natgillin/translations-raw huggingface dataset:
På den måde kan det kontrolleres, om det er sikkert for dig at fortsætte behandlingen med dette lægemiddel.
This is to see if you can continue to take this medicine safely.
Ved venetoclax + rituximab behandling blev febril neutropeni rapporteret hos 4% af patienterne, grad ≥3 infektioner hos 18% og alvorlige infektioner hos 21% af patienterne.
With venetoclax + rituximab treatment, febrile neutropenia was reported in 4% of patients, grade ≥3 infections in 18%, and serious infections in 21% of patients.
I alt gennemførte 130 patienter i venetoclax + rituximab-armen 2 års venetoclax-behandling uden progression.
In total, 130 patients in the venetoclax + rituximab arm completed 2 years of venetoclax treatment without progression.
Et randomiseret (1:1), multicenter, åbent fase-3 studie evaluerede virkning og sikkerhed af Venclyxto + rituximab overfor BR hos patienter med tidligere behandlet CLL.
A randomised (1:1), multicenter, open-label phase 3 study evaluated the efficacy and safety of Venclyxto + rituximab versus BR in patients with previously treated CLL.
Vistor hf. Sími: +354 535 7000
Vistor hf. Tel: +354 535 7000
Frekvensen af grad ≥3 unormale laboratorieværdier relevante for TLS var hyperkaliæmi 1%, hyperfosfatæmi 1% og hyperurikæmi
The rates of grade ≥3 laboratory abnormalities relevant to TLS were hyperkalaemia 1%, hyperphosphataemia 1%, and hyperuricaemia 1%.
Ved klinisk tumorlysesyndrom eller ændringer i blodprøver, der ikke fortager sig i løbet af 48 timer, skal behandlingen genoptages med reduceret dosis (se tabel 2).
For events of clinical TLS or blood chemistry changes requiring more than 48 hours to resolve, treatment should be resumed at a reduced dose (see Table 2).
Patienterne i Venclyxto + rituximab-armen gennemførte Venclyxtos 5-ugers dosistitreringsplan og fik så 400 mg én gang dagligt i 24 måneder fra 1. dag i 1. rituximab-cyklus indtil sygdomsprogression eller uacceptabel toksicitet.
Patients in the Venclyxto + rituximab arm completed the Venclyxto 5-week dose-titration schedule and then received 400 mg once daily for 24 months from Cycle 1 Day 1 of rituximab in the absence of disease progression or unacceptable toxicity.
PFS, % (95 % KI) 12-måneders estimat 24-måneders estimat
PFS, % (95% CI) 12-month estimate 24-month estimate
MRD-negativitetsrate ved afslutningen på kombinationsbehandlingenb
MRD negativity rate at end of combination treatmentb
Figur 1: Kaplan-Meier-kurver af investigator vurderet progressionsfri overlevelse (intent-to-treat population) i MURANO (skæringsdato for data 8. maj 2018).
Figure 1: Kaplan-Meier curves of investigator-assessed progression-free survival (intent-to-treat population) in MURANO (data cut-off date 8 May 2018)
Venetoclax binder direkte til BCL-2-proteinets BH3-bindende sted og fortrænger pro-apoptotiske proteiner, der indeholder en BH3-sekvens, som BIM og initierer dermed permeabilisering af mitokondriets ydre membran (MOMP), caspase-aktivering og programmeret celledød.
Venetoclax binds directly to the BH3-binding groove of BCL-2, displacing BH3 motif-containing pro-apoptotic proteins like BIM, to initiate mitochondrial outer membrane permeabilization (MOMP), caspase activation, and programmed cell death.
Der blev påvist 17p-deletion hos 26,9% af patienterne, TP53-mutation hos 26,3%, 11q-deletion hos 36,5% og umuteret IgVH gen hos 68,3%.
A 17p deletion was detected in 26.9% of patients, TP53 mutations in 26.3%, 11q deletion in 36.5%, and unmutated IgVH gene in 68.3%.
Der foreligger ikke tilstrækkelige kontrollerede data fra anvendelse af venetoclax til gravide kvinder.
There are no adequate and well-controlled data from the use of venetoclax in pregnant women.
MURANO var et randomiseret, kontrolleret studie, hvor 194 patienter med tidligere behandlet CLL, fik venetoclax i kombination med rituximab.
