natgillin/translations-raw huggingface dataset:
• Hævelse i arme, fødder eller ben
• Swelling in the arms, feet or legs
De mest almindelige grad ≥ 3 bivirkninger var anæmi (6,0 %), dyspnø (3,9 %) og abdominalsmerter (3,0 %).
The most common Grade ≥ 3 adverse reactions were anaemia (6.0%), dyspnoea (3.9%), and abdominal pain (3.0%).
Behandlingen med avelumab bør genoptages, når der er opnået metabolisk kontrol med insulinbehandling.
Treatment with avelumab should be resumed when metabolic control is achieved on insulin replacement therapy.
Autoimmun tyroiditis, hypofysitis
Autoimmune thyroiditis, hypophysitis
I 1-måneds og 3-måneders toksikologistudier med gentagne doser hos aber, var der ingen bemærkelsesværdig virkning på de hunlige reproduktionsorganer.
In 1-month and 3-month repeat-dose toxicology studies in monkeys, there were no notable effects in the female reproductive organs.
Mediantiden til respons var 6 uger (interval: 6 uger til 36 uger) efter den første dosis avelumab.
The median time to response was 6 weeks (range: 6 weeks to 36 weeks) after the first dose of avelumab.
Steady-state-koncentrationen af avelumab blev nået efter ca. 4 til 6 uger (2 til 3 cyklusser) med en gentagen dosering på 10 mg/kg hver 2. uge, og den systemiske akkumulation var ca. 1,25 gange.
Steady-state concentrations of avelumab were reached after approximately 4 to 6 weeks (2 to 3 cycles) of repeated dosing at 10 mg/kg every 2 weeks, and systemic accumulation was approximately 1.25-fold.
Kaplan-Meier-kurven over PFS for de 88 patienter (del A) med metastatisk MCC er angivet i figur 1.
The Kaplan-Meier curve of PFS of the 88 patients (Part A) with metastatic MCC is presented in Figure 1.
• Følelse af træthed eller svaghed
• Feeling tired or weak
Avelumabs virkning og sikkerhed blev undersøgt i studie EMR100070-003 med to dele.
The efficacy and safety of avelumab was investigated in the study EMR100070-003 with two parts.
Non-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af toksicitet efter gentagne doser hos Cynomolgus-aber, der fik administreret intravenøse doser af 20, 60 eller 140 mg/kg én gang ugentligt i 1 måned og 3 måneder, efterfulgt af en 2-måneders rekonvalescensperiode efter 3-måneders doseringsperioden.
Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity in Cynomolgus monkeys administered intravenously doses of 20, 60 or 140 mg/kg once a week for1 month and 3 months, followed by a 2-month recovery period after the 3-month dosing period.
Farmakoterapeutisk klassifikation: Andre antineoplastiske stoffer, monoklonale antistoffer, ATCkode: L01XC31.
Pharmacotherapeutic group: Other antineoplastic agents, monoclonal antibodies, ATC code: L01XC31.
• Sunitinib 50 mg en gang dagligt oralt i 4 uger, efterfulgt af 2 uger uden (N = 444) indtil radiografisk eller klinisk progression eller uacceptabel toksicitet.
• Sunitinib 50 mg once daily orally for 4 weeks followed by 2 weeks off (N=444) until radiographic or clinical progression or unacceptable toxicity.
Behandling med avelumab og axitinib fortsatte indtil RECIST v1.1-defineret sygdomsprogression i henhold til vurdering fra en blindet uafhængig central bedømmelse (blinded independent central review, BICR) eller uacceptabel toksicitet.
Treatment with avelumab and axitinib continued until RECIST v1.1-defined progression of disease by Blinded Independent Central Review (BICR) assessment or unacceptable toxicity.
Hos ADA-positive patienter kan der være en øget risiko for infusionsrelaterede reaktioner (ca. 40 % og 25 % hos hhv. ADA-altid-positive og ADA-aldrig-positive patienter).
In ADA positive patients, there may be an increased risk for infusion-related reactions (about 40% and 25% in ADA ever-positive and ADA never-positive patients, respectively).
Patientfordelingens risikogrupper ifølge International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) var 21 % favorabel, 62 % intermediær og 16 % dårlig.
