natgillin/translations-raw huggingface dataset:
Substanser, der kan øge serumkoncentrationerne af nilotinib Nilotinib metaboliseres hovedsageligt i leveren og er også substrat for multiefflukspumpen, P - glykoprotein (Pgp).
Substances that may increase nilotinib serum concentrations Nilotinib is mainly metabolised in the liver and is also a substrate for the multi-drug efflux pump, P- glycoprotein (Pgp).
Derfor kan absorption og efterfølgende udskillelse af systemisk absorberet nilotinib påvirkes af midler, der påvirker CYP3A4 og/ eller Pgp.
Therefore, absorption and subsequent elimination of systemically absorbed nilotinib may be influenced by substances that affect CYP3A4 and/ or Pgp.
Eksponeringen for nilotinib hos raske forsøgspersoner 3- dobledes ved samtidig administration med den stærke CYP3A4- hæmmer ketoconazol.
The exposure to nilotinib in healthy subjects was increased 3-fold when co-administered with the strong CYP3A4 inhibitor ketoconazole.
4. 2 og 4. 4).
Concomitant treatment with strong CYP3A4 inhibitors, including ketoconazole, itraconazole, voriconazole, ritonavir, moxifloxacin, clarithromycin, and telithromycin, should therefore be avoided (see sections 4.2 and 4.4).
Øget eksponering for nilotinib kan muligvis også forventes med moderate CYP3A4- hæmmere.
Increased exposure to nilotinib might also be expected with moderate CYP3A4 inhibitors.
Samtidig behandling med alternative præparater uden eller med minimal CYP3A4- hæmning bør overvejes.
Alternative concomitant medications with no or minimal CYP3A4 inhibition should be considered.
Substanser, der kan mindske serumkoncentrationerne af nilotinib Rifampicin, en potent CYP3A4- inducer, nedsætter nilotinib Cmax med 64% og reducerer nilotinib AUC med 80%.
Substances that may decrease nilotinib serum concentrations Rifampicin, a potent CYP3A4 inducer, decreases nilotinib Cmax by 64% and reduces nilotinib AUC by 80%.
Samtidig administration af andre lægemidler, som inducerer CYP3A4 (f. eks. phenytoin, carbamazepin, phenobarbital og prikbladet perikum), kan ligeledes sandsynligvis mindske eksponeringen for nilotinib i klinisk relevant grad.
The concomitant administration of other medicinal products that induce CYP3A4 (e. g. phenytoin, carbamazepine, phenobarbital and St.
Man bør vælge alternative stoffer med mindre enzyminduktionspotentiale hos patienter, for hvem CYP3A4- inducere er indiceret.
John’ s Wort) is likewise likely to reduce exposure to nilotinib to a clinically relevant extent.
Nilotinib har pH- afhængig opløsning.
In patients for whom CYP3A4 inducers are indicated, alternative agents with less enzyme induction potential should be selected.
Derfor kan absorption af nilotinib nedsættes, af substanser som undertrykker mavesyresekretion.
Nilotinib has pH dependent solubility, therefore, absorption of nilotinib might be reduced by substances that suppress gastric acid secretion.
Samtidig anvendelse af antacida, H2- blokkere eller protonpumpehæmmere med Tasigna er frarådet.
The concomitant use of antacids, H2 blockers, or proton pump inhibitors with Tasigna is not recommended.
Substanser, hvis systemiske koncentration kan ændres af nilotinib Nilotinib er en relativt stærk hæmmer af CYP3A4, CYP2C8, CYP2C9, CYP2D6 og UGT1A1 in vitro, der potentielt kan øge koncentrationerne af lægemidler, som elimineres af disse enzymer.
Substances that may have their systemic concentration altered by nilotinib Nilotinib is a relatively strong inhibitor of CYP3A4, CYP2C8, CYP2C9, CYP2D6 and UGT1A1 in vitro, potentially increasing the concentrations of substances eliminated by these enzymes.
Desuden øgede
The clinical relevance of these potential interactions has not been studied but caution is advised especially with concomitant use of nilotinib and medicinal products with a narrow therapeutic index.
5 Tasigna midazolameksponeringen med 30% hos raske forsøgspersoner, når det blev administreret som enkeltdosis samtidig med oralt administreret midazolam.
In addition, single-dose administration of Tasigna with orally administered midazolam to healthy subjects increased midazolam exposure by 30%.
Det kan ikke udelukkes at effekten af nilotinib er højere ved steady state.
It cannot be excluded that the effect of nilotinib is greater at steady state.
