natgillin/translations-raw huggingface dataset:
Venetoclax hæmmer ikke UGT1A4, UGT1A6, UGT1A9 og UGT2B7.
Venetoclax is not an inhibitor of UGT1A4, UGT1A6, UGT1A9 and UGT2B7.
• 112 (4 x 28) tabletter (4 æsker med 7 blisterkort hver med 4 tabletter).
• 112 (4 x 28) tablets (4 cartons of 7 blisters each with 4 tablets).
Hyppigheden af bivirkninger ved Venclyxto er vist i tabel 3.
The frequencies of adverse reactions reported with Venclyxto are summarised in Table 3.
• uden tilstedeværelse af 17p-deletion eller TP53-mutation hos voksne patienter, hvor både kemoimmunbehandling og en B-celle-receptor-hæmmer har fejlet.
• in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.
Venetoclax er en svag hæmmer af CYP2C8, CYP2C9 og UGT1A1 in vitro, men forventes ikke at forårsage klinisk relevant hæmning.
Venetoclax is a weak inhibitor of CYP2C8, CYP2C9 and UGT1A1 in vitro, but it is not predicted to cause clinically relevant inhibition.
Doseringsplanen med dosistitrering over 5 uger er udformet for at reducere tumorbyrden gradvist og mindske risikoen for tumorlysesyndrom.
The 5-week dose-titration schedule is designed to gradually reduce tumour burden (debulk) and decrease the risk of tumour lysis syndrome.
I de indledende fase 1-studier til dosisbestemmelse, der havde en kortere (2-3 ugers) titreringsfase og en højere startdosis, var incidensen af tumorlysesyndrom 13 % (10/77; 5 tilfælde af tumorlysesyndrom i henhold til laboratorieværdier, 5 tilfælde af klinisk tumorlysesyndrom), herunder 2 tilfælde med dødelig udgang og 3 tilfælde med akut nyresvigt, hvoraf 1 var dialysekrævende.
In the initial Phase 1 dose-finding studies, which had a shorter (2 to 3 week) titration phase and higher starting dose, the incidence of TLS was 13% (10/77; 5 laboratory TLS; 5 clinical TLS), including 2 fatal events and 3 events of acute renal failure, 1 requiring dialysis.
Ud fra dyreforsøg vurderes det, at Venclyxto kan forårsage ufrugtbarhed hos manden (lavt antal eller fravær af sædceller).
Based on findings in animals, Venclyxto may cause male infertility (low or no sperm count).
Hvis det er nødvendigt at anvende en moderat CYP3A-hæmmer, skal start- og titreringsdoserne af venetoclax reduceres med mindst 50 %.
If a moderate CYP3A inhibitor must be used, the initiation and titration doses of venetoclax should be reduced by at least 50%.
Neutropeni af grad 3 og 4 er rapporteret hos patienter, der har fået venetoclax i kombinationsstudiet med rituximab (GO28667/MURANO) og i monoterapi-studierne (se pkt.
Grade 3 or 4 neutropenia has been reported in patients treated with venetoclax in the combination study with rituximab (GO28667/MURANO) and in the monotherapy studies (see section 4.8).
I studier af den embryo-føtale udvikling hos mus var venetoclax forbundet med øget postimplantationstab og nedsat fostervægt ved eksponeringer svarende til 1,1 gange eksponeringen (AUC) hos mennesker ved den anbefalede dosis.
In embryo-foetal development studies in mice, venetoclax was associated with increased post-implantation loss and decreased foetal body weight at exposures of 1.1 times the human AUC exposure at the recommended dose.
CR = komplet remission; CRi = komplet remission med ufuldstændig knoglemarvsregeneration; IRC = uafhængig review-kommité; MRD = minimal residual sygdom; nPR = nodulær partiel remission; NA = ikke tilgængelig; NR = ikke opnået; ORR = den samlede responsrate (CR + CRi + nPR + PR); PR = partiel remission.
CR = complete remission; CRi = complete remission with incomplete marrow recovery; IRC = independent review committee; MRD = minimal residual disease; nPR = nodular partial remission; NA = not available; NR = not reached; ORR = overall response rate (CR + CRi + nPR + PR); PR = partial remission.
Følg den normale doseringsplan næste dag.