Patient distribution by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk groups was 21% favourable, 62% intermediate, and 16% poor.
Renalcellekarcinom (studie B9991003)
Renal cell carcinoma (study B9991003)
Patienterne skal overvåges for øget serumkreatinin før behandlingen, og periodisk under behandlingen.
Patients should be monitored for elevated serum creatinine prior to and periodically during treatment.
Avelumab har også vist sig at inducere naturel killer celler (NK) direkte tumorcellelyse via antistofafhængig cellemedieret cytotoksicitet (antibody-dependent cell mediated cytotoxicity, ADCC).
Avelumab has also shown to induce natural killer (NK) cell-mediated direct tumour cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC).
Indlægsseddel: Information til patienten Bavencio 20 mg/ml koncentrat til infusionsvæske, opløsning avelumab Dette lægemiddel er underlagt supplerende overvågning.
Package leaflet: Information for the patient Bavencio 20 mg/mL concentrate for solution for infusion avelumab This medicine is subject to additional monitoring.
Hazard ratio (95 % CI) p-værdi*
Hazard ratio (95% CI) p-value*
Den anbefalede dosis af avelumab er 800 mg hver 2. uge.
The recommended dose of avelumab is 800 mg every 2 weeks.
Den mediane varighed for responset kunne ikke estimeres (95 % CI: 4 måneder, kunne ikke estimeres) med en varighed på minimum 1,2 måneder til maksimum 8,3 måneder.
The median duration of response was not estimable (95% CI: 4 months, not estimable) with a minimum of 1.2 months to a maximum of 8.3 months duration.
Hvis du oplever bivirkninger bør du tale med din læge.
If you get any side effects, talk to your doctor.
Ved infusionsrelaterede reaktioner af grad 1 skal infusionshastigheden nedsættes med 50 % for den aktuelle infusion.
For Grade 1 infusion-related reactions, the infusion rate should be slowed by 50% for the current infusion.
• Følelsesløshed, prikkende fornemmelse, svaghed, brændende fornemmelse i arme eller ben
• Numbness, tingling, weakness, burning sensation in arms or legs
• Den fortyndede opløsning blandes ved at vende posen forsigtigt på hovedet for at undgå skumdannelse eller for kraftig rystning af opløsningen.
• The diluted solution should be mixed by gently inverting the bag in order to avoid foaming or excessive shearing of the solution.
• Type 1 diabetes, herunder syre i blodet fra sukkersyge (diabetisk ketoacidose),
• Type 1 diabetes, including acid in the blood produced from diabetes (diabetic ketoacidosis);
Hvis vedvarende (længere end 5 dage), skal kortikosteroidbehandling med prednison eller lignende overvejes, efterfulgt af en nedtrapning.
If persistent (greater than 5 days), corticosteroid therapy with prednisone or equivalent followed by a taper should be considered.
Du må ikke amme, mens du får Bavencio, og i mindst 1 måned efter din sidste dosis.
Do not breast-feed while receiving Bavencio and for at least 1 month after your last dose.
Eksponeringen af avelumab blev øget dosisproportionalt i dosisområdet på 10 mg/kg til 20 mg/kg hver 2. uge.
The exposure of avelumab increased dose-proportionally in the dose range of 10 mg/kg to 20 mg/kg every 2 weeks.
IHC: Immunhistokemi; MCV: Merkelcelle-polyomavirus; ORR: objektiv responsrate a Baseret på data fra patienter, som kunne evalueres for PD-L1 b Baseret på data fra patienter, som kunne evalueres for MCV med immunhistokemi (IHC)
IHC: Immunohistochemistry; MCV: Merkel cell polyomavirus; ORR: objective response rate a Based on data from patients evaluable for PD-L1 b Based on data from patients evaluable for MCV by immunohistochemistry (IHC)
De primære endepunkter for virkning var progressionsfri overlevelse (progression-free survival, PFS), evalueret ved BICR ved brug af RECIST v1.1 og samlet overlevelse (overall survival, OS) ved førstevalgsbehandling af patienter med fremskredent RCC, som har PD-L1-positive tumorer (PD-L1ekspressionsniveau ≥ 1 %).
