natgillin/translations-raw huggingface dataset:
Thyroideasygdomme (hypothyreoidisme/hyperthyreoidisme) Immunrelaterede thyroideasygdomme er observeret hos patienter, der har fået cemiplimab.
Thyroid disorders (Hypothyroidism/Hyperthyroidism) Immune-related thyroid disorders have been observed in patients receiving cemiplimab.
Opbevares i køleskab (2°C - 8°C).
Store in a refrigerator (2°C to 8°C).
Progressionsfri overlevelse (PFS)a, c
Progression free survival (PFS)
Cemiplimabs sikkerhed er blevet undersøgt hos 591 patienter med fremskredne solide maligniteter, inklusive 219 patienter med avanceret kutant planocellulært karcinom, der fik cemiplimab som monoterapi i 2 kliniske studier (R2810-ONC-1423 og R2810-ONC-1540).
The safety of cemiplimab has been evaluated in 591 patients with advanced solid malignancies including 219 advanced CSCC patients who received cemiplimab monotherapy in 2 clinical studies (R2810-ONC-1423 and R2810-ONC-1540).
Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, monoklonale antistoffer.
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies.
Der findes kun begrænsede data for LIBTAYO hos patienter med svært nedsat nyrefunktion CLcr <30 ml/min (se pkt.
There are limited data for LIBTAYO in patients with severe renal impairment CLcr <30 ml/min (see section 5.2).
h. Pruritus er en sammensat term, der omfatter pruritus og allergisk pruritus.
h. Pruritus is a composite term that includes pruritus and pruritus allergic.
De hyppigste immunrelaterede bivirkninger var hypothyreoidisme (7,1 %), pneumonitis (3,7 %), immunrelaterede hudreaktioner (2,0 %), hyperthyreoidisme (1,9 %) og hepatitis (1,9 %) (se ”Beskrivelse af udvalgte bivirkninger” nedenfor, Særlige advarsler og forsigtighedsregler i pkt.
The most common immune-related adverse reactions were hypothyroidism (7.1%), pneumonitis (3.7%), immune-related skin adverse reactions (2.0%), hyperthyroidism (1.9%) and hepatitis (1.9%) (see “Description of selected adverse reactions” below, Special warnings and precautions for use in section 4.4 and Recommended treatment modifications in section 4.2).
Opløsningen kan indeholde spormængder af gennemsigtige til hvide partikler i hætteglas til engangsbrug.
The solution may contain trace amounts of translucent to white particles in a single-use vial.
Cemiplimab forstærker T-celleresponset, herunder anti-tumorresponset, ved at blokere bindingen imellem PD-1 og liganderne PD-L1 og PD-L2.
Cemiplimab potentiates T cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands.
Initiér symptomatisk behandling
Initiate symptomatic management
• Du får LIBTAYO på et hospital eller en klinik under tilsyn af en læge med erfaring i behandling af kræft.
How you are given LIBTAYO • LIBTAYO will be given to you in a hospital or clinic - supervised by a doctor experienced in cancer treatment.
LIBTAYO fås i et 10 ml klart glas (type 1) hætteglas med en grå chlorbutylprop med FluroTec overtræk og flip-off-låg.
LIBTAYO is provided in a 10 ml clear Type 1 glass vial, with a grey chlorobutyl stopper with FluroTec coating and seal cap with a flip-off button.
Bivirkninger er anført efter systemorganklasse og hyppighed i nedenstående tabel 2.
Listed in Table 2 are adverse reactions by system organ class and by frequency.
• forhøjet indhold af leverenzymer i blodet, unormalt resultat af leverfunktionstest
• increased liver enzymes in blood, abnormal kidney function test
• Du må ikke amme dit barn, mens du behandles med LIBTAYO og i mindst 4 måneder efter den sidste dosis.
• Do not breast-feed while you are being treated with LIBTAYO and for at least 4 months after the last dose.
Vurdering af tumorrespons blev udført hver 8. eller 9. uge (hos patienter der fik henholdsvis 3 mg/kg hver 2. uge eller 350 mg hver 3. uge).
Tumour response assessments were performed every 8 or 9 weeks (for patients receiving 3 mg/kg every 2 weeks or 350 mg every 3 weeks, respectively).
Der er ikke udført studier for at undersøge cemiplimabs karcinogene og genotoksiske potentiale.
