natgillin/translations-raw huggingface dataset:
Contents of the pack and other information What Venclyxto contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Venclyxto
o When you are receiving Venclyxto therapy in combination with rituximab, you will receive the 400 mg daily dose for 24 months.
o Če jemljete zdravilo Venclyxto v kombinaciji z rituksimabom, boste jemali 400 mg dnevni odmerek 24 mesecev.
Of the 107 patients who were evaluated for efficacy from M13-982 study, 57% were 65 years or older.
Med 107 bolniki, pri katerih so v študiji M13-982 ocenjevali učinkovitost, je bilo 57 % starih 65 let ali več.
TTR, months, median (range)
TTR, meseci, mediana (razpon)
Serious infections including events of sepsis with fatal outcome have been reported.
Poročali so o resnih okužbah, vključno s pojavom sepse, s smrtnim izidom.
Prevention of tumour lysis syndrome (TLS)
Preprečevanje sindroma tumorske lize (TLS - Tumour Lysis Syndrome)
Venetoclax is not an inhibitor of UGT1A4, UGT1A6, UGT1A9 and UGT2B7.
Venetoklaks ne zavira UGT1A4, UGT1A6, UGT1A9 ali UGT2B7.
Venclyxto monotherapy is indicated for the treatment of CLL:
Zdravilo Venclyxto kot monoterapija je indicirano za zdravljenje KLL:
Concomitant use of venetoclax with P-gp and BCRP inhibitors at initiation and during the dose-titration phase should be avoided; if a P-gp and BCRP inhibitor must be used, patients should be monitored closely for signs of toxicities (see section 4.4).
Sočasni uporabi venetoklaksa z zaviralci P-gp in BCRP na začetku in med fazo titracije odmerka se je potrebno izogibati; če je uporaba zaviralcev P-gp in BCRP nujna, je treba bolnike skrbno spremljati glede znakov toksičnosti (glejte poglavje 4.4).
• 112 (4 x 28) tablets (4 cartons of 7 blisters each with 4 tablets).
• 112 (4 x 28) tablet (4 škatle s 7 pretisnimi omoti s po 4 tabletami).
Median OS and DOR were not reached with median follow-up of approximately 14.3 months for Arm A and 14.7 months for Arm B.
Mediana OS (čas celokupnega preživetja) in DOR (trajanje odziva) nista bila dosežena v času spremljanja v približno 14,3 mesecih (mediana) za skupino A in 14,7 mesecih (mediana) za skupino B.
Dose-titration schedule
Shema titracije odmerka
Tumour lysis syndrome, including fatal events, has occurred in patients with previously treated CLL with high tumour burden when treated with venetoclax.
Do sindroma tumorske lize, vključno s smrtnimi dogodki, je prišlo pri bolnikih s predhodno zdravljeno KLL in veliko tumorsko obremenitvijo, ko so bili zdravljeni z venetoklaksom.
Venclyxto works by blocking a protein in the body called “BCL-2”.
Zdravilo Venclyxto deluje tako, da v telesu zavira beljakovino, imenovano “BCL-2”.
Prior to initiating venetoclax, tumour burden assessment, including radiographic evaluation (e.g., CT scan), must be performed for all patients.
Pred začetkom zdravljenja z venetoklaksom je treba pri vseh bolnikih narediti oceno tumorske obremenitve, vključno z radiografskim vrednotenjem (npr. posnetek z računalniško tomografijo (CT)).
Preparations containing St. John's wort are contraindicated during treatment with venetoclax, as efficacy may be reduced (see section 4.3).
Preparati, ki vsebujejo šentjanževko, so med zdravljenjem z venetoklaksom kontraindicirani, ker je učinkovitost lahko zmanjšana (glejte poglavje 4.3).
Concomitant use of venetoclax with strong or moderate CYP3A4 inducers should be avoided (see sections 4.3 and 4.5).
Sočasni uporabi venetoklaksa z močnimi ali zmernimi induktorji CYP3A4 se je potrebno izogibati (glejte poglavji 4.3 in 4.5).
Before starting treatment, counselling on sperm storage may be considered in some male patients.
Pred začetkom zdravljenja se je pri nekaterih moških bolnikih smiselno posvetovati o shranitvi semenske tekočine.
The median time on treatment at the time of evaluation was 12 months (range: 0 to 22 months).
Mediani čas zdravljenja je bil ob času ovrednotenja 12 mesecev (razpon: od 0 do 22 mesecev).
If a moderate CYP3A inhibitor must be used, the initiation and titration doses of venetoclax should be reduced by at least 50%.