The primary efficacy endpoints were progression-free survival (PFS), as assessed by BICR using RECIST v1.1 and overall survival (OS) in the first-line treatment of patients with advanced RCC who have PD-L1-positive tumours (PD-L1 expression level ≥ 1%).
Patienterne skal overvåges hyppigere for ændringer af leverfunktionen og symptomer, sammenlignet med når avelumab anvendes som monoterapi.
Patients should be more frequently monitored for changes in liver function and symptoms as compared to when avelumab is used as monotherapy.
• Guillain-Barrés syndrom (en sygdom i immunsystemet, der kan forårsage nervebetændelse og føre til smerter, svaghed, muskelsvaghed og gangbesvær)
• Guillain-Barré Syndrome (an immune system disorder that causes nerve inflammation and can result in pain, numbness, muscle weakness and difficulty walking)
Hos symptomatiske patienter skal der udføres en kardiologisk konsultation og laboratorieundersøgelser for at sikre, at de relevante behandlinger påbegyndes på et tidligt stadie.
In symptomatic patients, obtain cardiologic consultation and laboratory investigations to ensure the initiation of appropriate measures at an early stage.
Fra et mikrobiologisk synspunkt bør lægemidlet fortyndes og straks infunderes umiddelbart efter anbrud.
From a microbiological point of view, once opened, the medicinal product should be diluted and infused immediately.
Type 1 diabetes mellitus gik ikke væk hos nogen af patienterne på tidspunktet for data cut-off.
Type 1 diabetes mellitus did not resolve in any of the patients at the time of data cut-off.
Vurderingen af tumorresponset blev udført hver 6. uge af en uafhængig komité, der gennemgik endepunkterne (Independent Endpoint Review Committee, IERC) ved hjælp af evalueringskriterier for respons i solide tumorer (Response Evaluation Criteria in Solid Tumours, RECIST) v1.1.
Tumour response assessments were performed every 6 weeks, as assessed by an Independent Endpoint Review Committee (IERC) using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
Patientinformationskortet skal indeholde de følgende nøglebeskeder:
The Patient Alert Card shall contain the following key messages:
Tyreoideasygdomme (hypotyroidisme/hypertyroidisme) Tyreoideasygdomme kan opstå på alle tidspunkter under behandlingen (se pkt.
Thyroid disorders (hypothyroidism/hyperthyroidism) Thyroid disorders can occur at any time during treatment (see section 4.8).
Hver ml koncentrat indeholder 20 mg avelumab.
Each mL of concentrate contains 20 mg of avelumab.
Et hætteglas på 10 ml indeholder 200 mg avelumab.
One vial of 10 mL contains 200 mg of avelumab.
Avelumab bør afbrydes, og der bør administreres anti-hyperglykæmika til patienter med grad ≥ 3 hyperglykæmi.
Avelumab should be withheld and antihyperglycaemics in patients with Grade ≥ 3 hyperglycaemia should be administered.
Lægemiddeludslæt, erythema multiforme, psoriasis
Drug eruption, erythema multiforme, psoriasis
Patientfordelingens risikogrupper ifølge Memorial Sloan-Kettering Cancer Center (MSKCC) var 22 % favorabel, 65 % intermediær og 11 % dårlig.
Patient distribution by Memorial Sloan-Kettering Cancer Center (MSKCC) risk groups was 22% favourable, 65% intermediate, and 11% poor.
De vigtigste sekundære endepunkter var PFS baseret på BICRbedømmelse i henhold til RECIST v1.1 og OS uanset PD-L1-ekspression.
The key secondary endpoints were PFS based on BICR assessment per RECIST v1.1 and OS irrespective of PD-L1 expression.
Ikke almindelig Tubulointerstitiel nefritis*
Tubulo-interstitial nephritis*
Pakningsstørrelser og yderligere oplysninger Bavencio indeholder:
Contents of the pack and other information What Bavencio contains
Bavencio indeholder det aktive stof avelumab, et monoklonalt antistof (en form for protein), som binder sig til et specifikt mål i kroppen kaldet PD-L1.
Bavencio contains the active substance avelumab, a monoclonal antibody (a type of protein) that attaches to a specific target in the body called PD-L1.
