natgillin/translations-raw huggingface dataset:
ORR i den BRAF mutationspositive undergruppe var 17 % (95 % CI: 8,4, 29,0) for nivolumab og 11 % (95 % CI: 2,4, 29,2) for kemoterapi og i BRAF vildtype undergruppen var det henholdsvis 30 % (95 % CI: 24,0, 36,7) og 9 % (95 % CI: 4,6, 16,7)
The ORRs in the BRAF mutation-positive subgroup were 17% (95% CI: 8.4, 29.0) for nivolumab and 11% (95% CI: 2.4, 29.2) for chemotherapy, and in the BRAF wild-type subgroup were 30% (95% CI: 24.0, 36.7) and 9% (95% CI: 4.6, 16.7), respectively.
Nivolumab eller nivolumab i kombination med ipilimumab skal seponeres permanent i tilfælde af livstruende diabetes.
Nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued for life-threatening diabetes.
OPDIVO 10 mg/ml koncentrat til infusionsvæske, opløsning nivolumab
OPDIVO 10 mg/mL concentrate for solution for infusion nivolumab
OS hos lav-risikopatienterne, der fik nivolumab plus ipilimumab, havde en hazard ratio på 1,13 (95 % CI: 0,64; 1,99; p = 0,6710) sammenlignet med sunitinib.
OS in favourable risk patients receiving nivolumab plus ipilimumab compared to sunitinib had a hazard ratio of 1.13 (95% CI: 0.64, 1.99; p = 0.6710).
PD-L1-tumorekspression blev bestemt ved hjælp af PD-L1 IHC 28-8 pharmDx-analyse.
Tumour PD-L1 expression was determined using the PD-L1 IHC 28-8 pharmDx assay.
Afstødning af et transplanteret fast organ (solidt organ) En gruppe af stofskiftekomplikationer, som sker efter kræftbehandling, karakteriseret ved høje blodniveauer af kalium og phosphat, og lave blodniveauer af calcium (tumorlysesyndrom) En betændelsessygdom (højst sandsynligt af autoimmun oprindelse), der påvirker øjnene, huden og membranerne i ørerne, hjernen og rygmarven (Vogt-Koyanagi-Harada syndrom) Betændelseslignende reaktion i sækken der ligger omkring hjertet og ophobning af væske omkring hjertet (sygdomme i perikardiet)
A group of metabolic complications occurring after cancer treatment characterised by high blood levels of potassium and phosphate, and low blood levels of calcium (tumour lysis syndrome) An inflammatory disorder (most likely of autoimmune origin) affecting the eyes, skin and the membranes of the ears, brain and spinal cord (Vogt-Koyanagi-Harada syndrome) Inflammation of the covering of the heart and accumulation of fluid around the heart (pericardial disorders)
De første tumorvurderinger blev udført 4 uger efter behandlingsstart og fortsatte derefter indtil sygdomsprogression eller seponering.
The first tumour assessments were conducted 4 weeks after the start of treatment and continued thereafter until disease progression or treatment discontinuation.
Hos patienter, der blev behandlet med nivolumab-monoterapi, var hyppigheden af pneumonitis, herunder interstitiel lungesygdom og lungeinfiltration, 3,4 % (87/2.578).
In patients treated with nivolumab monotherapy, the incidence of pneumonitis, including interstitial lung disease and lung infiltration, was 3.4% (87/2578).
51 (64 %)M / 29 (36 %)K
51 (64%) M 29 (36%) F
Studiet inkluderede voksne patienter, som havde en ECOG-performance-status score på 0 eller 1, med stadie IIIB/C eller stadie IV American Join Committee on Cancer (AJCC), 7. udgave, histologisk bekræftet melanom som var komplet kirurgisk resekteret.
with Stage IIIB/C or Stage IV American Joint Committee on Cancer (AJCC), 7th edition, histologically confirmed melanoma that is completely surgically resected.
Hos disse patienter bør fordelen ved behandling med nivolumab vurderes mod den potentielle risiko (se pkt.
