrations do not appear to decline as significantly as for midostaurin and CGP62221.
Effekten og sikkerheden af midostaurin i kombination med standardkemoterapi versus placebo plus standardkemoterapi og som enkeltstof-vedligeholdelsesbehandling blev undersøgt hos 717 patienter (i alderen 18-60 år) i et randomiseret, dobbeltblindet fase III-studie. 
The efficacy and safety of midostaurin in combination with standard chemotherapy versus placebo plus standard chemotherapy and as single agent maintenance therapy was investigated in 717 patients (18 to 60 years of age) in a randomised, double-blind, phase III study.
Midostaurin i kombination med kemoterapeutika (cytarabin, doxorubicin, idarubicin og daunorubicin) resulterede i synergistisk væksthæmning i FLT3-ITD-udtrykkende AML-cellelinjer. 
Midostaurin in combination with chemotherapeutic agents (cytarabine, doxorubicin, idarubicin and daunorubicin) resulted in synergistic growth inhibition in FLT3-ITD expressing AML cell lines.
Fortæl det straks til lægen, apotekspersonalet eller sundhedspersonalet, hvis du får nogen af disse symptomer under behandling med Rydapt: - hvis du har feber, ondt i halsen eller mundsår, da disse kan være tegn på, at du har for få hvide blodlegemer. 
Tell your doctor, pharmacist or nurse straight away if you get any of these symptoms during treatment with Rydapt: - if you have fever, sore throat or mouth ulcers, because these may indicate that your white blood cell count is low.
DFS (CR induktion) (HR) 
DFS (CR induction) (HR)
Når data blev censureret ved tidspunktet for SCT, understøttede følsomhedsanalyser for både OS og EFS også den kliniske fordel med midostaurin plus standardkemoterapi sammenlignet med placebo plus standardkemoterapi. 
Sensitivity analyses for both OS and EFS when censored at the time of SCT also supported the clinical benefit with midostaurin plus standard chemotherapy over placebo.
Efter flere orale doser udviste midostaurin en tidsafhængig farmakokinetik med en initial stigning i plasmakoncentrationerne i løbet af den første uge (højeste Cmin) efterfulgt af et fald med tiden til et steady state efter ca. 28 dage (2,5 gange fald). 
Following multiple oral doses, midostaurin displayed time-dependent pharmacokinetics with an initial increase in plasma concentrations during the first week (peak Cmin) followed by a decline with time to a steady-state after approximately 28 days (2.5-fold decrease).
- hvis du har nye symptomer eller forværring af symptomer som fx feber, hoste med eller uden slim, smerter i brystkassen, vejrtrækningsbesvær eller åndenød, da disse kan være tegn på infektioner eller lungeproblemer. 
- if you have new or worsening symptoms such as fever, cough with or without mucous, chest pain, trouble breathing or shortness of breath, because these may be signs of infections or lung problems.
På dag 7 var AUCCtrough (eksponering under kurven for Ctrough fra dag 1 til dag 7) 5410 ng*t/ml hos raske forsøgspersoner og var reduceret med 35 % og 20 % hos forsøgspersoner med henholdsvis let og moderat nedsat leverfunktion. 
On day 7, AUCCtrough (exposure under the curve of Ctrough from day 1 to day 7) was 5410 ng*h/ml in healthy subjects and was decreased by 35% and 20% in subjects with mild and moderate hepatic impairment, respectively.
Kvinder i den fertile alder bør informeres om, at midostaurin i dyrestudier har vist sig at have en skadelig virkning på det udviklende foster. 
Women of childbearing potential should be informed that animal studies show midostaurin to be harmful to the developing foetus.
Gravide kvinder bør informeres om den mulige risiko for fosteret, og kvinder i den fertile alder bør rådes til at tage en graviditetstest inden for 7 dage før behandling med Rydapt initieres, samt til at anvende sikker kontraception under behandling med Rydapt og i mindst 4 måneder efter behandlingsophør. 
