natgillin/translations-raw huggingface dataset:
Hos patienter med B-celle-maligniteter, der tog IMBRUVICA sammen med mad, forøgede samtidig administration af CYP3A4-hæmmeren erythromycin Cmax 3,4 gange og AUC 3,0 gange.
In patients with B-cell malignancies taking IMBRUVICA with food, co-administration of the CYP3A4 inhibitor erythromycin increased Cmax by 3.4-fold and AUC by 3.0-fold.
Ved baseline havde 65 % af patienterne CLL/SLL med høje risikofaktorer (del17p/TP53-mutation [18 %], del11q [15 %], eller ikke-muteret IGHV [54 %]).
At baseline, 65% of patients presented with CLL/SLL with high risk factors (del17p/TP53 mutation [18%], del11q [15%], or unmutated IGHV [54%]).
(AUClast) sammenlignet med enten 30 minutter før, 30 minutter efter (dvs. i forbindelse med et måltid) eller 2 timer efter et morgenmåltid med højt fedtindhold.
Administration of ibrutinib in fasted condition resulted in approximately 60% of exposure (AUClast) as compared to either 30 minutes before, 30 minutes after (fed condition) or 2 hours after a high fat breakfast.
Medianantallet af tidligere behandlinger var 4 (interval: 1 til 7 behandlinger).
The median number of prior treatments was 4 (range, 1 to 7 treatments).
CI = konfidensinterval; DOR = varighed af respons; NR = ikke nået; MR = mindre respons; PR = partielt respons; VGPR = meget godt partielt respons; ORR = MR+PR+VGPR Median opfølgningstid i studiet = 14,8 måneder.
CI=confidence interval; DOR=duration of response; NR=not reached; MR=minor response; PR=partial response; VGPR=very good partial response; ORR=MR+PR+VGPR Median follow-up time on study=14.8 months
Samtidig administration af rifampicin, en potent CYP3A4-induktor, hos 18 fastende, raske forsøgspersoner mindskede eksponering (Cmax og AUC) for ibrutinib med hhv. 92 og 90 %.
Co-administration of rifampicin, a strong CYP3A4 inducer, in 18 fasted healthy subjects, decreased exposure (Cmax and AUC) of ibrutinib by 92 and 90%, respectively.
Monitorer patienten nøje for toksicitet, og følg vejledningen vedr.
Monitor patient closely for toxicity and follow dose modification guidance as needed.
Hos drægtige kaniner associeredes ibrutinib med misdannelser i skelettet (sammenvoksede sternebrae) ved en dosis på 15 mg/kg/dag og med øget tab efter implantation ved en dosis på 45 mg/kg/dag.
In pregnant rabbits, ibrutinib at a dose of 15 mg/kg/day or greater was associated with skeletal malformations (fused sternebrae) and ibrutinib at a dose of 45 mg/kg/day was associated with increased post-implantation loss.
Mave-tarm-kanalen Meget almindelig Diarré Opkastning
Gastrointestinal disorders Very common Diarrhoea Vomiting
90 hårde kapsler 120 hårde kapsler
120 hard capsules
Den anbefalede dosis IMBRUVICA er fire kapsler (560 mg) en gang om dagen.
The recommended dose of IMBRUVICA is four capsules (560 mg) once a day.
Hver hård kapsel indeholder 140 mg ibrutinib.
Each hard capsule contains 140 mg of ibrutinib.
Behandlingsafbrydelse og dosisreduktion på grund af bivirkninger Af de 1.200 patienter, som blev behandlet med IMBRUVICA for B-celle-maligniteter, afbrød 5 % behandlingen primært som følge af bivirkninger, bl.a. pneumoni, atrieflimren, blødning og trombocytopeni.
Discontinuation and dose reduction due to adverse reactions Of the 1200 patients treated with IMBRUVICA for B-cell malignancies, 5% discontinued treatment primarily due to adverse reactions.
