natgillin/translations-raw huggingface dataset:
In most cases of severe liver injury, liver dysfunction had an onset within the first 2 months of therapy, and was characterized by a hepatocellular pattern of injury with transaminase elevations >20xULN, followed by bilirubin increase.
V večini primerov hude okvare jeter, se je moteno delovanje jeter pojavilo v prvih dveh mesecih zdravljenja, in je bila zanj značilna poškodba jetrnih celic s povečanimi vrednostmi transaminaz > 20 x ULN, ki so mu sledile povečane vrednosti bilirubina.
This indicates that co-administration of regorafenib may increase systemic exposure to UGT1A1 and UGT1A9 substrates.
To kaže, da lahko sočasna uporaba regorafeniba poveča sistemsko izpostavljenost substratoma UGT1A1 in UGT1A9.
In addition, regorafenib reduced the levels of tumour associated macrophages and has shown anti-metastatic effects in vivo.
Poleg tega je regorafenib zmanjšal ravni s tumorjem povezanih makrofagov in in vivo pokazal tudi učinke proti metastazam.
Once the bottle is opened the medicinal product has shown to be stable for 7 weeks.
Po prvem odprtju plastenke je zdravilo stabilno 7 tednov.
Contains sodium and lecithin (derived from soya).
SEZNAM POMOŽNIH SNOVI Vsebuje natrij in lecitin (pridobljen iz soje).
These events are also known to be common disease-related complications in patients with intra-abdominal malignancies.
Znano je, da so to pogosti zapleti, povezani z boleznijo, pri bolnikih z intraabdominalnimi malignimi tumorji.
Before you start taking Stivarga your doctor may decide to do blood tests.
Pred začetkom jemanja zdravila Stivarga se bo zdravnik morda odločil za krvne preiskave.
Based on its mechanism of action regorafenib is suspected to cause foetal harm when administered during pregnancy.
Glede na mehanizem delovanja regorafeniba obstaja sum, da njegova uporaba pri nosečnicah škoduje plodu.
Clinical data indicate that regorafenib has no effect on digoxin pharmacokinetics, therefore can be given concomitantly with p-glycoprotein substrates, such as digoxin, without a clinically meaningful drug interaction.
Klinični podatki kažejo, da regorafenib ne vpliva na farmakokinetiko digoksina, zato se ga lahko daje sočasno s substrati glikoproteina P, npr. digoksin, ne da bi prišlo do klinično pomembnega medsebojnega delovanja.
Before you take Stivarga tell your doctor if any of these conditions apply to you.
Pred začetkom jemanja zdravila Stivarga, se posvetujte z zdravnikom, če se katero koli od teh stanj nanaša na vas.
Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitor; ATC Code: L01XE21
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, zaviralci proteinskih kinaz; oznaka ATC: L01XE21
System Organ Class (MedDRA)
Organski sistem (po MedDRA)
Following single doses of 60 mg or 100 mg, the average relative bioavailability of tablets compared to an oral solution was 69% and 83%, respectively.
Po enkratnem odmerku 60 mg oziroma 100 mg je bila povprečna relativna biološka uporabnost tablet v primerjavi s peroralno raztopino 69 % oziroma 83 %.
The exposure for regorafenib was increased by 48% when administered with a high-fat breakfast, and 36% when administered with a low fat breakfast, compared to fasting.
Izpostavljenost regorafenibu se je povečala za 48 %, ko je bil zaužit z zajtrkom, ki je vseboval veliko maščob in za 36 %, ko je bil zaužit z zajtrkom, ki je vseboval malo maščob, v primerjavi z izpostavljenostjo, ko je bil zaužit na tešče.
- if you have high blood pressure Stivarga can raise your blood pressure.
- če imate visok krvni tlak.
The abnormalities are generally of mild to moderate severity, not associated with clinical manifestations, and do not usually require dose interruptions or reductions.
Odstopanja od normalnih vrednosti so običajno majhna do zmerna in niso klinično izražena ter običajno zaradi tega ni treba prekiniti zdravljenja ali zmanjšati odmerka.
>20 times ULN (Grade 4)
> 20-kratnik ULN (stopnja 4)
In clinical studies, no relevant differences in exposure or efficacy were observed between patients of different ethnic groups.