• betændelse i hjertet (myokarditis),
• inflammation of your heart (myocarditis);
Merkelcellekarcinom (studie EMR100070-003)
Merkel cell carcinoma (study EMR100070-003)
Hos patienter med ALAT ≥ 3 gange ULN (grad 2-4, n = 82) bedredes ALAT til grad 0-1 hos 92 %.
In patients with ALT ≥ 3 times ULN (Grades 2-4, n=82), ALT resolved to Grades 0-1 in 92%.
Varighed af respons (duration of response, DOR)
Duration of response (DOR)
Tabel 3: Bivirkninger hos patienter i behandling med avelumab i kombination med axitinib i klinisk studie B9991002 og B9991003
Table 3: Adverse reactions in patients treated with avelumab in combination with axitinib in clinical studies B9991002 and B9991003
I tilfælde af tilbagevendende grad 1 eller grad 2 infusionsrelateret reaktion, kan patienten fortsætte med at få avelumab under nøje overvågning, efter passende modifikation af infusionshastigheden og præmedicinering med paracetamol og antihistamin (se pkt.
In case of recurrence of Grade 1 or Grade 2 infusion-related reaction, the patient may continue to receive avelumab under close monitoring, after appropriate infusion rate modification and premedication with paracetamol and antihistamine (see section 4.2).
Avelumabs virkning og sikkerhed i kombination med axitinib blev vist i studie B9991003, et randomiseret, åbent multicenterstudie af avelumab i kombination med axitinib hos 886 patienter med ubehandlet fremskredent eller metastatisk RCC med en clear cell-komponent.
The efficacy and safety of avelumab in combination with axitinib was demonstrated in study B9991003, a randomised, multicentre, open-label study of avelumab in combination with axitinib in 886 patients with untreated advanced or metastatic RCC with a clear-cell component.
• Avelumab 10 mg/kg intravenøs infusion hver 2. uge i kombination med axitinib 5 mg to gange dagligt oralt (N = 442).
• Avelumab 10 mg/kg intravenous infusion every 2 weeks in combination with axitinib 5 mg twice daily orally (N=442).
Bavencio er kompatibelt med infusionsposer af polyethylen, polypropylen og ethylen-vinylacetat, glasflasker, infusionssæt af polyvinylchlorid og in-line-filtre med polyethersulfonmembraner med en porestørrelse på 0,2 mikrometer.
Bavencio is compatible with polyethylene, polypropylene, and ethylene vinyl acetate infusion bags, glass bottles, polyvinyl chloride infusion sets and in-line filters with polyethersulfone membranes with pore sizes of 0.2 micrometre.
Avelumab er hyppigst forbundet med immunrelaterede bivirkninger.
Avelumab is most frequently associated with immune-related adverse reactions.
• Tørhed i munden
• Dryness in the mouth
I begge studier blev avelumab administreret med 10 mg/kg hver 2. uge.
In both studies, avelumab was administered at 10 mg/kg every 2 weeks.
• Kuldefølelse
• Feeling cold
Median, måneder (interval)
Median, months (range)
Del A var et enkelarmet multicenter studie, hvor patienterne var diagnostiseret med histologisk bekræftet metastatisk MCC og sygdomsprogression under eller efter kemoterapi mod metastatisk sygdom, hvor den forventede levetid var over 3 måneder.
Part A was a single-arm, multi-centre study conducted in patients with histologically confirmed metastatic MCC, whose disease had progressed on or after chemotherapy administered for distant metastatic disease, with a life expectancy of more than 3 months.
Betændelsen kan forårsage alvorlige skader på kroppen, og nogle betændelsestilstande kan være livstruende og kræve behandling, eller det kan være nødvendigt at stoppe behandlingen med Bavencio.
Inflammation may cause serious damage to your body and some inflammatory conditions may lead to death and need treatment or withdrawal of Bavencio.
Hos symptomatiske patienter skal der udføres en gastroenterologikonsultation og laboratorieundersøgelser (herunder billeddannelse) for at sikre, at de relevante behandlinger pågyndes på et tidligt stadie.
In symptomatic patients, obtain gastroenterology consultation and laboratory investigations (including imaging) to ensure the initiation of appropriate measures at an early stage.