Return to your normal dose schedule the next day.
• hvis du har nyreproblemer, da din risiko for at få en bivirkning, der kaldes tumorlysesyndrom, i så fald kan øges
• you have any kidney problems as your risk for a side effect called tumour lysis syndrome may increase
Baseret på en farmakokinetisk populationsanalyse har syrehæmmende midler (f.eks. protonpumpehæmmere, H2-receptor-antagonister og antacida) ingen indvirkning på venetoclax' biotilgængelighed.
Based on population pharmacokinetic analysis, gastric acid reducing agents (e.g., proton pump inhibitors, H2-receptor antagonists, antacids) do not affect venetoclax bioavailability.
37 % (34/91) af patienterne var fludarabinrefraktære, 81 % (30/37) havde umuteret IgVH-gen, og 72 % (60/83) havde TP53-mutation.
Of the patients, 37% (34/91) were fludarabine refractory, 81% (30/37) harboured the unmutated IgVH gene, and 72% (60/83) had TP53 mutation.
ORR for patienter med 17p-deletion og/eller TP53-mutation var 72 % (33/46) (95 %) KI: 56,5; 84,0) i gruppe A og 67 % (8/12) (95 % KI: 34,9; 90,1) i gruppe B. For patienter uden 17p-deletion og/eller TP53mutation var ORR 69 % (31/45) (95 % KI: 53,4; 81,8) i gruppe A og 71 % (17/24) (95 % KI: 48,9; 87,4) i gruppe B.
The ORR for patients with 17p deletion and/or TP53 mutation was 72% (33/46) (95% CI: 56.5, 84.0) in Arm A and 67% (8/12) (95% CI: 34.9, 90.1) in Arm B. For patients without 17p deletion and/or TP53 mutation, the ORR was 69% (31/45) (95% CI: 53.4, 81.8) in Arm A and 71% (17/24) (95% CI: 48.9, 87.4) in Arm B.
25 % (32/127) af patienterne var MRD-negative i det perifere blod, inklusive 8 patienter, som også var MDR-negativ i knoglemarven.
Twenty-five percent (32/127) of patients were MRD negative in the peripheral blood, including 8 patients who were also MRD negative in bone marrow.
Dyrestudier med venetoclax har vist toksiske virkninger, herunder dosisafhængige reduktioner i lymfocytter og røde blodlegemer.
Toxicities observed in animal studies with venetoclax included dose -dependent reductions in lymphocytes and red blood cell mass.
Doseringsafbrydelse eller dosisreduktion anbefales hos patienter med svær neutropeni (se pkt.
Dose interruptions or reductions are recommended for patients with severe neutropenia (see section 4.2).
Perifert blod, % (95% KI)c
Peripheral blood, % (95% CI)c
• forhøjet indhold af saltet (elektrolytten) fosfat i blodet
• higher level of a body salt (electrolyte) called phosphate
Hvis du har taget for meget Venclyxto, skal du sige det til lægen, apotekspersonalet eller sundhedspersonalet eller tage på hospitalet med det samme.
If you take more Venclyxto than you should, talk to your doctor, pharmacist, or nurse or go to hospital immediately.
Stoffer, hvis plasmakoncentration kan ændres af venetoclax
Agents that may have their plasma concentrations altered by venetoclax
Kromosomafvigelser var 11q-deletion (34 %, 43/127), 17p-deletion (40 %, 50/126), TP53-mutation (38 %, 26/68) og umuteret IgVH (78 %, 72/92).
Chromosomal aberrations were 11q deletion (34%, 43/127), 17p deletion (40%, 50/126), TP53 mutation (38%, 26/68) and unmutated IgVH (78%, 72/92).
Det skal du vide, før du begynder at tage Venclyxto Tag ikke Venclyxto:
What you need to know before you take Venclyxto Do not take Venclyxto if:
I et lægemiddel-interaktionsstudie, resulterede administration af en enkelt 100 mg dosis venetoclax sammen med 0,5 mg digoxin, et P-gp substrat, i en 35% stigning i digoxin Cmax og en 9% stigning i digoxin AUC∞.
In a drug-drug interaction study, administration of a single 100 mg dose of venetoclax with 0.5 mg digoxin, a P-gp substrate, resulted in a 35% increase in digoxin Cmax and a 9% increase in digoxin AUC∞.
