natgillin/translations-raw huggingface dataset:
I et lægemiddelinteraktionsstudie hos tre raske forsøgspersoner resulterede samtidig administration af en enkelt dosis på 400 mg venetoclax sammen med 5 mg warfarin i en stigning i Cmax og AUC∞ for R-warfarin og S-warfarin på 18-28 %.
In a drug-drug interaction study in three healthy volunteers, administration of a single dose of 400 mg venetoclax with 5 mg warfarin resulted in an 18% to 28% increase in Cmax and AUC∞ of R-warfarin and S-warfarin.
Mediantiden efter diagnosen var 6,8 år (interval: 0,1-32 år; N = 106).
The median time since diagnosis was 6.8 years (range: 0.1 to 32 years; N=106).
Det mediane antal tidligere behandlinger var 1 (interval: 1-5); og inkluderede alkylerende stoffer (94%), anti-CD20 antistoffer (77%), B-celle receptor-hæmmere (2%) og tidligere behandling med purin-analoger (81%, inklusive 55% FCR).
Median prior lines of therapy was 1 (range: 1 to 5); and included alkylating agents (94%), anti-CD20 antibodies (77%), B-cell receptor pathway inhibitors (2%) and prior purine analogs (81%, including 55% FCR).
Indlægsseddel: Information til patienten Venclyxto 10 mg filmovertrukne tabletter Venclyxto 50 mg filmovertrukne tabletter Venclyxto 100 mg filmovertrukne tabletter venetoclax Dette lægemiddel er underlagt supplerende overvågning.
Package leaflet: Information for the patient Venclyxto 10 mg film-coated tablets Venclyxto 50 mg film-coated tablets Venclyxto 100 mg film-coated tablets venetoclax This medicine is subject to additional monitoring.
Hazard-ratio (95% KI) P-værdia
Hazard ratio (95% CI) P-valuea
- Kvinder, der kan få børn, skal bruge en sikker præventionsmetode under Venclyxto-behandlingen og i mindst 30 dage efter den sidste dosis for at undgå at blive gravide.
- Women of childbearing age must use a highly effective method of contraception during treatment and for at least 30 days after receiving Venclyxto to avoid becoming pregnant.
Patienterne skal informeres om, at de skal drikke meget vand hver dag i hele dosistitreringsfasen, og at de skal starte med dette 2 dage før behandlingsstart.
Patients should be instructed to drink plenty of water daily starting 2 days before and throughout the dose-titration phase.
Mediantiden efter diagnosen var 6,7 år (interval: 0,3-29,5).
Median time since diagnosis was 6.7 years (range: 0.3 to 29.5).
Ved behandlingsstart og i dosistitreringsfasen bør samtidig anvendelse af venetoclax og moderate CYP3Ahæmmere (f.eks.ciprofloxacin, diltiazem, erythromycin, fluconazol og verapamil) undgås.
At initiation and during the dose-titration phase, concomitant use of venetoclax with moderate CYP3A inhibitors (e.g., ciprofloxacin, diltiazem, erythromycin, fluconazole, verapamil) should be avoided.
Den toksiske virkning på såvel lymfocytter som røde blodlegemer var reversibel efter seponering af venetoclax, idet lymfocytterne var gendannet 18 uger efter behandlingen.
Both effects were reversible after cessation of dosing with venetoclax, with recovery of lymphocytes occurring 18 weeks post treatment.
Hvis en patient kaster op efter at have taget sin dosis, må han/hun ikke tage en ekstra dosis den dag.
If a patient vomits following dosing, no additional dose should be taken that day.
De hyppigst rapporterede alvorlige bivirkninger (≥ 2 %) hos patienter, som fik venetoclax i kombination med rituximab var pneumoni, febril neutropeni og tumorlysesyndrom.
The most frequently reported serious adverse reactions (≥2%) in patients receiving venetoclax in combination with rituximab were pneumonia, febrile neutropenia, and TLS.
Patienter med moderat nedsat leverfunktion skal monitoreres meget nøje for tegn på toksicitet ved behandlingsstart og i dosistitreringsfasen (se pkt.
Patients with moderate hepatic impairment should be monitored more closely for signs of toxicity at initiation and during the dose-titration phase (see section 4.8).
Venetoclax som monoterapi til behandling af patienter, der har kronisk lymfatisk leukæmi med 17p-deletion eller TP53-mutation - studie M13-982
Venetoclax as monotherapy for the treatment of patients with CLL harbouring 17p deletion or TP53 mutation - study M13-982
Hæmmere af P-gp eller BCRP kan også øge venetoclax-eksponeringen.