V kliničnih študijah niso opazili pomembnih razlik v izpostavljenosti ali učinkovitosti med bolniki iz različnih etničnih skupin.
P-value (one-sided)
Vrednost p (enostranska)
There is limited data in patients with PS ≥2.
Podatkov o bolnikih s PS ≥ 2 je malo.
What Stivarga is and what it is used for What you need to know before you take Stivarga How to take Stivarga
Kaj je zdravilo Stivarga in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Stivarga Kako jemati zdravilo Stivarga Možni neželeni učinki
Other medicines and Stivarga
Druga zdravila in zdravilo Stivarga
Both women of childbearing potential and men should use effective contraception during treatment and for at least eight weeks after completion of treatment.
Ženske v rodni dobi in moški morajo med zdravljenjem in še vsaj osem tednov po zaključenem zdravljenju uporabljati učinkovito kontracepcijsko metodo.
Bile saltsequestering agents such as cholestyramine and cholestagel may interact with regorafenib by forming insoluble complexes which may impact absorption (or reabsorption), thus resulting in potentially decreased exposure.
Adsorbenti žolčnih kislin, kot sta npr. holestiramin in holestagel, lahko medsebojno delujejo z regorafenibom tako, da tvorijo netopne komplekse, ki lahko vplivajo na absorpcijo (ali reabsorpcijo), in posledično zmanjšajo izpostavljenost regorafenibu.
Before you start taking Stivarga and during treatment your doctor will check how well your heart is working.
Preden začnete jemati zdravilo Stivarga in med zdravljenjem, bo zdravnik preverjal, kako deluje vaše srce.
Approximately 90% of the radioactive dose was recovered within 12 days after administration, with about 71% of the dose excreted in faeces (47% as parent compound, 24% as metabolites), and about 19% of the dose excreted in urine as glucuronides.
Približno 90 % radioaktivnega odmerka se je izločilo v 12 dneh po uporabi, pri čemer se je približno 71 % odmerka izločilo v blatu (47 % kot izhodna spojina, 24 % kot presnovki) in približno 19 % odmerka se je izločilo v seču v obliki glukuronidov.
An example of a light (low-fat) meal would include 1 portion of cereal (about 30 g), 1 glass of skimmed milk, 1 slice of toast with jam, 1 glass of apple juice, and 1 cup of coffee or tea (520 calories, 2 g fat).
Lahek obrok (z majhno vsebnostjo maščob) naj bi na primer vseboval 1 obrok kosmičev (približno 30 g), 1 kozarec posnetega mleka, 1 rezino opečenca z marmelado, 1 kozarec jabolčnega soka in 1 skodelico kave ali čaja (520 kalorij, 2 g maščobe).
Demographics and baseline disease characteristics were comparable between the Stivarga- and placebo-treated groups and are shown below for all 573 randomised patients:
Demografski podatki in osnovne značilnosti bolezni so bili primerljivi med skupino bolnikov, ki so bili zdravljeni z zdravilom Stivarga in skupino, ki je prejemala placebo in so prikazani spodaj za vseh 573 randomiziranih bolnikov:
These effects occurred at systemic exposures in the range of or below the anticipated human exposure (based on AUC comparison).
Ti učinki so se pojavili pri sistemski izpostavljenosti, v razponu, ki je bil enak ali manjši od pričakovane izpostavljenosti pri ljudeh (glede na primerjavo AUC).
You must not breast-feed your baby during Stivarga treatment, as this medicine may interfere with the growth and development of your baby.
Med zdravljenjem z zdravilom Stivarga ne smete dojiti, saj lahko to zdravilo vpliva na rast in razvoj vašega otroka.
If no improvement occurs despite dose reduction, interrupt therapy for a minimum of 7 days, until toxicity resolves to Grade 0-1.
Če kljub zmanjšanju odmerka ni izboljšanja, je treba zdravljenje prekiniti za vsaj 7 dni, dokler ni stopnja toksičnosti ponovno med 0 in 1.
The primary site of disease was colon (65%), rectum (29%), or both (6%).
Primarno mesto bolezni je bilo debelo črevo (65 %), danka (29 %) ali oboje (6 %).
For patients with observed worsening of liver function tests considered related to treatment with Stivarga (i.e. where no alternative cause is evident, such as post-hepatic cholestasis or disease progression), the dose modification and monitoring advice in Table 2 should be followed (see section 4.2).