Af 296 patienter, som blev evalueret for sikkerhed i 3 åbne monoterapi-studier, var 57 % ≥ 65 år.
Of the 296 patients evaluated for safety from 3 open-label monotherapy trials, 57% were 65 years or older.
Hos 168 patienter med CLL i studierne M13-982 og M14-032, der begyndte med en daglig dosis på 20 mg og steg til en daglig dosis på 400 mg i løbet af 5 uger, var frekvensen af tumorlysesyndrom 2 %.
In 168 patients with CLL starting with a daily dose of 20 mg and increasing over 5 weeks to a daily dose of 400 mg in studies M13-982 and M14-032, the rate of TLS was 2%.
Neutropeni er en risiko ved Venclyxto-behandling.
Neutropenia is an identified risk with Venclyxto treatment.
Den mediane behandlingstid på evalueringstidspunktet var 12 måneder (interval: 0-22 måneder).
The median time on treatment at the time of evaluation was 12 months (range: 0 to 22 months).
Ved en opdateret effektanalyse af alle patienter uden behandling (skæringsdato for data 8. maj 2018 og median opfølgning på 36 måneder) var 36-måneders PFS-estimat i venetoclax + rituximab-armen 71,4% [95% KI: 64,8; 78,1] og i bendamustin + rituximab-armen 15,2% [95% KI: 9,1; 21].
At an updated efficacy analysis with all patients off treatment (data cut-off date 8 May 2018 and median follow-up of 36 months) the 36-month PFS estimate in the venetoclax + rituximab arm was 71.4% [95% CI: 64.8, 78.1] and in the bendamustine + rituximab arm was 15.2% [95% CI: 9.1, 21].
Let nedsat leverfunktion blev defineret som normal total-bilirubin og aspartataminotransferase (ASAT) > den øvre normalgrænse eller total-bilirubin > 1,0-1,5 gange den øvre normalgrænse; moderat nedsat leverfunktion blev defineret som total-bilirubin > 1,5-3,0 gange den øvre normalgrænse, og svært nedsat leverfunktion blev defineret som total-bilirubin > 3,0 den øvre normalgrænse.
Mild hepatic impairment was defined as normal total bilirubin and aspartate transaminase (AST) > upper limit of normal (ULN) or total bilirubin >1.0 to 1.5 times ULN, moderate hepatic impairment as total bilirubin >1.5 to 3.0 times ULN, and severe hepatic impairment as total bilirubin >3.0 ULN.
Samtidig administration af galdesyre-kompleksdannere og venetoclax anbefales ikke, da absorptionen af venetoclax kan reduceres.
Co-administration of bile acid sequestrants with venetoclax is not recommended as this may reduce the absorption of venetoclax.
(≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000),
Den mediane opfølgningstid til primær analyse var 23,8 måneder (interval: 0,0-37,4 måneder).
Median follow-up time for primary analysis was 23.8 months (range: 0.0 to 37.4 months).
Lægen kan vurdere, at nogle patienter, navnlig patienter med større risiko for tumorlysesyndrom, skal være indlagt den dag, de får den første dosis venetoclax med henblik på mere intensiv profylakse og monitorering de første 24 timer (se pkt.
Based on physician assessment, some patients, especially those at greater risk of TLS, may require hospitalisation on the day of the first dose of venetoclax for more intensive prophylaxis and monitoring during the first 24 hours (see section 4.8).
Tabel 3: Bivirkninger rapporteret hos patienter med CLL, der har fået venetoclax-behandling
Table 3: Adverse drug reactions reported in patients with CLL treated with venetoclax
Almindelig Forhøjet kreatinin i blodet Ikke almindelig
Common Blood creatinine increased
Hvis du er i risiko for at få tumorlysesyndrom, kan du blive behandlet på hospitalet, så du om nødvendigt kan få væske i en blodåre (væskedrop), få taget blodprøver oftere og blive overvåget for bivirkninger.
If you are at risk of TLS you may be treated in hospital so that you can be given fluids into the vein if needed, have blood tests done more often and to check for side effects.
Venetoclax var ikke genotoksisk i en bakteriel mutagenicitetstest, i en in vitro kromosomafvigelsestest eller i en in vivo mikronukleustest hos mus.
