natgillin/translations-raw huggingface dataset:
Vurder formodede immunrelaterede bivirkninger grundigt, for at bekræfte ætiologien eller for at udelukke andre årsager.
For suspected immune-related adverse reactions, ensure adequate evaluation to confirm aetiology or to rule out other causes.
Patienter med de følgende sygdomme blev ekskluderet fra kliniske studier: aktive metastaser i centralnervesystemet (CNS), aktiv eller tidligere autoimmunsygdom, andre maligniteter inden for de seneste 5 år, organtransplantation, sygdomme, der kræver terapeutisk immunsuppression eller aktiv HIV-infektion eller hepatitis B eller C.
Patients with the following conditions were excluded from clinical trials: active central nervous system (CNS) metastasis; active or a history of autoimmune disease; a history of other malignancies within the last 5 years; organ transplant; conditions requiring therapeutic immune suppression or active infection with HIV, or hepatitis B or C.
Ikke almindelig Lægemiddeloverfølsomhed, anafylaktiske overfølsomhedsreaktioner, type I overfølsomhed
Drug hypersensitivity, hypersensitivity anaphylactic reaction, Type I hypersensitivity
Medianvarigheden var 2,8 måneder (interval: 3 dage til over 15,5 måneder).
The median duration was 2.8 months (range: 3 days to more than 15.5 months).
Alle 3 patienter med immunrelateret pneumonitis blev behandlet med højdosis kortikosteroider i en median periode på 3,3 måneder (interval: 3 uger til 22,3 måneder).
All 3 patients with immune-related pneumonitis were treated with high-dose corticosteroids for a median of 3.3 months (range: 3 weeks to 22.3 months).
Der er blevet rapporteret træthed efter administration af avelumab (se pkt.
Fatigue has been reported following administration of avelumab (see section 4.8).
Avelumab skal seponeres permanent, hvis der bekræftes immunrelateret pankreatitis (se pkt.
Avelumab should be permanently discontinued if immune-related pancreatitis is confirmed (see section 4.2).
Der er blevet rapporteret immunrelateret myokarditis hos patienter, der fik avelumab.
Immune-related myocarditis has been reported in patients receiving avelumab.
Immunrelateret colitis
Immune-related colitis
• Tegn på nyrebetændelse kan omfatte unormale nyrefunktionsprøver, mindre hyppigt vandladningsbehov, blod i urinen eller hævede ankler.
• Signs of inflammation of the kidney may include abnormal kidney function tests, urinating less than usual, blood in your urine, or swelling in your ankles.
• betændelse i bugspytkirtlen (pankreatitis),
• inflammation of your pancreas (pancreatitis);
Ud af disse patienter var der 1 (0,2 %) patient med grad 3 type 1 diabetes mellitus.
Of these patients, there was 1 (0.2%) patient with Grade 3 Type 1 diabetes mellitus.
Immunrelateret pneumonitis gik væk hos 2 (66,7 %) af de 3 patienter på tidspunktet for data cut-off.
Immune-related pneumonitis resolved in 2 (66.7%) of the 3 patients at the time of data cut-off.
Patienterne skal overvåges for tegn og symptomer på immunrelateret pneumonitis, og andre årsager end immunrelateret pneumonitis skal udelukkes.
Patients should be monitored for signs and symptoms of immune-related pneumonitis and causes other than immune-related pneumonitis should be ruled out.
Medianvarigheden var 2,1 uger (interval: 2 dage til 8,9 måneder).
The median duration was 2.1 weeks (range: 2 days to 8.9 months).
• Tegn på tarmbetændelse (colitis) kan omfatte diarré (løs afføring) eller flere afføringer end normalt, blod i afføringen eller mørke, tjæreagtige, klæbrige afføringer, eller svære mavesmerter eller ømhed.
• Signs of inflammation of the intestines (colitis) may include diarrhoea (loose stools) or more bowel movements than usual, blood in your stools or dark, tarry, sticky stools, or severe stomach (abdomen) pain or tenderness.
Begge patienter med immunrelateret nefritis blev behandlet med højdosis kortikosteroider i en mediantid på 1,1 måneder (interval: 3 dage til 1,9 uger).
All 2 patients with immune-related nephritis were treated with high-dose corticosteroids for a median of 1.1 weeks (range: 3 days to 1.9 weeks).
Ud af disse patienter var der 1 (0,1 %) patient med et dødeligt udfald, 1 (0,1 %) patient med grad 4 og 5 (0,3 %) patienter med grad 3 immunrelateret pneumonitis.
