natgillin/translations-raw huggingface dataset:
The primary endpoint was to evaluate the efficacy of Alecensa by ORR as per central IRC assessment using RECIST version 1.1.
Primarni opazovani dogodek je bila ocena učinkovitosti zdravila Alecensa na podlagi ORR, kot ga je ocenil IRC na podlagi meril RECIST (različica 1.1).
In pregnant rats, alectinib caused total embryo-foetal loss (miscarriage) at exposures 4.5-fold of the human AUC exposure and small foetuses with retarded ossification and minor abnormalities of the organs at exposures 2.7-fold of the human AUC exposure.
Pri brejih podganah je alektinib pri izpostavljenosti, ki je bila (glede na AUC) 4,5-krat večja od izpostavljenosti pri človeku, povzročil embrio-fetalno izgubo (splave) in pri izpostavljenosti, ki je bila (glede na AUC) 2,7-krat večja od izpostavljenosti pri človeku, majhne plodove z zapoznelo osifikacijo in manjšimi nepravilnostmi organov.
No adverse effects on male and female reproductive organs were observed in general toxicology studies.
V splošnih toksikoloških študijah niso ugotovili neugodnih vplivov na reproduktivne organe samcev in samic.
● abnormal results of blood tests to check for liver disease or bone disorders (high level of alkaline phosphatase)
● nenormalni izvidi preiskav krvi, ki odražajo bolezen jeter ali bolezni kosti (velika koncentracija alkalne fosfataze);
Elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 5 times the ULN as well as bilirubin elevations of more than 3 times the ULN occurred in patients in pivotal clinical trials with Alecensa (see section 4.8).
Pri bolnikih v ključnih kliničnih preskušanjih z zdravilom Alecensa so se pojavila zvišanja alaninaminotransferaze (ALT) in aspartat-aminotransferaze (AST) na več kot 5-kratno ZMN in zvišanja bilirubina na več kot 3-kratno ZMN (glejte poglavje 4.8).
ALT = alanine aminotransferase; AST = aspartate aminotransferase; CPK = creatine phosphokinase; CTCAE = NCI Common Terminology Criteria for Adverse Events; ILD = interstitial lung disease; ULN = upper limit of normal a
ALT = alanin-aminotransferaza, AST = aspartat-aminotransferaza, CPK = kreatin-fosfokinaza,
Elimination Following administration of a single dose of 14C-labeled alectinib administered orally to healthy subjects the majority of radioactivity was excreted in faeces (mean recovery 97.8%) with minimal excretion in urine (mean recovery 0.46%).
C označenega alektiniba pri zdravih osebah se je večina radioaktivnosti izločila v blatu (povprečno se je v blatu pojavilo 97,8 %), izločanje v urinu pa je bilo minimalno (povprečno se je v urinu pojavilo 0,46 %).
Alecensa may cause foetal harm when administered to a pregnant woman.
Zdravilo Alecensa lahko škoduje plodu, če je uporabljeno med nosečnostjo.
White shellac
Beli šelak
Mothers should be advised against breast-feeding while receiving Alecensa.
Materam se priporoča, naj med jemanjem zdravila Alecensa ne dojijo.
What Alecensa looks like and contents of the pack Alecensa hard capsule are white, with ‘ALE' printed in black ink on the cap and ‘150 mg' printed in black ink on the body.
Trde kapsule zdravila Alecensa so bele barve ter imajo na pokrovčku s črno barvo izpisano "ALE", na telesu pa prav tako s črno barvo "150 mg".
The data described below reflect exposure to Alecensa in 405 patients with ALK-positive advanced NSCLC who participated in one randomised Phase III clinical trial (BO28984) and in two single-arm phase II clinical trials (NP28761, NP28673).
Podatki, opisani v nadaljevanju, odsevajo izpostavljenost zdravilu Alecensa pri 405 bolnikih z ALKpozitivnim napredovalim nedrobnoceličnim rakom pljuč, ki so sodelovali v enem randomiziranem kliničnem preskušanju faze III (BO28984) in v dveh kliničnih preskušanjih z eno skupino faze II (NP28761, NP28673).
INFORMATION IN BRAILLE alecensa
PODATKI V BRAILLOVI PISAVI
● Printing ink: red iron oxide (E172), yellow iron oxide (E172), indigo carmine aluminium lake (E132), carnauba wax, white shellac and glyceryl monooleate.
● Barva za napis: rdeči železov oksid (E172), rumeni železov oksid (E172), indigotin (E132), karnauba vosek, bel šelak in glicerilmonooleat.