Če je uporaba zmernega zaviralca CYP3A nujna, je treba začetne in titracijske odmerke venetoklaksa zmanjšati za vsaj 50 %.
Venetoclax shows minimal accumulation with accumulation ratio of 1.30-1.44.
Kopičenje venetoklaksa je minimalno; razmerje kopičenja je od 1,30 do 1,44.
• If it is more than 8 hours since the time you usually take your dose, do not take the dose that day.
• Če je od časa, ko običajno vzamete vaš odmerek, minilo več kot 8 ur, ta dan ne vzemite odmerka.
It is recommended that venetoclax should be administered with a meal (see section 4.2).
Venetoklaks je priporočljivo jemati med obrokom (glejte poglavje 4.2).
The safety and efficacy of venetoclax in 107 patients with previously treated CLL with 17p deletion were evaluated in a single arm, open-label, multi-center study (M13-982).
Varnost in učinkovitost venetoklaksa pri 107 bolnikih s predhodno zdravljeno KLL z delecijo 17p so proučili v odprti, multicentrični študiji z eno samo skupino (M13-982).
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.
ORR za bolnike z 17p delecijo in/ali TP53 mutacijo je bil 72 % (33/46) (95 % IZ: 56.5, 84.0) v skupini A in 67 % (8/12) (95 % IZ: 34.9, 90.1) v skupini B. Za bolnike brez 17p delecije in/ali TP53 mutacije pa je bil ORR 69 % (31/45) (95 % IZ: 53.4, 81.8) v skupini A in 71 % (17/24) (95 % IZ: 48.9, 87.4) v skupini B.
aThe modified dose should be continued for 1 week before increasing the dose.
a S prilagojenim odmerkom je treba nadaljevati 1 teden,
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.
Če pri vas obstaja tveganje za TLS vas bodo morda zdravili v bolnišnici, tako da boste, če bo potrebno, lahko prejeli tekočine v veno, pogosteje vam bodo opravljali preiskave krvi in vas spremljali glede neželenih učinkov.
The M27 metabolite was negative for genotoxicity in the bacterial mutagenicity and chromosomal aberration assays.
Presnovek M27 je bil negativen glede genotoksičnosti v preizkusu mutagenosti pri bakterijah in preizkusu kromosomskih aberacij.
Median follow-up time for primary analysis was 23.8 months (range: 0.0 to 37.4 months).
Mediana spremljanja primarne analize je bila 23,8 mesecev (razpon: 0,0 do 37,4 mesecev).
Of the patients, 37% (34/91) were fludarabine refractory, 81% (30/37) harboured the unmutated IgVH gene, and 72% (60/83) had TP53 mutation.
Med bolniki je bilo 37 % (34/91) odpornih proti fludarabinu, 81 % (30/37) jih je imelo nemutiran gen IgVH in 72 % (60/83) jih je imelo mutacijo TP53.
No clinical TLS was observed in patients who followed the current 5-week dose-titration schedule and TLS prophylaxis and monitoring measures (see section 4.2).
Pri bolnikih, ki so sledili sedanji 5-tedenski shemi titracije odmerka in profilaksi TLS ter ukrepom spremljanja, niso opazili nobenega kliničnega TLS (glejte poglavje 4.2).
Venetoclax can cause rapid reduction in tumour, and thus poses a risk for TLS in the initial 5-week dose-titration phase.
Venetoklaks lahko povzroči hitro zmanjšanje tumorja in tako predstavlja tveganje za TLS v začetni 5
In non-clinical studies, venetoclax has demonstrated cytotoxic activity in tumour cells that overexpress BCL-2.
V predkliničnih študijah je venetoklaks izkazal citotoksično aktivnost v tumorskih celicah s prekomerno izraženim BCL-2.
Chromosomal aberrations were 11q deletion (34%, 43/127), 17p deletion (40%, 50/126), TP53 mutation (38%, 26/68) and unmutated IgVH (78%, 72/92).
Kromosomske aberacije so bile delecija 11q (34 %,43/127), delecija 17p (40 %, 50/126), mutacija TP53 (38 %, 26/68) in nemutiran IgVH (78 %, 72/92).
M27 was identified as a major metabolite in plasma with an inhibitory activity against BCL-2 that is at least 58-fold lower than venetoclax in vitro.
Glavni presnovek v plazmi je M27; njegovo inhibicijsko delovanje na BCL-2 je in vitro vsaj 58-krat manjše od venetoklaksa.
The most frequently reported serious adverse reactions (≥2%) in patients receiving venetoclax in combination with rituximab were pneumonia, febrile neutropenia, and TLS.
