natgillin/translations-raw huggingface dataset:
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER - TREATMENT INITIATION PACK - 90 MG
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER - KUTIJA ZA POČETNO LIJEČENJE - 90 MG
In patients given brigatinib 180 mg once daily, the geometric mean apparent oral clearance (CL/F) of brigatinib at steady state was 13 L/h and the median plasma elimination half-life was 24 h.
U bolesnika kojima je davano 180 mg brigatiniba jedanput dnevno, geometrijska sredina prividnog peroralnog klirensa (CL/F) brigatiniba u stanju dinamičke ravnoteže iznosila je 13 l/h, a medijan poluvijeka eliminacije iz plazme iznosio je 24 sati.
In vitro studies demonstrated that brigatinib is a substrate of CYP2C8.
In vitro ispitivanja pokazala su da je brigatinib supstrat CYP2C8.
Agents that may increase brigatinib plasma concentrations
Tvari koje mogu povećati koncentracije brigatiniba u plazmi
Alkaline phosphatase increased Hyperbilirubinaemia
Povišeni ALT Povišeni AST Povišena alkalna fosfataza Hiperbilirubinemija
• cyclosporine, sirolimus, tacrolimus: medicines to suppress the immune system
• ciklosporin, sirolimus, takrolimus: lijekovi za potiskivanje imunološkog sustava
Fasting serum glucose should be assessed prior to initiation of Alunbrig and monitored periodically thereafter.
Prije početka liječenja lijekom Alunbrig potrebno je odrediti glukozu u serumu natašte i nakon toga je periodički pratiti.
Very common Insomnia
Vrlo često Nesanica
Bradycardia (HR less than 60 bpm)
Bradikardija (srčana frekvencija niža od 60 otkucaja u minuti)
*90 mg once daily regimen †180 mg once daily with 7-day lead-in at 90 mg once daily
*režim 90 mg jedanput dnevno †180 mg jedanput dnevno uz uvodno 7-dnevno uzimanje 90 mg jedanput dnevno
Grade 4 elevation of CPK (> 10.0 × ULN)
Porast vrijednosti CPK 4. stupnja (> 10,0 × GGN)
Upon recovery, the dose should be modified accordingly (see section 4.2).
Nakon oporavka, potrebno je odgovarajuće prilagoditi dozu (vidjeti dio 4.2).
• phenobarbital, phenytoin: medicines to treat epilepsy
• fenobarbital, fenitoin: lijekovi za liječenje epilepsije
Treatment initiation pack
Početno pakiranje
No dose adjustment of Alunbrig is required for patients with mild hepatic impairment (Child-Pugh class A) or moderate hepatic impairment (Child-Pugh class B).
Nije potrebna prilagodba doze lijeka Alunbrig u bolesnika s blagim oštećenjem jetre (Child-Pugh stadij A) ili umjerenim oštećenjem jetre (Child-Pugh stadij B).
Hepatotoxicity Grade ≥ 3 elevation (> 5.0 × ULN) of either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) with bilirubin ≤ 2 × ULN
Porast vrijednosti alanin aminotransferaze (ALT) ili aspartat aminotransferaze (AST) ≥ 3. stupnja (> 5,0 × GGN) s bilirubinom  2 × GGN
if you are allergic to brigatinib or any of the other ingredients of this medicine (listed in section 6).
Što morate znati prije nego počnete uzimati Alunbrig Nemojte uzimati Alunbrig: ako ste alergični na brigatinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
• reduced blood level of magnesium
• snižena razina magnezija u krvi
Agents that may decrease brigatinib plasma concentrations
Tvari koje mogu smanjiti koncentracije brigatiniba u plazmi
Hyperglycaemia For Grade 3 (greater than 250 mg/dL or
Hipertenzija 3. stupnja (SKT ≥ 160 mmHg ili
• ketoconazole, itraconazole, voriconazole: medicines to treat fungal infections
• ketokonazol, itrakonazol, vorikonazol: lijekovi za liječenje gljivičnih infekcija
• vision disturbance
• smetnje vida
In six healthy male subjects given a single 180 mg oral dose of [14C]brigatinib, 65% of the administered dose was recovered in faeces and 25% of the administered dose was recovered in urine.