Der er blevet observeret en stor stigning i antallet af cirkulerende lymfocytter (f.eks. > 400 x 10
A large increase in the number of circulating lymphocytes (e.g., >400,000/mcL) has been observed in some patients.
Tabel 7: Effektresultaterne hos patienter med CLL (studiet PCYC-1112-CA) Endepunkt
Table 7: Efficacy results in patients with CLL (Study PCYC-1112-CA) Endpoint
Ibrutinibs behandlingsvirkning i PCYC-1115-CA-studiet var konsekvent på tværs af højrisikopatienter med del17p/TP53-mutation, del11q og/eller ikke-muteret IGHV.
The treatment effect of ibrutinib in Study PCYC-1115-CA was consistent across high-risk patients with del17p/TP53 mutation, del11q, and/or unmutated IGHV.
Mediantiden efter diagnosticering var 43 måneder, og det mediane antal tidligere behandlinger var 2 (1 til 9 behandlinger), herunder 51 % med tidligere højdosis-kemoterapi, 18 % med tidligere behandling med bortezomib, 5 % med tidligere behandling med lenalidomid og 24 % med tidligere stamcelletransplantation.
The median time since diagnosis was 43 months, and median number of prior treatments was 2 (range: 1 to 9 treatments), including 51% with prior high-dose chemotherapy, 18% with prior bortezomib, 5% with prior lenalidomide, and 24% with prior stem cell transplant.
Antal hændelser (%) Median (95 % CI), måneder
Number of events (%) Median (95% CI), months
Ikke almindelig Angioødem Panniculitis*
Uncommon Angioedema Panniculitis
Dosisjusteringer Moderate og potente CYP3A4-hæmmere øger eksponeringen for ibrutinib (se pkt.
Dose adjustments Moderate and strong CYP3A4 inhibitors increase the exposure of ibrutinib (see sections 4.4 and 4.5).
Hvis en moderat CYP3A4-hæmmer (f.eks. fluconazol, erythromycin, amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, diltiazem, fosamprenavir, imatinib, verapamil, amiodaron og dronedaron) er indiceret, skal IMBRUVICA-dosis reduceres til 280 mg i det tidsrum, hæmmeren anvendes.
If a moderate CYP3A4 inhibitor (e.g., fluconazole, erythromycin, amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, diltiazem, fosamprenavir, imatinib, verapamil, amiodarone and dronedarone) is indicated, reduce IMBRUVICA dose to 280 mg for the duration of the inhibitor use.
Tabel 3: Effektresultater hos patienter med recidiverende eller refraktær MCL (MCL3001-studiet)
Table 3: Efficacy Results in patients with relapsed or refractory MCL (Study MCL3001) Endpoint
Amning skal ophøre under behandling med IMBRUVICA.
Breast-feeding should be discontinued during treatment with IMBRUVICA.
Det kan være infektioner i næsen, bihulerne eller svælget (de øvre luftveje), i lungerne eller i huden.
sinus or throat (upper respiratory tract infection), or lung, or skin.
CI = konfidensinterval; HR = hazard ratio; CR = komplet respons; ORR = samlet responsrate; OS = samlet overlevelse; PFS = progressionsfri overlevelse; PR = partielt respons IRC-vurderet, median opfølgning 18,4 måneder.
CI=confidence interval; HR=hazard ratio; CR=complete response; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; PR=partial response IRC evaluated, median follow-up 18.4 months.
Den anbefalede dosis til behandling af CLL, enten som monoterapi eller som kombinationsbehandling, er 420 mg en gang dagligt (for yderligere oplysninger om kombinationsregimet, se pkt.
The recommended dose for the treatment of CLL, either as a single agent or in combination, is 420 mg once daily (for details of the combination regimen, see section 5.1).