Pregnant women should be informed of the potential risk to a foetus; females of reproductive potential should be advised to have a pregnancy test within 7 days prior to starting treatment with Rydapt and to use effective contraception during treatment with Rydapt and for at least 4 months after stopping treatment.
Der var en trend til fordel for Rydapt for CR-rate ved dag 60 for midostaurin-armen (58,9 % versus 53,5 %; p = 0,073), som fortsatte, når alle CR'er under induktionen blev taget i betragtning (65,0 % versus 58,0 %; p = 0,027). 
There was a trend favouring midostaurin for CR rate by day 60 for the midostaurin arm (58.9% versus 53.5%; p = 0.073) that continued when considering all CRs during induction (65.0% versus 58.0%; p = 0.027).
For EFS ved komplette remissioner inden for 60 dage efter behandlingsstart var HR 0,602 (95% CI: 0,372, 0,974) for patienter med SCT og 0,827 (95% CI: 0,689, 0,993) for patienter uden SCT, der favoriserer midostaurin. 
For EFS, considering complete remissions within 60 days of study treatment start, the HR was 0.602 (95% CI: 0.372, 0.974) for patients with SCT and 0.827 (95% CI: 0.689, 0.993) for patients without SCT, favouring midostaurin.
Andre bivirkninger hos patienter med ASM, SM-AHN og mastcelleleukæmi Andre bivirkninger omfatter dem, der er anført nedenfor. 
Other possible side effects in patients with ASM, SM-AHN and MCL Other side effects include those listed below.
Ved steady state af midostaurin (50 mg to gange daglig i 21 dage) og med den potente CYP3A4hæmmer itraconazol ved steady state hos en undergruppe af patienter (N=7), var steady stateeksponeringen for midostaurin (Cmin) øget 2,09 gange. 
At steady state of midostaurin (50 mg twice daily for 21 days), with the strong CYP3A4 inhibitor itraconazole at steady state in a subset of patients (N=7), midostaurin steady-state exposure (Cmin) was increased by 2.09-fold.
Stop omgående med at tage Rydapt, og fortæl det straks til lægen, hvis du bemærker noget af følgende, da det kan være tegn på en allergisk reaktion: - vejrtrækningsbesvær eller synkebesvær - svimmelhed - hævelse af ansigt, læber, tunge eller svælg - voldsom hudkløe med rødt udslæt eller hævede knopper 
Stop taking Rydapt and tell your doctor straight away if you notice any of the following as these could be signs of an allergic reaction: - difficulty breathing or swallowing - dizziness - swelling of the face, lips, tongue or throat - severe itching of the skin, with a red rash or raised bumps
Tabel 1 Anbefalinger til doseringssafbrydelse, reduktion og seponering af Rydapt hos patienter med AML 
Table 1 Rydapt dose interruption, reduction and discontinuation recommendations in patients with AML
Tabel 7 Virkning af midostaurin ved ASM, SM-AHN og mastcelleleukæmi (MCL): primær effekt-population 
Table 7 Efficacy of midostaurin in ASM, SM-AHN and MCL: primary efficacy population
- Øvrige indholdsstoffer: ricinusolie, polyoxyleret, hydrogeneret, gelatine, macrogol, glycerol, vandfri ethanol, majsolie-mono-di-triglycerider, titandioxid (E 171), all-rac-alfa-tocopherol, gul jernoxid, (E 172), rød jernoxid (E 172), carminer (E 120), hypromellose, propylenglycol, renset vand. 
- The other ingredients are: macrogolglycerol hydroxystearate, gelatin, macrogol, glycerol, ethanol anhydrous, maize oil mono-di-triglycerides, titanium dioxide (E171), all-rac-alpha-tocopherol, iron oxide yellow (E172), iron oxide red (E172), carmine (E120), hypromellose, propylene glycol, purified water.
Midostaurin hæmmer ikke CYP3A4 in vivo. 
Midostaurin is not an inhibitor of CYP3A4 in vivo.
Alternativt fortsæt med 50 mg Rydapt en gang daglig. 
Otherwise continue Rydapt 50 mg once daily.