Der bør udvises forsigtighed ved samtidig administration af Tasigna og substrater af disse enzymer, der har et smalt terapeutisk indeks (f. eks. astemizol, terfenadin, cisaprid, pimozid, quinidin, bepridil eller ergotalkaloider (ergotamin, dihydroergotamin)).
Caution should be exercised when co-administering Tasigna with substrates of these enzymes that have a narrow therapeutic index [e. g. astemizole, terfenadine, cisapride, pimozide,
Da warfarin metaboliseres af CYP2C9 og CYP3A4, bør det gives med forsigtighed.
Since warfarin is metabolised by CYP2C9 and CYP3A4 it should be given with caution.
Andre antikoagulantia bør overvejes.
Other medicinal products for anticoagulation should be considered.
4. 4).
Anti-arrhythmic medicinal products and other substances that may prolong QT Nilotinib should be used with caution in patients who have or may develop prolongation of QT, including those patients taking anti-arrhythmic medicinal products such as amiodarone, disopyramide, procainamide, quinidine and sotalol or other medicinal products that may lead to QT prolongation such as chloroquine, halofantrine, clarithromycin, haloperidol and methadone (see section 4.4).
Andre interaktioner, der kan påvirke serumkoncentrationerne Absorptionen af Tasigna øges, hvis det tages sammen med mad, hvilket resulterer i højere serumkoncentration (se pkt.
Other interactions that may affect serum concentrations The absorption of Tasigna is increased if it is taken with food, resulting in higher serum concentration (see sections 4.2, 4.4 and 5.2).
Graviditet Der foreligger ikke data om brugen af Tasigna hos gravide kvinder.
Pregnancy There are no data on the use of Tasigna in pregnant women.
Tasigna bør ikke anvendes under graviditet, medmindre det er klart nødvendigt.
Tasigna should not be used during pregnancy unless clearly necessary.
Kvinder i den fertile alder skal rådgives til at anvende effektiv kontraception under behandling med Tasigna.
Women of childbearing potential must be advised to use effective contraception during treatment with Tasigna.
Amning Det vides ikke, om nilotinib udskilles i human modermælk.
Lactation It is not known whether nilotinib is excreted in human milk.
Dyreforsøg viser, at det udskilles i mælken.
Studies in animals demonstrate that it is excreted into milk.
Kvinder bør ikke amme under behandling med Tasigna, eftersom risiko for barnet ikke kan udelukkes.
Women should not breast-feed during treatment with Tasigna, as a risk to the infant cannot be excluded.
Der er ikke foretaget undersøgelser af nilotinibs virkning på evnen til at føre motorkøretøj eller betjene maskiner.
No studies on the effects of nilotinib on the ability to drive and use machines have been performed.
4. 8).
Patients experiencing dizziness, fatigue, visual impairment or other undesirable effects with a potential impact on the ability to drive or use machines safely should refrain from these activities as long as the undesirable effects persist (see section 4.8).
De nedenfor beskrevne data afspejler eksponeringen for Tasigna hos 438 patienter i et open- label -, multicenterstudie.
The data described below reflect exposure to Tasigna in 438 patients in an open-label multicentre study.
Ved cut- off havde 46% af patienterne med kronisk CML (CML- CP) eksponeringsvarigheder på 6- 12 måneder, og 18% af patienterne havde en eksponeringsvarighed på mere end 12 måneder.
At cut-off, 46% of patients in chronic-phase CML (CML-CP) had a duration of exposure of 6 to 12 months and 18% of patients had a duration of exposure of more than 12 months.
62% af patienterne med accelereret CML (CML- AP) havde eksponeringsvarigheder på 3- 12 måneder, og 10% af patienterne havde en eksponeringsvarighed på mere end 12 måneder.
62% of patients in accelerated-phase CML (CML-AP) had a duration of exposure of 3 to 12 months and 10% of patients had a duration of exposure of more than 12 months.
Dosis var 400 mg to gange dagligt.
The dose was 400 mg twice daily.
Den gennemsnitlige eksponeringsvarighed i dage var 245 (1- 502) for disse patienter med CML- CP og 138 (2- 503) for patienter med CML- AP.
The median duration of exposure in days was 245 (1-502) for the CML-CP patients and 138 (2-503) for the CML- AP patients.
De hyppigste ikke- hæmologiske lægemiddelrelaterede bivirkninger var udslæt, pruritus, kvalme, træthed og hovedpine.
