March 2022: Secundum Johnson & Johnson, cura therapia a societate evoluta eiusque socium Sinarum fundatum Legenda Biotech Corp ut tractaret quaedam cancer cellae albae sanguinis a Cibus et medicamentis Administration US approbata est.
The FDA’s decision clears the way for Legend’s first product to be approved in the United States, at a time when the agency has increased its scrutiny of medication trials done in China. The Legend-J&J treatment was first tried in China, then in the United States and Japan.
Curatio; Carvykti/Cilta-cel, pertinet ad genus medicamentorum quae CAR-T therapiae vel chimeric antigen receptor T-cell therapies. CAR-T medicines work by extracting and genetically modifying a patient’s own disease-fighting T-cells to target specific proteins on cancer cells, then replacing them to seek out and attack cancer.
Legenda et J&J medicamentum in Maiori Sinis 70-30 scissurae in lucro vendent, et in omnibus aliis regionibus in lucro 50-50 scissurae.
February 28, 2022-Legenda Biotech Corporation (NASDAQ: LEGN) (Legenda Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved its first product, CARVYKTI™(ciltacabtagene autoleucel; ciltacel), for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (Janssen) to develop and commercialize ciltacel in December 2017.
CARVYKTITM est antigenus receptor chimica T-cellula (CAR-T) therapia cum duabus antigenis (BCMA) maturationis B-cellae unius dominii oppugnantibus
elementorum et infusio unius temporis data cum commendatione dosis amplitudinis 0.5 ad 1.0 x 106 CAR-positivi viable T cellulis per kg pondus corporis. In studio cartitudinum cardo-Iorum, alta et durabilia responsa visa sunt patientibus RRMM (n=1), cum alta altiore rate responsionis (ORR) 97 percent (98 percent fiduciae interstitium [CI]: 95-92.7) comprehendo. LXXVIII percent de aegris assequendum severius
completa responsio (sCR, 95 percent CI: 68.8-86.1).
1 In mediana duodeviginti mensium sequentium, mediana periodus responsionis (DOR) 18 mensium fuit (21.8 percent CI 95-non aestimabilis).
1
CARVYKTI praesto est solum per rationem restrictam sub periculo Aestimationis et Mitigationis Strategy (REMS) appellatam CARVYKTI
REMS Program.1 Salutis Information pro CARVYKTI> Monitum boxed de Cytokine Dimissione Syndrome (CRS), Immunis
Effector Cell-Associated syndrome neurotoxicitatis (ICANS), Parkinsonismus et Guillain-Barré syndrome, hemophagocytica.
lymphohistiocytosis/macrophage activationis syndromae (HLH/MAS), et diuturna et/vel cytopenia recurrens.
I Admonitiones et Cautiones
includunt longas et recurrentes cytopenias, infectiones, hypogammaglobulinemia, motus hypersensivitatis, malignitates secundariae et
effectus ad facultatem repellere et uti machinis.
1 Communissimae reactiones adversae (≥20 cento) sunt pyrexia, CRS,
hypogammaglobulinemia, hypotensio, dolor musculoskeletalis, lassitudo, infectiones pathogenia non specificata, tussis, frigora, diarrhoea, nausea, encephalopathy, appetitus decrescentes, tractus respiratorii superioris, contagio capitis, tachycardia, vertigo, dyspnoea, hydropicus, infectiones virales, coagulopathy, constipatio, et vomitus.
“Multiple myeloma remains an incurable disease with heavily pretreated patients facing poor prognoses with limited treatment options,” said Ying Huang, PhD, CEO and CFO of Legend Biotech. “Today’s approval of CARVYKTI is a pivotal moment for Legend Biotech because it
prima nostra semper ipsum adprobatio est, sed id quod vere nos excitat medicamentorum potentia est ut optionis justo impacti efficiatur aegros longis, curatio liberorum intervallis indigentium. Haec est prima multarum therapiarum cellularum quae aegros ferre instituimus dum pergimus ad nostros pipelines contra morbos status progredientes."
