natgillin/translations-raw huggingface dataset:
For at bekræfte virkningen hos kemoterapi-naive patienter, der behandles, skal indehaveren af markedsføringstilladelsen indsende de endelige resultater af studiet EMR100070-003 - del B.
In order to confirm the efficacy for chemotherapy-naïve treated patients, the MAH should submit the final results of study EMR 100070-003 - Part B.
Tumorprøver blev undersøgt for PD-L1-ekspression på tumorceller og for Merkelcelle-polyomavirus (MCV) med en eksperimentel immunhistokemisk test (IHC).
Tumour samples were evaluated for PD-L1 tumour cell expression, and for Merkel cell polyomavirus (MCV) using an investigational immunohistochemistry (IHC) assay.
Figur 4: Forest-afbildning af progressionsfri overlevelse baseret på BICR-vurdering hos patienter uanset ekspression af PD-L1
Figure 4: Forest plot of progression-free survival based on BICR assessment in patients irrespective of PD-L1 expression
Hvis du holder op med at få Bavencio
If you stop receiving Bavencio
De følgende bivirkninger er blevet indberettet i de kliniske studier med avelumab i kombination med axitinib:
The following side effects have been reported in clinical trials with avelumab in combination with axitinib:
Der er ikke tilstrækkelige data for patienter med moderat eller svært nedsat leverfunktion til doseringsanbefalinger.
There are insufficient data in patients with moderate or severe hepatic impairment for dosing recommendations.
Meget almindelig Vægttab, forhøjet alaninaminotransferase (ALAT), forhøjet aspartataminotransferase (ASAT)
Weight decreased, alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased
Objektiv responsrate (ORR) n (%) (95% CI)
Objective response rate (ORR) n (%) (95% CI)
Type 1 diabetes mellitus Avelumab kan forårsage type 1 diabetes mellitus, herunder diabetisk ketoacidose (se pkt.
Type 1 diabetes mellitus Avelumab can cause Type 1 diabetes mellitus, including diabetic ketoacidosis (see section 4.8).
• Nedsat antal røde blodlegemer
• Decrease in the number of red blood cells
Brug af anden medicin sammen med Bavencio
Other medicines and Bavencio
Andre klinisk vigtige immunrelaterede bivirkninger blev rapporteret hos under 1 % af patienterne: myositis, hypopituitarisme, uveitis, og Guillain-Barrés syndrom (se pkt.
Other clinically important immune-related adverse reactions were reported in less than 1% of patients: myositis, hypopituitarism, uveitis, and Guillain-Barré syndrome (see section 4.8).
Behandling med insulin påbegyndes ved type 1 diabetes mellitus.
Initiate treatment with insulin for Type 1 diabetes mellitus.
Hos denne patientpopulation var de mest almindelige bivirkninger diarré (62,8 %), hypertension (49,3 %), træthed (42,9 %), kvalme (33,5 %), dysfoni (32,7 %), nedsat appetit (26,0 %), hypotyroidisme (25,2 %), hoste (23,7 %), hovedpine (21,3 %), dyspnø (20,9 %) og artralgi (20,9 %).
In this patient population, the most common adverse reactions were diarrhoea (62.8%), hypertension (49.3%), fatigue (42.9%), nausea (33.5%), dysphonia (32.7%), decreased appetite (26.0%), hypothyroidism (25.2%), cough (23.7%), headache (21.3%), dyspnoea (20.9%), and arthralgia
Klar, farveløs til let gullig opløsning.
Clear, colourless to slightly yellow solution.
Ældre Dosisjustering er ikke nødvendig for ældre patienter (≥ 65 år) (se pkt.
Elderly No dose adjustment is needed for elderly patients (≥ 65 years) (see sections 5.1 and 5.2).
28 (90,3 %) ud af 31 patienter fik højdosis kortikosteroider i en median periode på 2,4 uger (interval: 1 dag til 10,2 måneder).
Twenty-eight (90.3%) of the 31 patients received high dose corticosteroids for a median of 2.4 weeks (range: 1 day to 10.2 months).
Infusionsrelaterede reaktioner, som kan være svære, er blevet rapporteret hos patienter, der fik avelumab (se pkt.
Infusion-related reactions, which might be severe, have been reported in patients receiving avelumab (see section 4.8).
Avelumab er et humant immunoglobulin G1 (IgG1) monoklonalt antistof rettet mod liganden for programmeret celledød 1 (PD-L1).