• medicin, der kaldes antibiotika, som anvendes til at behandle bakterieinfektioner clarithromycin, telithromycin, ciprofloxacin, erythromycin eller rifampicin
• medicines called antibiotics to treat bacterial infections - clarithromycin, telithromycin,
10 filmovertrukne tabletter
30 film-coated tablets
Samtidig administration af grapefrugtjuice, som indeholder CYP3A4-hæmmere, hos otte raske forsøgspersoner øgede eksponering (Cmax og AUC) for ibrutinib hhv. ca. 4 og 2 gange.
Co-administration of grapefruit juice, containing CYP3A4 inhibitors, in eight healthy subjects, increased exposure (Cmax and AUC) of ibrutinib by approximately 4- and 2-fold, respectively.
Patienterne (n = 391) blev randomiseret 1:1 til at modtage enten 420 mg IMBRUVICA dagligt indtil sygdomsprogression eller uacceptabel toksicitet eller op til 12 doser ofatumumab (300/2.000 mg).
Patients (n=391) were randomised 1:1 to receive either IMBRUVICA 420 mg daily until disease progression or unacceptable toxicity, or ofatumumab for up to 12 doses (300/2,000 mg).
Kaplan-Meier-kurven for PFS er vist i figur 6.
The Kaplan-Meier curve for PFS is shown in Figure 6.
Den opdaterede Kaplan-Meier-kurve for PFS er vist i figur 7.
The updated Kaplan-Meier curve for PFS is shown in Figure 7.
Ved baseline var 52 % på et fremskredent klinisk stadie (Rai-stadie III eller IV), 32 % af patienterne havde omfangsrig sygdom (≥ 5 cm), 44 % havde anæmi ved baseline, 22 % havde trombocytopeni ved baseline, 28 % havde CrCL < 60 ml/min og CIRS-G (Median Cumulative Illness Rating Score for Geriatrics) var 4 (interval: 0 til 12).
At baseline, 52% had advanced clinical stage (Rai Stage III or IV), 32% of patients had bulky disease (≥5 cm), 44% with baseline anemia, 22% with baseline thrombocytopenia, 28% had a CrCL <60 mL/min, and the median Cumulative Illness Rating Score for Geriatrics (CIRS-G) was 4 (range, 0 to 12).
Samtidig administration af ketoconazol, en meget potent CYP3A4-hæmmer, hos 18 fastende, raske forsøgspersoner øgede eksponering (Cmax og AUC) for ibrutinib hhv. 29 og 24 gange.
Co-administration of ketoconazole, a very strong CYP3A4 inhibitor, in 18 fasted healthy subjects, increased exposure (Cmax and AUC) of ibrutinib by 29- and 24-fold, respectively.
Den opdaterede Kaplan-Meier-kurve for PFS er vist i figur 4.
The updated Kaplan-Meier curve for PFS is shown in Figure 4.
93 % af patienterne havde en ECOG-performancestatus ved baseline på 0 eller 1, og 7 % af patienterne havde en ECOG-performancestatus ved baseline på 2.
Ninety-three percent of patients had a baseline ECOG performance status of 0 or 1, and 7% of patients had a baseline ECOG performance status of 2.
Den mediane investigatorvurderede PFS i henhold til IWCLLkriteriet var hhv. 44,1 måneder [95 % CI (38,47; 56,18)] i IMBRUVICA-gruppen og 8,1 måneder [95 % CI (7,79; 8,25)] i ofatumumab-gruppen (HR = 0,15 [95 % CI (0,11; 0,20)]).
The median investigator-assessed PFS according to IWCLL criteria was 44.1 months [95% CI (38.47, 56.18)] in the IMBRUVICA arm and 8.1 months [95% CI (7.79, 8.25)] in the ofatumumab arm, respectively; HR=0.15 [95% CI (0.11, 0.20)].
Patienterne (n = 150) blev randomiseret 1:1 til at modtage enten 420 mg IMBRUVICA dagligt eller placebo i kombination med rituximab indtil sygdomsprogression eller uacceptabel toksicitet.