Of these patients, there was 1 (0.1%) patient with a fatal outcome, 1 (0.1%) patient with Grade 4, and 5 (0.3%) patients with Grade 3 immune-related pneumonitis.
Udslæt*, pruritus*, makulopapuløst udslæt*, tør hud Ikke almindelig Kløende udslæt*, erytem*, generaliseret udslæt*, psoriasis*, erytematøst udslæt*, makulært udslæt*, papulært udslæt*, eksfoliativ dermatitis*, erythema multiforme*, pemfigoid*, generaliseret pruritus*, eksem, dermatitis
Rash pruritic*, erythema*, rash generalised*, psoriasis*, rash erythematous*, rash macular*, rash papular*, dermatitis exfoliative*, erythema multiforme*, pemphigoid*, pruritus generalised*, eczema, dermatitis
• Forhøjet blodtryk
• Increases in blood pressure
Dette er meget almindeligt for skjoldbruskkirtlen, almindeligt for binyrerne og ikke almindeligt for hypofysen.
This is very common for thyroid gland, common for adrenal glands, and uncommon for pituitary gland.
Hypotension, rødme
Hypotension, flushing
Tyreoideasygdommene gik væk hos 7 (7 %) af de 98 patienter på tidspunktet for data cut-off.
Thyroid disorders resolved in 7 (7%) of the 98 patients at the time of data cut-off.
Patienter med aktiv eller tidligere metastase i centralnervesystemet (CNS), aktiv eller tidligere autoimmunsygdom, andre tidligere maligniteter inden for de seneste 5 år, organtransplantation, sygdomme, der kræver terapeutisk immunsuppression eller aktiv infektion med HIV eller hepatitis B eller C, blev ekskluderet.
Patients with active or a history of central nervous system (CNS) metastasis; active or a history of autoimmune disease; a history of other malignancies within the last 5 years; organ transplant; conditions requiring therapeutic immune suppression or active infection with HIV, or hepatitis B or C were excluded.
Immunrelaterede endokrinopatier
Immune-related endocrinopathies
§ Reaktion kun observeret i studie EMR100070-003 (del B) efter dataafskæringen i den samlede analyse, derfor er hyppigheden estimeret
Infusion related reaction * Immune-related adverse reaction based on medical review § Reaction only observed from study EMR 100070-003 (Part B) after the data cut-off of the pooled analysis, hence frequency estimated
Mediantiden til immunrelateret pneumonitis opstod var 3,7 måneder (interval: 2,7 måneder til 8,6 måneder).
The median time to onset of immune-related pneumonitis was 3.7 months (range: 2.7 months to 8.6 months).
Avelumabs sikkerhed som monoterapi er blevet evalueret i kliniske studier hos 1.738 patienter med solide tumorer, herunder metastatisk MCC.
The safety of avelumab as monotherapy has been evaluated in 1,738 patients with solid tumours including metastatic MCC receiving 10 mg/kg every 2 weeks of avelumab in clinical studies.
Immunrelateret nefritis gik væk hos 1 (50 %) af de 2 patienter på tidspunktet for data cut-off.
Immune-related nephritis resolved in 1 (50%) of the 2 patients at the time of data cut-off.
Patienterne skal overvåges for tegn og symptomer på immunrelateret pankreatitis.
Patients should be monitored for signs and symptoms of immune-related pancreatitis.
• Røde, kløende, skællende pletter på huden
• Red, itchy, scaly patches on the skin
Immunrelateret colitis gik væk hos 18 (70 %) af de 26 patienter på tidspunktet for data cut-off.
Immune-related colitis resolved in 18 (70%) of 26 patients at the time of data cut-off.
Studiepopulationens karakteristika var en medianalder på 61 år (interval: 27,0 til 88,0), 38 % af patienterne var 65 år eller ældre, 75 % var mænd, 75 % var kaukasere og ECOG performance score var 0 (63 %) eller 1 (37 %).
The study population characteristics were: median age of 61 years (range: 27.0 to 88.0), 38% of patients were 65 years or older, 75% were male, 75% were White, and the ECOG performance score was 0 (63%) or 1 (37%).
Hos patienter behandlet med avelumab som monoterapi udviklede 6 % (98/1.738) af patienterne immunrelaterede tyreoideasygdomme, herunder 90 (5 %) af patienterne med hypotyroidisme, 7 (0,4 %) med hypertyroidisme og 4 (0,2 %) med tyroiditis.