Pri bolnikih z opaženim poslabšanjem izvidov preiskav delovanja jeter, za katera se meni, da so posledica zdravljenja z zdravilom Stivarga (tj. ko ni očitnega drugega vzroka, npr. posthepatična holestaza ali napredovanje bolezni), je treba upoštevati priporočila za spremembe odmerka in spremljanje v preglednici 2 (glejte poglavje 4.2).
- if you had or have any bleeding problems and if you are taking warfarin, phenprocoumon or another medicine that thins the blood to prevent blood clots.
- če ste imeli ali imate težave s krvavitvami in če jemljete varfarin, fenprokumon ali kakšno drugo zdravilo za redčenje ali preprečevanje strjevanja krvi.
These may be signs of severe stomach or bowel problems.
To so lahko znaki hudih težav v želodcu ali črevesju.
Patients with a history of ischaemic heart disease should be monitored for clinical signs and symptoms of myocardial ischaemia.
Bolnike z ishemično boleznijo srca v anamnezi je treba spremljati glede kliničnih znakov in simptomov miokardne ishemije.
Do not use this medicine after the expiry date which is stated on the carton and the bottle label after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
* International normalized ratio BSC = Best Supportive Care
* Mednarodno umerjeno razmerje (INR - international normalized ratio) najboljša podporna oskrba (BSC - Best Supportive Care)
Patients with unstable angina or new onset angina (within 3 months of starting Stivarga therapy), recent myocardial infarction (within 6 months of starting Stivarga therapy) and those with cardiac failure New York Heart Association (NYHA) Classification 2 or higher were excluded from the clinical studies.
Bolniki z nestabilno angino pektoris ali na novo nastalo angino pektoris (v treh mesecih po začetku zdravljenja z zdravilom Stivarga), nedavno prebolelim miokardnim infarktom (v šestih mesecih po začetku zdravljenja z zdravilom Stivarga) in tisti s srčnim popuščanjem 2. stopnje ali več po funkcijski razvrstitvi Newyorškega društva za srce (NYHA - New York Heart Association) so bili izključeni iz kliničnih študij.
No studies on the effects of Stivarga on the ability to drive or use machines have been performed.
Študij o vplivu zdravila Stivarga na sposobnost vožnje ali upravljanja strojev niso izvedli.
Recommended measures and dose modification
Priporočeni ukrepi in spremembe odmerka
Pharmacokinetic data indicate that regorafenib may be given concomitantly with substrates of CYP2C8, CYP2C9, CYP3A4, and CYP2C19 without a clinically meaningful drug interaction (see also section 4.4).
Farmakokinetični podatki kažejo, da se lahko regorafenib sočasno uporablja s substrati CYP2C8, CYP2C9, CYP3A4 in CYP2C19 brez klinično pomembnih interakcij med zdravili (glejte tudi poglavje 4.4).
The in vitro inhibitory potency towards CYP3A4 (Ki value of 11.1 micromolar) and CYP2C19 (Ki value of 16.4 micromolar) was less pronounced.
Učinkovitost zaviranja in vitro proti CYP3A4 (vrednost Ki 11,1 mikromolarna) in CYP2C19 (vrednost Ki 16,4 mikromolarna) je bila manj izrazita.
Metabolites M-2 and M-5 are weak substrates of P-gp.
Presnovka M-2 in M-5 sta šibka substrata P-gp.
Strong inducers of CYP3A4 should be avoided, or selection of an alternate concomitant medicinal product, with no or minimal potential to induce CYP3A4 should be considered.
Uporabi močnih induktorjev CYP3A4 se je treba izogibati ali za sočasno uporabo izbrati drugo zdravilo, ki ne inducira ali blago inducira CYP3A4.
The safety profile of regorafenib in these studies was consistent with the safety results of a phase III B study conducted in 2872 patients with metastatic colorectal cancer whose disease had progressed after treatment with standard therapies.
Varnostni profil regorafeniba v teh študijah je bil v skladu z izsledki glede varnosti v III. fazi študije B pri 2872 bolnikih z metastatskim kolorektalnim rakom, pri katerih je bolezen napredovala po zdravljenju s standarnimi oblikami zdravljenj.
M-5 may be reduced to M-4 in the gastrointestinal tract by microbial flora, allowing reabsorption of M-4 (enterohepatic circulation).