Patients (n=150) were randomized 1:1 to receive either IMBRUVICA 420 mg daily or placebo in combination with rituximab until disease progression or unacceptable toxicity.
Den anbefalede dosis IMBRUVICA er 560 mg en gang om dagen.
The recommended dose of IMBRUVICA is 560 mg once a day.
Den anbefalede dosis til behandling af MCL er 560 mg en gang dagligt.
The recommended dose for the treatment of MCL is 560 mg once daily.
Median (95 % CI), måneder
Median (95% CI), months
Rituximab blev administreret med en dosis på 375 mg/m2 på dag 1 i den første serie og 500 mg/m2 på dag 1 i serie 2 til 6.
Rituximab was administered at a dose of 375 mg/m2 in the first cycle,
Det skal du vide, før du begynder at tage IMBRUVICA Sådan skal du tage IMBRUVICA Bivirkninger
What you need to know before you take IMBRUVICA Do not take IMBRUVICA
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 October 2014
Den anbefalede dosis til behandling af CLL, enten som monoterapi eller som kombinationsbehandling, er 420 mg (tre kapsler) en gang dagligt (for yderligere oplysninger om kombinationsregimet, se pkt.
The recommended dose for the treatment of CLL, either as a single agent or in combination, is 420 mg (three capsules) once daily (for details of the combination regimen, see section 5.1).
CI = konfidensinterval; CR = komplet respons; DOR = varighed af respons; ORR = samlet responsrate; PR = partielt respons; NR = ikke nået
CI=confidence interval; CR=complete response; DOR=duration of response; ORR=overall response rate; PR=partial response; NR=not reached
Figur 1: Kaplan-Meier-kurver for PFS (ITT-population) i MCL3001-studiet
Figure 1: Kaplan-Meier curve of PFS (ITT Population) in Study MCL3001
81 % af patienterne havde en ECOG-performancestatus ved baseline på 0 eller 1, og 19 % havde en ECOG-performancestatus ved baseline på 2.
Eighty-one percent of patients had a baseline ECOG performance status of 0 or 1, and 19% had a baseline ECOG performance status of 2.
Leukostase
Leukostasis
EU/1/14/945/001 (90 hårde kapsler) EU/1/14/945/002 (120 hårde kapsler)
MARKETING AUTHORISATION NUMBER(S) EU/1/14/945/001 (90 hard capsules) EU/1/14/945/002 (120 hard capsules)
anvendelse af IMBRUVICA til gravide kvinder.
There are no data from the use of IMBRUVICA in pregnant women.
Den anbefalede dosis til behandling af MCL er 560 mg (fire kapsler) en gang dagligt.
The recommended dose for the treatment of MCL is 560 mg (four capsules) once daily.
Hvis toksiciteten forekommer igen, skal dosis en gang dagligt reduceres med 140 mg.
If the toxicity reoccurs, the once daily dose should be reduced by 140 mg. A second reduction of dose by 140 mg may be considered as needed.
Brug af anden medicin sammen med IMBRUVICA Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Hvis en moderat CYP3A4-hæmmer (f.eks. fluconazol, erythromycin, amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, diltiazem, fosamprenavir, imatinib, verapamil, amiodaron og dronedaron) er indiceret, skal IMBRUVICA-dosis reduceres til 280 mg (to kapsler) i det tidsrum, hæmmeren anvendes.
CYP3A4 inhibitor (e.g., fluconazole, erythromycin, amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, diltiazem, fosamprenavir, imatinib, verapamil, amiodarone and dronedarone) is indicated, reduce IMBRUVICA dose to 280 mg (two capsules) for the duration of the inhibitor use.
Gulliggrønne til grønne runde tabletter (9 mm) med påskriften ”ibr” på den ene side og ”140” på den anden side.
Yellow-green to green round (9 mm) tablets, written with “ibr” on one side and “140” on the other side.