In patients treated with avelumab as monotherapy, 6% (98/1,738) of patients developed immune-related thyroid disorders, including 90 (5%) patients with hypothyroidism, 7 (0.4%) with hyperthyroidism, and 4 (0.2%) with thyroiditis.
Immunrelateret pneumonitis gik væk hos 12 (57 %) af de 21 patienter på tidspunktet for data cut-off.
Immune-related pneumonitis resolved in 12 (57%) of the 21 patients at the time of data cut-off.
Avelumab blev seponeret hos 4,7 % (23/489) af patienterne, på grund af immunrelateret hepatitis.
Avelumab was discontinued in 4.7% (23/489) of patients due to immune-related hepatitis.
Immunrelateret pankreatitis
Immune-related pancreatitis
Ud af disse patienter var der 2 (0,1 %) patienter med et dødeligt udfald og 11 (0,6 %) patienter med grad 3 immunrelateret hepatitis.
Of these patients, there were 2 (0.1%) patients with a fatal outcome, and 11 (0.6%) patients with Grade 3 immune-related hepatitis.
Medianvarigheden var 2,5 måneder (interval: 1 dag til over 7,4 måneder).
The median duration was 2.5 months (range: 1 day to more than 7.4 months).
Bavencio 20 mg/ml koncentrat, sterilt avelumab i.v.
Bavencio 20 mg/mL sterile concentrate avelumab
• Tegn på betændelse i bugspytkirtlen (pankreatitis) kan omfatte mavesmerter, kvalme og opkastning.
• Signs of inflammation of the pancreas (pancreatitis) may include abdominal pain, nausea and vomiting.
Infusionen skal administreres med et steril, ikke-pyrogen, lavproteinbindende 0,2 mikrometer in-line- eller add-on-filter.
Administer the infusion using a sterile, non-pyrogenic, low-protein binding 0.2 micrometre in-line or addon filter.
Mediantiden til immunrelateret nefritis opstod var 1,2 måneder (interval: 2,9 uger til 1,8 måneder).
The median time to onset of immune-related nephritis was 1.2 months (range: 2.9 weeks to 1.8 months).
Formodet pankreatitis
Suspected pancreatitis
Tabel 6: Efterfølgende interimanalyse af respons på avelumab 10 mg/kg hver 2. uge hos patienter med metastatisk MCC i studie EMR100070-003 (del B)*
Table 6: Subsequent interim analysis of response to avelumab 10 mg/kg every 2 weeks in patients with metastatic MCC in study EMR100070-003 (Part B)*
Håndteringsanvisninger Anvend aseptisk teknik for at forberede infusionsvæsken, opløsningen.
Handling instructions An aseptic technique for the preparation of the solution for infusion should be used.
Medianvarigheden var 7 uger (interval: 4 dage til over 4 måneder).
The median duration was 7 weeks (range: 4 days to more than 4 months).
Immunrelatet colitis gik over hos 10 (76,9 %) af de 13 patienter på tidspunktet for data cut-off.
Immune-related colitis resolved in 10 (76.9%) of 13 patients at the time of data cut-off.
Ud af de 88 patienter var 65 (74 %) mænd, medianalderen var 73 år (interval 33 år til 88 år), 81 (92 %) af patienterne var kaukasere, og 49 (56 %) patienter og 39 (44 %) patienter havde en Eastern Cooperative Oncology Group (ECOG) performancestatus på hhv. 0 og 1.
Of the 88 patients, 65 (74%) were male, the median age was 73 years (range 33 years to 88 years), 81 (92%) patients were Caucasian, and 49 (56%) patients and 39 (44%) patients with an Eastern Cooperative Oncology Group (ECOG) performance status 0 and 1, respectively.
Hypertyroidisme, binyreinsufficiens, tyroiditis
Hyperthyroidism, adrenal insufficiency, thyroiditis
• Nedsat blodtryk
• Decreases in blood pressure
Grad 2 eller grad 3 colitis eller diarré Afbryd, indtil bivirkningerne bedres til grad 0-1
Grade 2 or Grade 3 colitis or diarrhoea Withhold until adverse reactions recover to
Patienterne skal overvåges for tegn og symptomer på immunrelateret colitis, og andre årsager end immunrelateret colitis skal udelukkes.
Patients should be monitored for signs and symptoms of immune-related colitis and causes other than immune-related colitis should be ruled out.
Immunrelateret colitis Der er blevet rapporteret immunrelateret colitis hos patienter, der fik avelumab (se pkt.