U šest zdravih muških ispitanika koji su dobili jednokratnu peroralnu dozu od 180 mg [14C]brigatiniba, 65 % primijenjene doze izlučilo se u fecesu, a
• increased blood level of calcium
• povišena razina kalcija u krvi
• If ILD/pneumonitis recurs, Alunbrig should be permanently discontinued.
• Ako se IBP/pneumonitis ponovno javi, liječenje lijekom Alunbrig se mora trajno prekinuti.
For severe hypertension (≥ Grade 3), Alunbrig should be withheld until hypertension has recovered to Grade 1 or to baseline.
U slučajevima teške hipertenzije (≥ 3. stupanj), primjenu lijeka Alunbrig treba prekinuti dok se hipertenzija ne vrati do 1. stupnja ili početne vrijednosti.
• If Grade 4 hypertension recurs, Alunbrig should be permanently discontinued.
• Ako se vrati hipertenzija 4. stupnja, liječenje lijekom Alunbrig se mora trajno prekinuti.
The concomitant use of strong CYP3A inhibitors with Alunbrig, including but not limited to certain antivirals (e.g., indinavir, nelfinavir, ritonavir, saquinavir), macrolide antibiotics (e.g., clarithromycin, telithromycin, troleandomycin), antifungals (e.g., ketoconazole, voriconazole), mibefradil, and nefazodone should be avoided.
Potrebno je izbjegavati istodobnu primjenu snažnih inhibitora CYP3A s lijekom Alunbrig, uključujući između ostalog određene antivirotike (npr. indinavir, nelfinavir, ritonavir, sakvinavir), makrolidne antibiotike (npr. klaritromicin, telitromicin, troleandomicin), antimikotike (npr.
Dose reduction for visual disturbance occurred in two patients (1.8%) at the 180 mg regimen (see sections 4.2 and 4.4).
Doza je zbog poremećaja vida smanjena u dva bolesnika (1,8 %) na režimu doziranja od 180 mg (vidjeti dijelove 4.2 i 4.4).
Do not breast-feed during treatment with Alunbrig.
Ne smijete dojiti za vrijeme liječenja lijekom Alunbrig.
Agents that may have their plasma concentrations altered by brigatinib
Tvari čija se koncentracija u plazmi može promijeniti pod utjecajem brigatiniba
Dose reduction for elevation of lipase and amylase occurred in 1.8% and 0.9% of patients, respectively at the 180 mg regimen (see sections 4.2 and 4.4).
Doza je zbog porasta razina lipaze i amilaze smanjena u u 1,8 %, odnosno 0,9 % bolesnika na režimu doziranja od 180 mg (vidjeti dijelove 4.2 i 4.4).
Median (months) 95% CI
Vrijeme do odgovora Medijan (mjeseci) Trajanje odgovora Medijan (mjeseci) 95 % CI
Patients were randomised in a 1:1 ratio to receive Alunbrig either 90 mg once daily (90 mg regimen, N = 112) or 180 mg once daily with 7-day lead-in at 90 mg once daily (180 mg regimen, N = 110).
Bolesnici su randomizirani u omjeru 1:1 kako bi primali Alunbrig 90 mg jedanput dnevno (režim doziranja 90 mg, N = 112) ili 180 mg jedanput dnevno uz uvodno 7-dnevno uzimanje 90 mg jedanput dnevno (režim doziranja 180 mg, N = 110).
Dose reduction for CPK elevation occurred in 6.4% patients at the 180 mg regimen (see sections 4.2 and 4.4).
Doza je zbog porasta razine CPK smanjena u 6,4 % bolesnika na režimu doziranja od 180 mg (vidjeti dijelove 4.2 i 4.4).
Within each frequency grouping, undesirable effects are presented in order of frequency.
Unutar svake grupe učestalosti nuspojave su prikazane prema redoslijedu učestalosti.
