natgillin/translations-raw huggingface dataset:
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.
U bolesnika koji su završili fazu titracije doze i primaju stabilnu dnevnu dozu venetoklaksa, dozu venetoklaksa treba smanjiti za 50% pri istodobnoj primjeni s umjerenim inhibitorima CYP3A te za 75% pri istodobnoj primjeni sa snažnim inhibitorima CYP3A.
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].
U trenutku provedbe analize ažuriranih podataka o djelotvornosti u svih bolesnika koji više nisu primali liječenje (završni datum prikupljanja podataka: 8. svibnja 2018.; medijan praćenja od 36 mjeseci), 36-mjesečni procijenjeni PFS u skupini koja je primala venetoklaks + rituksimab iznosio je 71,4% (95% CI: 64,8; 78,1), dok je u skupini koja je primala bendamustin + rituksimab iznosio 15,2% (95% CI: 9,1; 21).
Median time since diagnosis was 6.7 years (range: 0.3 to 29.5).
Medijan vremena od dijagnoze iznosio je 6,7 godina (raspon: 0,3 do 29,5).
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).
(CrCl < 80 ml/min) možda će biti potrebna intenzivnija profilaksa i praćenje kako bi se smanjio rizik od TLS-a pri uvođenju liječenja i tijekom faze titracije doze (vidjeti odlomak „Prevencija sindroma lize tumora“ u prethodnom tekstu).
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 smanjenja doze zbog nuspojava došlo je u 15% bolesnika liječenih kombinacijom venetoklaksa i rituksimaba u ispitivanju MURANO i 14% bolesnika liječenih venetoklaksom u ispitivanjima monoterapije.
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.
U bolesnika koji primaju stabilnu dnevnu dozu lijeka Venclyxto, dozu venetoklaksa treba smanjiti za 50% pri istodobnoj primjeni s umjerenim inhibitorima CYP3A te za 75% pri istodobnoj primjeni sa snažnim inhibitorima CYP3A.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING CARTON multipack (without blue box)
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU KUTIJA - višestruko pakiranje (bez plavog okvira)
Venetoclax is a potent, selective inhibitor of B-cell lymphoma (BCL)-2, an anti-apoptotic protein.
Venetoklaks je snažan, selektivan inhibitor antiapoptotskog proteina B-staničnog limfoma 2 (engl.
Ask your doctor for advice on sperm storage before starting treatment with Venclyxto.
Obratite se svom liječniku za savjet o pohrani sperme prije nego započnete liječenje lijekom
Treatment with Venclyxto should be withheld for any grade 3 or 4 non-haematological toxicities, grade 3 or 4 neutropenia with infection or fever, or grade 4 haematological toxicities, except lymphopenia.
3. ili 4. stupnja, neutropenije 3. ili 4. stupnja praćene infekcijom ili vrućicom, ili hematoloških toksičnosti 4. stupnja, osim limfopenije.
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.
U početnim ispitivanjima faze 1 provedenima radi određivanja doze, koja su imala kraću (2 do 3 tjedna) fazu titracije i višu početnu dozu, incidencija TLS-a iznosila je 13% (10/77; 5 laboratorijski utvrđenih
Post-titration dose for venetoclax in combination with rituximab
Doza venetoklaksa u kombinaciji s rituksimabom nakon titracije
Concomitant use of preparations containing St. John's wort (see sections 4.4 and 4.5).
Istodobna primjena pripravaka koji sadrže gospinu travu (vidjeti dijelove 4.4 i 4.5).
Venetoclax as monotherapy for the treatment of patients with CLL harbouring 17p deletion or TP53 mutation - study M13-982
Venetoklaks u monoterapiji za liječenje bolesnika s KLL-om koji imaju deleciju 17p ili mutaciju gena TP53 - ispitivanje M13-982
Initiation and titration phase
Uvođenje liječenja i faza titracije
It is not known whether the active substance in Venclyxto passes into breast milk.
Nije poznato izlučuje li se djelatna tvar lijeka Venclyxto u majčino mlijeko.
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%.
U ispitivanju interakcija s drugim lijekovima provedenom u 12 zdravih ispitanika, istodobna primjena 500 mg azitromicina prvog dana, a zatim 250 mg azitromicina jedanput na dan tijekom 4 dana, snizila je Cmax venetoklaksa za 25%, a njegov AUC∞ za 35%.