Immune-related colitis Immune-related colitis has been reported in patients receiving avelumab (see section 4.8).
Avelumab bør afbrydes ved grad 2 eller grad 3 nefritis, indtil reaktionen er reduceret til ≤ grad 1, og permanent seponeres for grad 4 nefritis.
Avelumab should be withheld for Grade 2 or Grade 3 nephritis until resolution to ≤ Grade 1 and permanently discontinued for Grade 4 nephritis.
Medianvarigheden var 1,3 uger (interval: over 4 dage til 1,3 uger).
The median duration was 1.3 weeks (range: more than 4 days to 1.3 weeks).
Medianvarigheden kunne ikke estimeres (interval: 2 dage til over 6 måneder).
The median duration was not estimable (range: 2 days to more than 6 months).
Avelumab blev seponeret hos 0,2 % (1/489) af patienterne, på grund af type 1 diabetes mellitus.
Avelumab was discontinued in 0.2% (1/489) of patients due to Type 1 diabetes mellitus.
Dosisjustering er ikke nødvendig for patienter med let nedsat leverfunktion (se pkt.
No dose adjustment is needed for patients with mild hepatic impairment (see section 5.2).
Medianvarigheden kunne ikke estimeres (interval: 1 dag til over 26 måneder).
The median duration was not estimable (range: 1 day to more than 26 months).
Ved bedring bør det overvejes at genoptage behandlingen med Bavencio eller axitinib eller at genoptage kombinationsbehandlingen sekventielt med både Bavencio og axitinib.
Rechallenge with Bavencio or axitinib or sequential rechallenge with both Bavencio and axitinib after recovery should be considered.
Mediantiden til immunrelateret binyreinsufficiens opstod var 5,5 måneder (interval: 3,6 uger til 8,7 måneder).
The median time to onset of immune-related adrenal insufficiency was 5.5 months (range: 3.6 weeks to 8.7 months).
Tabel 5 opsummerer PD-L1-ekpression og MCV-status for patienter med metastatisk MCC i studie EMR100070-003 (del A).
Table 5 summarises the PD-L1 expression and MCV status of patients with metastatic MCC in study EMR100070-003 (Part A).
Der opstod immunrelateret pneumonitis hos patienter, der blev behandlet med avelumab.
Immune-related pneumonitis occurred in patients treated with avelumab.
Hovedpine, svimmelhed, perifer neuropati Ikke almindelig Guillain-Barrés syndrom*
Headache, dizziness, neuropathy peripheral
Hos patienter behandlet med avelumab i kombination med axitinib opstod der immunrelateret nefritis hos 0,4 % (2/489) af patienterne.
In patients treated with avelumab in combination with axitinib, immune-related nephritis occurred in 0.4% (2/489) of patients.
• Nedsat antal blodplader i blodet
• Decrease in the number of platelets in the blood
Avelumab bør afbrydes ved grad 3 eller grad 4 endokrinopatier, indtil reaktionerne forsvinder (se pkt.
Avelumab should be withheld for Grade 3 or Grade 4 endocrinopathies until resolution (see section 4.2).
Hos patienter behandlet med avelumab som monoterapi opstod der immunrelateret myokarditis hos mindre end 1 % (5/4.000) af patienterne i alle kliniske studier af flere tumortyper, og hos 0,6 % (3/489) af patienterne, der fik avelumab i kombination med axitinib, herunder hos 2 (0,4 %) af patienterne med dødelig udgang.
In patients treated with avelumab as monotherapy, immune-related myocarditis occurred in less than 1% (5/4,000) of patients across clinical trials in multiple tumour types and in 0.6% (3/489) of patients receiving avelumab in combination with axitinib including 2 (0.4%) patients with fatal outcome.
Der opstod immunrelateret hepatitis hos patienter, der blev behandlet med avelumab.
Immune-related hepatitis occurred in patients treated with avelumab.
Alle 8 patienter med immunrelateret binyreinsufficiens blev behandlet med kortikosteroider, 4 (50 %) af de 8 patienter fik højdosis systemiske kortikosteroider (≥ 40 mg prednison eller tilsvarende) efterfulgt af en nedtrapning i en mediantid på 1 dag (interval: 1 dag til 24 dage).
All 8 patients with immune-related adrenal insufficiency were treated with corticosteroids, 4 (50%) of the 8 patients received high-dose systemic corticosteroids (≥ 40 mg prednisone or equivalent) followed by a taper for a median of 1 day (range: 1 day to 24 days).