Der er blevet indberettet tilfælde af leukostase hos patienter i behandling med IMBRUVICA.
Cases of leukostasis have been reported in patients treated with IMBRUVICA.
Medianalderen var 73 år (interval 65 til 90 år), 63 % var mænd, og 91 % var kaukasiere.
The median age was 73 years (range, 65 to 90 years), 63% were male, and 91% were Caucasian.
PFS Median (95 % CI), måneder
PFS Median (95% CI), months
Patienterne skal monitoreres for lungesymptomer, der kan tyde på ILS.
Monitor patients for pulmonary symptoms indicative of ILD.
IMBRUVICAs sikkerhed og virkning hos patienter med tidligere behandling for CLL blev evalueret yderligere i et randomiseret dobbeltblindt fase 3-multicenterstudie af IMBRUVICA i kombination med BR versus placebo + BR (CLL3001-studiet).
The safety and efficacy of IMBRUVICA in patients previously treated for CLL were further evaluated in a randomised, multicenter, double-blinded phase 3 study of IMBRUVICA in combination with BR versus placebo+BR (Study CLL3001).
IMBRUVICAs sikkerhed og virkning ved WM blev yderligere evalueret hos patienter med ubehandlet eller tidligere behandlet WM i et randomiseret, dobbeltblindet fase 3 multicenterstudie med IMBRUVICA i kombination med rituximab versus placebo i kombination med rituximab (PCYC-1127-CA).
The safety and efficacy of IMBRUVICA in WM were further evaluated in patients with treatmentnaïve or previously treated WM in a randomized, multicenter, double-blinded phase 3 study of IMBRUVICA in combination with rituximab versus placebo in combination with rituximab (PCYC-1127-CA).
Patienterne (n = 229) blev randomiseret 1:1 til at modtage enten 420 mg IMBRUVICA dagligt indtil sygdomsprogression eller uacceptabel toksicitet eller chlorambucil ved en dosis på 0,5 mg/kg på dag 1 og 15 i hver 28-dages serie, i 6 på hinanden følgende serier.
Patients (n=229) were randomized 1:1 to receive either IMBRUVICA 420 mg daily until disease progression or unacceptable toxicity or chlorambucil at a dose of 0.5 mg/kg on Days 1 and 15 of each 28-day cycle for 6 cycles.
Alle forsøgspersoner Del17P Ja Nej Refraktær sygdom til purin analog Ja Nej Alder
Refractory disease to purine analog Yes
Ved baseline var 45 % på et fremskredent klinisk stadie (Rai-stadie III eller IV), 35 % af patienterne havde mindst én tumor ≥ 5 cm, 39 % havde anæmi ved baseline, 23 % havde trombocytopeni ved baseline, 65 % havde forhøjet β2-mikroglobulin > 3500 mikrog/l, 47 % havde CrCl < 60 ml/min, 20 % af patienterne havde del11q, 6 % af patienterne havde del17p/tumorprotein 53 (TP53)-mutation, og 44 % af patienterne havde ikke-muterede gener i den variable region af den tunge kæde af immunglobulinet (IGHV).
At baseline, 45% had advanced clinical stage (Rai Stage III or IV), 35% of patients had at least one tumor ≥5 cm, 39% with baseline anemia, 23% with baseline thrombocytopenia, 65% had elevated β2 microglobulin >3500 mcg/L, 47% had a CrCL <60 mL/min, 20% of patients presented with del11q, 6% of patients presented with del17p/tumor protein 53 (TP53) mutation, and 44% of patients presented with unmutated immunoglobulin heavy chain variable region (IGHV).
IMBRUVICAs sikkerhed og virkning hos patienter med ubehandlet CLL/SLL blev yderligere vurderet i et randomiseret, åbent fase 3 multicenterstudie (PCYC-1130-CA) med IMBRUVICA i kombination med obinutuzumab versus chlorambucil i kombination med obinutuzumab.