The benefit of treatment with nivolumab versus the possible risk should be considered in these patients (see section 4.8).
Hos patienter, som blev behandlet med nivolumab-monoterapi, var hyppigheden af thyroidearelaterede bivirkninger, herunder hypotyroidisme og hypertyroidisme, 9,6 % (248/2.578).
In patients treated with nivolumab monotherapy, the incidence of thyroid disorders, including hypothyroidism or hyperthyroidism, was 9.6% (248/2578).
Ved grad 2 diarre eller colitis udsættes nivolumab eller nivolumab i kombination med ipilimumab.
For Grade 2 diarrhoea or colitis, nivolumab or nivolumab in combination with ipilimumab should be withheld.
Ikke almindelig spondylartropati, Sjögrens syndrom, artritis, myopati, myositis (inklusive polymyositis)a,e, rabdomyolysea,f polymyalgia rheumatica, myositis (inklusive polymyositis), rabdomyolyse
Uncommon spondyloarthropathy, Sjogren's syndrome, arthritis, myopathy, myositis (including polymyositis)a,e, rhabdomyolysisa,f polymyalgia rheumatica, myositis (including polymyositis), rhabdomyolysis
Dosis/doser udsættes, indtil symptomerne forsvinder, radiografiske anormaliteter bedres, og behandling med kortikosteroid er afsluttet
Withhold dose(s) until symptoms resolve, radiographic abnormalities improve, and management with corticosteroids is complete
Median-OS var 17,3 måneder (95 % CI: 12,5; 37,8), og estimerede OS-rater var 42 % (95 % CI: 32; 51) ved år 3, 35 % (95 % CI: 23, 44) ved år 4 og 34 % (95 % CI: 25, 43) ved år 5 (minimumsopfølgning på 45 måneder).
The median OS was 17.3 months (95% CI: 12.5, 37.8), and the estimated OS rates were 42% (95% CI: 32, 51) at 3 years, 35% (95% CI: 26, 44) at 4 years, and 34% (95% CI: 25, 43) at 5 years (minimum follow-up of 45 months).
Samlet modtog 906 randomiserede patienter enten 3 mg/kg nivolumab (n = 453) administreret hver 2. uge, eller ipilimumab 10 mg/kg (n = 453), administretet hver 3. uge for 4 doser, derefter hver 12. uge, med start i uge 24 i op til 1 år.
A total of 906 patients were randomised to receive either nivolumab 3 mg/kg (n = 453) administered every 2 weeks or ipilimumab 10 mg/kg (n = 453) administered every 3 weeks for 4 doses then every 12 weeks beginning at week 24 for up to 1 year.
I alt 405 patienter blev randomiseret til enten nivolumab (n = 272) 3 mg/kg hver 2. uge indgivet intravenøst over en periode på 60 minutter eller kemoterapi (n = 133), som bestod af investigators valg af enten dacarbazin (1000 mg/m2 hver 3. uge) eller carboplatin (AUC 6 hver 3. uge) og paclitaxel (175 mg/m2 hver 3. uge).
A total of 405 patients were randomised to receive either nivolumab (n = 272) administered intravenously over 60 minutes at 3 mg/kg every 2 weeks or chemotherapy (n = 133) which consisted of the investigator's choice of either dacarbazine (1000 mg/m2 every 3 weeks) or carboplatin (AUC 6 every 3 weeks) and paclitaxel (175 mg/m2 every 3 weeks).
I forhold til nivolumab-monoterapi er forbedring af PFS for kombinationen nivolumab og ipilimumab udelukkende dokumenteret hos patienter med lav PD-L1-tumorekspression.
Relative to nivolumab monotherapy, an increase in PFS for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression.
Hos patienter med PD-L1-tumorekspression ≥1 % var ORR 33,5 % for nivolumab (n=179; 95 % CI: 26,7, 40,9) og 13,5 % for kemoterapi (n=74; 95 % CI: 6,7, 23,5).
