natgillin/translations-raw huggingface dataset:
What Zydelig is and what it is used for What you need to know before you take Zydelig How to take Zydelig
Kaj je zdravilo Zydelig in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Zydelig Kako jemati zdravilo Zydelig Možni neželeni učinki
• atorvastatin, lovastatin, simvastatin, medicines used to lower cholesterol
• atorvastatin, lovastatin, simvastatin; zdravila, ki se uporabljajo za nižanje holesterola
ANC 1,000 to < 1,500/mm3
ANC 1.000 do < 1.500/mm3
Population pharmacokinetic analyses indicated that gender and race had no clinically relevant effect on the exposures to idelalisib or GS-563117.
Analize populacijske farmakokinetike kažejo, da spol in rasa nimata klinično pomembnega učinka na izpostavljenost idelalizibu ali GS-563117.
↑ serum concentrations Careful monitoring of adverse reactions (e.g., respiratory depression, sedation) is recommended.
↑ koncentracij v serumu Priporoča se skrbno spremljanje neželenih učinkov (npr. respiratorna depresija, sedacija).
Zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment (see section 4.4).
Zdravilo Zydelig je indicirano kot monoterapija za zdravljenje odraslih bolnikov s folikularnim limfomom (FL), neodzivnim na dve predhodni obliki zdravljenja (glejte poglavje 4.4).
Further investigation of this topic in current B-cell malignancy studies is not planned.
V študijah malignosti celic B, ki so v teku, ne načrtujejo dodatnih raziskav v zvezi s tem.
For patients with CrCl < 60 mL/min, alternative antibacterials should be considered.
Pri bolnikih s CrCl < 60 ml/min je treba razmisliti o uporabi alternativnega zdravila za zdravljenje okužb z bakterijami.
The Kaplan-Meier curve for PFS is provided in Figure 2.
Kaplan-Meierjeva krivulja za PFS je na sliki 2.
Tyrosine kinase inhibitors such as dasatinib and nilotinib, also vincristine and vinblastine
zaviralci tirozin kinaze, kot so dasatinib in nilotinib, tudi vinkristin in vinblastin
ANC 500 to < 1,000/mm3
ANC 500 do < 1.000/mm3
Population pharmacokinetic analyses indicated that age had no clinically relevant effect on the exposures to idelalisib or GS-563117, including elderly subjects (65 years of age and older), compared to younger subjects.
Analize populacijske farmakokinetike kažejo, da starost nima klinično pomembnega učinka na izpostavljenost idelalizibu ali GS-563117, vključno s starejšimi osebami (65 let in več), v primerjavi z mlajšimi osebami.
No human data on the effect of idelalisib on fertility are available.
Podatki o vplivu idelaliziba na plodnost pri ljudeh niso na voljo.
What you need to know before you take Zydelig Do not take Zydelig
Kaj morate vedeti, preden boste vzeli zdravilo Zydelig Ne jemljite zdravila Zydelig
Very common
zelo pogosti pogosti
• bosentan, a medicine used to treat pulmonary arterial hypertension
• bosentan, zdravilo, ki se uporablja za zdravljenje pljučne arterijske hipertenzije
If you accidentally take more than the recommended dose of Zydelig, you may be at increased risk of side effects with this medicine (see section 4, Possible side effects).
Če ste vzeli večji odmerek zdravila Zydelig, kot bi smeli Če ste pomotoma zaužili odmerek zdravila Zydelig, višji od priporočenega, obstaja povečano tveganje za neželene učinke tega zdravila (glejte poglavje 4, Možni neželeni učinki).
The idelalisib AUC (unbound), after accounting for differences in protein binding, was ~80% (1.8-fold) higher in moderate and ~152% (2.5-fold) higher in severe impairment compared to matched controls.