No studies have been performed to test the potential of cemiplimab for carcinogenicity or genotoxicity.
Opløsningen må ikke rystes.
Do not shake the solution.
I alt 161 (83,4 %) patienter var mænd, og 187 (96,9 %) patienter var kaukasere; ECOG-performance-score var 0 (44,6 %) eller 1 (55,4 %).
A total of 161 (83.4 %) patients were male, and 187 (96.9%) patients were White; the ECOG performance score was 0 (44.6%) or 1 (55.4%).
Det vides ikke, om cemiplimab udskilles i modermælk.
It is unknown whether cemiplimab is secreted in human milk.
Ikke almindelig Almene symptomer og reaktioner på administrationsstedet Træthed k
Uncommon General disorders and administration site conditions Fatigue k
Immunrelateret diarré eller colitis havde fortaget sig hos 4 (57,1 %) af de 7 patienter på tidspunktet for data cut-off.
Resolution of immune-related diarrhoea or colitis had occurred in 4 (57.1%) of the 7 patients at the time of data cut-off.
Type 1-diabetes mellitus Grad 3 eller 4 (hyperglykæmi)
Grade 3 or 4 (hyperglycaemia)
Afhængigt af bivirkningens sværhedsgrad bør cemiplimab pauseres eller seponeres permanent (se pkt.
Depending upon the severity of the adverse reaction, cemiplimab should be withheld or permanently discontinued (see section 4.2).
Permanent seponering
Permanently discontinue
Cemiplimab skal pauseres og anti-hyperglykæmika eller insulin administreres til patienter med svær eller livstruende (grad ≥ 3) hyperglykæmi.
Cemiplimab should be withheld and anti-hyperglycaemics or insulin should be administered in patients with severe or life-threatening (Grade ≥ 3) hyperglycaemia.
Tilfælde af SJS, letal TEN og stomatitis forekom efter den første dosis cemiplimab hos patienter, der tidligere var behandlet med idelalisib, som deltog i et klinisk studie, der undersøgte cemiplimab til Non-Hodgkin lymfom (NHL), og som for nyligt havde været behandlet med sulfa-holdige antibiotika (se pkt.
Cases of SJS, fatal TEN and stomatitis occurred following 1 dose of cemiplimab in patients with prior exposure to idelalisib, who were participating in a clinical trial evaluating cemiplimab in Non-Hodgkin Lymphoma (NHL), and who had recent exposure to sulfa containing antibiotics (see section 4.8).
Toksicitet er klassificeret i henhold til version v.4.03 af NCI CTCAE.
Version v.4.03 of NCI CTCAE was used to grade toxicity.
• Træk 7 ml (350 mg) ud af hætteglasset med LIBTAYO og overfør dem til en infusionspose, der indeholder natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning eller glucose 50 mg/ml (5 %) injektionsvæske.
• Withdraw 7 ml (350 mg) from the vial of LIBTAYO and transfer into an intravenous infusion bag containing sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection.
• Hvis du ammer eller planlægger at amme dit barn, skal du spørge din læge til råds, før du tager dette lægemiddel.
• If you are breast-feeding or plan to breast-feed, ask your doctor for advice before you are given this medicine.
Der kan forekomme immunrelaterede bivirkninger med cemiplimab.
Immune-related adverse reactions can occur with cemiplimab.
Diarré er en sammensat term, der omfatter diarré og colitis.
Diarrhoea is a composite term that includes diarrhoea and colitis.
Der er ikke udført reproduktionsstudier med cemiplimab i dyr.
Animal reproduction studies have not been conducted with cemiplimab.
Tabel over bivirkninger hos patienter behandlet med cemiplimab Systemorganklasse
Tabulated list of adverse reactions in patients treated with cemiplimab System organ class preferred term
LIBTAYO indeholder Aktivt stof: Cemiplimab.
What LIBTAYO contains The active substance is cemiplimab:
Der må ikke administreres andre lægemidler i samme infusionsslange.
Other medicinal products should not be co-administered through the same infusion line.
Blandt 22 patienter med avanceret CSCC med PD-L1 < 1 % var ORR ifølge uafhængig central vurdering 40,9 % (9/22).
22 advanced CSCC patients with PD-L1 < 1%, ORR per independent central review was 40.9% (9/22).