In patients with tumour PD-L1 expression ≥1%, ORR was 33.5% for nivolumab (n=179; 95% CI: 26.7, 40.9) and 13.5% for chemotherapy (n=74; 95% CI: 6.7, 23.5).
Patienter med aktiv autoimmun sygdom, okulært melanom, aktive hjerne- eller leptomeningeale metastaser eller ipilimumab-relatererede bivirkninger af høj sværhedsgrad (grad 4 efter CTCAE v4.0), med undtagelse af ophørt kvalme, træthed, infusionsreaktioner eller endokrinopatier, i anamnesen, blev udelukket fra studiet.
Patients with active autoimmune disease, ocular melanoma, active brain or leptomeningeal metastases or a known history of prior ipilimumab-related high-grade (Grade 4 per CTCAE v4.0) adverse reactions, except for resolved nausea, fatigue, infusion reactions, or endocrinopathies, were excluded from the study.
Der blev observeret klinisk aktivitet uanset tumor-PD-L1-ekpressionsstatus.
Clinical activity was observed regardless of tumour PD-L1 expression status.
Nivolumab+ipilimumab versus nivolumab (deskriptiv analyse) - HR (95 % CI): 0,85 (0,68; 1,07)
Nivolumab+ipilimumab vs nivolumab (descriptive analysis) - HR (95% CI): 0.85 (0.68, 1.07)
Sekundære effektparametre omfattede investigatorvurderet ORR og PFS.
Secondary efficacy assessments included investigator-assessed ORR and PFS.
Rate (95 % CI) ved 18 måneder
Rate (95% CI) at 18 months
Ikke almindelig arytmi (herunder ventrikulær arytmi)a,d, atrieflimren, myocarditisa,f arytmi (herunder ventrikulær arytmi), myocarditisc
Uncommon arrhythmia (including ventricular arrhythmia)a,d, atrial fibrillation, myocarditisa,f arrhythmia (including ventricular arrhythmia), myocarditisc
Objektivt respons (95 % CI) Oddsratio (versus ipilimumab) (99,5 % CI) Komplet respons (CR) Partielt respons (PR) Stabil sygdom (SD) Responsvarighed Median (interval), måneder
Objective response (95% CI) Odds ratio (vs. ipilimumab) (99.5% CI) Complete response (CR) Partial response (PR) Stable disease (SD) Duration of response Median (range), months
Ikke almindelig brystsmerter Undersøgelserb Meget almindelig forhøjet ASAT, forhøjet ALAT, forhøjet total-bilirubin, forhøjet alkalisk phosphatase, forhøjet lipase, forhøjet amylase, forhøjet kreatinin, hyperglykæmic, hypoglykæmi, lymfopeni, leukopeni, neutropeni, trombocytopeni, anæmik, hypocalcæmi, hyperkaliæmi, hypokaliæmi, hypomagnesiæmi, hyponatriæmi forhøjet ASAT, forhøjet ALAT, forhøjet total-bilirubin, forhøjet alkalisk phosphatase, forhøjet lipase, forhøjet amylase, forhøjet kreatinin, hyperglykæmic, hypoglykæmi, lymfopeni, leukopeni, neutropenic, trombocytopeni, anæmik, hypercalcæmi, hypocalcæmi, hyperkaliæmi, hypokaliæmi, hypomagnesiæmi, hyponatriæmi
Very common increased AST, increased ALT, increased total bilirubin, increased alkaline phosphatase, increased lipase, increased amylase, increased creatinine, hyperglycaemiac, hypoglycaemia, lymphopaenia, leucopoenia, neutropaenia, thrombocytopaenia, anaemiak, hypocalcaemia, hyperkalaemia, hypokalaemia, hypomagnesaemia, hyponatraemia increased AST, increased ALT, increased total bilirubin, increased alkaline phosphatase, increased lipase, increased amylase, increased creatinine, hyperglycaemiac, hypoglycaemia, lymphopaenia, leucopoenia, neutropaeniac, thrombocytopaenia, anaemiak, hypercalcaemia, hypocalcaemia, hyperkalaemia, hypokalaemia, hypomagnesaemia, hyponatraemia
Studiet inkluderede patienter (18 år eller ældre), som havde oplevet sygdomsprogression under eller efter 1 eller 2 tidligere anti-angiogenese-behandlingsregimer og højst 3 tidligere systemiske behandlingsforløb.