The most frequent non-haematological drug-related adverse events were rash, pruritus, nausea, fatigue and headache.
Obstipation, diarré, smerter i knoglerne, artralgi, muskelkramper og perifert ødem blev observeret mindre hyppigt og har været milde til moderate.
Constipation, diarrhoea, bone pain, arthralgia, muscle spasms and peripheral oedema were observed less commonly and have been of mild to moderate severity.
Behandlingsstop grundet bivirkninger uanset kausalitet blev observeret hos 16% af CP - og 14% af AP- patienterne.
Discontinuation for adverse events regardless of causality was observed in 16% of CP and 14% of AP patients.
6 Behandlingsfremkaldt hæmatologisk toksicitet omfattede trombocytopeni (27%), neutropeni (15%) og anæmi (13%).
Treatment emergent haematological toxicities included thrombocytopenia (27%), neutropenia (15%) and anaemia (13%).
Pleural og perikardiel effusion samt komplikationer med væskeretention forekom hos < 1% af de patienter, der modtog Tasigna.
Pleural and pericardial effusions as well as complications of fluid retention occurred in < 1% of patients receiving Tasigna.
Hjertesvigt observeredes hos 1% af patienterne.
Congestive heart failure was observed in 1% of
Gastrointestinal og CNS- blødning blev rapporteret hos henholdsvis 3% og 1% af patienterne.
Gastrointestinal and CNS haemorrhage were reported in 3% and 1% of patients, respectively.
Der blev observeret QTcF på over 500 msek. hos < 1% af patienterne.
QTcF exceeding 500 msec was observed in < 1% of patients.
Der blev ikke observeret nogen episoder med torsade de pointes (forbigående eller vedvarende).
No episodes of torsade de pointes (transient or sustained) were observed.
Ikke- hæmatologiske bivirkninger (ekskl. laboratorieabnormaliteter), som rapporteres hos mindst 5% af patienterne i kliniske studier af Tasigna, er vist i tabel 2.
Non-haematological adverse reactions (excluding laboratory abnormalities) that are reported in at least 5% of the patients in Tasigna clinical studies are shown in Table 2.
De er anført efter hyppighed med følgende konvention: meget almindelig (≥1/ 10) eller almindelig (≥1/ 100 til < 1/ 10).
These are ranked under heading of frequency using the following convention: very common (≥ 1/ 10) or common (≥ 1/ 100 to < 1/ 10).
Bivirkninger (≥5% af alle patienter, n=438)
Adverse reactions (≥ 5% of all patients, n=438)
Hyppighed Bivirkning
Frequency Adverse All reaction
Grad
grades
Kronisk
Grade 3-4
Accelereret
Chronic phase Grade 3-4
grad 3- 4
Accelerated phase Grade 3-4
Kvalme Obstipation Diarré Opkastning Abdominalsmerter
Nausea Constipation Diarrhoea Vomiting Abdominal pain
subkutane væv
subcutaneous tissue disorders
Pruritus Alopeci
Pruritus Alopecia
Myalgi Artralgi Muskelkramper Knoglesmerter
Myalgia Arthralgia Muscle spasms Bone pain
Metabolisme og ernæring
Metabolism and Common nutrition disorders
Almene symptomer og reaktioner på administrations - stedet
General disorders and administration site conditions
Meget almindelig Almindelig Almindelig
Very common Common Common
Træthed Asteni Ødem perifert
Fatigue Asthenia Oedema peripheral
Yderligere data fra andre kliniske forsøg Følgende bivirkninger er indberettet hos patienter i kliniske studier af Tasigna med en hyppighed på mindre end 5% (almindelig er ≥1/ 100 til < 1/ 10, ikke almindelig er > 1/ 1. 000 til < 1/ 100, enkeltstående hændelser har hyppigheden ikke kendt [kan ikke estimeres fra forhåndenværende data]).
Additional data from clinical trials The following adverse reactions were reported in patients in the Tasigna clinical studies at a frequency of less than 5% (common is ≥ 1/ 100 to< 1/10; uncommon is > 1/1,000 to< 1/100; single events are captured as frequency not known [cannot be estimated from the available data]).
For laboratorieabnormaliteter er meget almindelige bivirkninger (≥1/ 10), der ikke er medtaget i tabel 2, også rapporteret.
For laboratory abnormalities, very common events (≥ 1/ 10) not included in Table 2 are also reported.
Disse bivirkninger er medtaget ud fra klinisk relevans og ordnet med de alvorligste først inden for hver kategori.