The safety and efficacy of IMBRUVICA in patients with treatment naïve CLL/SLL were further evaluated in a randomized, multi-center, open-label, Phase 3 study (PCYC-1130-CA) of IMBRUVICA in combination with obinutuzumab versus chlorambucil in combination with obinutuzumab.
Mediantiden efter diagnose var 91 måneder, og medianantallet af tidligere behandlinger var 2 (interval: 1 til 13 behandlinger).
The median time since diagnosis was 91 months and the median number of prior treatments was 2 (range: 1 to 13 treatments).
Progressionsfri overlevelse (PFS), som vurderet af en IRC i henhold til kriterierne fra IWCLL, indikerede en statistisk signifikant reduktion på 78 % af risikoen for død eller progression for patienter i IMBRUVICA-gruppen.
Progression free survival (PFS) as assessed by an IRC according to IWCLL criteria indicated a 78% statistically significant reduction in the risk of death or progression for patients in the IMBRUVICA arm.
Moderate CYP3A4-hæmmere
Moderate CYP3A4 inhibitors
Medianalderen var 71 år (interval: 40 til 87 år), 64 % var mænd, og 96 % var kaukasiere.
The median age was 71 years (range, 40 to 87 years), 64% were male, and 96% were Caucasian.
Der er rapporteret tilfælde af ILS hos patienter i behandling med IMBRUVICA.
Cases of ILD have been reported in patients treated with IMBRUVICA.
Dosis af ibrutinib skal reduceres til 280 mg en gang dagligt ved brug samtidig med moderate CYP3A4-hæmmere.
The dose of ibrutinib should be reduced to 280 mg once daily when used concomitantly with moderate CYP3A4 inhibitors.
Patienterne (n = 578) blev randomiseret 1:1 til at få enten 420 mg IMBRUVICA dagligt + BR eller placebo + BR indtil sygdomsprogression eller uacceptabel toksicitet.
Patients (n=578) were randomised 1:1 to receive either IMBRUVICA 420 mg daily or placebo in combination with BR until disease progression, or unacceptable toxicity.
Tabel 5: Effektresultater i PCYC-1130-CA-studiet
Table 5: Efficacy results in Study PCYC-1130-CA
Dosis af ibrutinib skal reduceres til 140 mg en gang dagligt (én kapsel) eller indstilles i op til 7 dage ved brug samtidig med potente CYP3A4-hæmmere.
The dose of ibrutinib should be reduced to 140 mg once daily (one capsule) or withheld for up to 7 days when it is used concomitantly with strong CYP3A4 inhibitors.
Dosis af ibrutinib skal reduceres til 280 mg en gang dagligt (to kapsler) ved brug samtidig med moderate CYP3A4-hæmmere.
The dose of ibrutinib should be reduced to 280 mg once daily (two capsules) when used concomitantly with moderate CYP3A4 inhibitors.
Interstitiel lungesygdom*
Interstitial lung disease
Den højeste øvre grænse af det tosidede 90 % CI for den baseline-justerede gennemsnitsforskel mellem ibrutinib og placebo var under 10 ms. I det samme studie sås en koncentrationsafhængig forkortelse af QTc-intervallet (-5,3 ms [90 % CI: -9,4; -1,1] ved en Cmax på 719 nanogram/ml efter den supraterapeutiske dosis på 1.680 mg).
In this same study, a concentration dependent shortening in the QTc interval was observed (-5.3 ms [90% CI: -9.4, -1.1] at a Cmax of 719 ng/mL following the supratherapeutic dose of 1,680 mg).
Figur 4: Kaplan-Meier-kurve for PFS (ITT-population) PCYC-1115-CA-studiet med 48 måneders opfølgning
Figure 4: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1115-CA with 48 Months Follow-up
Medianalderen var 64 år (31 til 86 år), 66 % var mænd, og 91 % var kaukasiere.
The median age was 64 years (range, 31 to 86 years), 66% were male, and 91% were Caucasian.