En kartonæske indeholder 1 hætteglas med 7 ml koncentrat.
Each carton contains 1 glass vial with 7 ml of concentrate.
Øjne: keratitis Mave-tarm-kanalen: stomatitis a omfatter meningitis og aseptisk meningitis b omfatter encefalitis og ikke-infektiøs encefalitis c omfatter autoimmun myocarditis og myocarditis d omfatter artritis og polyartritis
Eye disorders: Keratitis Gastrointestinal disorders: Stomatitis a includes meningitis and meningitis aseptic b includes encephalitis and noninfective encephalitis c includes autoimmune myocarditis and myocarditis d includes arthritis and polyarthritis
Koncentrat til infusionsvæske, opløsning 350 mg/7 ml
concentrate for solution for infusion 350 mg/7 ml
Afbryd infusion eller nedsæt infusionshastigheden
Interrupt or slow rate of infusion
Blandt 53 patienter med avanceret CSCC med PD-L1 ≥ 1 % var ORR 54,7 % (29/53).
Among 53 advanced CSCC patients with PD-L1 ≥ 1%, ORR was 54.7% (29/53).
Følgende klinisk signifikante, immunrelaterede bivirkninger forekom med en hyppighed på mindre end 1 % af de 591 patienter, der fik cemiplimab.
The following clinically significant, immune-related adverse reactions occurred at an incidence of less than 1% of 591 patients treated with cemiplimab.
Muskuloskeletale smerter er en sammensat term, der omfatter rygsmerter, muskuloskeletale smerter, myalgi, nakkesmerter og smerter i arme og ben.
Musculoskeletal pain is a composite term that includes back pain, musculoskeletal pain, myalgia, neck pain and pain in extremity.
Immunrelaterede bivirkninger bør behandles med modifikationer i cemiplimab-behandlingen, hormonsubstitutionsbehandling (hvis det er klinisk indiceret) og kortikosteroid.
Immune-related adverse reactions should be managed with cemiplimab treatment modifications, hormone replacement therapy (if clinically indicated), and corticosteroids.
Muskuloskeletale smerter i
Musculoskeletal pain i
E. SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER BETINGEDE OMSTÆNDIGHEDER
SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
Dispose of any unused medicinal product or waste material in accordance with local requirements.
Artritis er en sammensat term, der omfatter artritis og polyartritis.
Arthritis is a composite term that includes arthritis and polyarthritis.
• hvis du har problemer med dine lunger eller din vejrtrækning
• you have lung or breathing problems
Dette inkluderer opbevaringstid for infusionsvæsken i den intravenøse infusionspose ved stuetemperatur og tid til administration af infusionsvæsken
This includes room temperature storage of the infusion solution in the intravenous container and time for administration of the infusion
Cemiplimab bør genoptages, når metabolisk kontrol er opnået med insulin eller anti-hyperglykæmika (se pkt.
Cemiplimab should be resumed when metabolic control is achieved on insulin replacement or anti-hyperglycaemics (see section 4.2).
Lever og galdeveje Hepatitis f
Hepatobiliary disorders Hepatitis f
De hyppigste symptomer på en infusionsrelateret reaktion var kvalme, pyreksi, opkastning, mavesmerter, kulderystelser og ansigtsrødme.
The most common symptoms of infusion-related reaction were nausea, pyrexia, vomiting, abdominal pain, chills and flushing.
LIBTAYO anvendes til behandling af den type hudkræft, der hedder fremskreden kutant planocellulært karcinom eller CSCC hos voksne.
LIBTAYO is used in adults to treat a type of skin cancer called advanced cutaneous squamous cell carcinoma or CSCC.
Cemiplimab kan forårsage alvorlige eller livstruende infusionsrelaterede reaktioner (se pkt.
Cemiplimab can cause severe or life-threatening infusion-related reactions (see section 4.8).
Hepatitis havde fortaget sig hos 8 (72,7 %) af de 11 patienter på tidspunktet for data cut-off.
Resolution of hepatitis had occurred in 8 (72.7%) of the 11 patients at the time of data cut-off.
• betændelse i hjertemusklen, som kan vise sig som åndenød, uregelmæssig hjerterytme, træthed eller smerter i brystkassen
• inflammation of the heart muscle, which may present as shortness of breath, irregular heartbeat, feeling tired or chest pain
Cemiplimab-eksponering er sammenlignelig på tværs af alle aldersgrupper (se pkt.
