natgillin/translations-raw huggingface dataset:
Efter en opfølgningsperiode på 28 måneder blev medianresponsvarighed hos patienter med PD-L1tumorekspressionsniveau ≥ 5 % ikke nået (0+-31,6+) i kombinationsarmen, ikke nået (2,8-30,6) i nivolumab-monoterapi-armen og ikke nået (1,4-30,6+) i ipilimumab-armen.
After 28 months of follow-up, median durations of response for patients with tumour PD-L1 expression level ≥5% were not reached (range: 0+-31.6+) in the combination arm, not reached (range: 2.8-30.6+) in the nivolumab monotherapy arm and not reached (range: 1.4-30.6+) in the ipilimumab arm. At tumour PD-L1 expression <5%, median durations of response were not reached (range: 0+-33.3+) in the combination arm, not reached (range: 0+-32.3+) in the nivolumab monotherapy arm and 18.2 months (range: 0.0+-31.5+) in the ipilimumab monotherapy arm.
Resolution forekom hos 33 patienter (94,3 %) med en mediantid til resolution på 6,1 uger (0,3-35,1).
Resolution occurred in 33 patients (94.3%) with a median time to resolution of 6.1 weeks (range: 0.3-35.1).
OPDIVO indeholder:
What OPDIVO contains
markedsføringstilladelsen udføre og indsende resultaterne fra et randomiseret klinisk studie, hvor effekt og sikkerhed af kombinationen af nivolumab og ipilimumab sammenlignes med nivolumab som monoterapi hos tidligere ubehandlede voksne patienter med fremskredent renalcellekarcinom i mellemeller højrisikogruppen og med et passende spektrum af PD-L1ekspressionsniveauer.
Post authorisation efficacy study (PAES): In order to further elucidate the contribution of ipilimumab to the efficacy and toxicity of the combination regimen of nivolumab and ipilimumab, the MAH should conduct and submit the results of a randomised, clinical study comparing the efficacy and safety of the combination of nivolumab and ipilimumab to nivolumab monotherapy in previously untreated adult patients with intermediate/poorrisk advanced renal cell carcinoma and with an appropriate spectrum of PDL1 expression levels.
De vigtigste sekundære effektparametre var investigatorvurderet PFS og objektiv responsrate (ORR).
The primary efficacy outcome measure was OS. Key secondary efficacy outcome measures were investigator-assessed PFS and objective response rate (ORR).
OS HR for nivolumab vs. kemoterapi var 0,69 (95 % CI: 0,49, 0,96) hos patienter med PD-L1tumorekspression ≥1 % og 1,52 (95 % CI: 0,89, 2,57) hos patienter med PD-L1-tumorekspression
The OS HRs for nivolumab vs. chemotherapy were 0.69 (95% CI: 0.49, 0.96) in patients with tumour PD-L1 expression ≥1% and 1.52 (95% CI: 0.89, 2.57) in patients with tumour PD-L1 expression <1%.
(27 nivolumab, 14 investigators valg)
(27 nivolumab, 14 investigator's choice)
Når OPDIVO administreres i kombination med ipilimumab og dosering af det ene stof udsættes, skal dosering af det andet stof ligeledes udsættes.
When OPDIVO is administered in combination with ipilimumab, if either agent is withheld, the other agent should also be withheld.
Median-OS var 9,7 måneder (95 % CI : 7,26, 16,16) og de estimerede OS-rater var 69,2 % (CI : 57,7, 78,2) ved 6 måneder og 45,6 % (CI : 34,2, 56,3) ved 12 måneder.
16.16) and the estimated OS rates were 69.2% (CI: 57.7, 78.2) at 6 months and 45.6% (CI: 34.2, 56.3) at 12 months.
Ingen grad 5 tilfælde blev rapporteret.
No Grade 5 cases were reported.
Der er observeret sjældne tilfælde af SJS og TEN, herunder tilfælde med dødelig udgang (se pkt.