Vrednost AUC idelaliziba (nevezanega) je bila po upoštevanju razlik pri vezavi na beljakovine ~ 80 (1,8-krat) % višja pri zmerni in ~ 152 % (2,5-krat) višja pri hudi okvari v primerjavi z ustrezno kontrolno skupino.
There is a potential risk that idelalisib, via its major metabolite, GS-563117, may cause photosensitivity in treated patients.
Obstaja potencialno tveganje, da bi lahko idelalizib, prek svojega glavnega presnovka, GS-563117, povzročil fotosenzitivnost pri zdravljenih bolnikih.
Idelalisib induces apoptosis and inhibits proliferation in cell lines derived from malignant B-cells and in primary tumour cells.
Idelalizib povzroči apoptozo in zavira proliferacijo celičnih linij, ki nastajajo iz malignih celic B in v celicah primarnega tumorja.
Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents, ATC code: L01XX47
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), druga zdravila z delovanjem na novotvorbe (citostatiki), oznaka ATC: L01XX47
Women of childbearing potential must use highly effective contraception while taking idelalisib and for 1 month after stopping treatment (see section 4.6).
Ženske v rodni dobi morajo med jemanjem idelaliziba in še 1 mesec po prenehanju zdravljenja uporabljati zelo učinkovito kontracepcijo (glejte poglavje 4.6).
Following oral administration of a single dose of idelalisib, peak plasma concentrations were observed 2 to 4 hours post-dose under fed conditions and after 0.5 to 1.5 hours under fasted conditions.
Po peroralnem dajanju enega odmerka idelaliziba so največje koncentracije v plazmi opazili 2 do 4 ure po odmerjanju s hrano in po 0,5 do 1,5 ure na tešče.
• The active substance is idelalisib.
• Učinkovina je idelalizib.
Zydelig contains sunset yellow FCF which may cause allergic reactions.
Zdravilo Zydelig vsebuje barvilo sončno rumeno FCF, ki lahko povzroči alergijske reakcije.
Idelalisib + O 174 (0) 162 (6) 151 (13) 140 (22) 129 (31) 110 (45) 82 (57) 44 (67) 37 (70) 7 (76) 1 (76) 0 (76) Ofatumumab 87 (0) 60 (14) 47 (21) 34 (30) 26 (34) 11 (49) 8 (51) 6 (52) 6 (52) 2 (54) 0 (54) 0 (54)
Idelalizib + O 174 (0) 162 (6) 151 (13) 140 (22) 129 (31) 110 (45) 82 (57) 44 (67) 37 (70) 7 (76) 1 (76) 0 (76) Ofatumumab 87 (0) 60 (14) 47 (21) 34 (30) 26 (34) 11 (49) 8 (51) 6 (52) 6 (52) 2 (54) 0 (54) 0 (54)
High density polyethylene (HDPE) bottle, capped with a polypropylene child-resistant closure, containing 60 film-coated tablets and a polyester coil.
Plastenka, narejena iz polietilena visoke gostote (HDPE-high density polyethylene), zaprta z za otroke varno zaporko iz polipropilena, vsebuje 60 filmsko obloženih tablet in poliestrsko vato.
Skin and subcutaneous tissue disorders Rash***
Bolezni kože in podkožja izpuščaj***
Blistering can also involve the lining of the mouth, genitals, and/or eyes.
Mehurji se lahko pojavijo tudi na ustni sluznici, spolovilih in/ali očeh.
Neutropenia Treatment with Zydelig should be withheld in patients while absolute neutrophil count (ANC) is below 500 per mm3.
Zdravljenje z zdravilom Zydelig je treba začasno ustaviti pri bolnikih z absolutnim številom nevtrofilcev (ANC) pod 500 na mm3.
Expected effect of idelalisib on drug levels
Pričakovani učinek idelaliziba na ravni zdravila
ANALGESICS
ANALGETIKI
Co-administration of multiple doses of idelalisib 150 mg twice daily to healthy subjects resulted in comparable exposures for rosuvastatin (AUC 90% CI: 87, 121) and digoxin (AUC 90% CI: 98, 111), suggesting no clinically relevant inhibition of BCRP, OATP1B1/1B3 or systemic P-gp by idelalisib.