Also inhibitors of P-gp or BCRP may increase venetoclax exposure (see section 4.5).
I et dedikeret studie hos patienter med nedsat leverfunktion var venetoclax Cmax og AUC hos forsøgspersoner med let (Child-Pugh A; n = 6) eller moderat nedsat leverfunktion (Child-Pugh B; n = 6) den samme som hos forsøgspersoner med normal leverfunktion efter indtagelse af 50 mg enkeltdosis venetoclax.
In a dedicated hepatic impairment study, venetoclax Cmax and AUC in subjects with mild (Child-Pugh A; n=6) or moderate (Child-Pugh B; n=6) hepatic impairment were similar to subjects with normal hepatic function, after receiving a 50 mg single dose of venetoclax.
Hos patienter i Venclyxto-behandling, der er på en stabil daglig dosis, skal venetoclax-dosis reduceres med 50 % ved samtidig behandling med moderate CYP3A-hæmmere og med 75 % ved samtidig behandling med potente CYP3A-hæmmere.
For patients who are on a steady daily dose of Venclyxto, the venetoclax dose should be reduced by 50% when used concomitantly with moderate CYP3A inhibitors and by 75% when used concomitantly with strong CYP3A inhibitors.
Ved baseline havde 41 % af patienterne én eller flere lymfeknuder ≥ 5 cm, og 31 % havde ALC ≥ 25 x 109/l.
At baseline, 41% of patients had one or more nodes ≥5 cm and 31% had ALC ≥25 x 109/l.
Hvis du har glemt at tage Venclyxto
If you forget to take Venclyxto
Det mediane antal tidligere behandlinger for kronisk lymfatisk leukæmi var 2 (interval: 1-10 behandlinger), 49,5 % var tidligere blevet behandlet med en nukleosidanalog, 38 % med rituximab og 94 % med et alkylerende middel (hvoraf 33 % tidligere var blevet behandlet med bendamustin).
The median number of prior anti-CLL treatments was 2 (range: 1 to 10 treatments); 49.5% with a prior nucleoside analogue, 38% with prior rituximab, and 94% with a prior alkylator (including 33% with prior bendamustine).
Er du i tvivl, så spørg lægen, apotekspersonalet eller sundhedspersonalet, før du tager Venclyxto.
If you are not sure about this, talk to your doctor, pharmacist or nurse before taking Venclyxto.
• nedsat calcium
• lower level of calcium
systemorganklasse og hyppighed.
Adverse reactions are listed below by MedDRA body system organ class and by frequency.
Patienterne, som blev randomiseret til BR, fik bendamustin 70 mg/m2 på dag 1 og 2 i 6 cykler og rituximab,
Patients randomised to BR received bendamustine at 70 mg/m2 on Days 1 and 2
In vitro-studier har vist, at venetoclax hovedsagelig metaboliseres via CYP3A4.
In vitro studies demonstrated that venetoclax is predominantly metabolised by cytochrome P450 CYP3A4.
Samtidig anvendelse af venetoclax og potente CYP3A-induktorer (f.eks. carbamazepin, phenytoin og rifampicin) eller moderate CYP3Ainduktorer (f.eks. bosentan, efavirenz, etravirin, modafinil og nafcillin) bør undgås.
Concomitant use of venetoclax with strong CYP3A inducers (e.g., carbamazepine, phenytoin, rifampin) or moderate CYP3A inducers (e.g., bosentan, efavirenz, etravirine, modafinil, nafcillin) should be avoided.
I MURANO-studiet forekom doseringsafbrydelse på grund af bivirkninger hos 71% af patienterne behandlet med kombinationen af venetoclax og rituximab: den mest almindelige bivirkning, som førte til afbrydelse af venetoclax-dosis, var neutropeni (43%).
In the MURANO study, dose interruptions due to adverse reactions occurred in 71% of patients treated with the combination of venetoclax and rituximab; the most common adverse reaction that led to dose interruption of venetoclax was neutropenia (43%).
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske - Multipakning (med blue box)
PARTICULARS TO APPEAR ON THE OUTER CARTON CARTON Multipack (with blue box)
Samtidig administration af venetoclax og P-gp eller BCRP-substrater med snævert terapeutisk indeks (f.eks. digoxin, dabigatran, everolimus, sirolimus) børundgås.
Co-administration of narrow therapeutic index P-gp, or BCRP substrates (e.g., digoxin, dabigatran, everolimus, sirolimus) with venetoclax should be avoided.