Efter administration af Bavencio skal slangen skylles med enten 9 mg/ml (0,9 %) natriumchlorid injektionsvæske, opløsning, eller med 4,5 mg/ml (0,45 %) natriumchlorid injektionsvæske, opløsning.
After administration of Bavencio, the line should be flushed with either sodium chloride 9 mg/mL (0.9%) solution for injection or with sodium chloride 4.5 mg/mL (0.45%) solution for injection.
8 (88,9%) patienter med immunrelateret binyreinsufficiens blev behandlet med kortikosteroider og 2 (25 %) af de 8 patienter fik højdosis kortikosteroider (≥ 40 mg prednison eller tilsvarende) i en mediantid på 8 dage (interval: 5 dage til 11 dage).
Eight (88.9%) patients with immune-related adrenal insufficiency were treated with corticosteroids and 2 (25%) of the 8 patients received high-dose corticosteroids (≥ 40 mg prednisone or equivalent) for a median of 8 days (range: 5 days to 11 days).
Hos patienter behandlet med avelumab som monoterapi opstod der immunrelateret pankreatitis hos mindre end 1 % (1/4.000) af patienterne i alle kliniske studier af flere tumortyper, og hos 0,6 % (3/489) af patienterne, der fik avelumab i kombination med axitinib, herunder hos 2 (0,4 %) af patienterne med dødelig udgang.
In patients treated with avelumab as monotherapy, immune-related pancreatitis occurred in less than 1% (1/4,000) of patients across clinical trials in multiple tumour types and in 0.6% (3/489) of patients receiving avelumab in combination with axitinib including 2 (0.4%) patients with fatal outcome.
Tyreoideasygdomme
Thyroid disorders
Behandlingsrelateret bivirkning
Treatment-related adverse reaction
såsom irritabilitet eller glemsomhed, kuldefølelse, meget lavt blodtryk (besvimelse, svimmelhed, træthed, kvalme), vægtændringer eller hovedpine.
may include extreme tiredness, rapid heartbeat, increased sweating, changes in mood or behaviour, such as irritability or forgetfulness, feeling cold, very low blood pressure (fainting, dizziness, fatigue, nausea), weight change or headache.
Bavencio skal fortyndes med enten 9 mg/ml (0,9 %) natriumchlorid injektionsvæske, opløsning, eller med 4,5 mg/ml (0,45 %) natriumchlorid injektionsvæske, opløsning.
Bavencio has to be diluted with either sodium chloride 9 mg/mL (0.9%) solution for injection or with sodium chloride 4.5 mg/mL (0.45%) solution for injection.
ULN eller totalt bilirubin ≥ 3 gange ULN, skal både Bavencio og axitinib seponeres permanent, og der bør overvejes kortikosteroidbehandling.
If ALT or AST ≥ 5 times ULN or > 3 times ULN with concurrent total bilirubin ≥ 2 times ULN or total bilirubin ≥ 3 times ULN, both Bavencio and axitinib should be permanently discontinued and corticosteroid therapy should be considered.
Ud af de 39 patienter var 30 (77 %) mænd med en medianalder på 75 år (interval: 47 til 88 år), 33 (85 %) var kaukasere og 31 (79 %) og 8 (21 %) havde en ECOG performancestatus på hhv. 0 og 1.
Of the 39 patients, 30 (77%) were male, the median age was 75 years (range: 47 to 88 years), 33 (85%) were Caucasian, and 31 (79%) and 8 (21%) had an ECOG performance status of 0 and 1 respectively.
Ud af disse patienter var der 9 (1,8 %) patienter med grad 3 immunrelateret colitis.
Of these patients, there were 9 (1.8%) patients with Grade 3 immune-related colitis.
Avelumab bør tilbageholdes ved grad 2 hepatotoksicitet, indtil reaktionen går væk, og det skal seponeres permanent for grad 3 eller grad 4 hepatotoksicitet.
Avelumab should be withheld for Grade 2 hepatotoxicity until resolution and permanently discontinued for Grade 3 or Grade 4 hepatotoxicity.
Mediantiden til tyreoideasygdomme opstod var 2,8 måneder (interval: 3,6 uger til 19,3 måneder).
The median time to onset of thyroid disorders was 2.8 months (range: 3.6 weeks to 19.3 months).
Mediantiden til immunrelateret hepatitis opstod var 3,2 måneder (interval: 1 uge til 15 måneder).