Sočasno dajanje več odmerkov idelaliziba 150 mg dvakrat na dan zdravim osebam je povzročilo primerljive izpostavljenosti za rosuvastatin (AUC 90 % IZ: 87, 121) in digoksin (AUC 90 % IZ: 98, 111), kar kaže, da naj idelalizib ne bi klinično pomembno zaviral BCRP, OATP1B1/1B3 ali sistemskega P-gp.
Solid line: idelalisib + R (N = 110), dashed line: placebo + R (N = 110) R: rituximab; N: number of subjects per group
Polna črta: idelalizib + R (N = 110), prekinjena črta: placebo + R (N = 110) R: rituksimab; N: število oseb na skupino
If any doubt exists, referral to a neurologist and appropriate diagnostic measures for PML including MRI scan preferably with contrast, cerebrospinal fluid (CSF) testing for JC viral DNA and repeat neurological assessments should be considered.
Ob vsakršnem dvomu je treba razmisliti o napotitvi k nevrologu in ustreznih diagnostičnih ukrepih za PML, vključno s slikanjem z magnetno resonanco, po možnosti s kontrastom, preiskavo za določanje prisotnosti DNA virusa JC v cerebrospinalni tekočini (CST) in ponovnimi nevrološkimi ocenami.
** Idelalisib-induced lymphocytosis should not be considered progressive disease in the absence of other clinical findings (see section 5.1).
** Brez prisotnosti drugih kliničnih rezultatov naj se z idelalizibom povzročene limfocitoze ne šteje za progresivno bolezen (glejte poglavje 5.1).
Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Paediatric population The pharmacokinetics of idelalisib in paediatric subjects has not been established (see section 4.2).
Pediatrična populacija Farmakokinetike idelaliziba pri pediatričnih osebah niso ugotavljali (glejte poglavje 4.2).
Thus, idelalisib has the potential to interact with medicinal products that are metabolised by CYP3A, which may lead to increased serum concentrations of the other product (see section 4.5).
Zato lahko idelalizib medsebojno deluje z zdravili, ki jih CYP3A presnavlja, kar lahko povzroči povečane koncentracije drugih zdravil v serumu (glejte poglavje 4.5).
Solid line: idelalisib + O (N = 174), dashed line: ofatumumab (N = 87) O: ofatumumab; N: number of subjects per group
Polna črta: idelalizib + O (N = 174), prekinjena črta: ofatumumab (N = 87) O: ofatumumab; N: število oseb na skupino
Zydelig is indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):
Zdravilo Zydelig je indicirano v kombinaciji z rituksimabom za zdravljenje odraslih bolnikov s kronično limfocitno levkemijo (KLL):
Zydelig is for oral use.
Zdravilo Zydelig je za peroralno uporabo.
In a rat male fertility study, decreases in epididymides and testes weight were observed but no adverse effects on mating or fertility parameters, and no degeneration or loss in spermatogenesis were observed.
V študiji plodnosti pri podganjih samcih so opazili zmanjšanje mase obmodkov in mod, vendar pa niso opazili neželenih učinkov na parametre parjenja ali plodnosti oz. degeneracije ali izgube spermatogeneze.
Female fertility was not affected in rats.
Pri podganah plodnost samic ni bila prizadeta.
If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8).
V primeru prevelikega odmerka je treba pri bolniku nadzorovati znake toksičnosti (glejte poglavje 4.8).
Zydelig should not be used with any other medicines unless your doctor has told you it is safe to do so.
Druga zdravila in zdravilo Zydelig Zdravila Zydelig ne uporabljajte z drugimi zdravili, razen če zdravnik potrdi, da je to varno.