Midostaurins farmakokinetik er ikke blevet vurderet hos patienter med svært nedsat leverfunktion (Child-Pugh-klasse C) ved baseline (se pkt. 
The pharmacokinetics of midostaurin have not been assessed in patients with baseline severe hepatic impairment (Child-Pugh Class C) (see section 4.4).
AML Den anbefalede dosis af Rydapt er 50 mg oralt to gange daglig. 
AML The recommended dose of Rydapt is 50 mg orally twice daily.
Et dedikeret QT-studie hos 192 raske forsøgspersoner med en dosis på 75 mg to gange daglig viste ingen klinisk signifikant forlængelse af QT forårsaget af midostaurin og CGP62221, men studiets varighed var ikke lang nok til at estimere indvirkningen af den langtidsvirkende metabolit CGP52421 på QTc-bredden. 
A dedicated QT study in 192 healthy subjects with a dose of 75 mg twice daily did not reveal clinically significant prolongation of QT by midostaurin and CGP62221 but the study duration was not long enough to estimate the QTc prolongation effects of the long-acting metabolite CGP52421.
Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Rydapt i en eller flere undergrupper af den pædiatriske population ved behandling af akut myeloid leukæmi (se pkt. 
The European Medicines Agency has deferred the obligation to submit the results of studies with Rydapt in one or more subsets of the paediatric population in the treatment of acute myeloid leukaemia (see section 4.2 for information on paediatric use).
Hvis du har spørgsmål til, hvor længe du skal tage Rydapt, så tal med lægen eller apotekspersonalet. 
If you have any questions about how long to take Rydapt, talk to your doctor or pharmacist.
9/l) var generelt reversibel, hvis behandling med Rydapt blev afbrudt indtil bedring eller seponeret i studierne af ASM, SM-AHN og mastcelleleukæmi. 
9/l) was generally reversible by withholding Rydapt until recovery and discontinuation in the ASM, SM-AHN and MCL studies.
Midostaurin hæmmer flere receptortyrosinkinaser, herunder FLT3- og KIT-kinase. 
Midostaurin inhibits multiple receptor tyrosine kinases, including FLT3 and KIT kinase.
Forhøjet lipaseniveau* 
Lipase increased*
Hos patienter med AML og patienter med ASM, SM-AHN og mastcelleleukæmi var de populationsfarmakokinetiske estimater af midostaurins clearance ved steady state henholdsvis 5,9 l/t og 4,4 l/t. 
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.
Der er begrænset klinisk erfaring med patienter med svært nedsat nyrefunktion og der foreligger ingen data om patienter med nyresygdom i slutstadiet (se pkt. 
Clinical experience in patients with severe renal impairment is limited and no data are available in patients with end-stage renal disease (see sections 4.4 and 5.2).
Virkningen af midostaurin hos patienter med ASM, SM-AHN og mastcelleleukæmi, samlet betegnet som fremskreden systemisk mastocytose (SM), blev vurderet i to ublindede multicenterstudier med en enkelt arm (142 patienter i alt). 
The efficacy of midostaurin in patients with ASM, SM-AHN and MCL, collectively referred to as advanced systemic mastocytosis (SM), was evaluated in two open-label, single-arm, multicentre studies (142 patients in total).
Rydapt indeholder det aktive stof midostaurin. 
Rydapt contains the active substance midostaurin.
Den samlede SCT-rate var 59,4 % (214/360) af patienterne i armen med midostaurin plus standardkemoterapi versus 55,2 % (197/357) i armen med placebo plus standardkemoterapi. 
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.
To hovedmetabolitter er blevet identificeret hos murine modeller og mennesker, dvs. CGP62221 og CGP52421. 
Two major metabolites have been identified in murine models and humans, i.e. CGP62221 and CGP52421.
Midostaurin hæmmer FLT3-receptor-signalering og inducerer cellecyklusstop og apoptose i leukæmiske celler, der udtrykker receptorer med en FLT3-ITD- eller TKD-mutation eller overudtrykker FLT3-vildtypereceptorer. 