Najpogosteje poročani resni neželeni učinki (≥ 2 %) pri bolnikih, ki so prejemali venetoklaks v kombinaciji z rituksimabom, so bili pljučnica, vročinska nevtropenija in TLS .
Agents that may have their plasma concentrations altered by venetoclax
Učinkovine, katerih koncentracije v plazmi se lahko spremenijo zaradi venetoklaksa
Overall, 65% of patients received prior nucleoside analogue, 86% rituximab, 39% other monoclonal antibodies, and 72% alkylating agent (including 41% with bendamustine).
V celoti je 65 % bolnikov predhodno prejemalo nukleozidni analog, 86% rituksimab, 39 % druga monoklonska protitelesa in 72 % alkilirajoče sredstvo (vključno 41 %, ki so prejemali bendamustin).
Cardiac electrophysiology
Farmakodinamični učinki Srčna elektrofiziologija
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.
Rituksimab je treba uporabiti po tem, ko je bolnik zaključil s titracijo odmerka po shemi in je 7 dni prejemal priporočeni dnevni odmerek 400 mg venetoklaksa.
• in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.
• z odsotno delecijo 17p ali mutacijo TP53 pri odraslih bolnikih, pri katerih tako kemoimunoterapija kot zdravljenje z zaviralcem receptorske poti celic B ni bilo uspešno.
27.2 (21.9, NR)
27,2 (21,9, ND)
• lower number of white blood cells called lymphocytes
• nizko število belih krvnih celic, imenovanih limfociti
A dose reduction of at least 50% throughout treatment is recommended for patients with severe hepatic impairment (see section 5.2).
Pri bolnikih s hudo okvaro jeter se priporoča zmanjšanje odmerka za vsaj 50 % skozi celotno obdobje zdravljenja (glejte poglavje 5.2).
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.
Petindvajset odstotkov (32/127) bolnikov je bilo MRD-negativnih po izvidu periferne krvi, vključno z 8 bolnikov, ki so bili MRD-negativen tudi po izvidu kostnega mozga.
In vitro studies demonstrated that venetoclax is predominantly metabolised by cytochrome P450 CYP3A4.
Študije in vitro kažejo, da se venetoklaks presnavlja predvsem s citokromom P450 3A4 (CYP3A4).
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].
Pri posodobljeni analizi učinkovitosti pri vseh bolnikih po zaključenem zdravljenju (upoštevani so podatki do 8. maja 2018 in mediana spremljanja 36 mesecev), je bila 36-mesečna ocena PFS v skupini, ki je prejemala venetoklaks + rituksimab 71,4 % [95 % IZ: 64,8, 78,1], v skupini, ki je prejemala bendamustin + rituksimab pa 15,2 % [95 % IZ: 9,1, 21].
Initiation and titration phase
Začetek zdravljenja in faza titracije
ORR, % (95% CI) CR + CRi, % nPR, %
ORR, % (95 % IZ) CR + CRi, % nPR, %
Venetoclax is a potent, selective inhibitor of B-cell lymphoma (BCL)-2, an anti-apoptotic protein.
Venetoklaks je močan, selektiven zaviralec anti-apoptotične beljakovine limfoma celic B (BCL)-2.
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.
Sedemindvajset odstotkov (42/158) bolnikov je bilo MRD-negativnih po izvidu periferne krvi, vključno s 16 bolniki, ki so bili MRD-negativni tudi po izvidu kostnega mozga.
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).
V študijah 1. faze in 2. faze je bilo 352 bolnikov s predhodno zdravljeno KLL zdravljenih z venetoklaksom v monoterapiji, vključno s 212 bolniki z delecijo 17p in 146 bolniki, pri katerih zdravljenje z zaviralcem receptorske poti celic B ni bilo uspešno.
The recommended dose of venetoclax in combination with rituximab is 400 mg once daily (see section 5.1 for details of the combination regimen).
Odmerjanje venetoklaksa v kombinaciji z rituksimabom po titraciji Priporočeni odmerek venetoklaksa v kombinaciji z rituksimabom je 400 mg enkrat na dan (za podrobnosti o kombiniranem režimu zdravljenja glejte poglavje 5.1).
Your doctor may change your dose of Venclyxto.
Zdravnik lahko spremeni vaš odmerek zdravila Venclyxto.
Table 3: Adverse drug reactions reported in patients with CLL treated with venetoclax
Preglednica 3: Neželeni učinki, o katerih so poročali pri bolnikih s KLL, ki so se zdravili z venetoklaksom
Following multiple oral administrations, maximum plasma concentration of venetoclax was reached 5-8 hours after dose.
Po večkratnem peroralnem dajanju je venetoklaks dosegel največjo koncentracijo v plazmi v 5 do8 urah po odmerku.