Ammende kvinder bør rådes til ikke at amme under behandlingen, og i mindst 1 måned efter den sidste dosis, på grund af risikoen for alvorlige bivirkninger hos ammede spædbørn.
Breast-feeding women should be advised not to breast-feed during treatment and for at least 1 month after the last dose due to the potential for serious adverse reactions in breast-fed infants.
Når avelumab 10 mg/kg blev administreret i kombination med axitinib 5 mg, var de tilhørende eksponeringer for avelumab og axitinib uændrede, sammenlignet med enkeltstofferne.
When avelumab 10 mg/kg was administered in combination with axitinib 5 mg, the respective exposures of avelumab and axitinib were unchanged compared to the single agents.
I kliniske studier havde 98,6 % (433/439) af patienterne med infusionsrelaterede reaktioner en første infusionsrelateret reaktion i løbet af de første 4 infusioner, hvoraf 2,7 % (12/439) var grad ≥ 3.
In clinical trials, 98.6% (433/439) of patients with infusion-related reactions had a first infusion-related reaction during the first 4 infusions of which 2.7% (12/439) were Grade ≥ 3.
Aspartataminotransferase (ASAT) eller alaninaminotransferase (ALAT) over 3 og op til 5 gange den øvre normalgrænse (upper limit of normal, ULN) eller totalt bilirubin over 1,5 og op til 3 gange ULN
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 and up to 5 times upper limit of normal (ULN) or total bilirubin greater than 1.5 and up to 3 times ULN
• infusionsrelaterede reaktioner,
• infusion-related reactions;
Kortikosteroider bør overvejes for grad ≥ 2 hændelser (se pkt.
Corticosteroids should be considered for Grade ≥ 2 events (see section 4.2).
Avelumab er ikke blevet undersøgt hos patienter med svært nedsat nyrefunktion (GFR 15-29 ml/min).
Avelumab has not been studied in patients with severe renal impairment (GFR 15 to 29 mL/min).
• problemer med nyrerne,
• problems with your kidneys;
Avelumab påvirker i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
Avelumab has negligible influence on the ability to drive and use machines.
Afbryd, indtil bivirkningerne bedres til grad 0-1
Withhold until adverse reactions recover to Grade 0-1
10 ml koncentrat i et hætteglas (type I-glas) med en prop af halobutylgummi og en aluminiumsforsegling forsynet med et aftageligt plasticlåg.
10 mL of concentrate in a vial (Type I glass) with a halobutyl rubber stopper and an aluminium seal fitted with a removable plastic cap.
Tabel 7: Virkningsresultater fra studie B9991003 hos patienter uanset ekspression af PD-L1 Effekt endepunkter (Baseret på BICR-bedømmelse)
Table 7: Efficacy results from study B9991003 in patients irrespective of PD-L1 expression Efficacy endpoints (Based on BICR assessment)
Avelumab binder sig til PD-L1 og blokerer påvirkningen mellem PD-L1 og receptorer for programmeret celledød 1 (PD-1) og B7.1.
Avelumab binds PD-L1 and blocks the interaction between PD-L1 and the programmed death 1 (PD-1) and B7.1 receptors.
Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. den er i det væsentlige natriumfri.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
• problemer på grund af betændelse i lungerne (pneumonitis),
• problems due to inflammation of your lungs (pneumonitis);
Der blev observeret perivaskulær mononuklær celle-infiltration i hjernen og rygsøjlen hos aber, der blev behandlet med avelumab ved ≥ 20 mg/kg i 3 måneder.
Perivascular mononuclear cell cuffing was observed in the brain and spinal cord of monkeys treated with avelumab at ≥ 20 mg/kg for 3 months.
Disse resultater indikerer en mulig risiko for, at administration af avelumab under graviditet kunne forårsage fosterskade, herunder en øget hyppighed for abort eller dødfødsel.
These results indicate a potential risk that administration of avelumab during pregnancy could cause foetal harm, including increased rates of abortion or stillbirth.
Selvom der ikke er udført studier for at evaluere virkningen på fertilitet, var der ingen bemærkelsesværdig virkning i kønsorganerne hos hunaber, baseret på 1-måneds og 3-måneders toksicitetsstudier med gentagne doser (se pkt.