Based on a population pharmacokinetic analysis, alectinib and M4 exposures were similar in patients with mild hepatic impairment and normal hepatic function.
Na podlagi populacijske farmakokinetične analize sta bili izpostavljenosti alektinibu in M4 pri bolnikih z blago okvaro jeter in bolnikih z normalnim delovanjem jeter podobni.
Based on in vitro data, CYP3A4 is the primary enzyme mediating the metabolism of both alectinib and its major active metabolite M4, and CYP3A contributes to 40% − 50% of total hepatic metabolism.
Na podlagi podatkov in vitro je CYP3A4 glavni encim v presnovi alektiniba in njegovega glavnega aktivnega presnovka M4; CYP3A katalizira od 40 do 50 % vse presnove v jetrih.
Elevations of CPK occurred in pivotal trials with Alecensa, including Grade 3 events (see section 4.8).
V ključnih preskušanjih z zdravilom Alecensa so se pojavila zvišanja CPK, vključno z dogodki stopnje 3 (glejte poglavje 4.8).
How to take Alecensa
Kako jemati zdravilo Alecensa
Temporarily withhold until recovery to baseline or to ≤ 2.5 times ULN, then resume at the same dose.
Začasno prekinite uporabo zdravila, dokler se vrednosti ne normalizirajo ali znižajo na ≤ 2,5kratno ZMN, nato znova začnite zdravljenje z enakim odmerkom.
● If Alecensa is packed in blisters, store in the original package in order to protect from moisture.
● Če je zdravilo Alecensa v pretisnih omotih, ga shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
Dose modifications of Alecensa treatment due to these adverse events were only required for two patients (0.5%); Alecensa treatment was not withdrawn due to these events of myalgia.
Prilagoditev zdravljenja z zdravilom Alecensa je bila zaradi teh učinkov potrebna le pri dveh bolnikih (0,5 %).
ADRs (MedDRA)
Neželeni učinek (MedDRA)
Time to CNS progression (IRC)*, ** Number of patients with event n (%)
(IRC)*, ** Število bolnikov z dogodkom n (%)
The mean in vitro human blood-to-plasma concentration ratios of alectinib and M4 are 2.64 and 2.50, respectively, at clinically relevant concentrations.
In vitro je bilo ob klinično pomembnih koncentracijah povprečno razmerje koncentracije alektiniba med človeško krvjo in plazmo 2,64, M4 pa 2,50.
Following oral administration of 600 mg twice daily under fed conditions in ALK-positive NSCLC patients, alectinib was absorbed reaching Tmax after approximately 4 to 6 hours.
Pri bolnikih z ALK-pozitivnim nedrobnoceličnim rakom pljuč se je alektinib po peroralni uporabi 600 mg dvakrat na dan na poln želodec absorbiral in je dosegel tmax po približno 4 do 6 urah.
CNS-ORR in patients with measurable and non-measurable CNS metastases at baseline (IRC)
Osrednje živčevje - ORR pri bolnikih z merljivimi in nemerljivimi metastazami v osrednjem živčevju v izhodišču (IRC)
Based on a population pharmacokinetic analysis alectinib and M4 exposures were similar in patients with mild and moderate renal impairment and normal renal function.
Na podlagi populacijske farmakokinetične analize je bila izpostavljenost alektinibu in M4 pri bolnikih z blago in zmerno okvaro ledvic podobna kot pri tistih z normalnim delovanjem ledvic.
Across clinical trials (NP28761, NP28673, BO28984) two patients with Grade 3-4 AST/ALT elevations had documented drug induced liver injury by liver biopsy.
V kliničnih preskušanjih (NP28761, NP28673, BO28984) sta imela dva bolnika z zvišanjem AST/ALT stopnje 3 do 4 zabeleženo z zdravilom povzročeno poškodbo jeter, potrjeno z jetrno biopsijo.
How Alecensa works
Kako deluje zdravilo Alecensa
Photosensitivity to sunlight has been reported with Alecensa administration (see section 4.8).
Med uporabo zdravila Alecensa je bila opisana fotosenzibilnost na sončno svetlobo (glejte poglavje 4.8).
NAME OF THE MEDICINAL PRODUCT Alecensa 150 mg hard capsules
IME ZDRAVILA Alecensa 150 mg trde kapsule
If you vomit after taking Alecensa
Če po zaužitju zdravila Alecensa bruhate
Increased hepatic alkaline phosphatase (ALP) and direct bilirubin as well as vacuolation/degeneration/necrosis of bile duct epithelium and enlargement/focal necrosis of hepatocytes was observed in rats and/or monkeys at exposures equal to or greater than 20-30% of the human exposure by AUC at the recommended dose.