Silica, kolloid vandfri (E551) Polysorbat 80 (E433)
Colloidal anhydrous silica (E551) Polysorbate 80 (E433)
P-gp- og BCRP-hæmmere
P-gp and BCRP inhibitors
• Tabletkernen: copovidon (K 28), polysorbat 80 (E433), silica, kolloid vandfri (E551),
• In the tablet core: copovidone (K 28), polysorbate 80 (E433), colloidal anhydrous silica (E551),
Disse patienter bør overvåges nøje for tegn på toksicitet (se pkt.
These patients should be monitored more closely for signs of toxicity (see section 4.8).
12-måneders PFS estimat (95% KI)
12-month PFS estimate (95% CI)
Tumorbyrden skal vurderes hos alle patienter inden påbegyndelse af venetoclax-behandling, herunder radiografisk undersøgelse (f.eks. CT-scanning).
Prior to initiating venetoclax, tumour burden assessment, including radiographic evaluation (e.g., CT scan), must be performed for all patients.
rifampicin - lægemider til forebyggelse af krampeanfald og behandling af epilepsi - carbamazepin, phenytoin - lægemidler til behandling af hiv-infektion - efavirenz, etravirin, ritonavir - lægemidler til behandling af forhøjet blodtryk eller hjertekrampe (angina pectoris) - diltiazem,verapamil - lægemidler, der bruges til at sænke indholdet af kolesterol i blodet - colestyramin, colestipol,
- medicines for fungal infections - fluconazole, itraconazole, ketoconazole, posaconazole, or voriconazole - antibiotics to treat bacterial infections - ciprofloxacin, clarithromycin, erythromycin, nafcillin, or rifampicin - medicines to prevent seizures or to treat epilepsy - carbamazepine, phenytoin - medicines for HIV infection - efavirenz, etravirine, ritonavir - medicines to treat raised blood pressure or angina - diltiazem, verapamil - medicines to lower cholesterol levels in the blood - cholestyramine, colestipol, colesevelam - a medicine used to treat a lung condition called pulmonary arterial hypertension - bosentan - a medicine to treat sleep disorder (narcolepsy) known as modafinil - a herbal medicine known as St. John's wort
Venetoclax som monoterapi til behandling af CLL-patienter, der har oplevet behandlingssvigt af en B-cellereceptor-hæmmer - studie M14-032
Venetoclax as monotherapy for the treatment of patients with CLL who have failed a B-cell receptor pathway inhibitor - study M14-032
Brug af anden medicin sammen med Venclyxto
Other medicines and Venclyxto
Samtidig brug af venetoclax og moderate CYP3A-hæmmere bør undgås ved behandlingsstart og i dosistitreringsfasen.
Concomitant use of venetoclax with moderate CYP3A inhibitors at initiation and during the dose-titration phase should be avoided.
Stoffer, der kan ændre plasmakoncentrationen af venetoclax
Agents that may alter venetoclax plasma concentrations
Almindelig Sepsis Urinvejsinfektion
Sepsis Urinary tract infection
Det kan være nødvendigt, at lægen ændrer din Venclyxto-dosis.
Your doctor may change your dose of Venclyxto.
calciumhydrogenfosfat, vandfrit (E341 (ii)), natriumstearylfumarat.
anydrous calcium hydrogen phosphate (E341 (ii)), sodium stearyl fumarate.
Alle tilfælde af tumorlysesyndrom blev identificeret ud fra laboratorieværdier (unormale værdier, der opfyldte ≥ 2 af følgende kriterier inden for et indbyrdes interval på 24 timer: kalium > 6 mmol/l, urinsyre > 476 µmol/l, calcium < 1,75 mmol/l eller phosphat > 1,5 mmol/l, eller som blev rapporteret som tilfælde af tumorlysesyndrom) og sås hos patienter, der havde en eller flere lymfeknuder ≥ 5 cm eller ALC ≥ 25 x 109/l.
potassium >6 mmol/l, uric acid >476 µmol/l, calcium <1.75 mmol/l, or phosphorus >1.5 mmol/l; or were reported as TLS events) and occurred in patients who had a lymph node(s) ≥5 cm or ALC ≥25 x 109/l.
Samtidig administration af en enkeltdosis på 600 mg rifampicin, en P-gp-hæmmer, hos 11 raske forsøgspersoner øgede venetoclax-Cmax 106 % og -AUC∞ 78 %.