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).
Dozu venetoklaksa koja se koristila prije uvođenja inhibitora CYP3A treba ponovno uvesti 2 do 3 dana nakon prekida primjene inhibitora (vidjeti dio 4.2).
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.
Najčešće nuspojave (≥ 20%) bilo kojeg stupnja u bolesnika koji su primali venetoklaks u ispitivanju kombinacije s rituksimabom bile su neutropenija, proljev i infekcija gornjih dišnih putova.
MRD negativity rate at end of combination treatmentb
Stopa negativnog nalaza na MRD na kraju kombiniranog liječenjab
Because venetoclax was not dosed to steady state, it is recommended that the international normalized ratio (INR) be monitored closely in patients receiving warfarin.
Budući da se venetoklaks nije primjenjivao do postizanja stanja dinamičke ravnoteže, preporučuje se pažljivo pratiti internacionalni normalizirani omjer (engl.
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∞.
U ispitivanju interakcija s drugim lijekovima, primjena jednokratne doze venetoklaksa od 100 mg zajedno s 0,5 mg digoksina, supstrata P-gp-a, povećala je Cmax digoksina za 35%, a AUC∞ digoksina za 9%.
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%).
U ispitivanjima monoterapije venetoklaksom, privremeni je prekid primjene zbog nuspojava zabilježen u 40% bolesnika; najčešća nuspojava koja je dovela do privremenog prekida primjene bila je neutropenija (5%).
P-gp and BCRP inhibitors
Inhibitori P-gp-a i BCRP-a
Blood chemistry (potassium, uric acid, phosphorus, calcium, and creatinine) should be assessed and pre-existing abnormalities corrected.
mokraćna kiselina, fosfor, kalcij i kreatinin) te korigirati postojeća odstupanja od normalnih vrijednosti.
Arm B: 69%).
70% (skupina A: 70%; skupina B: 69%).
Dose modifications for use with CYP3A inhibitors
Prilagodbe doze kod primjene s inhibitorima CYP3A
In the monotherapy studies with venetoclax, 11% of patients discontinued due to adverse reactions.
U ispitivanjima monoterapije venetoklaksom liječenje je zbog nuspojava prekinulo 11% bolesnika.
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).
Preživljenje bez progresije bolesti (engl. progression-free survival, PFS) ocjenjivali su ispitivači na temelju smjernica radne skupine koju je sponzorirao Nacionalni institut za rak (engl.
PFS, months, median (95% CI)
PFS, mjeseci, medijan (95% CI)
Prior to initiating venetoclax, tumour burden assessment, including radiographic evaluation (e.g., CT scan), must be performed for all patients.
Prije uvođenja venetoklaksa, u svih se bolesnika mora odrediti opterećenje tumorskom masom, što uključuje radiografsku ocjenu (npr. CT oslikavanje).
Adverse reactions are listed below by MedDRA body system organ class and by frequency.
3. Nuspojave u nastavku navedene su prema MedDRA klasifikaciji organskih sustava i učestalosti.
Efficacy data are presented for 107 patients with data cutoff date 30 April 2015.
bolesnika za koje su podaci prikupljani do 30. travnja 2015.
PARTICULARS TO APPEAR ON THE OUTER CARTON CARTON (5 day pack)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (5-dnevno pakiranje)
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%.
Istodobna primjena rifampina, inhibitora P-gp-a, u jednokratnoj dozi od 600 mg u 11 zdravih ispitanika, povećala je Cmax venetoklaksa za 106%, a AUC∞ za 78%.
Venetoclax is a P-gp, BCRP and OATP1B1 inhibitor in vitro.
Venetoklaks je inhibitor P-gp-a, BCRP-a i prijenosnika OATP1B1 in vitro.
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).
zimice, mučnine, povraćanja, smetenosti, nedostatka zraka, napadaja, nepravilnih otkucaja srca, tamne ili mutne mokraće, neuobičajenog umora, boli u mišićima ili zglobovima, boli u abdomenu i distenzije abdomena), kao i drugih toksičnosti (vidjeti dio 4.2).
aThe discrepancy between IRC- and investigator-assessed CR rate was due to interpretation of residual adenopathy on CT scans.
aNepodudarnost između stope potpune remisije prema ocjeni neovisnog ocjenjivačkog povjerenstva i stope potpune remisije prema ocjeni ispitivača posljedica je interpretacije rezidualne adenopatije na CT snimcima.