M-5 lahko mikrobna flora v prebavilih reducira v M-4, kar omogoča ponovno absorpcijo M-4 (enterohepatični obtok).
Patients receiving regorafenib who experienced disease progression and for whom in the investigator's opinion, treatment with regorafenib was providing clinical benefit, were offered the opportunity to continue open-label regorafenib.
Bolniki, ki so prejemali regorafenib, pri katerih je bolezen napredovala in katerim je, po oceni raziskovalca, zdravljenje z regorafenibom klinično koristilo, je bila ponujena možnost, da nadaljujejo zdravljenje z regorafenibom.
In preclinical studies regorafenib has demonstrated potent antitumour activity in a broad spectrum of tumour models including colorectal, gastrointestinal stromal and hepatocellular tumour models which is likely mediated by its anti-angiogenic and anti-proliferative effects.
V predkliničnih študijah je regorafenib pokazal močno protitumorno delovanje pri širokem spektru tumorskih modelov, vključno z modelom kolorektalnega, gastrointestinalnega stromalnega in hepatocelularnega tumorja,verjetno zaradi antiangiogenih in antiproliferativnih učinkov.
It is recommended to perform liver function tests (ALT, AST and bilirubin) before initiation of treatment with Stivarga and monitor closely (at least every two weeks) during the first 2 months of treatment.
Pred uvedbo zdravljenja z zdravilom Stivarga je priporočljivo opraviti preiskave delovanja jeter (ALT, AST in bilirubin) ter v prvih dveh mesecih zdravljenja skrbno nadzorovati delovanje jeter (vsaj vsaka dva tedna).
There is limited data on regorafenib in the black patient population.
Na voljo je malo podatkov za populacijo bolnikov črne rase.
Stivarga 40 mg tablets are available in packs containing one bottle or three bottles.
Zdravilo Stivarga 40 mg je na voljo v pakiranju, ki vsebuje 1 ali 3 plastenke.
>3 times ULN (Grade 2 or higher) with concurrent bilirubin >2 times ULN
> 3-kratnik ULN (stopnja 2 ali več) s sočasnimi vrednostmi bilirubina > 2-kratnik ULN
UGT1A1 and UGT1A9 substrates
Substrata UGT1A1 in UGT1A9
In case of vomiting after regorafenib administration, the patient should not take additional tablets.
Če bolnik po zaužitju regorafeniba bruha, ne sme vzeti dodatnih tablet.
The median secondary PFS (as measured by the investigator's assessment) were 5.0 and 4.5 months, respectively.
Mediani sekundarnega preživetja brez napredovana bolezni (izmerjenega po oceni raziskovalca) sta bili 5,0 oziroma 4,5 mesecev.
- if you have or have had an aneurysm (enlargement and weakening of a blood vessel wall)
- če imate ali ste imeli anevrizmo (razširitev in oslabitev stene krvne žile) ali raztrganino v steni krvne žile.
Cardiac electrophysiology/QT prolongation
Elektrofiziologija srca/podaljšanje QT intervala
Stivarga should be prescribed by physicians experienced in the administration of anticancer therapy.
Zdravilo Stivarga mora predpisati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
However, a potential of regorafenib to adversely affect male and female reproduction has to be considered based on morphological changes in the testes, ovaries, and the uterus observed after repeated dosing in rats and dogs at exposures below the anticipated human exposure (based on AUC comparison).
Vendar pa je treba upoštevati, da lahko regorafenib škodljivo vpliva na plodnost pri moških in ženskah zaradi morfoloških sprememb mod, jajčnikov in maternice, ki so jih opazili po ponavljajočem odmerjanju pri podganah in psih pri izpostavljenosti, ki je bila manjša od pričakovane izpostavljenosti pri ljudeh (glede na primerjavo AUC).
The overall safety profile of Stivarga is based on data from more than 4,800 treated patients in clinical trials including placebo-controlled phase III data for 636 patients with metastatic colorectal cancer (CRC), 132 patients with gastrointestinal stromal tumours (GIST) and 374 patients with hepatocellular carcinoma (HCC).