Avelumab is a human immunoglobulin G1 (IgG1) monoclonal antibody directed against programmed death ligand 1 (PD-L1).
Produktgrænse overlevelsesestimat (N = 116)
Product-Limit Survival Estimate (N=116)
Hjælpestoffer: Mannitol, koncentreret eddikesyre, polysorbat 20, natriumhydroxid, vand til injektionsvæsker.
Excipients: Mannitol, glacial acetic acid, polysorbate 20, sodium hydroxide, water for injections.
Ikke almindelig Colitis*, autoimmun colitis*, enterocolitis*, ileus Sjælden
Colitis*, autoimmune colitis*, enterocolitis*, ileus
• tarmbetændelse (colitis), diarré (vandig, løs eller blød afføring) eller flere afføringer end normalt,
• inflammation of your intestines (colitis), diarrhoea (watery, loose or soft stools) or more bowel movements than usual;
Binyreinsufficiens gik væk hos 1 patient efter kortikoidbehandling på tidspunktet for data cut-off.
Adrenal insufficiency resolved in 1 patient with corticoid treatment at the time of data cut-off.
Hepatitis, hepatotoksicitet, immunmedieret hepatitis, leversygdom
Hepatitis, hepatotoxicity, immune-mediated hepatitis, liver disorder
Retningslinjerne for behandling af disse bivirkninger er beskrevet i pkt.
The management guidelines for these adverse reactions are described in section 4.4.
• Tilbagevendende grad 3 immunrelateret bivirkning
• Recurrent Grade 3 immune-related adverse reaction
Forberedelse og administration Anvend aseptisk teknik for at forberede infusionsvæsken, opløsningen.
Preparation and administration An aseptic technique for the preparation of the solution for infusion should be used.
Komplet respons (complete response, CR)** n (%) Partielt respons (partial response, PR)** n (%)
Complete response (CR)** n (%) Partial response (PR)** n (%)
• Tegn på type 1 diabetes kan omfatte en større sult- eller tørstfølelse end normalt, et hyppigere vandladningsbehov, vægttab og træthedsfølelse.
• Signs of type 1 diabetes may include feeling more hungry or thirsty than usual, needing to urinate more often, weight loss, and feeling tired.
Der opstod hepatotoksicitet hos patienter i behandling med avelumab i kombination med axitinib med højere end forventede hyppigheder af grad 3 og grad 4 ALAT- og ASAT-forhøjelser, sammenlignet med avelumab alene (se pkt.
Hepatotoxicity occurred in patients treated with avelumab in combination with axitinib with higher than expected frequencies of Grade 3 and Grade 4 ALT and AST elevation compared to avelumab alone (see section 4.8).
Farmakokinetikken for avelumab blev vurderet ved brug af en population til at undersøge farmakokinetikken for avelumab som monoterapi, og avelumab i kombination med axitinib.
Avelumab pharmacokinetics (PK) was assessed using a population PK approach for avelumab as monotherapy and avelumab in combination with axitinib.
Positiv (n = 19) Negativ (n = 55)
Positive (n=19) Negative (n=55)
Hvis du ammer, skal du fortælle det til lægen.
If you are breast-feeding, tell your doctor.
Positiv (n = 58) Negativ (n = 16)
Positive (n=58) Negative (n=16)
Der blev ikke fundet nogen klinisk vigtige forskelle i clearance af avelumab mellem patienter med let nedsat leverfunktion (bilirubin ≤ ULN og ASAT > ULN eller bilirubin fra 1 til 1,5 gange ULN, n = 217) og normal leverfunktion (bilirubin og ASAT ≤ ULN, n = 1.388) i en populationsfarmakokinetisk analyse.
No clinically important differences in the clearance of avelumab were found between patients with mild hepatic impairment (bilirubin ≤ ULN and AST > ULN or bilirubin between 1 and 1.5 times ULN, n=217) and normal hepatic function (bilirubin and AST ≤ ULN, n=1,388) in a population PK analysis.
Avelumab bør tilbageholdes i tilfælde af formodet immunrelateret myokarditis.
Avelumab should be withheld in the event of suspected immune-related myocarditis.
Der er ikke udført interaktionsstudier med avelumab.
No interaction studies have been conducted with avelumab.
I murine(mus) drægtighedsmodeller har blokeringen af PD-L1-signalering vist forstyrrelse i tolerancen over for fosteret, og medført et øget fostertab (se pkt.
However, in murine models of pregnancy, blockade of PD-L1 signalling has been shown to disrupt tolerance to the foetus and to result in an increased foetal loss (see section 5.3).