Myeloma multiplex genus cellae sanguinis albae quae cellulae plasma appellatur, quae in medulla ossibus inveniuntur.
relapsus post subeundae initialis curatio et facies pauperum deplorationes post curatio cum tribus maioribus medicamento classes, comprehendo
agens immunomodulator, inhibitor proteasome et anti-CD38 antibody monoclonalis.3,4,5
“The treatment journey for the majority of patients living with multiple myeloma is a relentless cycle of remission and relapse with fewer patients achieving a deep response as they progress through later lines of therapy,” said Dr. Sundar Jagannath, MBBS, Professor of Medicine, Hematology and Medical Oncology at Mount Sinai, and principal study investigator. “This is why I have been really excited about the results from the CARTITUDE-1 study, which has demonstrated that cilta-cel can provide deep and durable responses and long-term
Intervalla curatio liberorum, etiam in hac multa myeloma patientis multitudo graviter pretractatur. Hodiernae approbatione CARVYKTI adiuvat magnam necessitatem his aegris inesse.
Ut medicamentum personale, administratio CARVYKTI amplam requirit institutionem, praeparationem et certificationem ut experientiam aegrorum inconsutilem invigilet. Per phased appropinquationem, Legenda et Janssen, retis certificati tractandi centra limitata excitabunt ut
operantur ut capacitatem productionis scandere et augere disponibilitatem CARVYKTI per US in MMXXII et ultra, curandi curationem CARVYKTI provideri possunt oncologists et aegros certo et opportuno modo.
About CARVYKTI™ (Ciltacabtagene autoleucel; cilta-cel) CARVYKTI™ is a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA. BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B-cells and plasma cells. The CARVYKTI™ CAR protein features two BCMA-targeting single domain antibodies designed to confer high avidity against human BCMA. Upon binding to
BCMA cellulas exprimentes, CAR T cellae activationem, expansionem et eliminationem cellularum clypei promovet.
Mense Decembri 2017, Legenda Biotech Corporation in exclusivam licentiam terrarum et collaborationis consensum iniit cum Janssen Biotech, Inc. ad explicandum et commercium cilta-cel.
Mense Aprili 2021, Legenda denuntiavit submissionem Applicationis Marketing LICENTIA ad Medicinae Europaeae Agency approbationem petendi cilta-cel pro curatione aegrorum relapsorum et/vel refractoriae myeloma multiplices. Praeter US Breakthrough Therapy Designationem datam mense Decembri 2019 , cilta-cel a Breakthrough Therapy Designationem in Sinis Augusto 2020 accepit .
DE CARTITUDO-1 Study
CARTITUDO-1 (NCT03548207) Phase permanens 1b/2, pittacium apertum, brachium unicum, iudicium multi- centri aestimandi cilta-cel ad curationem aegrorum adultorum cum myeloma relapso vel refractorio multiplex, qui ante tres saltem lineas priorum receperat. de curatione incluso proteasome inhibitoris (PI), agentis immunomodulatoris (IMiD) et anti-CD38 anticorporis monoclonalis. De aegris ascriptis 97
probatio 99 cento refractaria ad ultimam curationis lineam et 88 centesimas refractiones fuerunt triplex genus, quod cancer eorum non respondet, vel non amplius respondet, IMiD, a PI et anti-CD38 monoclonal antibody.1
Longior terminus efficacia et salus figura cilta-cel aestimatur in studio permanenti CARTITUDI-1, cum duobus-annus sequentibus eventibus recenter exhibitis in ASH 2021.6
Herpesvirus de Tullius
Myeloma multiplex est cancer sanguinis incurabilis, qui in medulla osse incipit et nimia multiplicatione cellularum plasmatis insignitur.
Anno 2022, aestimatur plus quam 34,000 homines multiplici myeloma dignosci fore, et plus quam 12,000 homines facient.
morbo mori in US
7 Dum aliqui aegroti cum myeloma multiplici nulla symptomata habent, maxime aegri dignoscuntur propter hoc
Signa quae possunt os problemata includere, humilis sanguinem comitum, calcium elevatio, renum problemata vel infectiones.
VIII licet curatio
in remissionem consequuntur, proh dolor, fere relapsus aegroti.
3 Aegris qui post curationem therapiae normae recedunt, inhibitores protease, agentium immunomodulatorium, et anti-CD38 anticorpus monoclonalis, pauperes prognos habent et paucae bene curationes in promptu habent.
CARVYKTI™ Important Safety Information INDICATIONS ET TRACTATIO
CARVYKTI (ciltacabtagena autoleucel) est maturatio B-cellula antigeni (BCMA) directa genetice modificata autologa T cellula immunotherapy indicata curatione aegrorum adultorum relapso vel refractorio multiplex myeloma, post quattuor vel plures lineas priorum therapiae, proteasome includens. inhibitor, agens immunomodulatorius, et anti-CD38 anticorpus monoclonalis.