Midostaurin inhibits FLT3 receptor signalling and induces cell cycle arrest and apoptosis in leukaemic cells expressing FLT3 ITD or TKD mutant receptors or over-expressing FLT3 wild type receptors.
- Patienter med ASM, SM-AHN eller mastcelleleukæmi 
- Patients with ASM, SM-AHN or MCL
Hver blød kapsel indeholder ca. 83 mg ethanol, vandfri og 415 mg ricinusolie, polyoxyleret, hydrogeneret. 
Each soft capsule contains approximately 83 mg ethanol anhydrous and 415 mg macrogolglycerol hydroxystearate.
To af dets metabolitter udviste farmakologisk aktivitet (CGP52421 og CGP62221). 
Two of its metabolites demonstrated pharmacological activities (CGP52421 and CGP62221).
I studierne med gentagne doser var målorganerne for toksicitet mave-tarm-kanalen (opkastning hos hunde og aber, diarré og slimhindeforandringer), testiklerne (nedsat sædudvikling), knoglemarven (hypocellularitet) og lymfeorganerne (udtømning/atrofi). 
In the repeat-dose studies, target organs for toxicity were the gastrointestinal tract (emesis in dogs and monkeys, diarrhoea and mucosal alteration), testes (decreased spermatogenesis), bone marrow (hypocellularity) and lymphoid organs (depletion/atrophy).
- Der er ingen særlige krav vedrørende opbevaringstemperaturer for dette lægemiddel. 
- This medicine does not require any special temperature storage conditions.
Dosisjustering er ikke nødvendig hos patienter med let eller moderat nedsat (Child-Pugh A eller B) leverfunktion (se pkt. 
No dose adjustment is required in patients with mild or moderate (Child-Pugh A or B) hepatic impairment (see section 5.2).
Der er forekommet neutropeni hos patienter, som fik Rydapt som monoterapi og i kombination med kemoterapi (se pkt. 
Neutropenia has occurred in patients receiving Rydapt as monotherapy and in combination with chemotherapy (see section 4.8).
Den sædvanlige daglige dosis er 100 mg (4 kapsler) to gange daglig. 
The usual daily dose is 100 mg (4 capsules) twice daily.
På nuværende tidspunkt vides det ikke, om midostaurin kan nedsætte effektiviteten af hormonelle kontraceptiva og derfor bør kvinder, der anvender hormonelle kontraceptiva, tilføje en svangerskabsforebyggende barrieremetode (se pkt. 
It is currently unknown whether midostaurin may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method of contraception (see section 4.6).
Maksimumskoncentrationen (Cmax) af midostaurin blev reduceret med 20 % med et standardmåltid og med 27 % med et fedtholdigt måltid i forholde til administration på tom mave (se pkt. 
Peak midostaurin concentration (Cmax) was reduced by 20% with a standard meal and by 27% with a high-fat meal versus on an empty stomach (see section 5.2).
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Rydapt i alle undergrupper af den pædiatriske population ved behandling af malign mastocytose og mastcelleleukæmi (se pkt. 
The European Medicines Agency has waived the obligation to submit the results of studies with Rydapt in all subsets of the paediatric population in the treatment of malignant mastocytosis and mast cell leukaemia (see section 4.2 for information on paediatric use).
Du skal bruge en sikker svangerskabsforebyggende metode, mens du tager Rydapt, og i mindst 4 måneder efter at du er stoppet med at tage det. 
You must use an effective method of contraception while taking Rydapt and for at least 4 months after you have stopped taking it.
Selvom den nøjagtige mekanisme bag den faldende koncentration af midostaurin ikke kendes, kan det sandsynligvis skyldes autoinduktionsegenskaber for midostaurin og dets to aktive metabolitter CGP52421 og CGP62221 på CYP3A4. 
While the exact mechanism for the declining concentration of midostaurin is unclear, it is likely due to the auto-induction properties of midostaurin and its two active metabolite CGP52421 and CGP62221 on CYP3A4.