Pneumonitisi Dyspnoeah
Pneumonitisi Dispnejah
Neutrophil count decreased
Smanjen broj neutrofila
• If ILD/pneumonitis occurs during the first 7 days of treatment, Alunbrig should be withheld until recovery to baseline, then resumed at next lower dose level as described in Table 1 and not escalated to 180 mg once daily.
• Ako se IBP/pneumonitis javi tijekom prvih 7 dana liječenja, uzimanje lijeka Alunbrig treba prekinuti do oporavka na početno stanje, a potom nastaviti liječenje sljedećom nižom razinom doze opisanom u Tablici 1 i ne je povećati na 180 mg jedanput dnevno.
Recommendations for dose modifications of Alunbrig for the management of adverse reactions are summarised in Table 2.
Preporuke za prilagodbe doze lijeka Alunbrig radi zbrinjavanja nuspojava sažete su u Tablici 2.
Alunbrig 90 mg once daily for the first 7 days, then Alunbrig 180 mg once daily.
Alunbrig 90 mg jedanput dnevno prvih 7 dana, a potom Alumbrig 180 mg jedanput dnevno.
Dosing interruption and/or dose reduction may be required based on individual safety and tolerability.
Temeljem sigurnosti i podnošljivosti lijeka za pojedinog bolesnika, može biti potrebno privremeno prekinuti primjenu i/ili smanjiti dozu.
Table 5: Intracranial efficacy in patients with measurable brain metastases at baseline in ALTA IRC-assessed efficacy parameter
Tablica 5: Intrakranijska djelotvornost u bolesnika s mjerljivim metastazama na početku liječenja u ispitivanju ALTA
• colchicine: a medicine to treat gout attacks
• kolhicin: lijek za liječenje napadaja gihta
Men with female partners of childbearing potential should be advised to use effective contraception during treatment and for at least 3 months after the last dose of Alunbrig (see section 4.6).
Muškarcima s partnericama reproduktivne dobi treba savjetovati da koriste učinkovitu kontracepciju za vrijeme liječenja i tijekom najmanje 3 mjeseca nakon posljednje doze lijeka Alunbrig (vidjeti dio 4.6).
Grade 3 elevation of lipase or amylase (> 2.0 × ULN)
Porast vrijednosti lipaze ili amilaze 3. stupnja (> 2,0 × GGN)
Patients were randomised in a 1:1 ratio to receive Alunbrig either 90 mg once daily continuously (90 mg regimen) or 180 mg once daily with 7-day lead-in at 90 mg once daily (180 mg regimen).
Bolesnici su bili randomizirani u omjeru 1:1 kako bi neprekidno primali Alunbrig 90 mg jedanput dnevno (režim doziranja 90 mg) ili 180 mg jedanput dnevno uz uvodno 7-dnevno uzimanje 90 mg jedanput dnevno (režim doziranja 180 mg).
Severe, life-threatening, and fatal pulmonary adverse reactions, including those with features consistent with ILD/pneumonitis, can occur in patients treated with Alunbrig (see section 4.8).
U bolesnika liječenih lijekom Alunbrig mogu se pojaviti teške, po život opasne i smrtonosne nuspojave na plućima, uključujući one sa simptomima koji ukazuju na ILD/pneumonitis (vidjeti dio 4.8).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON FOR TREATMENT INITIATION PACK - 21 TABLETS, 180 MG21 DAY TREATMENT (WITHOUT BLUE BOX)
UNUTARNJA KUTIJA POČETNOG PAKIRANJA - 21 TABLETA, 180 mg - 21-DNEVNO LIJEČENJE (BEZ PLAVOG OKVIRA)
The recommended starting dose of Alunbrig is 90 mg once daily for the first 7 days, then 180 mg once daily.
Preporučena početna doza lijeka Alunbrig je 90 mg jedanput dnevno tijekom prvih 7 dana, a potom 180 mg jedanput dnevno.
The pharmacokinetics of brigatinib was similar between healthy subjects with normal hepatic function and patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment.
Farmakokinetika brigatiniba slična je između zdravih ispitanika s normalnom funkcijom jetre, i bolesnika s blagim (Child-Pugh stadij A) ili umjerenim (Child-Pugh stadij B) oštećenjem jetre.