The study included patients (18 years or older) who have experienced disease progression during or after 1 or 2 prior anti-angiogenic therapy regimens and no more than 3 total prior systemic treatment regimens.
De estimerede OS-rater var henholdsvis 68 % (95 % CI: 56; 78) og 61 % (95 % CI: 49; 71) for kombinationen (n = 73) og henholdsvis 53 % (95 % CI: 36; 68) og 44 % (95 % CI: 28; 60) for ipilimumab alene (n = 37).
The estimated 2 and 3 year OS rates were 68% (95% CI: 56, 78) and 61% (95% CI: 49, 71), respectively, for the combination (n = 73) and 53% (95% CI: 36, 68) and 44% (95% CI: 28, 60), respectively, for ipilimumab (n = 37).
61 (64 %)M / 34 (36 %)K
61 (64%) M 34 (36%) F
Objektiv respons, n (%); (95 % CI) Komplet remission (CR), n (%); (95 % CI)
Objective response, n (%); (95% CI) Complete remission (CR), n (%); (95% CI) Partial remission (PR), n (%); (95% CI)
Antal patienter i risiko Nivolumab + Ipilimumab
Number of Subjects at Risk Nivolumab + Ipilimumab
Niveauet for PD-L1-tumorekspression var ens i de to behandlingsgrupper (nivolumab versus docetaxel) ved hvert af de prædefinerede PDL1-tumorekspressionsniveauer på ≥1 % (53 % versus 55 %), ≥5 % (41 % versus 38 %) og ≥10 % (37 % versus 35 %).
Tumour PD-L1 expression levels were balanced between the two treatment groups (nivolumab vs. docetaxel) at each of the predefined tumour PD-L1 expression levels of ≥ 1% (53% vs. 55%), ≥ 5% (41% vs. 38%), or ≥ 10% (37% vs. 35%).
──Δ─── Nivolumab (hændelser: 50/210), median og 95 % CI: N.A. = ikke tilgængelig - - -- - - Dacarbazin (hændelser: 96/208), median og 95 % CI: 10,84 (9,33; 12,09)
──Δ─── Nivolumab (events: 50/210), median and 95% CI: N.A. - - -- - - Dacarbazine (events: 96/208), median and 95% CI: 10.84 (9.33, 12.09)
Den anbefalede dosis er 3 mg/kg nivolumab i kombination med 1 mg/kg ipilimumab administreret intravenøst hver 3. uge for de første 4 doser.
The recommended dose is 3 mg/kg nivolumab in combination with 1 mg/kg ipilimumab administered intravenously every 3 weeks for the first 4 doses.
──Δ─── Nivolumab 3 mg/kg (hændelser: 86/135), median og 95 % CI: 9,23 (7,33; 13,27) - - -- - -Docetaxel (hændelser: 113/137), median og 95 % CI: 6,01 (5,13; 7,33)
──Δ─── Nivolumab 3 mg/kg (events: 86/135), median and 95% CI: 9.23 (7.33, 13.27) - - -- - - Docetaxel (events: 113/137), median and 95% CI: 6.01 (5.13, 7.33)
Før og regelmæssigt under behandlingen bør patienten monitoreres for kliniske tegn, symptomer og abnorme laboratorieværdier, som kan være tegn på elektrolytforstyrrelser og dehydrering.
Patients should be monitored for cardiac and pulmonary adverse reactions continuously, as well as for clinical signs, symptoms, and laboratory abnormalities indicative of electrolyte disturbances and dehydration prior to and periodically during treatment.