Rare cases of SJS and TEN some of them with fatal outcome have been observed (see sections 4.2 and 4.4).
En betændelseslignende reaktion (inflammation) i led (artritis), muskelkramper, muskelsvaghed Nyresvigt (inklusive pludseligt tab af nyrefunktion) Væskeansamlinger (hævelse), smerter, brystsmerter, kulderystelser
Inflammation of the joints (arthritis), muscle spasm, muscle weakness Kidney failure (including abrupt loss of kidney function) Oedema (swelling), pain, chest pain, chills
Spørg lægen, hvis der er mere, du vil vide.
- If you have any further questions, ask your doctor.
Tumorvurdering ifølge RECIST version 1.1 blev udført 9 uger efter randomisering og derefter hver 6. uge.
Tumour assessments, according to RECIST version 1.1, were conducted 9 weeks after randomisation and continued every 6 weeks thereafter.
Mediantid til indtræden af disse endokrinopatier var 1,9 måneder (0,0-28,1).
Median time to onset of these endocrinopathies was 1.9 months (range: 0.0-28.1).
Grad 3 udslæt
Grade 3 rash
Nivolumab 3 mg/kg i kombination med ipilimumab 1 mg/kg**
Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg**
Almindelig hypotyroidisme, hypertyroidisme Ikke almindelig binyrebarkinsufficiens, hypopituitarisme, hypofysitis, tyroiditis, diabetes mellitus Sjælden diabetisk ketoacidose
Uncommon adrenal insufficiency, hypopituitarism, hypophysitis, thyroiditis, diabetes mellitus Rare diabetic ketoacidosis
Blandt de patienter, der blev behandlet med nivolumab 1 mg/kg i kombination med ipilimumab 3 mg/kg i CA209067, opstod grad 3 eller 4 bivirkninger i den indledende kombinationsfase for 154/313 (49 %).
Among the patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in CA209067, 154/313 (49%) had the first onset of Grade 3 or 4 adverse reactions during the initial combination phase.
Studiet inkluderede patienter (18 år eller ældre), som havde oplevet sygdomsprogression under eller efter et tidligere platinbaseret dublet-kemoterapiregime, og som havde en ECOG-performance-score på 0 eller 1.
The study included patients (18 years or older) who have experienced disease progression during or after one prior platinum doublet-based chemotherapy regimen and an ECOG performance status score of 0 or 1.
Der er efter markedsføringen rapporteret om pludseligt opstået, alvorlig GVHD, nogle med dødelig udfald, hos patienter behandlet med nivolumab efter allogen HSCT.
In patients treated with nivolumab after allogeneic HSCT, rapid-onset and severe GVHD, some with fatal outcome, have been reported in the post-marketing setting.
96,85 % CI p-værdi
Hazard ratio 96.85% CI p-value
Progressionfri overlevelse Median (95 % CI) måneder Rate (95 % CI) ved 6 måneder
Progression-free survival Median (95% CI) months Rate (95% CI) at 6 months
95 % CI Hyppighed (95 % CI) ved 24 måneder Bekræftet objektivt respons (95 % CI) Medianresponsvarighed Måneder (interval) Progressionsfri overlevelse Hyppighed (95 % CI) ved 24 måneder
Overall survivalc Events Hazard ratioa (95% CI) Rate (95% CI) at 24 months Confirmed objective response (95% CI) Median duration of response Months (range) Progression-free survival Rate (95% CI) at 24 months
eller anti-CTLA-4 antistof (inklusive ipilimumab eller andre antistoffer eller lægemidler specifikt rettet mod T-celle-costimulation eller checkpoint pathways),
• patients treated with prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways),
Ved symptomatisk grad 2 eller 3 hypofysitis bør nivolumab eller nivolumab i kombination med ipilimumab udsættes og hormonsubstitution initieres efter behov.
For symptomatic Grade 2 or 3 hypophysitis, nivolumab or nivolumab in combination with ipilimumab should be withheld, and hormone replacement should be initiated as needed.