Venetoclax was not genotoxic in bacterial mutagenicity assay, in vitro chromosome aberration assay and in vivo mouse micronucleus assay.
Det skal du vide, før du begynder at tage Venclyxto 3.
What you need to know before you take Venclyxto 3.
Samtidig administration af transporter-substrater/hæmmere Venetoclax er et P-gp- og BCRP-substrat, en P-gp- og BCRP-hæmmer og en svag OATP1B1-hæmmer in vitro (se pkt.
Co administration with transporter substrates/inhibitors Venetoclax is a P-gp and BCRP substrate as well as a P-gp and BCRP inhibitor and a weak OATP1B1 inhibitor in vitro (see section 4.5).
Mediantiden efter diagnosen var 8,3 år (interval: 0,3-18,5 år; N = 96).
The median time since diagnosis was 8.3 years (range: 0.3 to 18.5 years; N=96).
Venetoclax virkning og sikkerhed hos CLL-patienter, der tidligere havde oplevet behandlingssvigt af ibrutinib eller idelalisib, blev vurderet i et åbent, ikke-randomiseret fase 2-multicenterstudie (M14-032).
The efficacy and safety of venetoclax in patients with CLL who had been previously treated with and failed ibrutinib or idelalisib therapy were evaluated in an open-label, multi-center, non-randomised, phase 2 study
Af 107 patienter, som blev evalueret for effekt i M13-982-studiet, var 57 % ≥ 65 år.
Of the 107 patients who were evaluated for efficacy from M13-982 study, 57% were 65 years or older.
Hos forsøgspersoner med alvorligt nedsat leverfunktion (Child-Pugh C, n = 5) var den gennemsnitlige venetoclax-Cmax den samme som for patienter med normal leverfunktion, men venetoclax AUCinf var i gennemsnit 2,7 gange højere (interval: ingen ændring til 5 gange højere) end venetoclax AUCinf hos forsøgspersoner med normal leverfunktion (se pkt.
In subjects with severe (Child-Pugh C; n=5) hepatic impairment, the mean venetoclax Cmax was similar to subjects with normal hepatic function but venetoclax AUCinf was on average 2.7-fold higher (range: no change to 5-fold higher) than venetoclax AUCinf in the subjects with normal hepatic function (see section 4.2).
Pædiatrisk population Venetoclax sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
The safety and efficacy of venetoclax in children aged less than 18 years have not been established.
Grapefrugt/grapefrugtjuice, pomerans og stjernefrugt (carambole) skal undgås under behandling med venetoclax, da de indeholder CYP3A-hæmmere.
Grapefruit products, Seville oranges, and starfruit (carambola) should be avoided during treatment with venetoclax as they contain inhibitors of CYP3A.
I de kliniske studier med venetoclax blev patienter med en eller flere lymfeknuder ≥ 10 cm og patienter med ALC ≥ 25 x 109/l plus en eller flere lymfeknuder ≥ 5 cm indlagt for at muliggøre mere intensiv hydrering og monitorering i de første 24 timer efter dosering af 20 mg og 50 mg i dosistitreringsfasen (se pkt.
In venetoclax clinical studies, patients with any measurable lymph node ≥10 cm or those with both an ALC ≥25 x 109/l and any measurable lymph node ≥5 cm were hospitalised to enable more intensive hydration and monitoring for the first day of dosing at 20 mg and 50 mg during the titration phase (see section 4.2).
Pakningsstørrelser og yderligere oplysninger Venclyxto indeholder:
Contents of the pack and other information What Venclyxto contains
• forhøjet kreatinin
• higher level of creatinine
Af 127 patienter, som blev evalueret for effekt i M14-032-studiet, var 58 % ≥ 65 år.
Of the 127 patients who were evaluated for efficacy from M14-032 study, 58% were 65 years or older.
Din læge vil muligvis reducere din Venclyxto-dosis
Your doctor may need to reduce your dose of Venclyxto
Der er risiko for tumorlysesyndrom i de første 5 uger af Venclyxto-behandlingen.
The risk for TLS is in the first 5 weeks of treatment with Venclyxto.