The median time to onset of immune-related hepatitis was 3.2 months (range: 1 week to 15 months).
Hypotyroidisme*
Hypothyroidism*
Mediantiden til immunrelateret pneumonitis opstod, var 2,5 måneder (interval: 3 dage til 11 måneder).
The median time to onset of immune-related pneumonitis was 2.5 months (range: 3 days to 11 months).
Tabel 4: Respons på avelumab 10 mg/kg hver 2. uge hos patienter med metastatisk MCC i studie EMR100070-003 (del A)*
Table 4: Response to avelumab 10 mg/kg every 2 weeks in patients with metastatic MCC in study EMR100070-003 (Part A)*
Mediantiden til immunrelateret colitis opstod var 5,1 måneder (interval: 2,3 uger til 14 måneder).
The median time to onset of immune-related colitis was 5.1 months (range: 2.3 weeks to 14 months).
Bavencio 20 mg/ml koncentrat til infusionsvæske, opløsning avelumab
Bavencio 20 mg/mL concentrate for solution for infusion avelumab
Alle 13 patienter med immunrelateret colitis blev behandlet med kortikosteroider og 12 (92,3 %) ud af 13 patienter fik højdosis kortikosteroider i en median periode på 2,3 uger (interval: 5 dage til 4,6 måneder).
All 13 patients with immune-related colitis were treated with corticosteroids and 12 (92.3%) of the 13 patients received high-dose corticosteroids for a median of 2.3 weeks (range: 5 days to 4.6 months).
Præmedicin
Premedication
Meget almindelig Diarré, kvalme, forstoppelse, opkastning, abdominalsmerter Almindelig
Diarrhoea, nausea, constipation, vomiting, abdominal pain
Tabel 5: Objektive responsrater efter PD-L1-ekspression og MCV-tumorstatus hos patienter med metastatisk MCC i studie EMR100070-003 (del A)
Table 5: Objective response rates by PD-L1 expression and MCV tumour status in patients with metastatic MCC in study EMR100070-003 (Part A)
Der skal administreres kortikosteroider (1-2 mg/kg/dag prednison, givet intravenøst eller som tilsvarende oral mængde) ved grad ≥ 3 binyreinsufficiens, efterfulgt af nedtrapning til dosisniveau på ≤ 10 mg/dag er nået.
Corticosteroids should be administered (1 to 2 mg/kg/day prednisone intravenously or oral equivalent) for Grade ≥ 3 adrenal insufficiency followed by a taper until a dose of less than or equal to 10 mg/day has been reached.
Avelumab bør tilbageholdes ved grad 2 immunrelateret pneumonitis, indtil reaktionen går væk, og skal seponeres permanent for grad 3, grad 4 eller tilbagevendende grad 2 immunrelateret pneumonitis (se pkt.
Avelumab should be withheld for Grade 2 immune-related pneumonitis until resolution, and permanently discontinued for Grade 3, Grade 4 or recurrent Grade 2 immune-related pneumonitis (see section 4.2).
Administrer infusionsvæsken, opløsningen, med et sterilt, ikke-pyrogent, lavproteinbindende 0,2 mikrometer in-line- eller add-on-filter, som beskrevet i pkt.
Administer the solution for infusion using a sterile, non-pyrogenic, low-protein binding 0.2 micrometre in-line or add-on filter as described in section 4.2.
(AIDS),
(HCV);
Medianvarigheden var 1,6 uger (interval: 1 dag til over 9 måneder).
The median duration was 1.6 weeks (range: 1 day to more than 9 months).
Bavencio 20 mg/ml koncentrat til infusionsvæske, opløsning
Bavencio 20 mg/mL concentrate for solution for infusion
Immunrelateret pneumonitis førte ikke til seponering af avelumab hos nogen patienter.
Immune-related pneumonitis did not lead to discontinuation of avelumab in any patient.
Mediantiden til immunrelateret colitis opstod var 2,1 måneder (interval: 2 dage til 11 måneder).
The median time to onset of immune-related colitis was 2.1 months (range: 2 days to 11 months).
Forhøjede leverfunktionsprøver
Liver function test increased
• Røde, kløende, skællende pletter på huden, aknelignende udslæt
• Red, itchy, scaly patches on the skin, acne-like rash
• Forhøjet niveau af muskelenzymer i blodet
• Increased muscle enzyme in the blood
Immunrelateret nefritis førte ikke til seponering af avelumab hos nogen patienter.
Immune-related nephritis did not lead to discontinuation of avelumab in any patient.