Median (95 % CI) måneder
Median (95% CI) months
I alt 272 patienter blev randomiseret til at få enten nivolumab (n = 135) 3 mg/kg intravenøst over 60 minutter hver 2. uge eller docetaxel (n = 137) 75 mg/m2 hver 3. uge.
A total of 272 patients were randomised to receive either nivolumab 3 mg/kg (n = 135) administered intravenously over 60 minutes every 2 weeks or docetaxel (n = 137) 75 mg/m2 every 3 weeks.
Grad 2 og grad 3 tilfælde blev rapporteret hos henholdsvis 20,3 % (91/448) og 7,6 % (34/448) af patienterne.
Grade 2 and Grade 3 cases were reported in 20.3% (91/448) and 7.6% (34/448) of patients, respectively.
Permanent seponering af behandlingen anbefales, hvis patienten har udviklet SJS eller TEN i forbindelse med behandling med nivolumab eller nivolumab i kombination med ipilimumab (se pkt.
If the patient has developed SJS or TEN with the use of nivolumab or nivolumab in combination with ipilimumab, permanent discontinuation of treatment is recommended (see section 4.2).
Hos patienter, der blev behandlet med nivolumab 1 m/kg i kombination med ipilimumab 3 mg/kg, var hyppigheden af overfølsomheds-/infusionsreaktioner 3,8 % (17/448); de var alle grad 1 eller 2 i sværhedsgrad.
In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg, the incidence of hypersensitivity/infusion reactions was 3.8% (17/448); all were Grade 1 or 2 in severity.
OS HRs for nivolumab i kombination med ipilimumab versus nivolumab-monoterapi var 0,71 (95 % CI: 0,45 ; 1,13) for BRAF[V600]mutationspositive patienter og 0,97 (95 % CI: 0,74 ; 1,28) for patienter med BRAF-vildtype.
The OS HRs for nivolumab in combination with ipilimumab vs. nivolumab monotherapy were 0.71 (95% CI: 0.45, 1.13) for BRAF[V600] mutation-positive patients and 0.97 (95% CI: 0.74, 1.28) for BRAF wild-type patients.
Medianalderen var 60 år (28-83) med 31 % ≥ 65 år og 5 % ≥ 75 år, 83 % var mænd og 83 % var kaukasiere.
The median age was 60 years (range: 28-83) with 31% ≥ 65 years of age and 5% ≥ 75 years of age, 83% were male, and 83% were white.
PD-L1-ekspression ≥ 5 %
PD-L1 expression ≥ 5%
Betændelseslignende reaktion i lungerne (pneumonitis med hoste og vejrtrækningsbesvær), åndenød (dyspnø), hoste
Inflammation of the lungs (pneumonitis, characterised by coughing and difficulty breathing), shortness of breath (dyspnoea), cough
Almindelig vitiligo, tør hud, erytem, alopeci Ikke almindelig erythema multiforme, psoriasis, rosacea, urticaria Sjælden toksisk epidermal nekrolysea,f, Stevens-Johnsons syndroma,f Knogler, led, muskler og bindevæv
Skin and subcutaneous tissue disorders Very common rashe, pruritus Common vitiligo, dry skin, erythema, alopecia Uncommon erythema multiforme, psoriasis, rosacea, urticaria Rare toxic epidermal necrolysisa,f, Stevens-Johnson syndromea,f Musculoskeletal and connective tissue disorders Common musculoskeletal paing, arthralgia Uncommon polymyalgia rheumatica, arthritis Rare
cyster og polypper) Sjælden histiocytisk nekrotiserende lymfadenitis (Kikuchi lymfadenitis) Blod og lymfesystem
Neoplasms benign, malignant and unspecified (including cysts and polyps) Rare histiocytic necrotising lymphadenitis (Kikuchi lymphadenitis) Blood and lymphatic system disorders Very common neutropaeniaa,b Uncommon eosinophilia Immune system disorders
Alvorligt udslæt skal behandles med højdosis-kortikosteroid i en dosis ækvivalent med 1-2 mg/kg/dag methylprednisolon.