Håndteringsanvisninger
Handling instructions
Koncentrat til infusionsvæske, opløsning (koncentrat, sterilt).
Concentrate for solution for infusion (sterile concentrate).
Tabel 6 opsummerer den efterfølgende interimanalyse af effektendepunkter, herunder et estimat af hyppighederne for DOR og PSF efter 6 måneder ved Kaplan-Meier, hos patienter, der fik avelumab ved den anbefalede dosis for studie EMR100070-003, del B.
Table 6 summarises the subsequent interim analysis of efficacy endpoints including an estimate of the 6-month rates by Kaplan-Meier for DOR and PFS, in patients receiving avelumab at the recommended dose for study EMR100070-003, Part B.
Hos denne patientpopulation var de mest almindelige bivirkninger med avelumab træthed (32,4 %), kvalme (25,1 %), diarré (18,9 %), nedsat appetit (18,4 %), obstipation (18,4 %), infusionsrelaterede reaktioner (17,1 %), vægttab (16,6 %) og opkastning (16,2 %).
In this patient population, the most common adverse reactions with avelumab were fatigue (32.4%), nausea (25.1%), diarrhoea (18.9%), decreased appetite (18.4%), constipation (18.4%), infusion-related reactions (17.1%), weight decreased (16.6%), and vomiting (16.2%).
Immunrelateret nefritis og nyredysfunktion Avelumab kan forårsage immunrelateret nefritis (se pkt.
Immune-related nephritis and renal dysfunction Avelumab can cause immune-related nephritis (see section 4.8).
Der er ikke udført reproduktionsstudier hos dyr med avelumab.
Animal reproduction studies have not been conducted with avelumab.
Immunrelateret hepatitis
Immune-related hepatitis
Avelumab er ikke blevet undersøgt hos patienter med moderat nedsat leverfunktion (bilirubin fra 1,5 til 3 gange ULN) eller svært nedsat leverfunktion (bilirubin > 3 gange ULN).
Avelumab has not been studied in patients with moderate hepatic impairment (bilirubin between 1.5 and 3 times ULN) or severe hepatic impairment (bilirubin > 3 times ULN).
efter fortynding
After opening
Almindelig (kan forekomme hos op til 1 ud af 10 personer)
Common (may affect up to 1 in 10 people)
Ved infusionsrelaterede reaktioner af grad 3 eller grad 4 skal infusionen stoppes, og avelumab skal seponeres permanent (se pkt.
For Grade 3 or Grade 4 infusion-related reactions, the infusion should be stopped and avelumab should be permanently discontinued (see section 4.2).
Minimum, maksimum (måneder) ≥ 3 måneder ved K-M, (95 % CI) ≥ 6 måneder ved K-M, (95 % CI) ≥ 12 måneder ved K-M, (95 % CI)
Minimum, maximum (months) ≥ 3 months by K-M, (95% CI) ≥ 6 months by K-M, (95% CI) ≥ 12 months by K-M, (95% CI)
Tyreoideasygdommene gik væk hos 15 (12,4 %) af de 121 patienter på tidspunktet for data cut-off.
Thyroid disorders resolved in 15 (12.4%) of the 121 patients at the time of data cut-off.
• Anbefaling om at se indlægssedlen
• Recommendation to consult the package leaflet
Figur 2: Kaplan-Meier-estimater for progressionsfri overlevelse (PFS) pr. RECIST v1.1, IERC (del B, N=116)
Figure 2: Kaplan-Meier estimates of progression-free survival (PFS) per RECIST v1.1, IERC (Part B, N=116)
• Nedsat antal af en type af hvide blodlegemer (lymfocytter)
• Decrease in the number of a type of white blood cells (lymphocytes)
Patienterne skal overvåges for kliniske tegn og symptomer på endokrinopatier.
Patients should be monitored for clinical signs and symptoms of endocrinopathies.
Det rette volumen Bavencio skal trækkes up af hætteglasset/hætteglassene, og overføres til infusionsposen.
The required volume of Bavencio should be withdrawn from the vial(s) and be transferred to the infusion bag.
Den fortyndede opløsning må ikke nedfryses eller omrystes.
Do not freeze or shake the diluted solution.
Immunrelateret myokarditis
Immune-related myocarditis
• Tegn på leverproblemer, herunder leverbetændelse (hepatitis) kan omfatte gulfarvning af huden (gulsot) eller det hvide i øjnene, svær kvalme eller opkastning, smerter i højre side af maveområdet (abdomen), døsighed, mørk urin (tefarvet), større tendens til blødning eller blå mærker end normalt, mindre sultfølelse end normalt, træthed eller unormale leverfunktionsprøver.