Splošni varnostni profil zdravila Stivarga temelji na podatkih zbranih pri več kot 4.800 zdravljenih bolnikih v kliničnih preskušanjih, vključno s podatki iz s placebom nadzorovane III. faze študije pri 636 bolnikih z metastatskim kolorektalnim rakom, 132 bolnikih z gastrointestinalnimi stromalnimi tumorji (GIST) in 374 bolnikih z rakom jetrnih celic (HCC).
Prior to and during treatment with Stivarga, your doctor will do blood tests to monitor your liver function.
Pred in med zdravljenjem z zdravilom Stivarga bo zdravnik opravil krvne preiskave za spremljanje delovanja vaših jeter.
In patients developing PRES, discontinuation of Stivarga, along with control of hypertension and supportive medical management of other symptoms is recommended.
Pri bolnikih, pri katerih se razvije PRES, se priporoča prenehanje zdravljenja z zdravilom Stivarga in hkrati nadzor hipertenzije ter podporno simptomatsko zdravljenje drugih simptomov.
Stivarga 40 mg tablets are light pink and oval, marked with “BAYER” on one side and “40” on the other side.
Zdravilo Stivarga 40 mg so svetlo rožnate ovalne tablete, z oznako "BAYER" na eni in "40" na drugi strani.
Since only limited data are available for patients with moderate hepatic impairment (Child Pugh B), no dose recommendation can be provided.
Ker je za bolnike z zmerno okvaro jeter (Child-Pugh B) na voljo le malo podatkov, priporočil za odmerjanje ni na voljo.
- if you get severe stomach and bowel problems (gastrointestinal perforation or fistula), your doctor should decide to discontinue treatment with Stivarga.
- če imate želodčne ali črevesne težave (gastrointestinalna perforacija ali fistula), se bo zdravnik odločil za prekinitev zdravljenja z zdravilom Stivarga.
Each daily dose of 160 mg contains 2.427 mmol (or 55.8 mg) of sodium (see section 4.4).
En dnevni odmerek 160 mg vsebuje 2,427 mmol (ali 55,8 mg) natrija (glejte poglavje 4.4).
If a dose is missed, then it should be taken on the same day as soon as the patient remembers.
Če bolnik pozabi vzeti odmerek, ga mora vzeti še isti dan, takoj ko se spomni.
Inhibitors of CYP3A4 and UGT1A9/inducers of CYP3A4
Zaviralci CYP3A4 in UGT1A9/induktorji CYP3A4
If patients experience symptoms affecting their ability to concentrate and react during treatment with Stivarga, it is recommended that they do not drive or use machines until the effect subsides.
Če bolnik med zdravljenjem z zdravilom Stivarga občuti simptome, ki vplivajo na njegovo zbranost in odzivnost je priporočljivo, da ne vozi in ne upravlja strojev, dokler učinki ne izzvenijo.
Pregnancy, breast-feeding and fertility Tell your doctor if you think you are pregnant, may be pregnant or plan on becoming pregnant as Stivarga should not be used during pregnancy unless clearly necessary.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, saj zdravila Stivarga med nosečnostjo ne smete uporabljati, če ni nujno potrebno.
After repeated dosing to mice, rats and dogs, adverse effects were observed in a number of organs, primarily in the kidneys, liver, digestive tract, thyroid gland, lympho-/haematopoietic system, endocrine system, reproductive system and skin.
Po ponavljajočem odmerjanju mišim, podganam in psom so neželene učinke opazili na številnih organih, predvsem na ledvicah, jetrih, prebavilih, ščitnici, limfopoetskem/hematopoetskem sistemu, endokrinem sistemu, reproduktivnem sistemu in koži.
When re-starting treatment, decrease dose by 40 mg (one tablet).
Pri ponovni uvedbi zdravljenja je treba odmerek zmanjšati za 40 mg (ena tableta).
Inhibitors of P-glycoprotein and BCRP/Inducers of P-glycoprotein and BCRP In vitro studies indicate that the active metabolites M-2 and M-5 are substrates for P-glycoprotein and BCRP.
Zaviralci glikoproteina P in BCRP / induktorji glikoproteina P in BCRP Študije in vitro kažejo, da sta aktivna presnovka M-2 in M-5 substrata glikoproteina P in BCRP.
The recommended dose of regorafenib is 160 mg (4 tablets of 40 mg) taken once daily for 3 weeks followed by 1 week off therapy.