In vitro studies demonstrated that brigatinib is a substrate of CYP3A4/5.
In vitro ispitivanja pokazala su da je brigatinib supstrat CYP3A4/5.
No dose adjustment of Alunbrig is required for patients with mild or moderate renal impairment (estimated glomerular filtration rate (eGFR) ≥ 30 mL/min).
U bolesnika s blagim ili umjerenim oštećenjem bubrega (procijenjena brzina glomerularne filtracije (eGFR) ≥ 30 ml/min) nije potrebna prilagodba doze lijeka Alunbrig.
Amylase increased Abdominal paink
Povišena amilaza Bol u abdomenuk
Tell your doctor if you have any unexplained muscle pain, tenderness or weakness.
Obavijestite svoj liječnika ako osjetite bilo kakav neobjašnjiv bol u mišićima, osjetljivost ili slabost.
Elevation of hepatic enzymes
Porast razine jetrenih enzima
One 90 mg tablet once daily for the first 7 treatment days; thereafter, one 180 mg tablet once daily.
Jedna tableta od 90 mg jedanput dnevno tijekom prvih 7 dana; zatim jedna tableta od 180 mg jedanput dnevno.
Tell your doctor if you are feeling very thirsty, need to urinate more than usual, feeling very hungry, sick to your stomach, weak or tired, or confused.
• povišeni šećer u krvi Obavijestite svog liječnika ako osjećate veliku žeđ, potrebu za mokrenjem češće nego obično, osjećate veliku glad, mučninu u trbuhu, slabost ili umor, ili ste smeteni.
Brigatinib may impair male fertility.
Brigatinib može smanjiti plodnost mužjaka.
• reduced blood level of phosphorus
• snižena razina fosfora u krvi
Grade 4 elevation of lipase or amylase (> 5.0 x ULN)
Porast vrijednosti lipaze ili amilaze 4. stupnja (> 5,0 x GGN)
Visual Disturbance Grade 2 or 3
Nuspojave 3. ili 4. stupnja
• increased blood level of bilirubin
• povišena razina bilirubina u krvi
• Alunbrig should be withheld until recovery to asymptomatic bradycardia or to a resting heart rate of 60 bpm or above.
• Potrebno je prekinuti primjenu lijeka Alunbrig do oporavka do asimptomatske bradikardije ili postizanja srčane frekvencije u mirovanju od 60 ili više otkucaja u minuti.
Visual disturbance
Poremećaj vidae
• If ILD/pneumonitis occurs after the first 7 days of treatment, Alunbrig should be withheld until recovery to baseline, then resumed at same dose level.
• Ako se IBP/pneumonitis javi nakon prvih 7 dana liječenja, uzimanje lijeka Alunbrig treba prekinuti do oporavka na početno stanje, a potom nastaviti istom dozom.
Women of childbearing age being treated with Alunbrig should avoid becoming pregnant.
Ženama reproduktivne dobi koje se liječe lijekom Alunbrig se ne preporučuje trudnoća.
Film-coated tablets 28 film-coated tablets 56 film-coated tablets 112 film coated tablets
Filmom obložene tablete 28 filmom obložene tablete 56 filmom obložene tablete 112 filmom obložene tablete
Upon recovery, Alunbrig may either be resumed at the next lower dose per Table 1 or permanently discontinued.
Nakon oporavka liječenje lijekom Alunbrig se može nastaviti sljedećom nižom dozom prema Tablici 1 ili se može trajno prekinuti.
• musculoskeletal chest pain
• mišićno-koštana bol u prsnom košu
Inform your doctor of any visual disturbance that occurs during treatment, such as seeing flashes of light, blurry vision or light hurting your eyes.
• Obavijestite svog liječnika o bilo kakvim smetnjama vida koje se jave tijekom liječenja, poput bljeskova, zamućenja vida ili osjetljivosti na svjetlo
Blood CPK increased
Povišen CPK u krvi
Tell your doctor if you experience any visual disturbances, such as seeing flashes of light, blurry vision or light hurting eyes.