MURANO was a randomised, controlled trial in which 194 patients with previously treated CLL received venetoclax in combination with rituximab.
M27-metabolitten var negativ for genotoksicitet i den bakterielle mutagenicitetstest og kromosomafvigelsestesten.
The M27 metabolite was negative for genotoxicity in the bacterial mutagenicity and chromosomal aberration assays.
Efter administration af en enkelt oral dosis på 200 mg radioaktivt mærket [14C]-venetoclax til raske forsøgspersoner blev > 99,9 % af dosen udskilt i fæces og < 0,1 % udskilt i urinen i løbet af 9 dage.
After a single oral administration of 200 mg radiolabeled [14C]-venetoclax to healthy subjects, >99.9% of the dose was recovered in faeces and <0.1% of the dose was excreted in urine within 9 days.
Den anbefalede venetoclax-dosis er 400 mg en gang dagligt.
The recommended dose of venetoclax is 400 mg once daily.
o Når du kun får behandling med Venclyxto, skal du blive på en daglig dosis på 400 mg, standarddosis, så længe, som det er nødvendigt.
o When you are receiving Venclyxto therapy alone, you will stay on the 400 mg daily dose, which is the standard dose, for as long as necessary.
Nogle mennesker kan udvikle unormale niveauer af salte (såsom kalium og urinsyre) i blodet.
Some people may develop unusual levels of some body salts (such as potassium and uric acid) in the blood caused by the fast breakdown of cancer cells during treatment.
Der sås ingen tilfælde af tumorlysesyndrom med kliniske konsekvenser som f.eks. akut nyresvigt, hjertearytmier eller pludselig død og/eller krampeanfald hos disse patienter.
No TLS with clinical consequences such as acute renal failure, cardiac arrhythmias or sudden death and/or seizures was observed in these patients.
Dette kaldes tumorlysesyndrom (TLS).
This is called tumour lysis syndrome (TLS).
Venclyxto filmovertrukne tabletter fås i PVC/PE/PCTFE-aluminiumsfolie-blisterkort med enten 1, 2 eller 4 filmovertrukne tabletter.
Venclyxto film-coated tablets are supplied in PVC/PE/PCTFE aluminium foil blisters containing either 1, 2 or 4 film-coated tablets.
Blodanalyser skal udføres på ny forud for hver dosisøgning i titreringsfasen.
Blood chemistries should be reassessed prior to each subsequent dose increase during the titration phase.
Blodprøveanalyser skal monitoreres og abnormiteter korrigeres øjeblikkeligt.
Blood chemistries should be monitored and abnormalities managed promptly.
Dosisændring ved anden toksicitet
Dose modifications for other toxicities
Substrater for P-gp, BCRP og OATP1B1
Substrates of P-gp, BCRP, and OATP1B1
Nedsat nyrefunktion (CrCl < 80 ml/min) øger risikoen yderligere.
Reduced renal function (CrCl <80 ml/min) further increases the risk.
Venetoclax bør kun administreres til patienter med svært nedsat nyrefunktion, hvis fordelene opvejer risiciene, og disse patienter skal monitoreres nøje for tegn på toksicitet på grund af den øgede risiko for tumorlysesyndrom (se pkt.
Venetoclax should be administered to patients with severe renal impairment only if the benefit outweighs the risk and patients should be monitored closely for signs of toxicity due to increased risk of TLS (see section 4.4).
I fase 2- og 1-studierne blev 352 patienter med tidligere behandlet CLL, som inkluderede 212 patienter med 17p-deletion og 146 patienter, der havde oplevet behandlingssvigt ved en B-celle-receptor-hæmmer behandlet med venetoclax i monoterapi (se pkt.
In the phase 2 and phase 1 studies, 352 patients with previously treated CLL, which included 212 patients with 17p deletion and 146 patients who had failed a B-cell receptor pathway inhibitor were treated with venetoclax monotherapy (see section 5.1).
Drik den samme mængde væske (mindst 1,5 til 2 liter dagligt) fra to dage før, dosis øges, samt på dagen for dosisøgning.
Drink the same amount of water (at least 1.5 to 2 litres daily) two days before and on the day that your dose is increased.