How Venclyxto works
Kako Venclyxto djeluje
Overall, 65% of patients received prior nucleoside analogue, 86% rituximab, 39% other monoclonal antibodies, and 72% alkylating agent (including 41% with bendamustine).
Ukupno je 65% bolesnika prethodno primalo nukleozidni analog, 86% rituksimab, 39% druga monoklonska protutijela, a 72% alkilirajući lijek
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.
CR (engl. complete remission) = potpuna remisija; CRi (engl. complete remission with incomplete marrow recovery) = potpuna remisija uz nepotpun oporavak koštane srži; IRC (engl. independent review committee) = neovisno ocjenjivačko povjerenstvo; MRD (engl. minimal residual disease), minimalna rezidualna bolest; nPR (engl. nodular partial remission) = nodularna djelomična remisija; ND = nije dostupno; NP = nije postignuto; ORR (engl. overall response rate) = stopa ukupnog odgovora (CR + CRi + nPR + PR); PR (engl. partial remission) = djelomična remisija.
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).
1 do 10 terapija); 49,5% prethodno se liječilo nukleozidnim analogom, 38% rituksimabom, a 94% alkilirajućim lijekom (uključujući 33% bolesnika koji su prethodno liječeni bendamustinom).
Concomitant use of venetoclax with moderate CYP3A inhibitors at initiation and during the dose-titration phase should be avoided.
Istodobnu primjenu venetoklaksa s umjerenim inhibitorima CYP3A pri uvođenju liječenja i tijekom faze titracije doze treba izbjegavati.
Venetoclax as monotherapy for the treatment of patients with CLL who have failed a B-cell receptor pathway inhibitor - study M14-032
Venetoklaks u monoterapiji za liječenje bolesnika s KLL-om koji nisu odgovorili na liječenje inhibitorom signalnih puteva B-staničnih receptora - ispitivanje M14-032
anydrous calcium hydrogen phosphate (E341 (ii)), sodium stearyl fumarate.
(E551), bezvodni kalcijev hidrogenfosfat (E341 (ii)), natrijev stearilfumarat.
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.
srednja vrijednost (± standardno odstupanje) Cmax i AUC24 venetoklaksa u stanju dinamičke ravnoteže uz dozu od 400 mg jedanput na dan iznosila je 2,1 ± 1,1 μg/ml odnosno 32,8 ± 16,9 μg•h/ml.
At baseline, 53% of patients had one or more nodes ≥5 cm, and 51% had ALC ≥25 x 109/l.
Na početku ispitivanja, 53% bolesnika imalo je jedan ili više čvorova ≥ 5 cm, dok ih je 51% imalo apsolutan broj limfocita ≥ 25 x 109/l.
PARTICULARS TO APPEAR ON THE OUTER CARTON CARTON (7 day pack)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (7-dnevno pakiranje)
Women of childbearing potential/Contraception in females Women should avoid becoming pregnant while taking Venclyxto and for at least 30 days after ending treatment.
Žene trebaju izbjegavati trudnoću dok uzimaju Venclyxto i još najmanje 30 dana nakon završetka liječenja.
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.
Svi događaji bili su laboratorijski utvrđeni TLS (odstupanja laboratorijskih vrijednosti koja su ispunjavala ≥ 2 od sljedećih kriterija u razmaku manjem od 24 sata: kalij > 6 mmol/l, mokraćna kiselina > 476 µmol/l, kalcij < 1,75 mmol/l ili fosfor > 1,5 mmol/l; ili su prijavljeni kao događaji TLS-a), a nastupili su u bolesnika koji su imali limfni(e) čvor(ove) ≥ 5 cm ili apsolutni broj limfocita ≥ 25 x 109/l.
In the open-label, randomised phase 3 study (MURANO), the incidence of TLS was 3% (6/194) in patients treated with venetoclax + rituximab.
U otvorenom, randomiziranom ispitivanju faze 3 (MURANO), incidencija TLS-a u bolesnika liječenih venetoklaksom + rituksimabom iznosila je 3% (6/194).