• Signs of liver problems, including inflammation of the liver (hepatitis) may include yellowing of your skin (jaundice) or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), drowsiness, dark urine (tea coloured), bleeding or bruising more easily than normal, feeling less hungry than usual, tiredness or abnormal liver function tests.
Figur 3: Kaplan-Meier-estimater for progressionsfri overlevelse baseret på BICR-bedømmelsen hos patienter uanset ekspression af PD-L1
Figure 3: Kaplan-Meier estimates for progression-free survival based on BICR assessment in patients irrespective of PD-L1 expression
Der er ikke udført fertilitetsstudier med avelumab.
Fertility studies have not been conducted with avelumab.
Immunrelaterede tyreoideasygdomme, immunrelateret binyreinsufficiens og type 1 diabetes mellitus er blevet rapporteret hos patienter, der fik avelumab (se pkt.
Immune-related thyroid disorders, immune-related adrenal insufficiency, and Type 1 diabetes mellitus have been reported in patients receiving avelumab (see section 4.8).
Bivirkninger Infektioner og parasitære sygdomme
Adverse reactions Infections and infestations
SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER BETINGEDE VILKÅR
SPECIFIC OBLIGATION TO COMPLETE POSTAUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
Vurderingen af tumorstatus blev udført ved baseline, efter randomisering efter 6 uger, derefter hver 6. uge op til 18 måneder efter
Assessment of tumour status was performed at baseline, after randomisation at 6 weeks, then every 6 weeks thereafter up to 18 months after randomisation, and every 12 weeks thereafter until documented confirmed disease progression by BICR.
Der skal udføres en tilstrækkelig evaluering af formodede, immunrelaterede bivirkninger for at bekræfte ætiologien eller udelukke andre årsager.
For suspected immune-related adverse reactions, adequate evaluation should be performed to confirm aetiology or exclude other causes.
Immunrelateret hepatitis gik væk hos 27 (87,1 %) af de 31 patienter på tidspunktet for data cut-off.
Immune-related hepatitis resolved in 27 (87.1%) of the 31 patients at the time of data cut-off.
Ikke almindelig Binyreinsufficiens*, hypertyroidisme*, tyroiditis*, autoimmun tyroiditis*, akut binyrebarkinsufficiens*, autoimmun hypotyroidisme*, hypopituitarisme*
Adrenal insufficiency*, hyperthyroidism*, thyroiditis*, autoimmune thyroiditis*, adrenocortical insufficiency acute*, autoimmune hypothyroidism*, hypopituitarism*
Bivirkninger Blod og lymfesystem
Adverse reactions Blood and lymphatic system disorders
• Patientinformationskort
• Patient Information brochure
Pankreatitis*
Pancreatitis*
For oplysninger om doseringen af axitinib henvises til produktinformationen for axitinib.
For information on the posology of axitinib, please refer to the axitinib product information.
• Tegn på betændelse i lungerne (pneumonitis) kan være vejrtrækningsbesvær eller hoste.
• Signs of inflammation of the lungs (pneumonitis) may be breathing difficulties or cough.
To tilfælde med dødelig udgang er blevet rapporteret hos patienter, der fik avelumab i kombination med axitinib (se pkt.
Two fatal cases have been reported in patients receiving avelumab in combination with axitinib (see section 4.8).
Merkelcelle-karcinom
Merkel cell carcinoma
Hos patienter behandlet med avelumab i kombination med axitinib udviklede 24,7 % (121/489) af patienterne immunrelaterede tyreoideasygdomme, herunder 111 (22,7 %) patienter med hypotyroidisme, 17 (3,5 %) med hypertyroidisme og 7 (1,4 %) med tyroiditis.
In patients treated with avelumab in combination with axitinib, 24.7% (121/489) of patients developed immune-related thyroid disorders, including 111 (22.7%) patients with hypothyroidism, 17 (3.5%) with hyperthyroidism, and 7 (1.4%) with thyroiditis.