Severe rash should be managed with high-dose corticosteroid at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Bekræftet objektivt respons (95 % CI) Oddsratio (95 % CI) p-værdi
Confirmed objective response (95% CI) Odds ratio (95% CI) p-value
Da der ikke foreligger data, bør nivolumab eller nivolumab i kombination med ipilimumab anvendes med forsigtighed hos disse populationer og kun efter omhyggelig afvejning af de potentielle fordele/risici for hver enkelt patient.
In the absence of data, nivolumab or nivolumab in combination with ipilimumab should be used with caution in these populations after careful consideration of the potential benefit/risk on an individual basis.
Resolution forekom hos 42 patienter (61,8 %) med en mediantid til resolution på 12,1 uger (0,3-79,1+).
Resolution occurred in 42 patients (61.8%) with a median time to resolution of 12.1 weeks (range: 0.3-79.1+).
Tabel 5: Bivirkninger ved nivolumab-monoterapi
Table 5: Adverse reactions with nivolumab monotherapy Nivolumab monotherapy
Mediantid til indtræden var 0,9 måneder (0,0-17,9).
Median time to onset was 0.9 months (range: 0.0-17.9).
Almindelig stomatitis, pancreatitis, obstipation, mundtørhed colitis, stomatitis, pancreatitis, abdominalsmerter, obstipation, mundtørhed
Common stomatitis, pancreatitis, constipation, dry mouth colitis, stomatitis, pancreatitis, abdominal pain, constipation, dry mouth
Ikke almindelig diabetisk ketoacidosec, diabetes mellitusc diabetisk ketoacidosec, hypopituitarisme Ikke kendt hypoparatyroidismeh hypoparatyroidismeh
Uncommon diabetic ketoacidosisc, diabetes mellitusc diabetic ketoacidosisc, hypopituitarism
Ustratificeret Hazard Ratio (95 % CI)
Unstratified Hazard Ratio (95% CI)
Effektresultater er vist i tabel 18.
Efficacy results are shown in Table 18.
Resolution forekom hos 296 patienter (88,1 %) med en mediantid til resolution på 2,1 uger (0,1-124,4+).
Resolution occurred in 296 patients (88.1%) with a median time to resolution of 2.1 weeks (range: 0.1-124.4+).
Ingen grad 4 eller 5 tilfælde blev rapporteret.
No Grade 4 or 5 cases were reported.
Medianalderen var 63 år (39-85) med 44 % ≥65 år og 11 % ≥75 år.
The median age was 63 years (range: 39-85) with 44% ≥65 years of age and 11% ≥75 years of age.
Sjælden arytmi (herunder ventrikulær arytmi)d, atrieflimren, myocarditisa,f Vaskulære sygdomme
Uncommon tachycardia, pericardial disordersj Rare arrhythmia (including ventricular arrhythmia)d, atrial fibrillation, myocarditisa,f Vascular disorders
Da der ikke foreligger data for patienter med autoimmun sygdom, symptomatisk interstitiel lungesygdom eller aktive hjernemetastaser og patienter, som havde fået systemiske immunsuppressiva før studieinklusion, skal nivolumab anvendes med forsigtighed hos disse populationer og kun efter omhyggelig afvejning af de potentielle fordele/risici for hver enkelt patient.
In the absence of data for patients with autoimmune disease, symptomatic interstitial lung disease, active brain metastases and patients who had been receiving systemic immunosuppressants prior to study entry, nivolumab should be used with caution in these populations after careful consideration of the potential benefit/risk on an individual basis Physicians should consider the delayed onset of nivolumab effect before initiating treatment in patients with poorer prognostic features and/or aggressive disease.
CA209205 kohorte Ba og CA209039
CA209205 Cohort Ba and CA209039
Ingen grad 4 eller grad 5 tilfælde blev rapporteret i dette studie.