• med tilstedeværelse af 17p-deletion eller TP53-mutation hos voksne patienter, som ikke er egnede til behandling med en B-celle-receptor-hæmmer, eller hvor behandling med en B-celle-receptorhæmmer har fejlet, eller
• in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, or
27 % (42/158) af patienterne var MRD-negative i det perifere blod, og heraf var 16 patienter også MRD-negative i knoglemarven.
Twenty-seven percent (42/158) of patients were MRD negative in the peripheral blood, including 16 patients who were also MRD negative in the bone marrow.
Patienter med stor tumorbyrde (f.eks. lymfeknuder med en diameter ≥ 5 cm eller et højt ALC ≥ 25 x 109/l) har større risiko for tumorlysesyndrom, når venetoclax-behandling indledes.
Patients with high tumour burden (e.g., any lymph node with a diameter ≥5 cm or high ALC ≥25 x 109/l) are at greater risk of TLS when initiating venetoclax.
Præparater, der indeholder perikon, er kontraindicerede under venetoclax-behandling, da dennes virkning ellers kan mindskes (se pkt.
Preparations containing St. John's wort are contraindicated during treatment with venetoclax, as efficacy may be reduced (see section 4.3).
Kvinder i den fertile alder skal bruge en meget sikker præventionsmetode, mens de tager venetoclax (se pkt.
Women of childbearing potential must use a highly effective method of contraception while taking venetoclax (see section 4.6).
Samtidig brug af venetoclax og potente CYP3A-hæmmere (f.eks. itraconazol, ketoconazol, posaconazol, voriconazol, clarithromycin, ritonavir) ved behandlingsstart og i dosistitreringsfasen er kontraindiceret på grund af øget risiko for tumorlysesyndrom (se pkt.
Concomitant use of venetoclax with strong CYP3A inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, ritonavir) at initiation and during the dose-titration phase is contraindicated due to increased risk for TLS (see section 4.3).
Samtidig anvendelse af venetoclax og potente eller moderate CYP3A4induktorer skal undgås (se pkt.
Concomitant use of venetoclax with strong or moderate CYP3A4 inducers should be avoided (see sections 4.3 and 4.5).
I et lægemiddel-interaktionsstudie hos 12 raske forsøgspersoner, nedsatte samtidig administration af 500 mg azithromycin på første dag efterfulgt af 250 mg azithromycin en gang daglig i 4 dage venetoclax Cmax med 25% og AUC∞ med 35%.
In a drug-drug interaction study in 12 healthy subjects, co-administration of 500 mg of azithromycin on the first day followed by 250 mg of azithromycin once daily for 4 days decreased venetoclax Cmax by 25% and AUC∞ by 35%.
Ved baseline havde 53 % af patienterne én eller flere lymfeknuder ≥ 5 cm, og 51 % havde ALC ≥ 25 x 109/l.
At baseline, 53% of patients had one or more nodes ≥5 cm, and 51% had ALC ≥25 x 109/l.
MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Æske - multipakning (uden blue box)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING CARTON multipack (without blue box)
De 1,5 til 2 liter må også gerne omfatte andre ikke-alkoholiske drikke og drikke uden koffein, men ikke juice med grapefrugt, pomerans og stjernefrugt (carambole).
You may also include non-alcoholic and non-caffeinated drinks in this amount, but exclude grapefruit, Seville orange, or starfruit (carambola) juices.
Patienterne skal specifikt informeres om, at de skal drikke 1,5 til 2 l vand hver dag allerede fra 2 dage før behandlingsstart og ved hver efterfølgende dosisøgning.
Patients should be particularly instructed to drink 1.5 to 2.0 L of water daily, 2 days prior to and the days of dosing at initiation and each subsequent dose increase.
Hvis toksiciteten vender tilbage én eller flere gange, skal anvisningerne om dosisreduktion i tabel 2 følges, når venetoclax-behandlingen genoptages, efter toksiciteten har fortaget sig.
If the toxicity recurs, and for any subsequent occurrences, the dose reduction guidelines in Table 2 should be followed when resuming treatment with venetoclax following resolution.
KI = konfidensinterval; NR = Ikke opnået aStratificeret P-værdi.
24-month PFS estimate (95% CI) CI = confidence interval; NR = not reached aStratified P-value.