Figur 2: Kaplan-Meier-kurver over overlevelse (intent-to-treat population) i MURANO
Figure 2: Kaplan-Meier curves of overall survival (intent-to-treat population) in MURANO
- hvis du er allergisk over for det aktive stof venetoclax eller et af de øvrige indholdsstoffer i Venclyxto (angivet i punkt 6)
- you are allergic to the active substance venetoclax or any of the other ingredients of this medicine (listed in section 6).
• Hvis der er gået mere end 8 timer, siden du skulle have taget din dosis, skal du lade være med at tage din dosis den dag.
• If it is more than 8 hours since the time you usually take your dose, do not take the dose that day.
I dosistitreringsfasen skal behandlingen afbrydes og patienterne monitoreres nøje for tegn og symptomer på tumorlysesyndrom (feber, kulderystelser, kvalme, opkastning, forvirring, åndenød, krampeanfald, uregelmæssig hjertefrekvens, mørk eller grumset urin, usædvanlig træthed, muskel- eller ledsmerter, abdominalsmerter og udspilet abdomen) og anden toksicitet (se pkt.
During dose-titration phase, treatment should be interrupted and patients should be monitored carefully for signs and symptoms of TLS (fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, muscle or joint pain, abdominal pain and distension) along with other toxicities (see section 4.2).
Aktivt stof: venetoclax.
The active substance is venetoclax.
Før administration: Inden den første dosis skal der udføres blodanalyser hos alle patienter med henblik på vurdering af nyrefunktionen, og eksisterende abnormiteter skal korrigeres.
Pre-dose: For all patients, blood chemistries should be assessed prior to the initial dose to evaluate kidney function and correct pre-existing abnormalities.
Der sås ingen effekt på fertiliteten i studier af fertilitet og tidlig fosterudvikling hos han- og hunmus.
No effects on fertility were observed in fertility and early embryonic development studies in male and female mice.
Rituximab blev initieret efter 5ugers dosistitreringsplanen med 375 mg/m2 i cyklus 1 og 500 mg/m2 i cyklus 2-6.
Rituximab was initiated after the 5-week dose-titration schedule at 375 mg/m2 for Cycle 1 and 500 mg/m2 for Cycles 26.
Det er ukendt, om det aktive stof i Venclyxto udskilles i mælken hos mennesker.
It is not known whether the active substance in Venclyxto passes into breast milk.
Den observerede PFS-fordel ved venetoclax + rituximab sammenlignet med bendamustin + rituximab var konsistent observeret på tværs af alle undergrupper af evaluerede patienter, hvilket inkluderede alder (< 65, ≥ 65 år og < 75, ≥ 75 år), tidligere behandlingslinier (1, >1), udbredt sygdom (< 5 cm, ≥ 5 cm), 17p-deletion, 11q-deletion, TP53-mutation, IgVH mutation og refraktær mod relaps ved den seneste behandling (figur 3).
The observed PFS benefit of venetoclax + rituximab compared with bendamustine + rituximab was consistently observed across all subgroups of patients evaluated, including age (< 65, ≥ 65 years and < 75, ≥ 75 years), prior lines of therapy (1, >1), bulky disease (< 5 cm, ≥ 5 cm), 17p deletion, 11q deletion, TP53 mutation, IgVH mutation, and refractory versus relapse to most recent therapy (Figure 3).
Du må ikke amme, mens du tager dette lægemiddel.
Do not breast-feed while you are taking this medicine.
Administrationen af et oralt P-gp- eller BCRP-substrat, som kan hæmmes i mave-tarm-kanalen (f.eks. dabigatranexetilat), skal være adskilt så meget som muligt fra administrationen af venetoclax for at minimere en potentiel interaktion.
For an orally administered P-gp or BCRP substrate sensitive to inhibition in the gastrointestinal tract (e.g., dabigatran exetilate), its administration should be separated from venetoclax administration as much as possible to minimise a potential interaction.
Testikulær toksicitet (tab af kimceller) blev observeret i studier af generel toksicitet hos hunde ved eksponeringer på 0,5-18 gange eksponeringen (AUC) hos mennesker ved den anbefalede dosis.
Testicular toxicity (germ cell loss) was observed in general toxicity studies in dogs at exposures of 0.5 to 18 times the human AUC exposure at the recommended dose.
Kontakt lægen, apotekspersonalet eller sundhedspersonalet med det samme, hvis du får et eller flere af de symptomer på tumorlysesyndrom, der er anført i punkt 4.