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.
Peroralno dajan P-gp ali BCRP substrat, ki je občutljiv na inhibicijo v gastrointestinalnem traktu (npr. dabigatraneteksilat), mora biti dan kolikor se da ločeno od dajanja venetoklaksa, da se s tem zmanjša možno interakcijo.
Figure 2: Kaplan-Meier curves of overall survival (intent-to-treat population) in MURANO
Slika 2:Krivulji Kaplan-Meier za vrednosti celokupnega preživetja (vsi bolniki, predvideni za zdravljenje) v študiji MURANO
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).
Bolnike z zmerno okvaro jeter je treba bolj skrbno spremljati glede znakov toksičnosti na začetku zdravljenja in med fazo titracije odmerka (glejte poglavje 4.8).
Venetoclax as monotherapy for the treatment of patients with CLL harbouring 17p deletion or TP53 mutation - study M13-982
Venetoklaks kot monoterapija za zdravljenje bolnikov s KLL in delecijo 17p ali mutacijo TP53študija M13-982
- Tell your doctor immediately if you become pregnant while you are taking this medicine.
- Takoj obvestite zdravnika, če zanosite med jemanjem tega zdravila.
If you take more Venclyxto than you should, talk to your doctor, pharmacist, or nurse or go to hospital immediately.
Če ste vzeli večji odmerek zdravila Venclyxto, kot bi smeli Če ste vzeli večji odmerek zdravila Venclyxto, kot bi smeli, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro oziroma pojdite takoj v bolnišnico.
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.
Če se izmenjevalce žolčnih kislin daje sočasno z ventoklaksom, je potrebno upoštevati povzetek glavnih značilnosti zdravila za izmenjevalce žolčnih kislin, da se zmanjša tveganje za interakcijo, venetoklaks pa je potrebno dati vsaj 4-6 ur po izmenjevalcu.
• 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
• s prisotno delecijo 17p ali mutacijo TP53 pri odraslih bolnikih, ki niso primerni za zdravljenje z zaviralcem receptorske poti celic B oziroma pri katerih zdravljenje ni bilo uspešno, ali
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.
Pri bolnikih, ki so na stalnem dnevnem odmerku venetoklaksa, je treba odmerek zdravila Venclyxto zmanjšati za 50 % pri sočasni uporabi z zmernimi zaviralci CYP3A in za 75 % pri sočasni uporabi z močnimi zaviralci CYP3A.
Blood chemistries should be monitored and abnormalities managed promptly.
Rezultate krvnih preiskav je treba spremljati in ob nepravilnostih takoj ustrezno ukrepati.
Peripheral blood, % (95% CI)c
Periferna kri, % (95 % IZ)c
The active substance is venetoclax.
Učinkovina je venetoklaks.
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%).
V študiji MURANO je prišlo do prekinitve odmerka zaradi neželenih učinkov pri 71 % bolnikov zdravljenih s kombinacijo venetoklaksa in rituksimaba; najpogostejši neželeni učinek, ki je povzročil prekinitev odmerka venetoklaksa, je bila nevtropenija (43%).
In total, 130 patients in the venetoclax + rituximab arm completed 2 years of venetoclax treatment without progression.
V skupini venetoklaks + rituksimab je skupno 130 bolnikov zaključilo 2 letno zdravljenje z venetoklaksom brez napredovanja.
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.
Če bolnik izpusti odmerek venetoklaksa in od časa, ko ga običajno vzame, ni minilo več kot 8 ur, naj izpuščeni odmerek vzame čim prej še isti dan.
Grapefruit products, Seville oranges, and starfruit (carambola) should be avoided during treatment with venetoclax as they contain inhibitors of CYP3A.
Med zdravljenjem z venetoklaksom se je treba izogibati izdelkom iz grenivke, seviljskim pomarančam in zvezdnemu sadežu (karamboli), ker vsebujejo zaviralce CYP3A.
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.
o Če jemljete zdravilo Venclyxto samo, 400 mg dnevni odmerek, ki je standarni odmerek,
Other medicines and Venclyxto
Druga zdravila in zdravilo Venclyxto
• Do not chew, crush, or break the tablets
• tablet ne žvečite, drobite ali lomite
Based on population pharmacokinetic analysis, gastric acid reducing agents (e.g., proton pump inhibitors, H2-receptor antagonists, antacids) do not affect venetoclax bioavailability.
Učinkovine, ki zmanjšajo kislost želodčne vsebine Glede na analizo populacijske farmakokinetike, učinkovine, ki zmanjšajo kislost želodčne vsebine (npr. zaviralci protonske črpalke, antagonisti receptorjev H2, antacidi), ne vplivajo na biološko razpoložljivost venetoklaksa.