• dark or cloudy urine
• tamnu ili mutnu mokraću
Patients with high tumour burden (e.g., any lymph node with a diameter ≥5 cm or high absolute lymphocyte count [ALC ≥25 x 109/l]) are at greater risk of TLS when initiating venetoclax.
Bolesnici s velikim opterećenjem tumorskom masom (npr. bilo kojim limfnim čvorom promjera ≥ 5 cm ili visokim apsolutnim brojem limfocita [≥ 25 x 109/l]) imaju veći rizik od TLS-a pri uvođenju venetoklaksa.
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 sections 4.4 and 4.5).
Dozu venetoklaksa koja se koristila prije uvođenja inhibitora CYP3A treba ponovno uvesti 2 do 3 dana nakon prekida primjene inhibitora (vidjeti dijelove 4.4 i 4.5).
• the starting dose is 20 mg (two 10 mg tablets) once a day for 7 days.
• početna doza je 20 mg (dvije tablete od 10 mg) jedanput na dan tijekom 7 dana
aOne patient did not harbour the 17p deletion.
TTR, mjeseci, medijan (raspon) aJedan bolesnik nije imao deleciju 17p.
These patients should be monitored more closely for signs of toxicity (see section 4.8).
Te bolesnike je potrebno pažljivije nadzirati zbog mogućih znakova toksičnosti (vidjeti dio 4.8).
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).
možda biti potrebna hospitalizacija na dan primjene prve doze venetoklaksa radi intenzivnije profilakse i praćenja tijekom prva 24 sata (vidjeti dio 4.8).
Concomitant use of venetoclax with strong or moderate CYP3A inhibitors increases venetoclax exposure and may increase the risk for TLS at initiation and during the dose-titration phase and for other toxicities (see section 4.5).
Istodobna primjena venetoklaksa sa snažnim ili umjerenim inhibitorima CYP3A povećava izloženost venetoklaksu i može povećati rizik od TLS-a pri uvođenju liječenja i tijekom faze titracije doze kao i rizik od drugih toksičnosti (vidjeti dio 4.5).
More intensive measures (intravenous hydration, frequent monitoring, hospitalisation) should be employed as overall risk increases.
Kako se ukupan rizik povećava, potrebno je uvesti i intenzivnije mjere (intravensku hidraciju, česte kontrole, hospitalizaciju).
Concomitant use of venetoclax with strong CYP3A inhibitors at initiation and during the dose-titration phase is contraindicated (see sections 4.3, 4.4, and 4.5).
Istodobna primjena venetoklaksa sa snažnim inhibitorima CYP3A pri uvođenju liječenja i tijekom faze titracije doze je kontraindicirana (vidjeti dijelove 4.3, 4.4 i 4.5).
• clarithromycin for bacterial infections
• klaritromicinom, za liječenje bakterijskih infekcija • ritonavirom, za liječenje HIV infekcije
- you are taking any of the medicines listed below when you start your treatment and while your dose is gradually being increased (usually over 5 weeks).
- ako na početku liječenja i tijekom razdoblja postupnog povećavanja doze (a koje obično traje
Response rate ORR, % (95% CI)
Stopa odgovora ORR, % (95% CI)
How to take Venclyxto
Kako uzimati Venclyxto
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.
cMeđu bolesnicima za koje su bili dostupni nalazi testiranja na MRD u perifernoj krvi, 72,5% (121/167) bolesnika u skupini liječenoj venetoklaksom + rituksimabom i 20% (26/128)
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%.
5 tjedana povećavala do dnevne doze od 400 mg u ispitivanjima M13-982 i M14-032, stopa TLS-a iznosila je 2%.
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.
Bolesnici s velikim opterećenjem tumorskom masom (npr. bilo kojim limfnim čvorom promjera ≥ 5 cm ili visokim apsolutnim brojem limfocita ≥ 25 x 109/l) imaju veći rizik od TLS-a pri uvođenju venetoklaksa.
25 (19.2, NR)
25 (19,2; NP)
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: Kaplan-Meierove krivulje preživljenja bez progresije bolesti (populacija predviđena za liječenje) prema ocjeni ispitivača u ispitivanju MURANO (završni datum prikupljanja podataka:
Minimal residual disease (MRD) was evaluated using flow cytometry in 93 of 158 patients who achieved complete remission (CR), complete remission with incomplete marrow recovery (CRi), or partial remission (PR) with limited remaining disease with venetoclax treatment.