Pri izpostavljenosti, ki je bila (glede na AUC) enaka ali večja od 20 do 30 % izpostavljenosti pri človeku ob uporabi priporočenih odmerkov, so pri podganah in/ali opicah opažali zvišanje jetrne alkalne fosfataze (ALP) in direktnega bilirubina, vakuolacijo/degeneracijo/nekrozo epitelija žolčnih vodov in povečanje/fokalno nekrozo hepatocitov.
Tell your doctor straight away if you have any new or worsening signs including difficulty in breathing, shortness of breath, or cough with or without mucous, or fever.
Takoj obvestite zdravnika, če se vam pojavijo kakšni novi bolezenski znaki ali poslabšanje bolezenskih znakov, na primer težko dihanje, kratka sapa, kašelj (z izkašljevanjem sluzi ali brez) ali zvišana telesna temperatura;
In the phase III clinical trial BO28984, Grade 3 or 4 bilirubin elevations occurred in 3.3% of patients receiving Alecensa versus no patient receiving crizotinib.
V kliničnem preskušanju faze III BO28984 se je zvišan bilirubin stopnje 3 ali 4 pojavil pri 3,3 % bolnikov, ki so prejemali zdravilo Alecensa, in pri nobenem od bolnikov, ki so prejemali krizotinib.
This event led to withdrawal from Alecensa treatment.
Ta dogodek je povzročil ukinitev zdravljenja z zdravilom Alecensa.
● inflammation of the mucous membrane of the mouth
● vnetje sluznice ust;
Table 3 ADRs reported in Alecensa clinical trials (NP28761, NP28673, BO28984; N=405) and during post-marketing
Neželeni učinki, poročani pri zdravilu Alecensa v kliničnih preskušanjih (NP28761, NP28673, BO28984; n = 405) in med obdobjem trženja
Therefore, alectinib and M4 may have the potential to increase plasma concentrations of co-administered substrates of P-gp.
Zato lahko alektinib in M4 zvečata koncentracijo sočasno uporabljenih substratov prenašalca P-gp v plazmi.
Study NP28761 was a Phase I/II single arm multicentre study conducted in patients with ALK positive advanced NSCLC who have previously progressed on crizotinib treatment.
Študija NP28761 je bila multicentrična študija faze I/II z eno samo skupino, opravljena pri bolnikih z ALK-pozitivnim napredovalim nedrobnoceličnim rakom pljuč, ki jim je bolezen pred tem napredovala med zdravljenjem s krizotinibom.
Based on the severity of the CPK elevation, Alecensa should be withheld, then resumed or dose reduced (see section 4.2).
Glede na izrazitost zvišanja CPK je treba uporabo zdravila Alecensa začasno prekiniti in zdravilo znova uvesti v manjšem odmerku (glejte poglavje 4.2).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains alectinib hydrochloride equivalent to 150 mg alectinib.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena trda kapsula vsebuje alektinibijev klorid, kolikor ga ustreza 150 mg alektiniba.
A total of 87 patients were included in the phase II part of the study and received Alecensa orally, at the recommended dose of 600 mg twice daily.
V delu študije, ki je bil faze II, je bilo skupaj vključenih 87 bolnikov, ki so prejemali zdravilo Alecensa peroralno v priporočenem odmerku 600 mg dvakrat na dan.
● If Alecensa is packed in bottles, store in the original package and keep the bottle tightly closed to protect from moisture.
● Če je zdravilo Alecensa v plastenkah, ga shranjujte v originalni ovojnini, plastenka naj bo tesno zaprta za zagotovitev zaščite pred vlago.
ECOG PS (0/1 vs. 2), race (Asian vs. non-Asian), and CNS metastases at baseline (yes vs. no) were stratification factors for randomisation.
Stratifikacijski dejavniki za randomizacijo so bili stanje zmogljivosti po ECOG (0/1 v primerjavi z 2), rasa (azijska v primerjavi z neazijsko) ter prisotnost metastaz v osrednjem živčevju v izhodišču (da v primerjavi z ne).
If vomiting occurs after taking a dose of Alecensa, patients should take the next dose at the scheduled time.
Če bolnik po uporabi odmerka zdravila Alecensa bruha, naj vzame naslednji odmerek ob predvidenem času.