Co-administration of a 600 mg single dose of rifampin, a P-gp inhibitor, in 11 healthy subjects increased venetoclax Cmax by 106% and AUC∞ by 78%.
Kvinder skal undgå at blive gravide, mens de tager Venclyxto og i mindst 30 dage efter behandlingens afslutning.
Women of childbearing potential/Contraception in females Women should avoid becoming pregnant while taking Venclyxto and for at least 30 days after ending treatment.
Medianalderen var 66 år (interval: 28-85 år), 70 % var mænd, og 92 % var hvide.
The median age was 66 years (range: 28 to 85 years), 70% were male, and 92% were white.
Hos patienter med alvorlig nedsat leverfunktion anbefales en dosisreduktion på mindst 50 % (se pkt.
A dose reduction of at least 50% throughout treatment is recommended for patients with severe hepatic impairment (see section 5.2).
Sådan skal du tage Venclyxto 4.
How to take Venclyxto 4.
Tumorlysesyndrom er en væsentlig risiko i forbindelse med behandlingsstart af venetoclax.
Tumour lysis syndrome is an important identified risk when initiating venetoclax.
Calciumhydrogenphosphat, vandfrit (E341 (ii))
Anhydrous calcium hydrogen phosphate (E341 (ii))
Venclyxto bør ikke anvendes til børn og unge, da lægemidlet ikke er undersøgt hos disse aldersgrupper.
Venclyxto should not be used in children and adolescents.
I monoterapi-studierne med venetoclax, forekom doseringsafbrydelse på grund af bivirkninger i 40% af patienterne; neutropeni (5%) var den mest almindelige bivirkning, som førte til doseringsafbrydelse.
In the monotherapy studies with venetoclax, dose interruptions due to adverse reactions occurred in 40% of patients; the most common adverse reaction leading to dose interruption was neutropenia (5%).
d76,9% (30/39) i venetoclax + rituximab-armen og 6,7% (2/30) i bendamustin + rituximab-armen af dem med tilgængelige MRD-testresultater i knoglemarv, viste sig at være MRD-negative.
dOf those with MRD assay results available in bone marrow, 76.9% (30/39) in the venetoclax + rituximab arm and 6.7% (2/30) in the bendamustine + rituximab arm were found to be MRD negative.
Mere intensiv profylakse og monitorering ved behandlingsstart og i dosistitreringsfasen kan være nødvendig hos patienter med nedsat nyrefunktion (CrCl < 80 ml/min) for at mindske risikoen for tumorlysesyndrom (se afsnittet "Forebyggelse af tumorlysesyndrom" ovenfor).
Patients with reduced renal function (CrCl <80 ml/min) may require more intensive prophylaxis and monitoring to reduce the risk of TLS at initiation and during the dose-titration phase (see “Prevention of tumour lysis syndrome” above).
Grapefrugt/grapefrugtjuice, pomerans og stjernefrugt (carambole) skal undgås under behandling med venetoclax (se pkt.
Grapefruit products, Seville oranges, and starfruit (carambola) should be avoided during treatment with venetoclax (see section 4.5).
c72,5% (121/167) i venetoclax + rituximab-armen og 20% (26/128) i bendamustin + rituximab-armen af dem med tilgængelige MRD-testresultater i det perifere blod, viste sig at være MRD-negative.
cOf those with MRD assay results available in peripheral blood, 72.5% (121/167) in the venetoclax + rituximab arm and 20% (26/128) in the bendamustine + rituximab arm were found to be MRD negative.
Der skal udvises forsigtighed, hvis samtidig behandling med et P-gp- eller BCRP-substrat med snævert terapeutisk indeks er nødvendig.
If a narrow therapeutic index P-gp or BCRP substrate must be used, it should be used with caution.
Hvis en patient har glemt at tage en dosis, og der er gået over 8 timer, må han/hun ikke tage den manglende dosis, men skal vente til næste dags dosis.
If a patient misses a dose by more than 8 hours, the patient should not take the missed dose and should resume the usual dosing schedule the following day.
ORR, % (95 % KI)
ORR, % (95% CI)
Den venetoclax-dosis, som patienten fik inden initiering af CYP3Ahæmmeren, skal genoptages 2-3 dage efter seponering af CYP3A-hæmmeren (se pkt.
The venetoclax dose that was used prior to initiating the CYP3A inhibitor should be resumed 2 to 3 days after discontinuation of the inhibitor (see section 4.2).
Spørg lægen til råds, før du begynder at tage Venclyxto.