Cemiplimab exposure is similar across all age groups (see sections 5.1 and 5.2).
laCSCC cemiplimab: 3 mg/kg hver anden uge (Gruppe 2) (N = 78)
laCSCC cemiplimab: 3 mg/kg Q2W (Group 2) (N = 78)
Der er ikke behov for dosisjustering af LIBTAYO til patienter med nedsat nyrefunktion.
No dose adjustment of LIBTAYO is recommended for patients with renal impairment.
(inklusive men ikke begrænset til meningitis, paraneoplastisk encefalomyelitis, artritis, Guillain-Barré syndrom, encefalitis, kronisk inflammatorisk demyeliniserende polyradikuloneuropati, inflammation i centralnervesystemet, autoimmun myocarditis og immun trombocytopenisk purpura, myalgi, Sjögrens syndrom, vasculitis, myasthenia gravis)b
(including but not limited to meningitis, paraneoplastic encephalomyelitis, arthritis, Guillain-Barre syndrome, encephalitis, chronic inflammatory demyelinating polyradiculoneuropathy, central nervous system inflammation, autoimmune myocarditis, and immune thrombocytopenic purpura, myalgia, Sjogren's syndrome, vasculitis, myasthenia gravis)b
Dette omfatter opbevaringstid for infusionsvæsken i den intravenøse beholder ved stuetemperatur og tid til administration af infusionsvæsken.
This includes room temperature storage of the infusion solution in the intravenous container and time for administration of the infusion.
Patienterne bør monitoreres for ændringer i thyroideafunktionen ved behandlingsstart og regelmæssigt under behandlingen, hvis indiceret på baggrund af klinisk evaluering (se pkt.
Patients should be monitored for changes in thyroid function at the start of treatment and periodically during the treatment as indicated based on clinical evaluation (see section 4.8).
Af de 219 patienter med mCSCC og laCSCC, som blev behandlet med cemiplimab, var 25,1 % (55/219) under 65 år, 34,2 % (75/219) var mellem 65 og 75 år og 40,6 % (89/219) var 75 år eller derover.
Of the 219 patients with mCSCC and laCSCC treated with cemiplimab, 25.1% (55/219) were less than 65 years, 34.2% (75/219) were 65 to less than 75 years, and 40.6% (89/219) were 75 years or older.
Nyrer og urinveje Nefritis
Renal and urinary disorders Nephritis
Øvrige indholdsstoffer: L-Histidin, L-Histidinmonohydrochloridmonohydrat, L-prolin, saccharose, polysorbat 80 og vand til injektionsvæsker.
The other ingredients are L-Histidine, L-Histidine monohydrochloride monohydrate, L-proline, sucrose, polysorbate 80 and water for injections.
• Der må ikke administreres andre lægemidler i samme infusionsslange.
• Do not co-administer other medicinal products through the same infusion line.
Luftveje, thorax og mediastinum Pneumonitis
Uncommon Respiratory, thoracic and mediastinal disorders Pneumonitis
LIBTAYO som monoterapi er indiceret til behandling af voksne patienter med metastatisk kutant planocellulært karcinom (CSCC) eller lokalt avanceret CSCC, som ikke er egnede til kurativ kirurgi eller kurativ strålebehandling.
LIBTAYO as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.
Gennemsnitsalderen var 72 år (interval: 38 til 96): 78 (40,4 %) patienter var 75 år eller derover, 66 patienter (34,2 %) var 65 til 75 år, og 49 patienter (25,4 %) var under 65 år.
The median age was 72 years (range: 38 to 96): Seventy-eight (40.4%) patients were 75 years or older, 66 patients (34.2%) were 65 to less than 75 years, and 49 patients (25.4%) were less than 65 years.
Fem ud af 398 patienter (1,3 %), der fik cemiplimab, udviklede behandlingsudløste antistoffer, og 1 ud af 398 patienter (0,3 %) udviste vedvarende antistofrespons.
Five out of 398 patients (1.3%) administered cemiplimab developed treatment-emergent antibodies, with 1 out of 398 patients (0.3%) exhibiting persistent antibody responses.
Grad 1-5
Grades 1-5
Pneumonitis havde fortaget sig hos 14 (63,6 %) af de 22 patienter på tidspunktet for data cut-off.