The Phase 1 and 2 studies assessed the safety of idelalisib in a total of 536 subjects with haematologic malignancies, including 400 subjects who received idelalisib (any dose) as a single agent and 136 subjects who received idelalisib in combination with an anti-CD20 monoclonal antibody (rituximab or ofatumumab).
V študijah 1. in 2. faze so ocenili varnost idelaliziba pri skupaj 536 osebah s hematološkimi malignostmi, vključno s 400 osebami, ki so prejemale idelalizib (kateri koli odmerek) kot edino zdravilo, in 136 osebami, ki so idelalizib prejemale v kombinaciji z monoklonskim protitelesom proti CD20 (rituksimabom ali ofatumumabom).
In studies 312-0116/0117 and 312-0119, rash (reported as dermatitis exfoliative generalised, drug eruption, rash, rash erythematous, rash generalised, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, rash vesicular, papule and skin plaque) occurred in 31.1% of subjects who received idelalisib + an anti-CD20 monoclonal antibody (rituximab or ofatumumab) and 8.2% who received an anti-CD20 monoclonal antibody only (rituximab or ofatumumab).
V študijah 312-0116/0117 in 312-0119 se je izpuščaj (o njem so poročali kot o generaliziranem eksfoliativnem dermatitisu, medikamentnem izpuščaju, izpuščaju, eritematoznem izpuščaju, generaliziranem izpuščaju, makularnem izpuščaju, makulopapularnem izpuščaju, papularnem izpuščaju, pruritičnem izpuščaju, pustularnem izpuščaju, vezikularnem izpuščaju, papulah in kožnem plaku) pojavil pri 31,1 % oseb, ki so prejemale idelalizib + monoklonsko protitelo proti CD20 (rituksimab ali ofatumumab), in pri 8,2 % oseb, ki so prejemale samo monoklonsko protitelo proti CD20 (rituksimab ali ofatumumab).
Therefore, caution is recommended when administering Zydelig in this population and an intensified monitoring of adverse reactions is recommended (see sections 4.4 and 5.2).
Zato se pri dajanju zdravila Zydelig tej populaciji priporoča previdnost in intenzivnejše spremljanje neželenih učinkov (glejte poglavji 4.4 in 5.2).
Of these, 5.7% who received idelalisib + an anti-CD20 monoclonal antibody (rituximab or ofatumumab) and 1.5% who received an anti-CD20 monoclonal antibody only (rituximab or ofatumumab) had rash of Grade 3, and no subjects had an adverse reaction of Grade 4.
Od teh je imelo 5,7 % oseb, ki so prejemale idelalizib + monoklonsko protitelo proti CD20 (rituksimab ali ofatumumab), in 1,5 % oseb, ki so prejemale samo monoklonsko protitelo proti CD20 (rituksimab ali ofatumumab), izpuščaj 3. stopnje, nobena oseba pa ni imela neželenega učinka 4. stopnje.
Idelalisib exposure may be reduced when co-administered with CYP3A inducers such as rifampicin, phenytoin, St. John's wort (Hypericum perforatum), or carbamazepine.
Izpostavljenost idelalizibu se lahko zmanjša pri sočasni uporabi z induktorji CYP3A, kot so rifampicin, fenitoin, šentjanževka (Hypericum perforatum) ali karbamazepin.
• clarithromycin, telithromycin, medicines used to treat bacterial infections
• klaritromicin, telitromicin, zdravili, ki se uporabljata za zdravljenje bakterijskih okužb
Zydelig is a cancer medicine that contains the active substance idelalisib.
Zdravilo Zydelig je zdravilo proti raku, ki vsebuje učinkovino idelalizib.
Serious and fatal infections have occurred with idelalisib, including opportunistic infections such as Pneumocystis jirovecii pneumonia (PJP) and cytomegalovirus (CMV).