Ask your doctor for advice on sperm storage before starting treatment with Venclyxto.
Medianalderen var 65 år (interval: 22-85); 74% var mænd og 97% var hvide.
Median age was 65 years (range: 22 to 85); 74% were male, and 97% were white.
Venetoclax hæmmer P-gp, BCRP og OATP1B1 in vitro.
Venetoclax is a P-gp, BCRP and OATP1B1 inhibitor in vitro.
Hvis en patient har glemt at tage en dosis venetoclax, og der er gået mindre end 8 timer, siden dosis skulle have været taget, skal han/hun tage den manglende dosis med det samme (samme dag).
If a patient misses a dose of venetoclax within 8 hours of the time it is usually taken, the patient should take the missed dose as soon as possible on the same day.
Medianalderen var 67 år (interval: 37-85 år), 65 % var mænd, og 97 % var hvide.
The median age was 67 years (range: 37 to 85 years); 65% were male, and 97% were white.
Seponering og dosisreduktion på grund af bivirkninger I MURANO-studiet forekom seponering på grund af bivirkninger hos 16% af patienterne behandlet med kombinationen af venetoclax og rituximab.
Discontinuation and dose reductions due to adverse reactions Discontinuations due to adverse reactions occurred in 16% of patients treated with the combination of venetoclax and rituximab in the MURANO study.
KI = konfidensinterval; CR = komplet remission; CRi = komplet remission med ufuldstændig knoglemarvsregeneration; DOR = responsvarighed; nPR = nodulær PR; NR = Ikke opnået; ORR= den samlede responsrate, OS= samlet overlevelse; PFS= progressionsfri overlevelse , PR = partiel remission; TTR= tid til første respons.
CI = confidence interval; CR = complete remission; CRi = complete remission with incomplete marrow recovery, DOR = duration of response; IRC = independent review committee; nPR = nodular PR; NA = not available; NR = not reached; ORR = overall response rate; PFS = progression-free survival, PR = partial remission; TTR = time to first response.
Tabel 6: Effektresultater hos patienter med 17p-deletion, der tidligere er behandlet for kronisk lymfatisk leukæmi (studie M13-982)
Table 6: Efficacy results in patients with previously treated CLL with 17p deletion (study M13-982) Endpoint
Daglig dosis af venetoclax
Venetoclax daily dose
Patienterne skal risikovurderes og have relevant profylakse mod tumorlysesyndrom,
Patients should be assessed for risk and should receive appropriate prophylaxis for TLS, including hydration and anti-hyperuricaemics.
• startdosis er 20 mg (to 10 mg-tabletter) én gang dagligt i 7 dage.
• the starting dose is 20 mg (two 10 mg tablets) once a day for 7 days.
I MURANO-studiet blev dosis reduceret på grund af bivirkninger hos 15 % af patienterne, som blev behandlet med kombinationen af venetoclax og rituximab og hos 14 % af patienterne behandlet med venetoclax i monoterapi-studierne.
Dosage reductions due to adverse reactions occurred in 15% of patients treated with the combination of venetoclax and rituximab in the MURANO study and 14% of patients treated with venetoclax in the monotherapy studies.
Hyperfosfatæmi Hyperkaliæmi Hypokalcæmi
Hyperkalaemia Hyperphosphataemia Hypocalcaemia
• 5 tabletter (5 blisterkort hver med 1 tablet)
• 5 tablets (5 blisters each with 1 tablet)
Steady state-AUC for venetoclax steg proportionalt med dosis i intervallet 150-800 mg. Ved indtagelse af 400 mg venetoclax én gang dagligt sammen med et fedtfattigt måltid var den gennemsnitlige steady stateCmax (± standardafvigelse) 2,1 ± 1,1 μg/ml, og AUC24 var 32,8 ± 16,9 μg•time/ml.
Under low-fat meal conditions, venetoclax mean (± standard deviation) steady state Cmax was 2.1 ± 1.1 μg/ml and AUC24 was 32.8 ± 16.9 μg•h/ml at the 400 mg once daily dose.
Tumorlysesyndrom Hyperkaliæmi Hyperfosfatæmi Hypokalcæmi
Tumour lysis syndrome Hyperkalaemia Hyperphosphataemia Hypocalcaemia
Hvad bruges Venclyxto til?
What Venclyxto is used for
АбВи ЕООД Тел: +359 2 90 30 430
Тел:+359 2 90 30 430
Samtidig administration af rifampicin, en potent CYP3A-induktor, 600 mg én gang dagligt i 13 dage hos 10 raske forsøgspersoner nedsatte venetoclax-Cmax 42 % og -AUC∞ 71 %.