Minimalna rezidualna bolest (engl. minimal residual disease, MRD) ocjenjivala se protočnom citometrijom u 93 od 158 bolesnika koji su liječenjem venetoklaksom postigli potpunu remisiju,
Investigator assessment (N=158)b
(N=158)b
Bile acid sequestrants
Sekvestranti žučne kiseline
• In the tablet core: copovidone (K 28), polysorbate 80 (E433), colloidal anhydrous silica (E551),
• U jezgri tablete: kopovidon (K 28), polisorbat 80 (E433), bezvodni koloidni silicijev dioksid
Median, months (95% CI)
Medijan, mjeseci (95% CI)
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.
Bolesnike osobito treba uputiti da 2 dana prije i na dan primjene doze na početku liječenja i pri svakom sljedećem povećanju doze svakodnevno popiju 1,5 do 2 l vode.
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%.
Istodobna primjena rifampina, snažnog induktora CYP3A, u dozi od 600 mg jedanput na dan tijekom 13 dana u 10 zdravih ispitanika smanjila je Cmax venetoklaksa za 42%, a AUC∞ za 71%.
If a moderate CYP3A inhibitor must be used, the initiation dose of venetoclax and the doses for the titration phase (see section 4.2) should be reduced by at least 50%.
CYP3A mora primijeniti, početnu dozu venetoklaksa i doze tijekom faze titracije (vidjeti dio 4.2) treba smanjiti za najmanje 50%.
• 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
u prisutnosti delecije 17p ili mutacije gena TP53 u odraslih bolesnika koji nisu pogodni za liječenje inhibitorom signalnih puteva B-staničnih receptora ili nisu na njega odgovorili, ili u odsustvu delecije 17p ili mutacije gena TP53 u odraslih bolesnika koji nisu odgovorili ni na kemoimunoterapiju ni na liječenje inhibitorom signalnih puteva
At baseline, 41% of patients had one or more nodes ≥5 cm and 31% had ALC ≥25 x 109/l.
Na početku ispitivanja, 41% bolesnika imalo je jedan ili više čvorova ≥ 5 cm, dok ih je 31% imalo apsolutni broj limfocita ≥ 25 x 109/l.
Blood chemistries should be monitored and abnormalities managed promptly.
Treba nadzirati biokemijske parametre krvi i odmah korigirati sva odstupanja od normalnih vrijednosti.
Tumour lysis syndrome Hyperkalaemia Hyperphosphataemia Hypocalcaemia
Poremećaji metabolizma i prehrane vrlo često hiperkalijemija hiperfosfatemija hipokalcijemija često sindrom lize tumora hiperuricemija sindrom lize tumora hiperkalijemija hiperfosfatemija hipokalcijemija manje često hiperuricemija
Hazard ratio (95% CI) P-valuea
Omjer hazarda (95% CI) P-vrijednosta
• 5 tablets (5 blisters each with 1 tablet)
• 5 tableta (5 blistera, svaki s 1 tabletom)
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).
(CrCl ≥ 30 ml/min i < 90 ml/min) (vidjeti dio 5.2).
Grapefruit products, Seville oranges, and starfruit (carambola) should be avoided during treatment with venetoclax as they contain inhibitors of CYP3A.
Seville) i zvjezdasto voće (karambolu) jer oni sadrže inhibitore CYP3A.
The frequencies of adverse reactions reported with Venclyxto are summarised in Table 3.
Učestalost nuspojava prijavljenih uz Venclyxto sažeto je prikazana u Tablici
Venetoclax daily dose
Dnevna doza venetoklaksa
Common (may affect up to 1 in 10 people)
Sindrom lize tumora (često - može se javiti u do 1 na 10 osoba)
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.
Prema populacijskoj farmakokinetičkoj analizi koja je obuhvatila 219 ispitanika s blagim oštećenjem bubrežne funkcije (CrCl ≥ 60 i < 90 ml/min), 86 ispitanika s umjerenim oštećenjem bubrežne funkcije
Patients randomised to BR received bendamustine at 70 mg/m2 on Days 1 and 2
Bolesnici randomizirani za protokol BR primali su bendamustin u dozi od 70 mg/m2 1. i 2. dana tijekom 6 ciklusa te rituksimab na prethodno opisan način.