Priporočeni odmerek regorafeniba je 160 mg (4 tablete po 40 mg) enkrat na dan 3 tedne, ki jim sledi 1 teden brez zdravljenja.
Regorafenib is a uridine diphosphate glucuronosyl transferase (UGT) 1A1 inhibitor (see section 4.5).
Regorafenib je zaviralec uridindifosfat-glukuroniltransferaze (UGT) 1A1 (glejte poglavje 4.5).
In the event of severe bleeding necessitating urgent medical intervention, permanent discontinuation of Stivarga should be considered.
V primeru hude krvavitve, zaradi katere je potrebna nujna medicinska pomoč, je treba razmisliti o trajnem prenehanju zdravljenja z zdravilom Stivarga.
The maximum daily dose is 160 mg.
Največji dnevni odmerek je 160 mg.
The primary efficacy endpoint was Overall Survival (OS).
Primarni cilj učinkovitosti je bilo celokupno preživetje (OS - Overall Survival).
Subgroup analyses for OS and PFS according to age (<65; ≥65), gender, ECOG PS, primary site of disease, time from first diagnosis of metastatic disease, prior anticancer treatment, prior treatment lines for metastatic disease, and KRAS mutation status showed a treatment effect favouring the regorafenib regimen over the placebo regimen.
Analize podskupin glede celokupnega preživetja in preživetja brez napredovanja bolezni glede na starost (< 65 let; ≥ 65 let), spol, ECOG PS, primarno mesto bolezni, čas od prve diagnoze metastatske bolezni, predhodno protitumorno zdravljenje, predhodne linije zdravljenja metastatske bolezni in status mutacije gena KRAS so pokazale terapevtski učinek v korist zdravljenja z regorafenibom v primerjavi s prejemanjem placeba.
What Stivarga looks like and contents of the pack
Izgled zdravila Stivarga in vsebina pakiranja
The clinical significance of this neomycin interaction is unknown, but may result in a decreased efficacy of regorafenib.
Klinični pomen te interakcije z neomicinom ni znan, vendar je posledično lahko zmanjšana učinkovitost regorafeniba.
PFS**
ND**
Alterations of teeth and bones and adverse effects in the reproductive system were more pronounced in young and growing animals as well as in juvenile rats and indicate a potential risk for children and adolescents.
Pri mladih, rastočih in juvenilnih podganah so bile bolj izražene spremembe na zobeh in kosteh ter neželeni učinki na reproduktivni sistem, kar kaže na možno tveganje pri otrocih in mladostnikih.
For recommended measures and dose modifications in case of worsening of liver function tests considered related to treatment with Stivarga see Table 2 (see also section 4.4).
Za priporočene ukrepe in spremembe odmerkov v primeru poslabšanja izvidov preiskav delovanja jeter, za katere se meni, da so posledica zdravljenja z zdravilom Stivarga, glejte preglednico 2 (glejte tudi poglavje 4.4).
There are no data for patients with Child-Pugh C (severe) hepatic impairment.
Na voljo ni podatkov za bolnike s Child-Pugh C (hudo) okvaro jeter.
The overall incidence of hand-foot skin reaction (74.8%, CRC, 88.2%, GIST and 67.1%, HCC) was higher in Stivarga-treated Asian patients, compared to other ethnicities.
Celokupna incidenca kožnih reakcij na dlaneh in podplatih (74,8 % (CRC) , 88,2 % (GIST) in 67,1 % (HCC)) je bila večja pri bolnikih azijske rase, ki so bili zdravljeni z zdravilom Stivarga, v primerjavi z drugimi etničnimi skupinami bolnikov.
It is unknown whether regorafenib or its metabolites are excreted in human milk.
Ni znano, ali se regorafenib ali njegovi presnovki izločajo v materino mleko.
A clinical probe substrate study was performed to evaluate the effect of 14 days of dosing with 160 mg regorafenib on the pharmacokinetics of probe substrates of CYP2C8 (rosiglitazone) CYP2C9 (S-warfarin), CYP 2C19 (omeprazole) and CYP3A4 (midazolam).
Izvedena je bila klinična študija preskušanega substrata za oceno učinka 14-dnevne uporabe 160 mg regorafeniba na farmakokinetiko preskušanih substratov CYP2C8 (rosiglitazon), CYP2C9 (S-varfarin), CYP2C19 (omeprazol) in CYP3A4 (midazolam).