Pri idelalizibu so se pojavile resne in smrtne okužbe, vključno z oportunističnimi okužbami, kot sta pljučnica, ki jo povzroča Pneumocystis jirovecii (PJP), in okužba s citomegalovirusom (CMV).
A dose-related increase in pancreatic islet cell tumors was observed at low incidence in male rats at exposures up to 0.4-fold compared to the human exposure at the recommended dose; a similar finding was not observed in female rats at 0.62-fold exposure margin.
Pri samcih podgan so ob 0,4-kratni izpostavljenosti v primerjavi s človeško izpostavljenostjo pri priporočenem odmerku opazili od odmerka odvisno povečanje tumorjev celic pankreasnih otočkov z majhno incidenco; pri samicah podgan pri 0,62-kratni meji izpostavljenosti podobnega učinka niso opazili.
Breast-feeding It is not known whether idelalisib and its metabolites are excreted in human milk.
Dojenje Ni znano, ali se idelalizib in njegovi presnovki izločajo v materino mleko.
Take care to not miss a dose of Zydelig.
Bodite skrbni in odmerkov zdravila Zydelig ne izpustite.
• quetiapine, a medicine used to treat schizophrenia, bipolar disorder and major depressive disorder
• kvetiapin; zdravilo, ki se uporablja za zdravljenje shizofrenije, bipolarne motnje in velike depresivne motnje
20.9 (20.9, NR)
20,9 (20,9; ND)
Idelalisib is a selective inhibitor of adenosine-5'-triphosphate (ATP) binding to the catalytic domain of PI3Kδ, resulting in inhibition of the phosphorylation of the key lipid second messenger phosphatidylinositol and prevention of Akt (protein kinase B) phosphorylation.
Idelalizib je selektivni zaviralec adenozin 5'-trifosfata (ATP), ki se veže na katalitično domeno PI3Kδ, kar povzroči zaviranje fosforilacije fosfatidilinozitola, glavnega lipidnega sekundarnega obveščevalca, in prepreči fosforilacijo Akt (proteinske kinaze B).
The recommended dose is 150 mg by mouth twice a day.
Priporočeni odmerek je 150 mg dvakrat na dan peroralno.
Since a reduction in idelalisib plasma concentrations may result in decreased efficacy, co-administration of Zydelig with moderate or strong CYP3A inducers should be avoided (see section 4.5).
Ker lahko zmanjšanje koncentracij idelaliziba v plazmi zmanjša učinkovitost, se je treba sočasnemu dajanju zdravila Zydelig z zmernimi ali močnimi induktorji CYP3A izogniti (glejte poglavje 4.5).
Through inhibition of chemokine receptors CXCR4 and CXCR5 signalling induced by the chemokines CXCL12 and CXCL13, respectively, idelalisib inhibits homing and retention of malignant B-cells in the tumour microenvironment including lymphoid tissues and the bone marrow.
Z zaviranjem prenosa signalov hemokinskih receptorjev CXCR4 in CXCR5, ki jih povzročita hemokina CXCL12 oz. CXCL13, idelalizib zavira zadrževanje in zastoj malignih celic B v mikrookolju tumorja, vključno z limfnimi tkivi in kostnim mozgom.
Idelalisib + R 110 (0) 101 (3) 93 (7) 73 (9) 59 (14) 31 (19) 20 (21) 9 (24) 7 (24) 4 (24) 1 (25) 0 (25) Placebo + R 110 (0) 84 (21) 48 (38) 29 (46) 20 (53) 9 (63) 4 (67) 1 (69) 0 (70) 0 (70) 0 (70) 0 (70)
Idelalizib + R 110 (0) 101 (3) 93 (7) 73 (9) 59 (14) 31 (19) 20 (21) 9 (24) 7 (24) 4 (24) 1 (25) 0 (25) Placebo + R 110 (0) 84 (21) 48 (38) 29 (46) 20 (53) 9 (63) 4 (67) 1 (69) 0 (70) 0 (70) 0 (70) 0 (70)
Caution is advised if Zydelig is used together with narrow therapeutic index drugs that are substrates of CYP2C8 (paclitaxel).