Obavijestite svog liječnika ako osjetite bilo kakve smetnje vida, poput bljeskova, zamagljenog vida ili vam smeta svjetlost.
Bradycardia In ALTA, bradycardia was reported in 4.5% of patients treated with Alunbrig at the 180 mg regimen.
U ispitivanju ALTA, bradikardija je prijavljena u 4,5 % bolesnika liječenih lijekom Alunbrig u režimu doziranja 180 mg.
Liver function, including AST, ALT and total bilirubin should be assessed prior to the initiation of Alunbrig and then every 2 weeks during the first 3 months of treatment.
Prije početka liječenja lijekom Alunbrig, a potom svaka 2 tjedna tijekom prva 3 mjeseca liječenja, potrebno je pratiti jetrenu funkciju, uključujući AST, ALT i ukupni bilirubin.
• Alunbrig 30 mg: 28, 56 or 112 film-coated tablets
• Alunbrig 30 mg: 28, 56 ili 112 filmom obloženih tableta
• Alunbrig should be permanently discontinued.
• Liječenje lijekom Alunbrig se mora trajno prekinuti.
7 film-coated tablets of Alunbrig 90 mg 21 film-coated tablets of Alunbrig 180 mg
7 filmom obloženih tableta lijeka Alunbrig 90 mg 21 filmom obložena tableta lijeka Alunbrig 180 mg
21 tablets of Alunbrig 180 mg
21 tablete lijeka Alunbrig 180 mg
• Alunbrig should be withheld until hypertension has recovered to Grade ≤ 1 (SBP < 140 mmHg and DBP < 90 mmHg), then resumed at same dose.
• Potrebno je prekinuti primjenu lijeka Alunbrig dok se hipertenzija ne vrati do stupnja ≤ 1 (SKT < 140 mmHg i DKT < 90 mmHg) i potom nastaviti liječenje istom dozom.
The adverse reactions described in this section were identified from two clinical trials: Study 201 (ALTA): A randomised, open-label, multicentre trial in patients treated with Alunbrig (N = 219) with ALK+ NSCLC who previously progressed on crizotinib.
Ispitivanje 201 (ALTA): randomizirano, otvoreno, multicentrično ispitivanje bolesnika (N = 219) s ALK+ NSCLC-om liječenih lijekom Alunbrig koji su prethodno imali progresiju na krizotinibu.
7 tablets of Alunbrig 90 mg
7 tablete lijeka Alunbrig 90 mg
Tablet coating Talc
Ovojnica tablete Talk
Duration of intracranial response‡,
Trajanje intrakranijskog odgovora‡, Medijan (mjeseci)
• If a concomitant medicinal product known to cause bradycardia is identified and discontinued, or its dose is adjusted, Alunbrig should be resumed at same dose upon recovery to asymptomatic bradycardia or to a resting heart rate of 60 bpm or above.
• Ako se identificira istodobno primjenjivani lijek za kojeg je poznato da uzrokuje bradikardiju i prekine se njegova primjena ili mu se prilagodi doza, primjenu lijeka Alunbrig treba nastaviti u istoj dozi nakon oporavka do asimptomatske bradikardije ili postizanja srčane frekvencije u mirovanju od 60 ili više otkucaja u minuti.
The concomitant use of moderate CYP3A inducers with Alunbrig, including but not limited to efavirenz, modafinil, bosentan, etravirine, and nafcillin should be avoided.
Potrebno je izbjegavati istodobnu primjenu umjerenih induktora CYP3A s lijekom Alunbrig, uključujući između ostalog efavirenz, modafinil, bosentan, etravirin i nafcilin.
• rapid heartbeat (tachycardia)
• ubrzani otkucaji srca (tahikardija)
Elevations of hepatic enzymes (aspartate aminotransferase, alanine aminotransferase) and bilirubin have occurred in patients treated with Alunbrig (see section 4.8).
U bolesnika liječenih lijekom Alunbrig javio se porast razina jetrenih enzima (aspartat aminotransferaze, alanin aminotransferaze) i bilirubina (vidjeti dio 4.8).