Co-administration of 600 mg once daily rifampin, a strong CYP3A inducer, for 13 days in 10 healthy subjects decreased venetoclax Cmax by 42% and AUC∞ by 71%.
Responsrate ORR, % (95% KI)
Response rate ORR, % (95% CI)
Median, måneder (95% KI)
Median, months (95% CI)
5.3) kan venetoclax skade fosteret, hvis det gives til gravide kvinder.
Based on embryo-foetal toxicity studies in animals (see section 5.3), venetoclax may harm the foetus when administered to pregnant women.
som beskrevet ovenfor.
for 6 cycles and rituximab as described above.
• forhøjet urinstof
• higher level of urea
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske (7-dages pakning)
PARTICULARS TO APPEAR ON THE OUTER CARTON CARTON (7 day pack)
Tabel 7: Effektresultater i henhold til investigators vurdering hos patienter, der havde oplevet behandlingssvigt af en B-celle-receptor-hæmmer (studie M14-032) Gruppe A (behandlingssvigt ved ibrutinib) (N = 91)
Table 7: Efficacy results as assessed by investigator in patients who have failed a B-cell receptor pathway inhibitor (study M14-032)
Patienterne skal monitoreres meget nøje for symptomer på tumorlysesyndrom.
Patients should be monitored more closely for signs and symptoms of TLS.
Samtidig brug af dette lægemiddel og potente eller moderate CYP3A-hæmmere øger venetoclaxeksponeringen og kan øge risikoen for tumorlysesyndrom ved behandlingsstart og i dosistitreringsfasen (se pkt.
Concomitant use of this medicinal product with strong or moderate CYP3A inhibitors increases venetoclax exposure and may increase the risk for TLS at initiation and during the dose-titration phase (see sections 4.2 and 4.3).
Det indeholder det aktive stof venetoclax og tilhører en gruppe lægemidler, der kaldes "BCL-2-hæmmere".
It belongs to a group of medicines called “BCL-2 inhibitors”.
Venclyxto er et lægemiddel til behandling af kræft.
Venclyxto is a cancer medicine that contains the active substance venetoclax.
Samtidig administration af 50 mg ritonavir, en stærk CYP3A- og P-gp-hæmmer, en gang dagligt i 14 dage hos 6 raske forsøgspersoner forhøjede venetoclax Cmax med 2,4-gange og AUC med 7,9-gange.
Coadministration of 50 mg once daily ritonavir, a strong CYP3A and P-gp inhibitor, for 14 days in 6 healthy subjects increased venetoclax Cmax by 2.4-fold and AUC by 7.9-fold.
Diarré Opkastning Kvalme Obstipation
Diarrhoea Vomiting Nausea Constipation
11 % af patienterne i monoterapi-studierne med venetoclax seponerede på grund af bivirkninger.
In the monotherapy studies with venetoclax, 11% of patients discontinued due to adverse reactions.
• 7 tabletter (7 blisterkort hver med 1 tablet)
• 7 tablets (7 blisters each with 1 tablet)
Samtidig administration af ketoconazol, en potent CYP3A-, P-gp- og BCRP-hæmmer, 400 mg én gang dagligt i 7 dage hos 11 tidligere behandlede patienter med NHL øgede venetoclax-Cmax 2,3 gange og -AUC∞ 6,4 gange.
Co-administration of 400 mg once daily ketoconazole, a strong CYP3A, P-gp and BCRP inhibitor, for 7 days in 11 previously treated patients with NHL increased venetoclax Cmax by 2.3-fold and AUC∞ by 6.4-fold.
• urinvejsinfektion/blærebetændelse
• urinary tract infection
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske (5-dages pakning)
PARTICULARS TO APPEAR ON THE OUTER CARTON CARTON (5 day pack)
Venetoclax-dosis i monoterapi efter titrering
Post-titration dose for venetoclax monotherapy
Median TTR, måneder
TTR, months, median (range)
Venclyxto 10 mg-tabletter De filmovertrukne tabletter leveres i æsker med 10 eller 14 tabletter (i blistre med 2 tabletter).
The film-coated tablets are supplied in cartons containing either 10 or 14 tablets (in blisters of 2 tablets).
Status for 17p-deletion og/eller TP53-mutation
17p deletion and/or TP53 mutation status ORR, % (95% CI)
OS % (95% KI)
OS, % (95% CI)