Median PFS, måneder (95 % CI) 3 måneders PFS-rate ved K-M, (95 % CI) 6 måneders PFS-rate ved K-M, (95 % CI) 12 måneders PFS-rate ved K-M, (95 % CI) CI: Konfidensinterval; RECIST: Response Evaluation Criteria in Solid Tumours; IERC: Independent Endpoint Review Committee; K-M: Kaplan-Meier * Effektdata med en minimumsopfølgning på 7 måneder (cut-off-dato 14. september 2018) ** CR eller PR blev bekræftet ved en efterfølgende tumorvurdering a Baseret på antallet af patienter med et bekræftet respons (CR eller PR)
Median PFS, months (95% CI) 3-month PFS rate by K-M, (95% CI) 6-month PFS rate by K-M, (95% CI) 12-month PFS rate by K-M, (95% CI) CI: Confidence interval; RECIST: Response Evaluation Criteria in Solid Tumours; IERC: Independent Endpoint Review Committee; K-M: Kaplan-Meier * Efficacy data with a minimum follow-up of 7 months (cut-off date 14 September 2018) ** CR or PR was confirmed at a subsequent tumour assessment a Based on number of patients with confirmed response (CR or PR)
Bekræftet myokarditis
Confirmed myocarditis
Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer)
Uncommon (may affect up to 1 in 100 people)
• Tegn på infusionsrelaterede reaktioner, såsom stakåndethed eller hvæsende vejrtrækning,
• Signs of infusion-related reactions such as shortness of breath or wheezing, chills or shaking,
Endepunkter for effekt (del A) (pr. RECIST v1.1, IERC)
Efficacy endpoints (Part A) (per RECIST v1.1, IERC)
Tabel 2: Bivirkninger hos patienter i behandling med avelumab som monoterapi i klinisk studie EMR100070-003 og bivirkninger fra et fase I-studie (EMR100070-001) af solide tumorer
Table 2: Adverse reactions in patients treated with avelumab as monotherapy in clinical study EMR100070-003 and adverse reactions from a phase I study (EMR100070-001) in solid tumours
Binyreinsufficiens gik over hos 4 (44,4 %) af de 9 patienter på tidspunktet for data cut-off.
Adrenal insufficiency resolved in 4 (44.4%) of the 9 patients at the time of data cut-off.
• Tegn på betændelse i hjertet (myokarditis) kan omfatte vejrtrækningsbesvær, svimmelhed eller besvimelse, feber, brystsmerter og trykken for brystet eller influenzalignende symptomer.
• Signs of inflammation of the heart (myocarditis) may include trouble breathing, dizziness or fainting, fever, chest pain and chest tightness or flu like symptoms.
Hvis PD-L1-signallering blokeres, har det vist sig at forstyrre tolerancen over for fosteret i murine drægtighedsmodeller og at føre til et øget fostertab.
Blockade of PD-L1 signalling has been shown in murine models of pregnancy to disrupt tolerance to the foetus and to result in an increase in foetal loss.
Median PFS, måneder (95 % CI) 6 måneders PFS-rate ved K-M, (95 % CI) 12 måneders PFS-rate ved K-M, (95 % CI) 24 måneders PFS-rate ved K-M, (95 % CI) 36 måneders PFS-rate ved K-M, (95 % CI) CI: Konfidensinterval, RECIST: Response Evaluation Criteria in Solid Tumours, IERC: Independent Endpoint Review Committee; K-M: Kaplan-Meier; + angiver en censureret værdi * Data for virkning med en minimumsopfølgning på 36 måneder (cut-off-dato 14. september 2018) ** CR eller PR blev bekræftet ved en efterfølgende tumorvurdering a Baseret på antallet af patienter med et bekræftet respons (CR eller PR)
Median PFS, months (95% CI) 6-month PFS rate by K-M, (95% CI) 12-month PFS rate by K-M, (95% CI) 24-month PFS rate by K-M, (95% CI) 36-month PFS rate by K-M, (95% CI) CI: Confidence interval; RECIST: Response Evaluation Criteria in Solid Tumours; IERC: Independent Endpoint Review Committee; K-M: Kaplan-Meier; +denotes a censored value * Efficacy data with a minimum follow-up of 36 months (cut-off date 14 September 2018) ** CR or PR was confirmed at a subsequent tumour assessment a Based on number of patients with confirmed response (CR or PR)
Perifert ødem, influenzalignende sygdom
Oedema peripheral, influenza like illness
Meget almindelig Træthed, pyreksi, perifert ødem Almindelig
Fatigue, pyrexia, oedema peripheral
Ikke almindelig Autoimmun hepatitis*, akut leversvigt*, leversvigt*, hepatitis*
Autoimmune hepatitis*, acute hepatic failure*, hepatic failure*, hepatitis*
Immunrelateret pneumonitis
Immune-related pneumonitis
Patienterne skal overvåges for ændring af leverfunktionen og symptomer på immunrelateret hepatitis, og andre årsager end immunrelateret hepatitis skal udelukkes.