How Alunbrig works
Kako djeluje Alunbrig
The maximum mean QTcF (corrected QT by the Fridericia method) change from baseline was less than 10 msec. An exposure-QT analysis suggested no concentration-dependent QTc interval prolongation.
Maksimalna prosječna promjena QTcF (QT korigiran metodom Fridericia) u odnosu na početnu vrijednost bila je manja od 10 msek.
Intracranial objective response rate
Intrakranijska stopa objektivnog odgovora 95 % CI
Lipase and amylase should be monitored regularly during treatment with Alunbrig.
Tijekom liječenja lijekom Alunbrig mora se redovito pratiti razine lipaze i amilaze.
A reduced starting dose of 60 mg once daily for the first 7 days, then 90 mg once daily is recommended for patients with severe renal impairment (eGFR < 30 mL/min) (see section 5.2).
U bolesnika s teškim oštećenjem bubrega (eGFR < 30 ml/min) preporučuje se smanjena početna doza od 60 mg jedanput dnevno tijekom prvih 7 dana, a potom 90 mg jedanput dnevno (vidjeti dio 5.2).
How to store Alunbrig
Kako čuvati Alunbrig
Non-cardiac chest pain Pyrexia
Nesrčana bol u prsištu Pireksija
In ALTA, visual disturbance adverse reactions were reported in 18% of patients treated with Alunbrig at the 180 mg regimen.
U ispitivanju ALTA, nuspojave poremećaja vida prijavljene su u 18 % bolesnika liječenih lijekom Alunbrig u režimu doziranja 180 mg.
Based on the severity of the CPK elevation, treatment with Alunbrig should be withheld, and the dose modified accordingly (see section 4.2).
Ovisno o težini porasta razina CPK, potrebno je prekinuti primjenu lijeka Alunbrig, i odgovarajuće prilagoditi dozu (vidjeti dio 4.2).
Very common Lipase increased Nausea
Vrlo često Povišena lipaza Mučnina
In healthy subjects, coadministration of multiple 600 mg daily doses of rifampicin, a strong CYP3A inducer, with a single 180 mg brigatinib dose decreased brigatinib Cmax by 60%, AUC0-INF by 80% (5-fold), and AUC0-120 by 80% (5-fold), relative to a 180 mg brigatinib dose administered alone.
U zdravih ispitanika, istodobna primjena višestruke dnevne doze rifampicina od 600 mg, snažnog induktora CYP3A, s jednom dozom brigatiniba od 180 mg smanjila je Cmax brigatiniba za 60 %, AUC0-INF za 80 % (peterostruko) i AUC0 -120 za 80 % (peterostruko), u odnosu na dozu brigatiniba od 180 mg primijenjenu samu.
Report any unexplained muscle pain, tenderness or weakness to your doctor.
Prijavite liječniku svaku neobjašnjivu bol u mišićima, osjetljivost ili slabost.
The concomitant use of Alunbrig with strong CYP3A inhibitors should be avoided.
Istodobnu primjenu lijeka Alunbrig s jakim inhibitorima CYP3A treba izbjegavati.
• Each 180 mg tablet contains 180 mg brigatinib.
• Jedna tableta od 180 mg sadrži 180 mg brigatiniba.
• Each 90 mg tablet contains 90 mg brigatinib.
• Jedna tableta od 90 mg sadrži 90 mg brigatiniba.
• Each 30 mg tablet contains 30 mg brigatinib.
• Jedna tableta od 30 mg sadrži 30 mg brigatiniba.
• Alunbrig should be withheld until hypertension has recovered to Grade ≤ 1 (SBP < 140 mmHg and DBP < 90 mmHg), then resumed at the next lower dose level per Table 1 or permanently discontinued.
• Potrebno je prekinuti primjenu lijeka Alunbrig dok se hipertenzija ne vrati do stupnja ≤ 1 (SKT < 140 mmHg i DKT < 90 mmHg) i potom nastaviti liječenje sljedećom nižom razinom doze prema Tablici 1 ili trajno prekinuti liječenje.