65 % af patienterne havde tidligere fået behandling med en nukleosidanalog, 86 % med rituximab, 39 % med andre monoklonale antistoffer og 72 % med alkylerende stoffer (hvoraf 41 % havde fået bendamustin).
Overall, 65% of patients received prior nucleoside analogue, 86% rituximab, 39% other monoclonal antibodies, and 72% alkylating agent (including 41% with bendamustine).
De hyppigste bivirkninger (≥ 20 %) af alle grader hos venetoclax-behandlede patienter i kombinationsstudiet med rituximab var neutropeni, diarré og øvre luftvejsinfektioner.
The most commonly occurring adverse reactions (≥20%) of any grade in patients receiving venetoclax in the combination study with rituximab were neutropenia, diarrhoea, and upper respiratory tract infection.
For patienter i venetoclax-behandling, der har gennemført dosistitreringsfasen og er på en stabil daglig dosis, skal venetoclax-dosen reduceres med 50 % ved samtidig brug af moderate CYP3A-hæmmere og med 75 % ved samtidig brug af potente CYP3A-hæmmere.
For patients who have completed the dose-titration phase and are on a steady daily dose of venetoclax, 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.
Derfor skal fertile kvinder bruge en meget sikker præventionsmetode, mens de tager venetoclax og i 30 dage efter behandlingens afslutning.
Therefore, women of childbearing potential must use highly effective contraceptive measures while taking venetoclax and for 30 days after stopping treatment.
I monoterapi-studierne, var de mest almindelige alvorlige bivirkninger (≥2%) pneumoni og febril neutropeni.
In the monotherapy studies, the most frequently reported serious adverse reactions (≥2%) were pneumonia and febrile neutropenia.
• muskelsmerter eller ubehag i leddene
• muscle pain or uncomfortable joints
Du skal undgå grapefrugt/grapefrugtjuice, pomerans og stjernefrugt (carambole), mens du tager Venclyxto; du må hverken spise disse frugter eller drikke juice eller tage kosttilskud, der indeholder dem, da de kan øge mængden af venetoclax i dit blod.
Do not eat grapefruit products, Seville oranges (bitter oranges), or starfruit (carambola) while you are taking Venclyxto - this includes eating them, drinking the juice or taking a supplement that might contain them.
Farmakokinetikken for venetoclax hos personer med svært nedsat nyrefunktion (CrCl < 30 ml/min) og patienter i dialyse er ikke undersøgt (se pkt.
The pharmacokinetics of venetoclax has not been studied in subjects with severe renal impairment (CrCl <30 ml/min) or patients on dialysis (see section 4.2).
Tumorlysesyndrom, herunder dødelige tilfælde, er set ved venetoclax-behandling hos patienter med tidligere behandlet CLL og høj tumorbyrde.
Tumour lysis syndrome, including fatal events, has occurred in patients with previously treated CLL with high tumour burden when treated with venetoclax.
• usædvanlig træthed
• feeling unusually tired
Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Venclyxto:
Talk to your doctor, pharmacist, or nurse before taking Venclyxto if:
Amning skal ophøre under behandling med Venclyxto.
Breast-feeding should be discontinued during treatment with Venclyxto.
En farmakokinetisk populationsanalyse, der omfattede 74 personer med let nedsat leverfunktion, 7 personer med moderat nedsat leverfunktion og 442 personer med normal leverfunktion, viste, at venetoclaxeksponeringen hos personer med let til moderat nedsat leverfunktion svarer til eksponeringen hos personer med normal leverfunktion.
Based on a population pharmacokinetic analysis that included 74 subjects with mild hepatic impairment, 7 subjects with moderate hepatic impairment and 442 subjects with normal hepatic function, venetoclax exposures are similar in subjects with mild and moderate hepatic impairment and normal hepatic function.
Du må ikke holde op med at tage Venclyxto
Do not stop taking Venclyxto
Elektrolytændringer, der er forenelige med tumorlysesyndrom, og som kræver øjeblikkelig intervention, kan allerede ses 6-8 timer efter den første dosis venetoclax og i forbindelse med hver dosisøgning.
Changes in electrolytes consistent with TLS that require prompt management can occur as early as 6 to 8 hours following the first dose of venetoclax and at each dose increase.