Resolution of pneumonitis had occurred in 14 (63.6%) of the 22 patients at the time of data cut-off.
• hvis du har problemer med din lever
• you have liver problems
Immunrelaterede bivirkninger medførte permanent seponering af cemiplimab hos 4,4 % af patienterne.
Immune-related adverse reactions led to permanent discontinuation of cemiplimab in 4.4% of patients.
Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne angivet i pkt.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Grad 3 eller 4 eller tilbagevendende grad 2
Grade 3 or 4 or recurrent Grade 2
Hyperthyreoidisme
Hyperthyroidism
o En beskrivelse af de vigtigste tegn eller symptomer på immunrelaterede bivirkninger (pneumonitis, colitis, hepatitis, endokrinopatier, immunrelaterede hudreaktioner, nefritis og andre immunrelaterede bivirkninger) og infusionsrelaterede reaktioner samt vigtigheden af straks at kontakte den behandlende læge, hvis der opstår et eller flere symptomer.
o Description of the main signs or symptoms of the immune-related adverse reactions (pneumonitis, colitis, hepatitis, endocrinopathies, immune-related skin adverse reactions, nephritis and other irARs) and infusion related reactions, and the importance of notifying their treating physician immediately if symptoms occur.
LIBTAYO er ikke undersøgt hos patienter med moderat eller svært nedsat leverfunktion.
LIBTAYO has not been studied in patients with moderate or severe hepatic impairment.
Immunrelateret type 1-diabetes mellitus, inklusive diabetisk ketoacidose, er observeret hos patienter, der har fået cemiplimab (se pkt.
Immune-related type 1 diabetes mellitus, including diabetic ketoacidosis, has been observed in patients receiving cemiplimab (see section 4.8).
Nervesystemet Paraneoplastisk encefalomyelitis
Nervous system disorders Paraneoplastic encephalomyelitis
Du må ikke få LIBTAYO:
You should not be given LIBTAYO if:
(grad 4), paraneoplastisk encefalomyelitis (grad 5), Guillain-Barré syndrom, inflammation i centralnervesystemet, kronisk inflammatorisk demyeliniserende polyradikuloneuropati, encefalitisb, myasthenia gravis, perifer neuropati Hjerte: myocarditis c, pericarditis
(Grade 4), Paraneoplastic encephalomyelitis (Grade 5), Guillain-Barre syndrome, central nervous system inflammation, Chronic inflammatory demyelinating polyradiculoneuropathy, Encephalitis b, Myasthenia gravis, Neuropathy peripheral.
Uåbnet hætteglas Opbevares i køleskab (2°C - 8°C).
Unopened vial Store in a refrigerator (2°C to 8°C).
Immunsystemet Infusionsrelateret reaktion
Immune system disorders Infusion-related reaction
Opbevaringsforhold efter anbrud eller fortynding af lægemidlet, se pkt.
For storage conditions after first opening or dilution of the medicinal product, see section 6.3.
Hjælpestoffer: L-histidin, L-histidinmonohydrochloridmonohydrat, L-prolin, polysorbat 80, saccharose og vand til injektionsvæsker.
Excipients: L-histidine, L-histidine monohydrochloride monohydrate, L-proline, polysorbate 80, sucrose, and water for injections.
Blandt 21 patienter med mCSCC var ORR 60 % (3/5) hos patienter med PD-L1 < 1 % og 56,3 % (9/16) blandt patienter med PD-L1 ≥ 1 %.
Among 21 mCSCC patients, ORR was 60% (3/5) in patients with PD-L1 < 1% and 56.3% (9/16) among patients with PD-L1 ≥ 1%.
• Lungeproblemer (lungebetændelse) som f.eks. ny eller forværret hoste, åndenød og smerter i brystkassen.
• Lung problems (pneumonitis) such as new or worsening cough, being short of breath and chest pain.
vægttab og træthed
• feeling tired
• Patientvejledningen skal indeholde følgende hovedelementer o En beskrivelse af de vigtigste tegn eller symptomer på immunrelaterede bivirkninger (pneumonitis, colitis, hepatitis, endokrinopatier, immunrelaterede hudreaktioner, nefritis og andre immunrelaterede bivirkninger) og infusionsrelaterede reaktioner samt vigtigheden af straks at kontakte den behandlende læge, hvis der opstår et eller flere symptomer.