Dosis/doser udsættes, indtil kreatinin vender tilbage til baseline, og behandling med kortikosteroid er afsluttet
Withhold dose(s) until creatinine returns to baseline and management with corticosteroids is complete
Komplikationer ved allogen HSCT ved klassisk Hodgkins lymfom
Complications of allogeneic HSCT in classical Hodgkin Lymphoma
Den anbefalede dosis er 1 mg/kg nivolumab i kombination med 3 mg/kg ipilimumab administreret intravenøst hver 3. uge for de første 4 doser.
The recommended dose is 1 mg/kg nivolumab in combination with 3 mg/kg ipilimumab administered intravenously every 3 weeks for the first 4 doses.
Grad 3 tilfælde blev rapporteret hos 1,6 % (41/2.578) af patienterne.
Grade 3 cases were reported in 1.6% (41/2578) of patients.
Hos patienter, som blev behandlet med nivolumab-monoterapi, var hyppigheden af abnorme leverfunktionstests 6,7 % (173/2.578).
In patients treated with nivolumab monotherapy, the incidence of liver function test abnormalities was 6.7% (173/2578).
Ikke-planocellulær NSCLC
Non-squamous NSCLC
Ipilimumab 3 mg/kg over 90 minutter
Ipilimumab 3 mg/kg over 90 minutes
PFS-rater ved 12 måneder og 95 % CI: 42 % (36; 47) - - -- - - Ipilimumab (hændelser: 245/315), median og 95 % CI: 2,89 (2,79; 3,42).
PFS rate at 12 months and 95% CI: 42% (36, 47) - - -- - - Ipilimumab (events: 245/315), median and 95% CI: 2.89 (2.79, 3.42).
Behandling efter sygdomsprogression var tilladt hos patienter, som efter investigators afgørelse oplevede kliniske fordele og ikke fik betydelige bivirkninger af studiemedicinen.
Treatment after disease progression was permitted for patients who had a clinical benefit and did not have substantial adverse effects with the study drug, as determined by the investigator.
Allergisk reaktion, reaktioner i forbindelse med infusion af medicinen Nedsat funktion af skjoldbruskkirtlen (som kan medføre træthed eller vægtstigning), øget funktion af skjoldbruskkirtlen (som kan medføre hurtig hjerterytme [puls], svedudbrud og vægttab)
Allergic reaction, reactions related to the infusion of the medicine Underactive thyroid gland (which can cause tiredness or weight gain), overactive thyroid gland (which can cause rapid heart rate, sweating and weight loss) Decreased appetite
Patienterne blev indrulleret i studiet uanset PD-L1-tumorstatus og papillomavirus (HPV)-status.
Patients were enrolled regardless of their tumour PD-L1 or human papilloma virus (HPV) status.
Efter en opfølgningsperiode på 28 måneder havde BRAF[V600]mutationspositive patienter og patienter med BRAF-vildtype, som blev randomiseret til nivolumab i kombination med ipilimumab, en ORR på henholdsvis 67,6 % (95 % CI: 57,7; 76,6; n = 102) og 54,7 % (95 % CI: 47,8; 61,5; n = 212), mens de patienter, der blev randomiseret til nivolumabmonoterapi, havde en ORR på henholdsvis 36,7 % (95 % CI: 27,2; 47,1; n = 98) og 48,2 % (95 % CI: 41,4; 55,0; n = 218).
After 28 months of follow-up, BRAF[V600] mutation-positive and BRAF wild-type patients randomised to nivolumab in combination with ipilimumab had an ORR of 67.6% (95% CI: 57.7, 76.6; n = 102) and 54.7% (95% CI: 47.8, 61.5; n = 212), while those in the nivolumab monotherapy arm had an ORR of 36.7% (95% CI: 27.2, 47.1; n = 98) and 48.2% (95% CI: 41.4, 55.0; n = 218), respectively.
Grad 2 diarre eller colitis
Grade 2 diarrhoea or colitis
54 (40,6 %) af patienterne i kemoterapiarmen fik efterfølgende en anti-PD1-behandling.