Interstitial lung disease (ILD)/pneumonitis
Intersticijska bolezen pljuč (IBP)/pnevmonitis
What Alecensa contains
Kaj vsebuje zdravilo Alecensa
● If it is more than 6 hours until your next dose, take the missed dose as soon as you remember.
Če ste pozabili vzeti zdravilo Alecensa ● Če je do naslednjega odmerka zdravila več kot 6 ur, vzemite pozabljeni odmerek takoj, ko se spomnite.
In vitro metabolism studies showed that CYP3A4 is the main CYP isozyme mediating alectinib and its major metabolite M4 metabolism, and is estimated to contribute 40-50% of alectinib metabolism.
Študije presnove in vitro so pokazale, da je CYP3A4 glavni izoencim CYP, ki sodeluje v presnovi alektiniba in njegovega glavnega presnovka M4; ocenjeni prispevek CYP3A4 k presnovi alektiniba je od 40 do 50 %.
NAME OF THE MARKETING AUTHORISATION HOLDER Roche Registration GmbH
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Roche Registration GmbH
Therefore, no dose adjustments are required when Alecensa is co-administered with proton pump inhibitors or other medicinal products which raise gastric pH (e.g. H2 receptor antagonists or antacids).
Glede na to med sočasno uporabo zdravila Alecensa in zaviralcev protonske črpalke ali drugih zdravil, ki zvišujejo pH v želodcu (npr. antagonistov receptorjev H2 ali antacidov), odmerka ni treba prilagoditi.
Alecensa treatment
Zdravljenje z zdravilom Alecensa
A total of 138 patients were included in the phase II part of the study and received Alecensa orally, at the recommended dose of 600 mg twice daily.
V delu študije, ki je bil faze II, je bilo skupaj vključenih 138 bolnikov, ki so prejemali zdravilo Alecensa peroralno v priporočenem odmerku 600 mg dvakrat na dan.
In the phase II clinical trials (NP28761, NP28673; N=253), the median duration of exposure to Alecensa was 11 months.
Varnost zdravila Alecensa so ocenili V preskušanjih faze II (NP28761, NP28673; n = 253) je bilo mediano trajanje izpostavljenosti zdravilu Alecensa 11 mesecev.
Table 2 Dose modification advice for specified Adverse Drug Reactions (see sections 4.4 and 4.8) CTCAE grade
Smernice za prilagoditev odmerka pri specifičnih neželenih učinkih (glejte poglavji 4.4 in 4.8)
Increased blood creatine phosphokinase
Huda mialgija in zvišanja kreatin-fosfokinaze (CPK)
The following side effects may happen with this medicine.
Med uporabo tega zdravila se lahko pojavijo spodaj navedeni neželeni učinki.
Study NP28673 was a Phase I/II single arm, multicentre study conducted in patients with ALK-positive advanced NSCLC who have previously progressed on crizotinib treatment.
Študija NP28673 je bila multicentrična študija faze I/II z eno samo skupino, opravljena pri bolnikih z ALK-pozitivnim napredovalim nedrobnoceličnim rakom pljuč, ki jim je bolezen pred tem napredovala med zdravljenjem s krizotinibom.
● abnormal results of blood tests to check kidney function (high level of creatinine)
● nenormalni izvidi preiskav krvi, ki odražajo delovanje ledvic (velika koncentracija kreatinina);
ORR results for studies NP28673 and NP28761 were consistent across subgroups of baseline patient characteristics such as age, gender, race, ECOG performance status, Central Nervous System (CNS) metastasis and prior chemotherapy use, especially when considering the small number of patients in some subgroups.
Rezultati ORR v študijah NP28673 in NP28761 so se skladali med podskupinami z različnimi izhodiščnimi značilnostmi bolnikov, npr. glede na starost, spol, raso, stanje zmogljivosti po ECOG,
Most of these events were of mild or moderate severity; Grade 3 events were reported for diarrhea (0.7%), nausea (0.5%), and vomiting (0.2%).
Med učinki stopnje 3 so bili driska (0,7 %), navzea (0,5 %) in bruhanje (0,2 %).
In the phase III clinical trial BO28984, one patient (0.2%) experienced a Grade 4 event of nausea in the Alecensa arm and the incidence of Grade 3 and 4 events for nausea, vomiting, and diarrhoea was 3.3%, 3.3%, and 2.0%, respectively, in the crizotinib arm.