No Grade 4 or 5 cases were reported in this study.
Derudover blev symptombedring og overordnet helbredsstatus vurderet ved hjælp af henholdsvis det gennemsnitlige symptombyrde-indeks fra Lung Cancer
In addition, symptom improvement and overall health status were assessed using the Lung Cancer Symptom Score (LCSS) average symptom burden index and the EQ-5D Visual Analogue Scale (EQ-VAS), respectively.
Ved inklusion i studiet havde 4 % af patienterne hjernemetastaser i anamnesen, og 36 % af patienterne havde LDH højere end ULN ved baseline.
Four percent of patients had a history of brain metastasis, and 36% of patients had a baseline LDH level greater than ULN at study entry.
Mediantid til indtræden var 0,5 måneder (0,0-19,4).
Median time to onset was 0.5 months (range: 0.0-19.4).
Patienter med hjernemetastaser i anamnesen, tidligere behandling med en mTOR- (mammalian target of rapamycin)-hæmmer, aktiv autoimmun sygdom eller en sygdomstilstand, der krævede systemisk immunsuppression, blev udelukket fra studiet.
Patients with any history of or concurrent brain metastases, prior treatment with an mammalian target of rapamycin (mTOR) inhibitor, active autoimmune disease, or medical conditions requiring systemic immunosuppression were excluded from the study.
(95,92 % CI) p-værdib Median (95 % CI) måneder Hyppighed (95 % CI) ved 12 måneder Bekræftet objektivt respons (95 % CI) Oddsratio (95 % CI) p-værdi Komplet respons (CR) Partielt respons (PR) Stabil sygdom (SD) Medianresponsvarighed Måneder (interval) Mediantid til respons Måneder (interval) Progressionsfri overlevelse Hændelser
Overall survival Events Hazard ratioa (95% CI) p-valueb Median (95% CI) (months) Rate (95% CI) at 6 months Rate (95% CI) at 12 months Rate (95% CI) at 18 months Progression-free survival Events Hazard ratio 95% CI p-value Median (95% CI) (months) Rate (95% CI) at 6 months Rate (95% CI) at 12 months Confirmed objective responsec (95% CI) Odds ratio (95% CI) Complete response (CR) Partial response (PR) Stable disease (SD) Median time to response Months (range) Median duration of response Months (range)
PD-L1-ekspression ≥ 1 %
PD-L1 expression ≥ 1%
Intravenøs anvendelse
Intravenous use.
Nivolumab 3 mg/kg over 30 minutter
Nivolumab 3 mg/kg over 30 minutes
Mediantid til indtræden var 1,5 måneder (0,0-30,1).
Median time to onset was 1.5 months (range: 0.0-30.1).
Mediantid til indtræden var 3,6 måneder (0,2-19,6).
Median time to onset was 3.6 months (range: 0.2-19.6).
Begge nivolumab-arme viste en signifikant PFS og OS-fordel og større ORR sammenlignet med ipilimumab alene.De observerede PFS-resultater ved 18 måneders opfølgningen og ORR- og OS
Both nivolumab-containing arms demonstrated a significant PFS and OS benefit and greater ORR compared with ipilimumab alone.
Rate (95 % CI) ved 12 måneder
Rate (95% CI) at 12 months
Sikkerhed og virkning for nivolumab 3 mg/kg som monoterapi til behandling af patienter med komplet resekteret melanom blev evalueret i et randomiseret dobbeltblindt fase 3-studie (CA209238).
The safety and efficacy of nivolumab 3 mg/kg as a single agent for the treatment of patients with completely resected melanoma were evaluated in a phase 3, randomised, double-blind study (CA209238).