Mediantiden efter diagnose var 74 måneder, og medianantallet af tidligere behandlinger var 2 (interval 1 til 11 behandlinger).
The median time since diagnosis was 74 months, and the median number of prior treatments was 2 (range: 1 to 11 treatments).
Dosis af ibrutinib skal reduceres til 140 mg en gang dagligt eller indstilles i op til 7 dage ved brug samtidig med potente CYP3A4-hæmmere.
The dose of ibrutinib should be reduced to 140 mg once daily or withheld for up to 7 days when it is used concomitantly with strong CYP3A4 inhibitors.
• urinvejsinfektioner
• infections of the urinary tract
Figur 7: Kaplan-Meier-kurve for PFS (ITT-population) PCYC-1112-CA-studiet ved den endelige analyse med 65 måneders opfølgning
Figure 7: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1112-CA at Final Analysis with 65 Months Follow-up
For patienter med moderat nedsat leverfunktion (Child-Pugh klasse B) er den anbefalede daglige dosis 140 mg dagligt.
For patients with moderate liver impairment (Child-Pugh class B), the recommended dose is 140 mg daily.
På tidspunktet for den endelige analyse var 133 (67,9 %) af de 196 forsøgspersoner, der oprindeligt blev randomiseret til ofatumumabbehandlingsgruppen, skiftet over til ibrutinib-behandling.
The investigator-assessed ORR in the IMBRUVICA arm was 87.7% versus 22.4% in the ofatumumab arm. At the time of final analysis, 133 (67.9%) of the 196 subjects originally randomized to the ofatumumab treatment arm had crossed over to ibrutinib treatment.
Derfor skal fertile kvinder anvende en meget sikker form for prævention, mens de tager IMBRUVICA, og i op til 3 måneder efter behandlingens afslutning.
Therefore, women of child-bearing potential must use highly effective contraceptive measures while taking IMBRUVICA and for three months after stopping treatment.
IMBRUVICA 140 mg filmovertrukne tabletter og IMBRUVICA 420 mg filmovertrukne tabletter Macrogol
IMBRUVICA 140 mg film-coated tablets and IMBRUVICA 420 mg film-coated tablets Macrogol
91 % af patienterne havde en ECOG-performancestatus ved baseline på 0 eller 1, og 9 % havde en ECOGperformancestatus på 2.
Ninety one percent of patients had a baseline ECOG performance status of 0 or 1 and 9% had an ECOG performance status of 2.
Efter indledning af behandlingen er der blevet observeret en reversibel stigning i lymfocyttallet (dvs. ≥ 50 % stigning fra baseline og et absolut tal på > 5 x 10
Upon initiation of treatment, a reversible increase in lymphocyte counts (i.e., ≥50% increase from baseline and an absolute count >5,000/mcL), often associated with reduction of lymphadenopathy, has been observed in about three fourths of patients with CLL treated with IMBRUVICA.
HR (95 % CI) Samlet responsrate a (%)
HR (95% CI) Overall Response Rate CR
Medianalderen var 67 år (interval: 30 til 88 år), 68 % var mænd og 90 % var kaukasiere.
The median age was 67 years (range: 30 to 88 years), 68% were male, and 90% were Caucasian.
For patienter med moderat nedsat leverfunktion (Child-Pugh klasse B) er den anbefalede daglige dosis 140 mg dagligt (én kapsel).
For patients with moderate liver impairment (Child-Pugh class B), the recommended dose is 140 mg daily (one capsule).
Tabel 4: Effektresultater i PCYC-1115-CA-studiet Endepunkt
Table 4: Efficacy results in Study PCYC-1115-CA Endpoint
For patienter med let nedsat leverfunktion (Child-Pugh klasse A) er den anbefalede daglige dosis 280 mg dagligt (to kapsler).
For patients with mild liver impairment (Child-Pugh class A), the recommended dose is 280 mg daily (two capsules).