• The patient guide shall contain the following key messages o Description of the main signs or symptoms of the immune-related adverse reactions (pneumonitis, colitis, hepatitis, endocrinopathies, immune-related skin adverse reactions, nephritis and other irARs) and infusion related reactions, and the importance of notifying their treating physician immediately if symptoms occur.
Sværhedsgrad a
Severity a
• Problemer i andre dele af kroppen som f.eks. hovedpine eller stivhed i nakken, feber, træthed eller svaghedsfølelse, forvirring, svækket hukommelse eller søvnighed, anfald (krampeanfald), man ser eller hører ting, der ikke er virkelige (hallucinationer), synsforstyrrelser, øjensmerter eller røde øjne, kraftige muskelsmerter, ændret hjerterytme som f.eks. hurtigere hjerterytme, følelse af at hjertet springer et slag over eller hjertebanken samt blå mærker på huden eller blødning.
• Problems in other parts of the body such as headache or stiff neck, fever, feeling tired or weak, confusion, memory problems or feeling sleepy, fits (seizures), seeing or hearing things that are not really there (hallucinations), changes in eyesight, eye pain or redness, severe muscle weakness, changes in heartbeat, such as beating fast or seeming to skip a beat or pounding sensation and bruises on the skin or bleeding.
Grad 4 eller tilbagevendende grad 3
Grade 4 or recurrent Grade 3
Initiér substitutionsbehandling med thyroideahormon hvis klinisk indiceret
Initiate thyroid hormone replacement as clinically indicated
Hypofysitis
Hypophysitis
Hos de 193 patienter i effektanalysen var den objektive responsrate ved ICR (95 % CI) 40,8 % (27,0 %; 55,8 %) hos patienterne under 65 år, 48,5 % (36,0 %; 61,1 %) hos patienterne mellem 65 og 75 år og 42,3 % (31,2 %; 54,0 %) hos patienterne i alderen 75 år eller derover.
In the 193 patients in the efficacy analysis, the objective response rate by ICR (95% CI) was 40.8% (27.0%, 55.8%) in patients less than 65 years, 48.5% (36.0%, 61.1%) in patients 65 to less than 75 years, and 42.3% (31.2%, 54.0%) in patients 75 years or older.
LIBTAYO er en klar til let opaliserende, farveløs til svagt gul opløsning, der kan indeholde spormængder af gennemsigtige til hvide partikler.
LIBTAYO is a clear to slightly opalescent, colourless to pale yellow solution that may contain trace amounts of translucent to white particles.
Cemiplimabs sikkerhed og virkning er blevet undersøgt hos patienter med metastatisk (lymfemetastaser eller fjernmetastaser) CSCC (mCSCC) og lokalt avanceret CSCC (laCSCC), der ikke var egnede til kurativ kirurgi eller kurativ strålebehandling, i et klinisk studie R2810-ONC-1540 (Studie 1540).
The efficacy and safety of cemiplimab in patients with metastatic (nodal or distant) CSCC (mCSCC) or locally advanced CSCC (laCSCC) who were not candidates for curative surgery or curative radiation were studied in clinical trial R2810-ONC-1540 (Study 1540).
Hætteglassene og/eller de intravenøse infusionsposer skal nå stuetemperatur inden brug, hvis de har været opbevaret i køleskab.
If refrigerated, the vials and/or intravenous bags must be allowed to reach room temperature prior to use.
Det endokrine system Hypothyreoidisme
Endocrine disorders Hypothyroidism
Cemiplimab er ikke undersøgt hos patienter med moderat eller svært nedsat leverfunktion.
Cemiplimab has not been studied in patients with moderate or severe hepatic impairment.
Blandt de 4 patienter med type 1-diabetes mellitus var tid til indtræden 2,3 måneder (interval: 28 dage til 6,2 måneder).
Among the 4 patients with type 1 diabetes mellitus, the median time to onset was 2.3 months (range: 28 days to 6.2 months).
Blandt 54 patienter med laCSCC var ORR 35,3 % (6/17) hos patienter med PD-L1 < 1 % og 54,1 % (20/37) blandt patienter med PD-L1 ≥ 1 %.
Among 54 patients with laCSCC, ORR was 35.3% (6/17) in patients with PD-L1 < 1% and 54.1% (20/37) among patients with PD-L1 ≥ 1%.