MONITUM: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, ET RETENTUS et REVENUS
CYTOPENIA
• Cytokine Release Syndrome (CRS), inter mortifera vel vita-minaces motus, in aegris cum sequentibus curatio occurrit.
CARVYKTI™. CARVYKTI aegros cum infectio activa vel inflammatoriae perturbationes non administrant. Gravis tracta vel minax CRS cum tocilizumab vel tocilizumab et corticosteroides.
• Immunis Effector Cell-Associated Syndrome Neurotoxicity (ICANS), quae mortiferum vel vita-minans esse potest, sequenti occurrit.
curatio cum CARVYKTI™, inclusis ante impetum CRS, simul cum CRS, post resolutionem CRS, vel in absentia CRS. Monitor rerum neurologicarum post curationem CARVYKTI™. Cura adminicula praebere et/vel corticosteroides ut opus est.
• Parkinsonismus et Guillain-Barré syndrome eorumque adiuncti complicationes quae consequiuntur motus fatales vel minaces vitales habent
occurrit haec curatio cum CARVYKTI™.
• Hemophagocytica lymphohistiocytosis/Macrophage Syndromae Activationis (HLH/MAS), inter motus mortiferas et minaces vitales;
occurrit in aegris sequenti curatione CARVYKTI™. HLH/MAS fieri potest cum CRS vel toxicitates neurologicae.
• Longa et/vel cytopenias recurrentes cum haemorrhagia et infectione et exigentia transplantationis caulis cellae pro hematopoietica
recuperatio facta est sequenti curatione CARVYKTI™.
• CARVYKTI in promptu est nisi per rationem restrictam sub periculo Aestimationis et Mitigationis Strategy (REMS) dicta in Programma CARVYKTI REMS.
WARNINGS pertinent,
Cytokine Solvo Syndroma (CRS) inter motus mortiferas vel minaces vitales, incidit curatio sequenti cum CARVYKTI™ in 95% (92/97) de aegris ciltacabtagen autoleucelis acceptis. Gradus 3 seu superior CRS (2019 ASTCT gradus) 1 factum est in 5% (5/97) aegrorum, cum Grade 5 CRS in 1 patiente relatum est. Tempus medianum ad incursus CRS erat 7 dierum (range: 1-12 dies). Frequentissima manifestationes CRS inclusa pyrexia (100%), hypotension (43%), aspartata aminotransferase (AST) (22%), frigora (15%) aucta, alaninum aminotransferasum (14%) auctum et sinus tachycardia (11%). . Gradus 3 vel eventus superiores cum CRS inclusa aucta AST et ALT, hyperbilirubinemia, hypotension, pyrexia, hypoxia, defectus respiratorii, laesio renis acuta, intravascularis disseminata.
coagulatio, HLH/MAS, angina pectoris, tachycardia supraventricularis et ventricularis, defectus, myalgias, interdum C-reactivum, ferritinum, sanguinem alcalina phosphatase et gamma-glutamyl transferase.
Ignosce CRS ex propositione clinica. Alias febres, hypoxias et hypotensiones causas aestimare et tractare. CRS relatum est cum inventis HLH/MAS sociandis, et physiologia syndromorum aliud incidere potest. HLH / MAS est potentia vita-minaces
conditio. In patientibus progressivis indicia CRS vel refractoria CRS non obstante curatione aestimanda pro testimonio HLH/MAS. Sexaginta undequadraginta 97 (71%) aegros tocilizumab et/vel corticosteroidem pro CRS receperunt post infusionem ciltacabtageni autoleucelis. quadraginta quattuor
(45%) aegros tantum tocilizumab receperunt, ex quibus 33 (34%) plus quam unum dosium unum acceperunt et 11 (11%) acceperunt; Aegri 24. (25%) tocilizumab et corticosteroides acceperunt, et unum aegrotum (1%) corticosteroides tantum receperunt. Curare ut minimum duarum doses tocilizumab praesto sint ante infusionem CARVYKTI™.