Although studies to evaluate the effect of avelumab on fertility have not been conducted, there were no notable effects in the female reproductive organs in monkeys based on 1-month and 3-month repeat-dose toxicity studies (see section 5.3).
For renalcellekræft skal Bavencio anvendes i kombination med axitinib.
For renal cell cancer, Bavencio is to be used in combination with axitinib.
Hvis du glemmer en dosis Bavencio
If you miss a dose of Bavencio
• Renalcellekarcinom (RCC), en type nyrekræft, når det er fremskredent (har spredt sig videre end nyrerne eller til andre dele af kroppen).
• Renal cell carcinoma (RCC), a type of kidney cancer, when it is advanced (has spread beyond the kidney or to other parts of the body).
Hvis du er en kvinde, som kan blive gravid, skal du bruge sikker prævention, mens du behandles med Bavencio, og i mindst 1 måned efter din sidste dosis.
If you are a woman who could become pregnant, you must use effective contraceptives while you are being treated with Bavencio and for at least 1 month after your last dose.
Andre immunrelaterede bivirkninger (herunder myositis, hypopituitarisme, uveitis, Guillain-Barrés syndrom)
Other immune-related adverse reactions (including myositis, hypopituitarism, uveitis, Guillain-Barré syndrome)
Blandt de 73 patienter, hvor enten avelumab (59 %) eller axitinib (85 %) blev genstartet som monoterapi eller med begge (55 %) oplevede 66 % ingen tilbagevending til ALT ≥ 3 gange ULN.
Among the 73 patients who were rechallenged with either avelumab (59%) or axitinib (85%) monotherapy or with both (55%), 66% had no recurrence of ALT ≥ 3 times ULN.
Baseret på en farmakokinetisk populationsanalyse for avelumab som monoterapi og i kombination med axitinib er der ingen forventede klinisk betydningfulde forskelle i eksponering for avelumab mellem administration hver 2. uge med 800 mg eller 10 mg/kg.
Based on a population PK analysis for avelumab as monotherapy and in combination with axitinib, there are no expected clinically meaningful differences in exposure of avelumab between settings administered every 2 weeks at 800 mg or 10 mg/kg.
Disse resultater indikerer en mulig risiko, baseret på virkningsmekanismen, for at administration af avelumab under graviditet kan medføre fosterskade, herunder en øget hyppighed af aborter eller dødfødsler.
These results indicate a potential risk, based on its mechanism of action, that administration of avelumab during pregnancy could cause foetal harm, including increased rates of abortion or stillbirth.
Brug ikke lægemidlet efter den udløbsdato, der står på hætteglassets etiket og æsken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date which is stated on the vial label and carton after EXP.
Bivirkninger rapporteret for 88 patienter med metastatisk MCC samt for 1.650 patienter i et fase I-studie af solide tumorer vises i tabel 2.
Adverse reactions reported for 88 patients with metastatic MCC and for 1,650 patients in a phase I study in solid tumours are presented in Table 2.
Før du får Bavencio
Before you receive Bavencio
Spørg lægen, hvis du har spørgsmål om axitinib.
If you have any questions about axitinib, ask your doctor.
En populationsfarmakokinetisk analyse tydede ikke på nogen forskel i den totale systemiske clearance af avelumab, baseret på alder, køn, race, PD-L1-status, tumorbyrde, nedsat nyrefunktion og let til moderat nedsat leverfunktion.
A population pharmacokinetic analysis suggested no difference in the total systemic clearance of avelumab based on age, gender, race, PD-L1 status, tumour burden, renal impairment and mild or moderate hepatic impairment.
Den anbefalede dosis af Bavencio i kombination med axitinib er 800 mg, administreret intravenøst over 60 minutter hver 2. uge, og axitinib 5 mg der tages oralt to gange dagligt (med 12 timers mellemrum) sammen med eller uden mad indtil sygdomsprogression eller uacceptabel toksicitet.
The recommended dose of Bavencio in combination with axitinib is 800 mg administered intravenously over 60 minutes every 2 weeks and axitinib 5 mg orally taken twice daily (12 hours apart) with or without food until disease progression or unacceptable toxicity.