Tell your doctor, pharmacist or nurse immediately if you get any of the symptoms of TLS listed in section 4.
Du skal begynde at drikke mindst 1,5 til 2 liter vand dagligt fra to dage før, du starter behandlingen med Venclyxto.
You should start drinking at least 1.5 to 2 litres of water daily two days before starting Venclyxto.
I en farmakokinetisk populationsanalyse blev venetoclax' tilsyneladende fordelingsvolumen (Vdss/F) hos patienter estimeret til 256-321 liter.
The population estimate for apparent volume of distribution (Vdss/F) of venetoclax ranged from 256-321 L in patients.
Alle seks patienter gennemførte dosistitreringen og opnåede den anbefalede daglige dosis på 400 mg venetoclax.
All six patients completed the dose titration and reached the recommended daily dose of 400 mg of venetoclax.
De filmovertrukne tabletter leveres i æsker med 7 (i blistre med 1 tablet) eller 14 tabletter (i blistre med 2 tabletter) eller en multipakning med 112 tabletter (4x28 i blistre med 4 tabletter)
The film-coated tablets are supplied in cartons containing either 7 (in blisters of 1 tablet) or 14 tablets (in blisters of 2 tablets); or a multipack containing 112 tablets (4 x 28 tablets (in blisters of 4 tablets)).
Dette gælder også medicin, som ikke er købt på recept, f.eks. naturlægemidler og kosttilskud.
This includes medicines obtained without a prescription, herbal medicines and supplements.
Venetoclax metaboliseres hovedsagelig via CYP3A.
Venetoclax is predominantly metabolised by CYP3A.
Rituximab bør adminstreres efter patienten har afsluttet dosistitreringsplanen og har fået den anbefalede daglige dosis på 400 mg venetoclax i 7 dage.
Rituximab should be administered after the patient has completed the dose-titration schedule and has received the recommended daily dose of 400 mg venetoclax for 7 days.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier af Venclyxto i alle undergrupper af den pædiatriske population med CLL (se pkt.
The European Medicines Agency has waived the obligation to submit the results of studies with Venclyxto in all subsets of the paediatric population in CLL (see section 4.2 for information on paediatric use).
På vurderingstidspunktet var den mediane behandlingsvarighed af venetoclax 14,3 måneder (interval: 0,1-31,4 måneder).
At the time of evaluation, median duration of treatment with venetoclax was 14.3 months (range: 0.1 to 31.4 months).
Venetoclax forventes ikke at hæmme OATP1B3, OCT1, OCT2, OAT1, OAT3, MATE1 eller MATE2K ved klinisk relevante koncentrationer.
Venetoclax is not expected to inhibit OATP1B3, OCT1, OCT2, OAT1, OAT3, MATE1 or MATE2K at clinically relevant concentrations.
Efter administration: Hos patienter med risiko for tumorlysesyndrom skal blodanalyser monitoreres 6-8 timer samt 24 timer efter den første dosis venetoclax.
Post-dose: For patients at risk of TLS, blood chemistries should be monitored at 6 to 8 hours and at 24 hours after the first dose of venetoclax.
Fortæl det altid til lægen, hvis du tager et eller flere af følgende lægemidler, da Venclyxto kan påvirke deres virkning:
Tell your doctor if you take any of the following medicines as Venclyxto may affect how they work:
• infektion i de øvre luftveje - tegnene kan f.eks. være løbende næse, ondt i halsen eller hoste
• upper respiratory tract infection - signs include runny nose, sore throat or cough
Hvis din læge vurderer, at du er i risiko for at få tumorlysesyndrom, kan du blive behandlet på hospitalet, så du om nødvendigt kan få ekstra væske i en blodåre (væskedrop), få taget blodprøver oftere og blive overvåget for bivirkninger.
If your doctor thinks that you are at risk of TLS, you may be treated in the hospital so that you can be given extra fluids into the vein if needed, have your blood tests more often and be checked for side effects.
Hvis en galdesyre-kompleksdanner skal administreres sammen med venetoclax, skal produktresuméet for galdesyre-kompleksdanneren følges for at mindske risikoen for interaktion, og venetoclax skal administreres mindst 4-6 timer efter kompleksdanneren.