Patients should be monitored for changes in liver function and symptoms of immune-related hepatitis and causes other than immune-related hepatitis should be ruled out.
Patienterne skal overvåges for tegn og symptomer på immunrelateret myokarditis.
Patients should be monitored for signs and symptoms of immune-related myocarditis.
• Mindre sultfølelse, vægttab
• Feeling less hungry, weight loss
Det skal administreres i løbet af 60 minutter som en intravenøs infusion med et sterilt, ikke-pyrogent, lavproteinbindende 0,2 mikrometer in-line- eller add-on-filter.
It is administered over 60 minutes as an intravenous infusion using a sterile, non-pyrogenic, low-protein binding 0.2 micrometre in-line or add-on filter.
Grad 2 infusionsrelateret reaktion
Grade 2 infusion-related reaction
Effekt endepunkter (del B) (pr. RECIST v1.1, IERC)
Efficacy endpoints (Part B) (per RECIST v1.1, IERC)
Mundtørhed, colitis
Dry mouth, colitis
Hos patienter behandlet med avelumab i kombination med axitinib opstod der type 1 diabetes mellitus uden en alternativ ætiologi hos 1,0% (5/489) af patienterne.
In patients treated with avelumab in combination with axitinib, Type 1 diabetes mellitus without an alternative aetiology occurred in 1.0% (5/489) of patients.
Ud af disse patienter var der 18 (3,7 %) patienter med grad 3 og 3 (0,6 %) patienter med grad 4 immunrelateret hepatitis.
Of these patients, there were 18 (3.7%) patients with Grade 3 and 3 (0.6%) patients with Grade 4 immune-related hepatitis.
Immunrelateret hepatitis gik væk hos 9 (56 %) af de 16 patienter på tidspunktet for data cut-off.
Immune-related hepatitis resolved in 9 (56%) of the 16 patients at the time of data cut-off.
Grad 4 colitis eller diarré eller tilbagevendende grad 3 colitis
Grade 4 colitis or diarrhoea or recurrent Grade 3 colitis
Medianvarigheden var 2,6 måneder (interval: 3,3 uger til over 7,9 måneder).
The median duration was 2.6 months (range: 3.3 weeks to more than 7.9 months).
Hos patienter behandlet med avelumab som monoterapi opstod der type 1 diabetes mellitus uden en alternativ ætiologi hos 0,1 % (2/1.738) af patienterne, herunder to grad 3-reaktioner, der førte til permanent seponering af avelumab.
In patients treated with avelumab as monotherapy, Type 1 diabetes mellitus without an alternative aetiology occurred in 0.1% (2/1,738) of patients including two Grade 3 reactions that led to permanent discontinuation of avelumab.
• Der skal anvendes en infusionspose af en passende størrelse (helst 250 ml), som indeholder enten 9 mg/ml (0,9 %) natriumchlorid injektionsvæske, opløsning, eller med 4,5 mg/ml (0,45 %) natriumchlorid injektionsvæske, opløsning.
• An infusion bag of appropriate size (preferably 250 mL) containing either sodium chloride 9 mg/mL (0.9%) solution for injection or with sodium chloride 4.5 mg/mL (0.45%) solution for injection should be used.
Avelumab skal seponeres permanent, hvis der bekræftes immunrelateret myokarditis (se pkt.
Avelumab should be permanently discontinued if immune-related myocarditis is confirmed (see section 4.2).
Dosisjustering er ikke nødvendig for patienter med let eller moderat nedsat nyrefunktion (se pkt.
No dose adjustment is needed for patients with mild or moderate renal impairment (see section 5.2).
Medianvarigheden kunne ikke estimeres (interval: 8 dage til over 23,9 måneder).
The median duration was not estimable (range: 8 days to more than 23.9 months).
• Nedsat nyrefunktion
• Decreased kidney function
Minimum, maksimum (måneder) ≥ 6 måneder ved K-M, (95 % CI) ≥ 12 måneder ved K-M, (95 % CI) ≥ 24 måneder ved K-M, (95 % CI) ≥ 36 måneder ved K-M, (95 % CI)
Minimum, maximum (months) ≥ 6 months by K-M, (95% CI) ≥ 12 months by K-M, (95% CI) ≥ 24 months by K-M, (95% CI) ≥ 36 months by K-M, (95% CI)