V kliničnem preskušanju faze III BO28984 je imel en bolnik (0,2 %) v skupini, zdravljeni z zdravilom Alecensa, navzeo stopnje 4, v skupini, zdravljeni s krizotinibom, pa je bila incidenca neželenih učinkov stopnje 3 in 4 naslednja: 3,3 % za slabost, 3,3 %
Co-administration of multiple oral doses of 400 mg posaconazole twice daily, a strong CYP3A inhibitor, with a single oral dose of 300 mg alectinib increased alectinib exposure Cmax and AUCinf by 1.18 and 1.75-fold respectively, and reduced M4 Cmax and AUCinf by 71% and 25% respectively.The effect on the combined exposure of alectinib and M4 was minor, reducing Cmax by 7% and increasing AUCinf 1.36-fold.
Sočasna uporaba večkratnih peroralnih odmerkov 400 mg posakonazola (ki je močan zaviralec CYP3A) dvakrat na dan z enkratnim peroralnim odmerkom 300 mg alektiniba je zvečala Cmax alektiniba 1,18-krat in AUCinf alektiniba 1,75-krat ter zmanjšala Cmax M4 za 71 % in AUCinf M4 za
If a contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, resume at reduced dose (see Table 1) upon recovery to ≤ Grade 1 (asymptomatic) bradycardia or to a heart rate of ≥ 60 bpm, with frequent monitoring as clinically indicated.
Če ne najdete sočasnega zdravila, ki je k temu pripomoglo ali če takega zdravila ne ukinete oz. ne prilagodite njegovega odmerka, znova začnite z manjšim odmerkom (glejte preglednico 1), ko se stanje izboljša na stopnjo ≤ 1 (asimptomatska bradikardija) oz. ko je srčna frekvenca ≥ 60 utripov/minuto.
The primary endpoint of the trial was to demonstrate superiority of Alecensa versus crizotinib based on Progression Free survival (PFS) as per investigator assessment using RECIST 1.1.
Alecensa v primerjavi s krizotinibom glede na preživetje brez napredovanja bolezni (PFS - progression free survival) po oceni raziskovalca z uporabo meril RECIST 1.1.
Women of childbearing potential must be advised to avoid pregnancy while on Alecensa.
Ženskam v rodni dobi je treba povedati, da med zdravljenjem z zdravilom Alecensa ne smejo zanositi.
Among the patients included in the study, 26% of the patients had previously progressed on crizotinib treatment only, and 74% had previously progressed on crizotinib and at least one chemotherapy treatment.
vključenimi v študijo, je bilo 26 % takšnih, ki jim je bolezen pred tem napredovala med zdravljenjem s samim krizotinibom, pri 74 % pa je pred tem napredovala med zdravljenjem s krizotinibom in vsaj še eno kemoterapijo.
Alectinib did not inhibit OATP1B1/OATP1B3, OAT1, OAT3 or OCT2 at clinically relevant concentrations in vitro.
Alektinib pri klinično pomembnih koncentracijah in vitro ne zavira OATP1B1/OATP1B3,
Look out for these while you are taking Alecensa.
Med jemanjem zdravila Alecensa bodite pozorni na te znake.
Temporarily withhold until recovery to ≤ Grade 1 (asymptomatic) bradycardia or to a heart rate of ≥ 60 bpm.
Začasno prekinite uporabo zdravila, dokler se ne izboljša na stopnjo ≤ 1 (asimptomatska bradikardija) oz. dokler ni srčna frekvenca ≥ 60 utripov/minuto.
No dose adjustment is required in patients with mild or moderate renal impairment.
Bolnikom z blago do zmerno okvaro ledvic odmerka ni treba prilagoditi.
Alectinib caused embryo-foetal toxicity in pregnant rats and rabbits.
Pri brejih podganah in kunkah je alektinib povzročil embrio-fetalno toksičnost.
NAME OF THE MEDICINAL PRODUCT Alecensa 150 mg hard capsules alectinib
IME ZDRAVILA Alecensa 150 mg trde kapsule alektinib
If no contributing concomitant medicinal product is identified, or if contributing concomitant medicinal products are not discontinued or dose
Če ne najdete sočasnega zdravila, ki je k temu pripomoglo, ukinite zdravljenje z zdravilom
SPECIAL STORAGE CONDITIONS Store in the original package and keep the bottle tightly closed in order to protect from moisture
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v originalni ovojnini, plastenka naj bo tesno zaprta za zagotovitev zaščite pred vlago
There were 66 of 365 patients (18%) treated with Alecensa who had post-dose heart rate values below 50 beats per minutes (bpm).