If a bile acid sequestrant is to be co-administered with venetoclax, the SmPC for the bile acid sequestrant should be followed to reduce the risk for an interaction, and venetoclax should be administered at least 4-6 hours after the sequestrant.
Filmovertræk:
In the film-coating:
Dosisjustering er ikke nødvendigt hos patienter med let eller moderat nedsat leverfunktion.
No dose adjustment is recommended in patients with mild or moderate hepatic impairment.
Venclyxto i kombination med rituximab er indiceret til behandling af kronisk lymfatisk leukæmi (CLL) hos voksne patienter, der har fået mindst en tidligere behandling.
Venclyxto in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.
Tabel 2: Dosisændring ved tumorlysesyndrom og anden toksicitet
Table 2: Dose modification for TLS and other toxicities
Samtidig administration af CYP- og UGT-substrater
Co administration with CYP and UGT substrates
Venclyxto-tabletter er tilgængelige i blisterkort, der er pakket i æsker:
Venclyxto tablets are provided in blisters which are packed in cartons as follows:
En risiko for børn, som ammes, kan ikke udelukkes.
A risk to the breast-feeding child cannot be excluded.
Det mediane antal tidligere cancerbehandlinger var 4 (interval: 1-15) for patienter i ibrutinib-gruppen og 3 (interval: 1-11) for patienter i idelalisib-gruppen.
The median number of prior oncology treatments was 4 (range: 1 to 15) in ibrutinib-treated patients and 3 (range: 1 to 11) in idelalisib-treated patients.
Venetoclax i kombination med rituximab til behandling af patienter med CLL, der har fået mindst en tidligere behandling - studie GO28667 (MURANO)
Venetoclax in combination with rituximab for the treatment of patients with CLL who have received at least one prior therapy - study GO28667 (MURANO)
o Når du får behandling med Venclyxto i kombination med rituximab, vil du få en dosis på 400 mg dagligt i 24 måneder.
o When you are receiving Venclyxto therapy in combination with rituximab, you will receive the 400 mg daily dose for 24 months.
Du skal starte behandlingen med at tage en lav dosis Venclyxto i 1 uge.
You will begin treatment with Venclyxto at a low dose for 1 week.
Administration sammen med et fedtfattigt måltid øgede venetoclax-eksponeringen med ca. 3,4 gange, og administration sammen med et fedtrigt måltid øgede venetoclax-eksponeringen med 5,1-5,3 gange i forhold til administration under faste.
Administration with a low-fat meal increased venetoclax exposure by approximately 3.4-fold and administration with a high-fat meal increased venetoclax exposure by 5.1- to 5.3-fold compared to fasting conditions.
I monoterapi-studierne, var de mest almindelige bivirkninger neutropeni/nedsat neutrofiltal, diarré, kvalme, anæmi, træthed og infektion i de øvre luftveje.
In the monotherapy studies, the most common adverse reactions were neutropenia/neutrophil count decreased, diarrhoea, nausea, anaemia, fatigue, and upper respiratory tract infection.
I prækliniske studier har venetoclax vist cytotoksisk aktivitet i tumorceller, der har overekspression af BCL-2.
In non-clinical studies, venetoclax has demonstrated cytotoxic activity in tumour cells that overexpress BCL-2.
Nedsat nyrefunktion (kreatininclearance [CrCl] < 80 ml/min) øger risikoen yderligere.
Reduced renal function (creatinine clearance [CrCl] <80 ml/min) further increases the risk.
Samtidig administration af venetoclax og andre potente CYP3A4-hæmmere formodes at kunne øge venetoclax-AUC gennemsnitlig 5,8-7,8 gange.
Co-administration of venetoclax with other strong CYP3A4 inhibitors is predicted to increase venetoclax AUC by on average 5.8- to 7.8-fold.
Det primære effektmål var den samlede responsrate (ORR) vurderet af en uafhængig review-komité på baggrund af 2008-retningslinjerne fra IWCLL opdateret af NCI-WG.
The primary efficacy endpoint was overall response rate (ORR) as assessed by an Independent Review Committee (IRC) using the IWCLL updated NCI-WG guidelines (2008).
Hvis der hos en patient ses ændringer i blodprøver, der kan være tegn på tumorlysesyndrom, skal venetoclaxdosering undlades den efterfølgende dag.