The primary OS analysis was not adjusted to account for subsequent therapies, with 54 (40.6%) patients in the chemotherapy arm subsequently receiving an anti-PD1 treatment.
Diethylentriaminpentaeddikesyre Polysorbat 80
Pentetic acid (diethylenetriaminepentaacetic acid) Polysorbate 80
Infektioner og parasitære sygdomme Almindelig pneumoni, infektion i øvre luftveje pneumoni, infektion i øvre luftveje, konjunktivitis
Infections and infestations Common pneumonia, upper respiratory tract infection pneumonia, upper respiratory tract infection, conjunctivitis
Hos patienter, som blev behandlet med nivolumab-monoterapi, var hyppigheden af udslæt 26,4 % (680/2.578).
In patients treated with nivolumab monotherapy, the incidence of rash was 26.4% (680/2578).
Tabel 13: Effektresultater (CA209238)
Table 13: Efficacy results (CA209238)
Hver ml koncentrat indeholder 10 mg nivolumab.
Each mL of concentrate contains 10 mg of nivolumab.
Samlet overlevelse kunne der også være bedring over tid af sygdomsrelaterede symptomer og ikke-sygdomsspecifik QoL, som blev vurderet ved brug af valide og pålidelige skalaer i Functional
Overall survival could be accompanied by an improvement over time in disease related symptoms and non-disease specific QoL as assessed using valid and reliable scales in the Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) and the EuroQoL EQ-5D.
Nivolumab eller nivolumab i kombination med ipilimumab skal seponeres permanent i tilfælde af livstruende hypertyroidisme eller hypotyroidisme.
Nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued for life-threatening hyperthyroidism or hypothyroidism.
Randomiseret fase 3-studie med nivolumab i kombination med ipilimumab versus sunitinib (CA209214)
Randomised phase 3 study of nivolumab in combination with ipilimumab vs. sunitinib (CA209214)
CA209205 kohorte Cb
CA209205 Cohort Cb
Samlet overlevelse Median (95 % CI) måneder
Overall survival Median (95% CI) months
Betændelseslignende reaktion i tarmene (colitis), diarre (vandig, løs eller blød afføring), opkastning, kvalme, mavesmerter
Inflammation of the intestines (colitis), diarrhoea (watery, loose or soft stools), vomiting, nausea, stomach pain
Almindelig (kan forekomme hos op til 1 ud af 10 personer) Infektioner i de øvre luftveje
Common (may affect up to 1 in 10 people)
Blandes forsigtigt ved at bevæge beholderen manuelt.
Gently mix the infusion by manual rotation.
OPDIVO 10 mg/ml sterilt koncentrat nivolumab
NAME OF THE MEDICINAL PRODUCT OPDIVO 10 mg/mL sterile concentrate nivolumab
På grund af den lille sub-population kan der ikke drages nogen endelige konklusioner på baggrund af disse data.
Because of the small size of this subgroup, no definitive conclusions can be drawn from these data.
Ved fravær af data bør nivolumab bruges med forsigtighed hos disse populationer, og under grundig hensynstagen til de potentielle fordele/risici på individuel basis.
In the absence of data, nivolumab should be used with caution in these populations after careful consideration of the potential benefit/risk on an individual basis.
Dosis/doser udsættes, indtil symptomerne forsvinder, og eventuel behandling med kortikosteroid (for symptomer på akut inflammation) er afsluttet.
Withhold dose(s) until symptoms resolve and management with corticosteroids (if needed for symptoms of acute inflammation) is complete.
Leverbetændelse (hepatitis)
Inflammation of the liver (hepatitis)
Sygdom hvor immunsystemet angriber kirtlerne der laver væsker til kroppen, f.eks. tåre og spyt (Sjögrens syndrom), muskelsmerter, ømme eller svage muskler, som ikke skyldes fysisk aktivitet (myopati), betændelseslignende reaktion i musklerne (myositis), stivhed i muskler og led, muskelkramper (rabdomyolyse)
Disease in which the immune system attacks the glands that make moisture for the body, such as tears and saliva (Sjogren's syndrome), aching muscles, muscle tenderness or weakness, not caused by exercise (myopathy), inflammation of the muscles (myositis), stiffness in muscles and joints, muscle spasm (rhabdomyolysis)
Ingen grad 5 tilfælde blev rapporteret i disse studier.