66 od 365 bolnikov (18 %), zdravljenih z zdravilom Alecensa,
These events did not lead to withdrawal from Alecensa treatment.
Ti učinki niso povzročili ukinitve zdravljenja z zdravilom Alecensa.
Cases of ILD/pneumonitis have been reported in clinical trials with Alecensa (see section 4.8).
V kliničnih preskušanjih z zdravilom Alecensa so poročali o primerih IBP/pnevmonitisa (glejte poglavje 4.8).
No starting dose adjustment is required in patients with underlying mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.
Bolnikom z obstoječo blago (razreda A po Child-Pughovi lestvici) ali zmerno okvaro jeter (razreda B
Proliferative zone extension in GI mucosa in both species was observed at exposures equal to or greater than 20-120% of the human AUC exposure at the recommended dose.
Pri izpostavljenosti, ki je bila (glede na AUC) enaka ali večja od 20 do 120 % izpostavljenosti pri človeku ob uporabi priporočenih odmerkov, so pri obeh živalskih vrstah opažali razširitev proliferacijske cone v sluznici prebavil.
CNS-ORR in patients with measurable CNS metastases at baseline
Osrednje živčevje - ORR pri bolnikih z merljivimi metastazami v osrednjem živčevju v izhodišču
Patients with underlying severe hepatic impairment (Child-Pugh C) should receive a starting dose of 450 mg taken twice daily (total dose of 900 mg) (see section 5.2).
Bolniki z obstoječo hudo okvaro jeter (razreda C po Child-Pughovi lestvici) naj prejmejo začetni odmerek 450 mg dvakrat na dan
Two of these cases led to withdrawal from Alecensa treatment.
V dveh od teh dveh primerov je bilo zdravilo Alecensa ukinjeno.
● constipation
● izpuščaj;
● Fainting, dizziness and low blood pressure (potential signs of slow heart beat)
● omedlevica, omotica in nizek krvni tlak (morebitni znaki počasnega srčnega utripa); ● novi bolezenski znaki ali poslabšanje bolezenskih znakov, kot so težko dihanje, kratka sapa, kašelj
Table 5 Efficacy results from studies NP28673 and NP28761
Rezultati učinkovitosti v študijah NP28673 in NP28761
● sirolimus, a medicine used to prevent the body's immune system from rejecting a transplanted kidney, heart or liver
● sirolimus, zdravilo za preprečevanje zavrnitve presajene ledvice, srca ali jeter zaradi imunskega odgovora telesa, ● topotekan, zdravilo za zdravljenje nekaterih vrst raka,
Take special care when driving and using machines as you may develop problems with vision or slowing of the heartbeat or low blood pressure that can lead to fainting or dizziness while you are taking Alecensa.
Alecensa pojavijo težave z vidom, upočasnjen srčni utrip ali nizek krvni tlak, ki lahko povzroči omedlevico ali omotico.
M4 Cmax and AUCinf was 39% and 34% lower respectively, resulting in a combined exposure of alectinib and M4 (AUCinf) 1.8-fold higher in patients with severe hepatic impairment compared with matched healthy subjects.
Skupna izpostavljenost alektinibu in M4 (AUCinf) je bila tako pri bolnikih s hudo okvaro jeter 1,8-krat večja kot pri zdravih preskušancih.
● lapatinib, a medicine used to treat certain types of breast cancer
● lapatinib, zdravilo za zdravljenje nekaterih vrst raka dojk,
What Alecensa is used for
Za kaj uporabljamo zdravilo Alecensa
Table 4 Summary of efficacy results from study BO28984 (ALEX)
Povzetek rezultatov učinkovitosti iz študije BO28984 (ALEX) krizotinib n = 151
* Key secondary endpoints part of the hierarchical testing ** Competing risk analysis of CNS progression, systemic progression and death as competing events *** 2 patients in the crizotinib arm and 6 patients in the alectinib arm had CR CI = confidence interval; CNS = central nervous system; CR = complete response; DOR = duration of response; HR = hazard ratio; IRC = Independent Review Committee; INV = investigator; NE = not estimable; ORR = objective response rate; PFS = progression free survival
** Kompetitivna analiza tveganja za napredovanje v osrednjem živčevju, sistemsko napredovanje in smrt kot kompetitivnih dogodkov *** Popolni odziv sta imela 2 bolnika v skupini, zdravljeni s krizotinibom, in 6 bolnikov v skupini, zdravljeni z alektinibom