Almindelig pyreksi, ødem (herunder perifert ødem) Ikke almindelig smerter, brystsmerter Undersøgelserb Meget almindelig forhøjet ASAT, forhøjet ALAT, forhøjet alkalisk phosphatase, forhøjet lipase, forhøjet amylase, hypocalcæmi, forhøjet kreatinin, hyperglykæmic, lymfopeni, leukopeni, trombocytopeni, anæmik, hypercalcæmi, hyperkaliæmi, hypokaliæmi, hypomagnesiæmi, hyponatriæmi
Very common increased AST, increased ALT, increased alkaline phosphatase, increased lipase, increased amylase, hypocalcaemia, increased creatinine, hyperglycaemiac, lymphopaenia, leucopoenia, thrombocytopaenia, anaemiak, hypercalcaemia, hyperkalaemia, hypokalaemia, hypomagnesaemia, hyponatraemia
Figur 1: Kaplan-Meier kurver for OS (CA209066)
Figure 1: Kaplan-Meier curves of OS (CA209066)
PFS HR for nivolumab vs. kemoterapi var 1,58 (95 % CI: 0,87, 2,87) hos BRAF-mutationpositive patienter og 0,82 (95 % CI 0,60, 1,12) hos patienter med BRAF-vildtype.
The PFS HRs for nivolumab vs. chemotherapy were 1.58 (95% CI: 0.87, 2.87) for BRAF mutationpositive patients and 0.82 (95% CI: 0.60, 1.12) for BRAF wild-type patients.
Hos melanom-patienter, der blev behandlet med nivolumab 1 mg/kg i kombination med ipilimumab 3 mg/kg, var hyppigheden af diarre eller colitis 46,7 % (209/448).
In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the incidence of diarrhoea or colitis was 46.7% (209/448).
Det er vigtigt, at du altid har patient-informationskortet på dig, så længe du er i behandling med OPDIVO.
- It is important that you keep the Alert Card with you during treatment.
Sikkerheden og virkningen af nivolumab 3 mg/kg til behandling af fremskredent (inoperabelt eller metastatisk) melanom blev undersøgt i et randomiseret, dobbeltblindt fase 3-studie (CA209066).
The safety and efficacy of nivolumab 3 mg/kg for the treatment of advanced (unresectable or metastatic) melanoma were evaluated in a phase 3, randomised, double-blind study (CA209066).
Grad 2, grad 3 og grad 4 tilfælde blev rapporteret hos henholdsvis 4,4 % (24/547), 0,7 % (4/547) og 0,5 % (3/547) af patienterne.
Grade 2, Grade 3, and Grade 4 cases were reported in 4.4% (24/547), 0.7% (4/547), and 0.5% (3/547) of patients, respectively.
Fase 2-enkeltarmsstudie (CA209171)
Single-arm phase 2 study (CA209171)
Klassisk Hodgkins Lymfom (klassisk HL)
Classical Hodgkin Lymphoma (cHL)
Everolimus 10 mg (hændelser: 215/411), median-OS og 95 % CI: 19,55 (17,64; 23,06)
Everolimus 10 mg (events: 215/411), median and 95% CI: 19.55 (17.64, 23.06)
PFS HR for nivolumab vs. kemoterapi var 0,76 (95 % CI: 0,54, 1,07) hos patienter med PD-L1tumorekspression ≥1 % og 1,92 (95 % CI: 1,05, 3,5) hos patienter med PD-L1-tumorekspression
The PFS HRs for nivolumab vs. chemotherapy were 0.76 (95% CI: 0.54, 1.07) in patients with tumour PD-L1 expression ≥1% and 1.92 (95% CI: 1.05, 3.5) in patients with tumour PD-L1 expression <1%.
Almindelig pneumonitisa,c, lungeembolia, hoste pneumonitis, dyspnø, pleuraeffusion, hoste
Respiratory, thoracic and mediastinal disorders Very common dyspnoea Common pneumonitisa,c, pulmonary embolisma, cough pneumonitis, dyspnoea, pleural effusion, cough
Nivolumabs CL øgedes med 1 % og ipilimumabs CL mindskedes med 1,5 % når nivolumab 3 mg/kg blev administeret i kombination med ipilimumab 1 mg/kg, hvilket ikke blev anset for klinisk relevant.