These adverse reactions are included based on clinical relevance and ranked in order of decreasing seriousness within each category.
7 Undersøgelser:
7 Investigations:
Meget almindelig: forhøjet lipase.
Very common: lipase increased.
Almindelig: forhøjet blodamylase, forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, forhøjet blodbilirubin, forhøjet blodalkalifosfatase, forhøjet gamma- glutamyltransferase, forhøjet blodkreatininfosfokinase, forhøjet blodglukose, vægttab, vægtstigning.
Common: blood amylase increased, alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, blood alkaline phosphatase increased, gamma- glutamyltransferase increased, blood creatinine phosphokinase increased, blood glucose increased, weight decreased, weight increased.
Ikke almindelig: forhøjet blodlaktatdehydrogenase, nedsat blodglukose, forhøjet blodkreatinin, forhøjet blodurea.
Uncommon: blood lactate dehydrogenase increased, blood glucose decreased, blood creatinine increased, blood urea increased.
Ikke kendt: forhøjet troponin, nedsat blodkalium, forhøjet ukonjugeret blodbilirubin.
Not known: troponin increased, blood potassium decreased, blood bilirubin unconjugated increased.
Almindelig: palpitationer, QT- forlængelse på EKG.
Common: palpitations, electrocardiogram QT prolonged.
Ikke almindelig: hjertesvigt, angina pectoris, atriefibrillation, perikardiel effusion, koronararteriesygdom, kardiomegali, hjertemislyd, bradykardi.
Uncommon: cardiac failure, angina pectoris, atrial fibrillation, pericardial effusion, coronary artery disease, cardiomegaly, cardiac murmur, bradycardia.
Ikke kendt: myokardieinfarkt, ventrikulær dysfunktion, perikardit, hjerteflimren, ekstrasystoler.
Not known: myocardial infarction, ventricular dysfunction, pericarditis, cardiac flutter, extrasystoles.
Almindelig febril neutropeni, pancytopeni.
Common: febrile neutropenia, pancytopenia.
Almindelig: svimmelhed, paræstesi.
Common: dizziness, paraesthesia.
Ikke almindelig: intrakraniel blødning, migræne, tremor, hypoæstesi, hyperæstesi.
Uncommon: intracranial haemorrhage, migraine, tremor, hypoaesthesia, hyperaesthesia.
Ikke kendt: hjerneødem, bevidstløshed, neuritis nervi optici, perifer neuropati.
Not known: brain oedema, loss of consciousness, optic neuritis, peripheral neuropathy.
Ikke almindelig: blødning i øje, nedsat synsstyrke, periorbitalt ødem, konjunktivit, øjenirritation, tørre øjne.
Uncommon: eye haemorrhage, visual acuity reduced, periorbital oedema, conjunctivitis, eye irritation, dry eye.
Ikke kendt: papillødem, diplopi, sløret syn, fotofobi, hævede øjne, blefarit, smerter i øjnene.
Not known: papilloedema, diplopia, vision blurred, photophobia, eye swelling, blepharitis, eye pain.
Ikke kendt: nedsat hørelse, smerter i ørerne.
Not known: hearing impaired, ear pain.
Almindelig: dyspnø, belastningsdyspnø, hoste, dysfoni.
Common: dyspnoea, dyspnoea exertional, cough, dysphonia.
Ikke almindelig: lungeødem, pleural effusion, interstitiel lungesygdom, pleurasmerter, pleurit, epistaxis, faryngolaryngeale smerter, halsirritation.
Uncommon: pulmonary oedema, pleural effusion, interstitial lung disease, pleuric pain, pleurisy, epistaxis, pharyngolaryngeal pain, throat irritation.
Ikke kendt: pulmonal hypertension.
Not known: pulmonary hypertension.
Almindelig: abdominalt ubehag, dyspepsi, flatulens.
Common: abdominal discomfort, dyspepsia, flatulence.
Ikke almindelig: pankreatit, gastrointestinal blødning, melæna, abdominal distension, ulcus i mund, gastroøsofageal reflux, stomatit, mundtørhed.
Uncommon: pancreatitis, gastrointestinal haemorrhage, melaena, abdominal distension, mouth ulceration, gastroesophageal reflux, stomatitis, dry mouth.
Ikke kendt: perforation af gastrointestinal ulcus, retroperitoneal blødning, hæmatemese, ventrikelulcus, ulcerativ øsofagit, subileus.
Not known: gastrointestinal ulcer perforation, retroperitoneal haemorrhage, haematemesis, gastric ulcer, oesophagitis ulcerative, subileus.