Previdnost se svetuje pri uporabi zdravila Zydelig skupaj z zdravili z ozkim terapevtskim indeksom, ki so substrati CYP2C8 (paklitaksel).
In an embryo-foetal development study in rats, increased post-implantation loss, malformations (absence of caudal vertebrae and in some cases also of sacral vertebrae), skeletal variations and lower foetal body weights were observed.
V študiji razvoja zarodka in ploda pri podganah so opazili večjo izgubo po ugnezditvi, deformacije (odsotnost repnih vretenc in v nekaterih primerih tudi križnih vretenc), spremembe v razvoju okostja in nižjo telesno maso zarodkov.
It is not known whether the active substance in Zydelig passes into human milk.
Ni znano, ali se učinkovina zdravila Zydelig izloča v materino mleko.
Idelalisib inhibits phosphatidylinositol 3-kinase p110δ (PI3Kδ), which is hyperactive in B-cell malignancies and is central to multiple signalling pathways that drive proliferation, survival, homing, and retention of malignant cells in lymphoid tissues and bone marrow.
Idelalizib zavira fosfatidilinozitol 3-kinazo p110δ (PI3Kδ), ki je pri malignostih B-celic hiperaktivna in osrednjega pomena za več poti prenosa signalov, ki so gonilo proliferacije, preživetja, zadrževanja in zastoja malignih celic v limfnih tkivih in kostnem mozgu.
Stevens-Johnson syndrome/ toxic epidermal necrolysis
Stevens-Johnsonov sindrom/ toksična epidermalna nekroliza redki redki
Idelalisib did not induce mutations in the microbial mutagenesis (Ames) assay, was not clastogenic in the in vitro chromosome aberration assay using human peripheral blood lymphocytes, and was not genotoxic in the in vivo rat micronucleus study.
Idelalizib v testih mutageneze na mikrobih (Amesov test) ni povzročil mutacij, v testu kromosomskih aberacij in vitro pri človeških limfocitih periferne krvi ni bil klastogen in v študiji s podganjimi mikronukleusi in vivo ni bil genotoksičen.
• sildenafil, tadalafil, medicines used to treat impotence and pulmonary hypertension, a lung disease that makes breathing difficult
• sildenafil, tadalafil, zdravili, ki se uporabljata za zdravljenje impotence in pljučne hipertenzije - bolezni pljuč, ki otežuje dihanje
Following a single 150 mg oral dose of [14C]-labelled idelalisib, approximately 78% and 15% was excreted in faeces and urine, respectively.
Po peroralnem dajanju enega 150 mg odmerka s [14C] označenega idelaliziba se ga je približno 78 % izločilo v blatu in približno 15 % v urinu.
• ciclosporin, sirolimus, tacrolimus, medicines used to control your body's immune response after a transplant
• ciklosporin, sirolimus, takrolimus, zdravila za nadzor imunskega odziva telesa po presaditvi
Blood counts should be monitored in all patients at least every 2 weeks for the first 6 months of treatment with idelalisib, and at least weekly in patients while ANC is less than 1,000 per mm3 (see section 4.2).
Pri vseh bolnikih je treba prvih 6 mesecev zdravljenja z idelalizibom najmanj vsaka 2 tedna spremljati krvno sliko, pri bolnikih z ANC pod 1.000 na mm3 pa najmanj enkrat tedensko (glejte poglavje 4.2).
For patients with evidence of CMV viraemia and clinical signs of CMV infection, consideration should be given to interrupting idelalisib until the infection has resolved.
Pri bolnikih z znaki viremije CMV in kliničnimi znaki okužbe s CMV je treba razmisliti o prekinitvi zdravljenja z idelalizibom, dokler okužba ne izgine.