When nivolumab 3 mg/kg was administered in combination with ipilimumab 1 mg/kg, the CL of nivolumab was increased by 1% and the CL of ipilimumab was decreased by 1.5%, which were not considered clinically relevant.
Dosis/doser udsættes, indtil laboratorieværdierne vender tilbage til baseline, og eventuel behandling med kortikosteroid er afsluttet
Withhold dose(s) until laboratory values return to baseline and management with corticosteroids, if needed, is complete
Nivolumab 1 mg/kg i kombination med ipilimumab 3 mg/kg
Nivolumab 1 mg/kg in Combination with Ipilimumab 3 mg/kg
Resolution forekom hos 140 patienter (91,5 %) med en mediantid til resolution på 2,4 uger (0,1-103,1+).
Resolution occurred in 140 patients (91.5%) with a median time to resolution of 2.4 weeks (range: 0.1-103.1+).
Sikkerheden og virkningen af nivolumab 3 mg/kg i kombination med ipilimumab 1 mg/kg til behandling af fremskredent/metastatisk RCC blev undersøgt i et randomiseret, åbent fase 3-studie (CA209214).
The safety and efficacy of nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg for the treatment of advanced/metastatic RCC was evaluated in a phase 3, randomised, open-label study (CA209214).
Nefritis og nedsat nyrefunktion
Nephritis and Renal Dysfunction
Ikke kendt aseptisk meningitish Blod og lymfesystem Almindelig eosinofili
Blood and lymphatic system disorders Common eosinophilia
Nivolumab som monoterapi (se pkt.
Nivolumab as monotherapy (see section 4.2)
Ved symptomatisk grad 2 binyrebarkinsufficiens bør nivolumab eller nivolumab i kombination med ipilimumab udsættes og fysiologisk kortikosteroidsubstitution initieres efter behov.
For symptomatic Grade 2 adrenal insufficiency, nivolumab or nivolumab in combination with ipilimumab should be withheld, and physiologic corticosteroid replacement should be initiated as needed.
Når der indtræder bedring, kan nivolumab eller nivolumab i kombination med ipilimumab genoptages efter nedtrapning af eventuelt kortikosteroid.
Upon improvement, nivolumab or nivolumab in combination with ipilimumab may be resumed after corticosteroid taper, if needed.
CA209205 kohorte Ba
CA209205 Cohort Ba
ECOG-performance-score ved baseline var 0 (31 %) eller 1 (69 %).
Baseline ECOG performance status was 0 (31%) or 1 (69%).
De hyppigste bivirkninger (≥ 10 %) i det puljede datasæt for nivolumab 3 mg/kg som monoterapi på tværs af tumortyper (n = 2.578) med en opfølgningperiode, som minimum spændte fra 2,3 til 28 måneder, var træthed (30 %), udslæt (17 %), pruritus (13 %), diarre (13 %) og kvalme (12 %).
In the pooled dataset of nivolumab 3 mg/kg as monotherapy across tumour types (n = 2578) with minimum follow-up ranging from 2.3 to 28 months, the most frequent adverse reactions (≥ 10%) were fatigue (30%), rash (17%), pruritus (13%), diarrhoea (13%), and nausea (12%).
ufortyndet efter overførsel til en infusionsbeholder ved brug af en passende steril sprøjte; eller efter fortynding ifølge disse instruktioner: den færdige koncentration i infusionsvæsken bør være fra 1 til 10 mg/ml.
or after diluting according to the following instructions: the final infusion concentration should range between 1 and 10 mg/mL.
Blandt de patienter, der blev behandlet med nivolumab 3 mg/kg i kombination med ipilimumab 1 mg/kg i CA209214 opstod grad 3 eller 4 bivirkninger i den indledende kombinationsfase for 169/547 (31 %).
Among the patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in CA209214, 169/547 (31%) had the first onset of Grade 3 or 4 adverse reactions during the initial combination phase.