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).
Farmakokinetike venetoklaksa niso raziskali pri bolnikih s hudo okvaro ledvic (CrCL < 30 ml/min) in tudi ne pri bolnikih na dializi (glejte poglavje 4.2).
Reduced renal function (CrCl <80 ml/min) further increases the risk.
[CrCL] <80 ml/min) dodatno poveča tveganje.
Figure 1: Kaplan-Meier curves of investigator-assessed progression-free survival (intent-to-treat population) in MURANO (data cut-off date 8 May 2018)
Slika 1: Krivulji Kaplan-Meier za vrednosti preživetja brez napredovanja bolezni ocenjene s strani raziskovalca (vsi bolniki predvideni za zdravljenje) v študiji MURANO (upoštevani so podatki do 8. maja 2018)
Venclyxto film-coated tablets are for oral use.
Način uporabe Filmsko obložene tablete zdravila Venclyxto so za peroralno uporabo.
Bendamustine + rituximab N = 195
bendamustine + rituksimab N = 195
Progression-free survival (PFS) was assessed by investigators using the International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines (2008).
Chronic Lymphocytic Leukaemia - IWCLL) in posodobljene smernice (2008) delovne skupine, ki jo sponzorira nacionalni inštitut za raka (National Cancer Institute-sponsored Working Group - NCIWG).
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.
Prekinitev zdravljenja in zmanjšanje odmerka zaradi neželenih učinkov Do prekinitve zdravljenja zaradi neželenih učinkov je prišlo pri 16 % bolnikov zdravljenih s kombinacijo venetoklaksa in rituksimaba v MURANO študiji.
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).
Pri preiskovancih s hudo jetrno okvaro (Child-Pugh C; n=5), je bila srednja Cmax venetoklaksa podobna kot pri preiskovancih z normalnim delovanjem jeter, vendar je bila AUCinf venetoklaksa v povprečju 2,7-krat višja (razpon: ni prišlo do 5-kratnega zvišanja vrednosti) kot AUCinf venetoklaksa pri preiskovancih z normalnim delovanjem jeter (glejte poglavje 4.2).
Macrogol 3350 (E1521) Talc (E553b)
makrogol 3350 (E1521), smukec (E553b).
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.
Pri bolnikih, ki so končali fazo titracije odmerka in so na stalnem dnevnem odmerku venetoklaksa, je treba odmerek venetoklaksa ob sočasni uporabi z zmernimi zaviralci CYP3A zmanjšati za 50 % in ob sočasni uporabi z močnimi zaviralci CYP3A za 75 %.
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.
Do zmanjšanja odmerka zaradi neželenih učinkov je prišlo pri 15 % bolnikov zdravljenih s kombinacijo venetoklaksa in rituksimaba v MURANO študiji in pri 14 % bolnikov zdravljenih z venetoklaksom v študijah z monoterapijo.
No dose adjustment is recommended in patients with mild or moderate hepatic impairment.
Prilagoditev odmerka pri bolnikih z blago ali zmerno okvaro jeter ni priporočljiva.
• abdominal pain and distension
• bolečina v trebuhu in napihnjenost
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.
Pri bolnikih, zdravljenih z ibrutinibom, je bilo mediano število predhodnih onkoloških zdravljenj 4 (razpon: od 1 do 15 zdravljenj), pri bolnikih, zdravljenih z idelalisibom, pa 3 (razpon: od 1 do 11 zdravljenj).
The median time since diagnosis was 8.3 years (range: 0.3 to 18.5 years; N=96).
Mediani čas od diagnoze je bil 8,3 let (razpon: od 0,3 do 18,5 let, N = 96).
Co-administration of narrow therapeutic index P-gp, or BCRP substrates (e.g., digoxin, dabigatran, everolimus, sirolimus) with venetoclax should be avoided.
Sočasnemu dajanju P-gp ali BCRP substratov z ozkim terapevtskim indeksom (npr. digoksin, dabigatran, everolimus, sirolimus) z venetoklaksom se je treba izogibati.
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.
Sočasni uporabi venetoklaksa z močnimi induktorji CYP3A (npr. karbamazepinom, fenitoinom, rifampinom) ali zmernimi induktorji CYP3A (npr. bozentanom, efavirenzom, etravirinom, modafinilom, nafcilinom) se je treba izogibati.
No effects on fertility were observed in fertility and early embryonic development studies in male and female mice.
V študijah plodnosti in zgodnjega embrionalnega razvoja pri mišjih samcih in samicah niso opazili vplivov na plodnost.