If a patient experiences blood chemistry changes suggestive of TLS, the following day's venetoclax dose should be withheld.
• nedsat antal hvide blodlegemer, de såkaldte lymfocytter
• lower number of white blood cells called lymphocytes
Dosisjustering er ikke nødvendig hos patienter med let eller moderat nedsat nyrefunktion (CrCl ≥ 30 ml/min og < 90 ml/min) (se pkt.
No dose adjustment is needed for patients with mild or moderate renal impairment (CrCl ≥30 ml/min and <90 ml/min) (see section 5.2).
Startdosis er 20 mg venetoclax én gang dagligt i 7 dage.
The starting dose is 20 mg of venetoclax once daily for 7 days.
Nogle lægemidler kan også påvirke den måde, Venclyxto virker på.
Also some other medicines can affect the way Venclyxto works.
Risikoen mindskes, efterhånden som tumorbyrden falder i løbet af venetoclax-behandlingen (se pkt.
The risk may decrease as tumour burden decreases with venetoclax treatment (see section 4.4).
Midler mod hyperurikæmi skal administreres 2-3 dage inden påbegyndelse af venetoclax-behandling hos patienter med højt urinsyreniveau eller med risiko for tumorlysesyndrom; disse midler kan administreres i hele titreringsfasen.
Anti-hyperuricaemic agents should be administered 2 to 3 days prior to starting treatment with venetoclax in patients with high uric acid levels or at risk of TLS and may be continued through the titration phase.
Hos kaniner medførte venetoclax maternel toksicitet, men ingen føtal toksicitet, ved eksponeringer svarende til 0,1 gange eksponeringen (AUC) hos mennesker ved den anbefalede dosis.
In rabbits, venetoclax produced maternal toxicity, but no foetal toxicity at exposures of 0.1 times the human AUC exposure at the recommended dose.
Ved at blokere virkningen af dette protein hjælper Venclyxto med at dræbe kræftcellerne og reducere antallet af dem.
Blocking this protein helps to kill and lower the number of cancer cells.
Den mediane behandlingstid for de 158 patienter var 17 måneder (interval: 0 til 34 måneder).
The median time on treatment for 158 patients was 17 months (range: 0 to 34 months).
I det åbne, randomiserede fase 3-studie (MURANO), var incidensen af TLS 3% (6/194) hos patienter behandlet med venetoclax + rituximab.
In the open-label, randomised phase 3 study (MURANO), the incidence of TLS was 3% (6/194) in patients treated with venetoclax + rituximab.
Hvis noget af ovenstående gælder for dig, eller hvis du er i tvivl, skal du tale med lægen, apotekspersonalet eller sundhedspersonalet, før du tager dette lægemiddel.
If any of the above apply to you, or you are not sure, talk to your doctor, pharmacist, or nurse before taking this medicine.
In vitro-studier tyder på, at venetoclax ikke hæmmer eller inducerer CYP1A2, CYP2B6, CYP2C19, CYP2D6 eller CYP3A4 ved klinisk relevante koncentrationer.
In vitro studies indicated that venetoclax is not an inhibitor or inducer of CYP1A2, CYP2B6, CYP2C19, CYP2D6 or CYP3A4 at clinically relevant concentrations.
Anvisningerne for "Forebyggelse af tumorlysesyndrom" skal følges (se pkt.
The instructions for “Prevention of tumour lysis syndrome” should be followed (see section 4.2).
En farmakokinetisk populationsanalyse, der omfattede 219 personer med let nedsat nyrefunktion (CrCl ≥ 60 og < 90 ml/min), 86 personer med moderat nedsat nyrefunktion (CrCl ≥ 30 og < 60 ml/min) og 217 personer med normal nyrefunktion (CrCl ≥ 90 ml/min), viste, at venetoclax-eksponeringen hos personer med let til moderat nedsat nyrefunktion svarer til eksponeringen hos personer med normal nyrefunktion.
Based on a population pharmacokinetic analysis that included 219 subjects with mild renal impairment (CrCl ≥60 and <90 ml/min), 86 subjects with moderate renal impairment (CrCl ≥30 and <60 ml/min) and 217 subjects with normal renal function (CrCl ≥90 ml/min), venetoclax exposures in subjects with mild or moderate renal impairment are similar to those with normal renal function.