No Grade 5 cases were reported in these studies.
Randomiseret fase 3-studie versus dacarbazin (CA209066)
Randomised phase 3 study vs. dacarbazine (CA209066)
Tumor PD-L1ekspression n nivolumab + ipilimumab Median-OS (95 % CI)
Tumour PD-L1 expression n nivolumab + ipilimumab Median OS (95% CI)
Forekomsten af neutraliserende antistoffer mod nivolumab var 0,5 % med 3 mg/kg nivolumab og 1 mg/kg ipilimumab hver 3. uge og 4,6 % med 1 mg/kg nivolumab og 3 mg/kg ipilimumab hver 3. uge.
0.5% with nivolumab 3 mg/kg and ipilimumab 1 mg/kg every 3 weeks and 4.6% with nivolumab 1 mg/kg and ipilimumab 3 mg/kg every 3 weeks.
PFS-rater ved 12 måneder og 95 % CI: 49 % (44; 55) ──Δ─── Nivolumab (hændelser: 183/316), median og 95 % CI: 6,87 (4,34; 9,46).
PFS rate at 12 months and 95% CI: 49% (44, 55) ──Δ─── Nivolumab (events: 183/316), median and 95% CI: 6.87 (4.34, 9.46).
Afhængigt af bivirkningens sværhedsgrad bør nivolumab eller nivolumab i kombination med ipilimumab udsættes og kortikosteroid administreres.
Based on the severity of the adverse reaction, nivolumab or nivolumab in combination with ipilimumab should be withheld and corticosteroids administered.
I forhold til nivolumab-monoterapi er forbedring af progressionsfri overlevelse (PFS) og samlet overlevelse (OS) med kombinationen nivolumab og ipilimumab udelukkende dokumenteret hos patienter med lav PD-L1-tumorekspression (se pkt.
Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1).
Hvis OPDIVO gives sammen med ipilimumab til behandling af fremskreden nyrekræft, er den anbefalede dosis OPDIVO 3 mg nivolumab pr. kilogram kropsvægt for de første 4 doser
When OPDIVO is given in combination with ipilimumab for the treatment of advanced kidney cancer, the recommended dose of OPDIVO is 3 mg of nivolumab per kilogram of your body weight for the first 4 doses (combination phase).
OPDIVO er som monoterapi indiceret til behandling af fremskredent renalcellekarcinom hos voksne efter tidligere behandling.
OPDIVO as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults.
Se produktresuméet for ipilumumab for yderligere information om sikkerhedsprofilen for ipilimumab-monoterapi.
For additional information on the safety profile of ipilimumab monotherapy, please refer to the ipilimumab SmPC.
Tumorvurdering blev udført 12 uger efter randomisering, dernæst hver 6. uge i det første år, og derefter hver 12. uge.
Tumour assessments were conducted 12 weeks after randomisation then every 6 weeks for the first year, and every 12 weeks thereafter.
Ikke kendt sygdomme i perikardietj Vaskulære sygdomme Almindelig hypertension hypertension
Not known pericardial disordersj Vascular disorders Common hypertension hypertension
98,52 % CI p-værdi
Hazard ratio 98.52% CI p-value
Når der indtræder bedring, kan nivolumab eller nivolumab i kombination med ipilimumab genoptages efter nedtrapning af kortikosteroid.
Upon improvement, nivolumab or nivolumab in combination with ipilimumab may be resumed after corticosteroid taper.
Overlevelse uden tilbagefald (måneder)
Recurrence-Free Survival (Months)
OPDIVO-infusion må ikke infunderes samtidig med andre lægemidler i samme infusionsslange.
OPDIVO infusion should not be infused at the same time in the same intravenous line with other agents.