Nyre og urinveje:
Renal and urinary disorders:
Ikke almindelig: dysuri, imperiøs vandladning, nykturi, pollakisuri.
Uncommon: dysuria, micturition urgency, nocturia, pollakiuria.
Ikke kendt: nyresvigt, hæmaturi, urininkontinens.
Not known: renal failure, haematuria, urinary incontinence.
Almindelig: natlige svedeture, eksem, urticaria, erytem, hyperhidrose, tør hud.
Common: night sweats, eczema, urticaria, erythema, hyperhidrosis, dry skin.
Ikke almindelig: eksfoliativt udslæt, ekkymose, hævet ansigt.
Uncommon: exfoliative rash, ecchymosis, swelling face.
Ikke kendt: erythema nodosum, hudulcus, petekkier, fotosensibilitet.
Not known: erythema nodosum, skin ulcer, petechiae, photosensitivity.
8 Knogler, led, muskler og bindevæv:
8 Musculoskeletal and connective tissue disorders:
Almindelig: muskuloskeletale brystsmerter, muskuloskeletale smerter.
Common: musculoskeletal chest pain, musculoskeletal pain.
Ikke almindelig: muskelsvaghed.
Uncommon: muscular weakness.
Ikke kendt: artrit, hævede led.
Not known: arthritis, joint swelling.
Ikke almindelig: hypertyroidisme.
Uncommon: hyperthyroidism.
Ikke kendt: hypotyroidisme, tyroidit.
Not known: hypothyroidism, thyroiditis.
Almindelig: hypomagnesiæmi, hyperkaliæmi, hyperglykæmi.
Common: hypomagnesaemia, hyperkalaemia, hyperglycaemia.
Ikke almindelig: hypokaliæmi, hyponatræmi, hypokalcæmi, hypofosfatæmi, dehydrering, nedsat appetit, øget appetit.
Uncommon: hypokalaemia, hyponatraemia, hypocalcaemia, hypophosphataemia, dehydration, decreased appetite, increased appetite.
Ikke kendt: diabetes mellitus, hyperkalcæmi, hyperfosfatæmi.
Not known: diabetes mellitus, hypercalcaemia, hyperphosphataemia.
Ikke almindelig: pneumoni, urinvejsinfektion, gastroenterit, faryngit.
Uncommon: pneumonia, urinary tract infection, gastroenteritis, pharyngitis.
Ikke kendt: sepsis, bronkit, herpes simplex, candidiasis.
Not known: sepsis, bronchitis, herpes simplex, candidiadis.
Ikke almindelig: hypertensiv krise, hæmatom.
Uncommon: hypertensive crisis, haematoma.
Ikke kendt: hæmoragisk shock, hypotension, trombose.
Not known: shock haemorrhagic, hypotension, thrombosis.
Almindelig: pyreksi.
Common: pyrexia.
Ikke almindelig: brystsmerter, ansigtsødem, gravitationsødem, influenzalignende sygdom, kulderystelse, utilpashed.
Uncommon: chest pain, face oedema, gravitational oedema, influenza-like illness, chills, malaise.
Ikke almindelig: hepatit.
Uncommon: hepatitis.
Ikke kendt: hepatotoksicitet, hepatomegali, icterus.
Not known: hepatotoxicity, hepatomegaly, jaundice.
Almindelig: søvnløshed.
Common: insomnia.
Ikke almindelig: depression, angst.
Uncommon: depression, anxiety.
Ikke kendt: desorientering, forvirring.
Not known: disorientation, confusional state.
9 Klinisk relevante eller alvorlige abnormaliteter ved rutinemæssige hæmatologiske eller biokemiske laboratorieværdier er vist i tabel 3.
9 Clinically relevant or severe abnormalities of routine haematological or biochemistry laboratory values are presented in Table 3.
Laboratorieabnormaliteter, grad 3- 4
Grade 3-4 laboratory abnormalities
CML- CP n=318% Grad 3- 4
CML-CP n=318% Grade 3-4
CML- AP n=120% Grad 3- 4
CML-AP n=120% Grade 3-4
- Neutropeni - Trombocytopeni - Anæmi
- Neutropenia - Thrombocytopenia - Anaemia
- Forhøjet kreatinin
- Elevated creatinine - Elevated lipase - Elevated SGOT (AST) - Elevated SGPT (ALT) - Hypophosphataemia - Elevated bilirubin (total)
< 1%
< 1% 15% 1% 4% 10% 9%
0%
0% 17% < 1% 2% 10% 10%
15% 1% 4% 10% 9%
4.9 Overdose
Proteinkinasehæmmere, ATC- kode:
Protein-kinase inhibitors, ATC code:
Tasigna er en potent hæmmer af Bcr- Abl- onkoproteinets Abl- tyrosinkinaseaktivitet både i cellelinjerne og i primære Philadelphia- kromosompositive leukæmiceller.