Its primary metabolite is GS-563117, which is not pharmacologically active.
Njegov primarni presnovek je GS-563117, ki ni farmakološko aktiven.
Serum transaminase elevations correlated with hepatic necrosis in dogs, but were not observed in rats.
Povečanje transaminaze v serumu je bilo pri psih soodvisno od jetrne nekroze, pri podganah pa tega niso opazili.
Stevens-Johnson syndrome and toxic epidermal necrolysis Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) with fatal outcomes have been reported when idelalisib was administered concomitantly with other medicinal products associated with these syndromes.
Stevens-Johnsonov sindrom in toksična epidermalna nekroliza Poročali so o Stevens-Johnsonovem sindromu (SJS) in toksični epidermalni nekrolizi (TEN) s smrtnimi izidi, ko so idelalizib dajali sočasno z drugimi zdravili, povezanimi s tema sindromoma.
Among the 122 subjects with measurable lymph nodes at both baseline and post-baseline, 71 subjects (58.2%) achieved a ≥ 50% decrease from baseline in the sum of the products of the diameters (SPD) of index lesions.
Med 122 osebami z merljivimi bezgavkami ob izhodišču in po izhodišču je 71 oseb (58,2 %) doseglo ≥ 50-odstotno zmanjšanje od izhodišča glede na vsoto zmnožkov premerov (SPD) indikacijskih lezij.
Caution is advised if Zydelig is used together with narrow therapeutic index drugs that are substrates of these enzymes (warfarin, phenytoin, S-mephenytoin).
Previdnost se svetuje pri uporabi zdravila Zydelig skupaj z zdravili z ozkim terapevtskim indeksom, ki so substrati teh encimov (varfarin, fenitoin, S-mefenitoin).
GS-563117 is not an inhibitor of the metabolising enzymes CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or UGT1A1, or of the transporters P-gp, BCRP, OATP1B1, OATP1B3, OAT1, OAT3, or OCT2.
GS-563117 ni zaviralec presnovnih encimov CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 ali UGT1A1 ali prenašalcev P-gp, BCRP, OATP1B1, OATP1B3, OAT1, OAT3 ali OCT2.
Monitor ANC at least weekly until ANC ≥ 500/mm3, then may resume Zydelig dosing at 100 mg twice daily.
ANC spremljajte najmanj enkrat tedensko, dokler ni ANC ≥ 500/mm3, nato lahko nadaljujete z odmerjanjem zdravila Zydelig 100 mg dvakrat dnevno.
Following 150 mg twice daily administration of idelalisib, average (range) Cmax and AUC at steady-state were 1,953 (272; 3,905) ng/mL and 10,439 (2,349; 29,315) ng•h/mL for idelalisib and 4,039 (669; 10,897) ng/mL and 39,744 (6,002; 119,770) ng•h/mL for GS-563117, respectively.
Po odmerjanju idelaliziba 150 mg dvakrat na dan sta bila povprečna (razpon) Cmax in AUC v stanju dinamičnega ravnovesja 1.953 (272; 3.905) ng/ml in 10.439 (2.349; 29.315) ng•h/ml za idelalizib oz. 4.039 (669; 10.897) ng/ml in 39.744 (6.002; 119.770) ng•h/ml za GS-563117.
The first infusion of ofatumumab was administered at a dose of 300 mg and was continued at a dose of either 1,000 mg in the idelalisib + ofatumumab group or a dose of 2,000 mg in the ofatumumab only group, weekly for 7 doses, and then every 4 weeks for 4 doses.
Prvo infundiranje ofatumumaba je vključevalo odmerek 300 mg in se je nadaljevalo s 7 tedenskimi odmerki 1.000 mg v skupini z idelalizibom + ofatumumabom ali 2.000 mg v skupini, ki je prejemala samo ofatumumab, nato pa s 4 odmerki vsake 4 tedne.