Patients should be advised to keep the desiccant canister in the bottle and not to swallow it. Any unused medicinal product or waste material should be disposed of in accordance with local requirements
Bolesnike treba savjetovati da spremnik sa sredstvom za sušenje čuvaju u bočici i da ga ne progutaju.
• Alunbrig 180 mg: 30 film-coated tablets
• Alunbrig 180 mg: 30 filmom obloženih tableta
In healthy subjects, coadministration of multiple 200 mg twice daily doses of itraconazole, a strong CYP3A inhibitor, with a single 90 mg brigatinib dose increased brigatinib Cmax by 21%, AUC0-INF by 101% (2-fold), and AUC0-120 by 82% (< 2-fold), relative to a 90 mg brigatinib dose administered alone.
U zdravih ispitanika, istodobna primjena višestruke doze itrakonazola od 200 mg dvaput na dan, snažnog inhibitora CYP3A, sa jednom dozom brigatiniba od 90 mg povisila je Cmax brigatiniba za 21 %, AUC0 -INF za 101 % (dvostruko) i AUC0 -120 za 82 % (< dvostruko), u odnosu na dozu brigatiniba od 90 mg primijenjenu samu.
• indinavir, nelfinavir, ritonavir, saquinavir: medicines to treat HIV infection
• indinavir, nelfinavir, ritonavir, sakvinavir: lijekovi za liječenje HIV infekcije
• Alunbrig 30 mg: 60 or 120 film-coated tablets
• Alunbrig 30 mg: 60 ili 120 filmom obloženih tableta
Tell your doctor if you have chest pain or discomfort, changes in heartbeat, dizziness, light-headedness or fainting.
• usporeni otkucaji srca Obavijestite svog liječnika ako imate bol ili nelagodu u prsnom košu, promjene u otkucajima srca, omaglicu, ošamućenost ili nesvjesticu.
Abdominal paink Dry mouth
Suha usta Stomatitisl
In healthy subjects, coadministration of multiple 600 mg twice daily doses of gemfibrozil, a strong CYP2C8 inhibitor, with a single 90 mg brigatinib dose reduced brigatinib Cmax by 41%, AUC0-INF by 12%, and AUC0-120 by 15%, relative to a 90 mg brigatinib dose administered alone.
U zdravih ispitanika, istodobna primjena višestruke doze gemfibrozila od 600 mg dvaput na dan, snažnog inhibitora CYP2C8, sa jednom dozom brigatiniba od 90 mg smanjila je Cmax brigatiniba za 41 %, AUC0 -INF za 12 % i AUC0 120 za 15 %, u odnosu na dozu brigatiniba od 90 mg primijenjenu samu.
• The film-coated tablets are approximately 19 mm long with “U13” on one side and plain on the other side.
• Filmom obložene tablete približne su dužine 19 mm s oznakom „U13“ na jednoj strani i bez oznaka na drugoj strani.
Film-coated tablets 60 film-coated tablets 120 film-coated tablets
OBLIK I SADRŽAJ Filmom obložene tablete 60 filmom obložene tablete 120 filmom obložene tablete
In ALTA, peripheral neuropathy adverse reactions were reported in 27.3% of patients treated at the 180 mg regimen.
U ispitivanju ALTA, nuspojavu periferne neuropatije prijavilo je 27,3 % bolesnika liječenih lijekom Alunbrig u režimu doziranja 180 mg.
Table 2: Recommended Alunbrig dose modifications for adverse reactions Adverse reaction Severity*
Tablica 2: Preporučene prilagodbe doze lijeka Alunbrig radi nuspojava Nuspojava
• Alunbrig 180 mg: 28 film-coated tablets
• Alunbrig 180 mg: 28 filmom obloženih tableta
No dose adjustment is required during coadministration with strong CYP2C8 inhibitors.
Tijekom istodobne primjene s jakim inhibitorima CYP2C8 nije potrebna prilagodba doze.
Alunbrig 180 mg film-coated tablets 2 years
Alunbrig 180 mg filmom obložene tablete 2 godine
Alunbrig 30 mg film-coated tablets 3 years
Alunbrig 30 mg filmom obložene tablete 3 godine