Tasigna is a potent inhibitor of the Abl tyrosine kinase activity of the Bcr-Abl oncoprotein both in cell lines and in primary Philadelphia-chromosome positive leukaemia cells.
Stoffet binder sig med høj affinitet til ATP- bindingsstedet på en sådan måde, at det er en potent hæmmer af vildtype Bcr- Abl og opretholder aktivitet mod 32/ 33- imatinibresistente muterede former af Bcr- Abl.
The substance binds with high affinity to the ATP-binding site in such a manner that it is a potent inhibitor of wild-type Bcr-Abl and maintains activity against 32/ 33 imatinib-resistant mutant forms of Bcr-Abl.
Som følge af denne biokemiske aktivitet hæmmer nilotinib selektivt proliferationen og inducerer apoptose i cellelinjer og i primære Philadelphia- kromosompositive leukæmiceller fra CML- patienter.
As a consequence of this biochemical activity, nilotinib selectively inhibits the proliferation and induces apoptosis in cell lines and in primary Philadelphia-chromosome positive leukaemia cells from CML patients.
Src, undtagen for PDGF -, Kit - and Ephrin- receptorkinaser, som det hæmmer ved koncentrationer inden for det interval, der opnås efter oral administration ved terapeutiske doser, der anbefales til behandling af CML (se tabel 4).
Tasigna has little or no effect against the majority of other protein kinases examined, including Src, except for the PDGF, Kit and Ephrin receptor kinases, which it inhibits at concentrations within the range achieved following oral administration at therapeutic doses recommended for the treatment of CML (see Table 4).
Nilotinibs kinaseprofil (fosforylation IC50 nM)
Kinase profile of nilotinib (phosphorylation IC50 nM)
10 Kliniske studier Der blev udført et open label -, ukontrolleret, multicenter -, fase II- forsøg for at fastslå Tasignas virkning hos patienter med imatinib- resistent eller - intolerant CML med separate behandlingsarme for kronisk og accelereret CML.
Clinical studies An open-label, uncontrolled, multicentre Phase II study was conducted to determine the efficacy of Tasigna in patients with imatinib resistant or intolerant CML with separate treatment arms for chronic
Studiet er stadig i gang.
The study is ongoing.
Virkningen var baseret på 320 rekrutterede CP - patienter og 119 rekrutterede AP- patienter.
Efficacy was based on 320 CP patients and 119 AP patients enrolled.
Denne gennemsnitlige behandlingsvarighed var 341 dage for CP- patienter og 202 dage for AP- patienter (se tabel 5).
Median duration of treatment was 341 days for CP patients and 202 days for AP patients (see Table 5).
Tasigna blev administreret kontinuerligt (to gange dagligt 2 timer efter et måltid og uden mad i mindst en time efter administrationen), medmindre der var tegn på utilstrækkelig respons eller sygdomsprogression.
Tasigna was administered on a continuous basis (twice daily 2 hours after a meal and with no food for at least one hour after administration) unless there was evidence of inadequate response or disease progression.
Dosiseskalering til 600 mg to gange dagligt var tilladt.
Dose escalation to 600 mg twice daily was allowed.
Eksponeringsvarighed med Tasigna
Duration of exposure with Tasigna
Kronisk CLM n=320
Chronic phase n=320
Accelereret CLM n=119
Accelerated phase n=119
Gennemsnitlig behandlingsvarighed i
Median duration of therapy in days
dage (25 - og 75- percentil)
(25th-75th percentiles)
Overordnet var 73% af patienterne imatinib- resistente, mens 27% var imatinib- intolerante.
Overall, 73% of patients were imatinib-resistant, while 27% were imatinib-intolerant.
De fleste af patienterne havde et langt forløb med CML med ekstensiv forudgående behandling med andre antineoplastiske stoffer, inkl. imatinib, hydroxyurea, interferon, og nogle med mislykket organtransplantation (tabel 6).
The majority of patients had a long history of CML that included extensive prior treatment with other antineoplastic agents, including imatinib, hydroxyurea, interferon, and some had even failed organ transplant (Table 6).