Monitor aegros saltem cotidie per X dies sequentes CARVYKTI™ infusionem ad facilitatem sanitatis REMS-certificatae pro signis et symptomatis CRS. Aegri monitoris signa vel indicia CRS pro saltem 10 septimanis post infusionem. Ad primum signum CRS, statim curationem adminicula cura, tocilizumab, vel tocilizumab et corticosteroides instituunt. Con- silium aegrorum ad curationem immediatam medicinae quaerendam debent signa vel indicia CRS quovis tempore occurrere. Neurologicae toxicitates, quae possunt esse graves, vitae minae vel funestae, inciderunt sequenti curatione cum CARVYKTI™. Toxicitates neurologicae includuntur ICANS, neurologica toxicitas cum signis et symptomata parkinsonismi, Guillain-Barré Syndroma, neuropathia peripherica, et paralyticus nervus cranialis. Consule aegros de signis et symptomatibus harum toxicitatum neurologicarum, et de tardante naturae impetu
harum aliquam toxicities. Aegros instrue ut medicinae operam immediatam ad ulteriora aestimationem et administrationem quaerant, si signa vel symptomata quarumlibet harum toxicitatum neurologicarum quovis tempore occurrant.
Altiore, unum vel plura subtypa toxicitatis neurologicae de quibus infra acciderunt sequentia ciltacabtagena autoleucella in 26% (25/97) aegrorum, e quibus 11% (11/97) aegrorum gradus 3 vel eventus superiores experti sunt. Haec subtypa neurologicorum toxicitatum in duobus studiis permanentibus observabantur.
Effector immunis cellae-Associatur syndrome neurotoxicitatis (ICANS): ICANS in 23% (22/97) de aegris acceptis ciltacabtageni autoleucelis recipiendis inter Gradus 3 vel 4 eventus in 3% (3/97) et Gradus 5 (mortales) eventus in 2% (2/97). Tempus medianum ad oppugnationem ICANS erat 8 dierum (1-28 dierum). 22 omnes cum ICANS aegros habuit CRS. Frequentissima (≥5%) manifestatio ICANS inclusa encephalopathy
(23%), aphasia (8%) et capitis (6%). Monitor aegros saltem cotidie per X dies sequentes CARVYKTI™ infusionem apud rems-certificatam facilitas sanitatis signa et indicia ICANS. Alias causas excludit ICANS symptomata. Aegri monitoris signa vel indicia ICANS per quattuor saltem septimanas post infusionem prompte tractant. Neurologic toxicitas cura adminicula et/vel corticosteroides prout opus est tractari debet.
Parkinsonismus: De 25 aegris in CARTITUDO-1 studio experiendi omnem neurotoxicitatem, quinque aegros masculi toxicitatem neurologicam habuerunt cum pluribus signis et symptomatibus parkinsonismi, distinctis ab effectore immune syndrome neurotoxicitatis-consociatae (ICANS). Neurologic
toxicitas cum parkinsonismo relata est in aliis iudiciis permanentibus de ciltacabtageni autoleucelis. Aegroti symptomata parkinsoniana et nonparkinsoniana, quae tremorem, bradykinesiam, motus involuntarium, stereotypum, amissionem motus spontanei, facies palliata, acedia, plana affectio, lassitudo, rigiditas, retardatio psychomotoria, micrographia, dysgraphia, apraxia, lethargia, confusio, sopores;
amissio conscientiae, morae reflexiones, hyperreflexia, damnum memoriae, difficultas deglutitio, alvus incontinentia, casus, status inclinatus, commiscens incessus, musculus debilitas et tabes, distemperantia motoria, amissio motoria et sensoria, mutismus akineticus, et lobus frontalis emissio signa.
Incursus medius parkinsonismi in 5 aegris in CARTITUDE-1 fuit 43 dies (per 15-108) ab infusione ciltacabtageni autoleucelis.
Aegri monitores sunt signa et indicia parkinsonismi quae in concursu differri possunt et cum cura adminicula remediis administrari possunt.
Data efficacia limitata est cum medicamentis adhibitis ad curationem morbi Parkinson, ad emendationem vel resolutionem.
Parkinsonismum symptomata quae sequuntur CARVYKTI™ tractationem.
Guillain-Barré Syndrome: Exitus funestus sequens Guillain-Barré Syndrome (GBS) incidit in alio studio permanenti
ciltacabtagena autoleucella obstante curatione immunoglobulorum intravenorum. Symptomata nuntiata includunt consentanea cum MillerFisher variantibus GBS, encephalopathy, debilitate motore, perturbationibus loquelae et polyradiculoneuritis.
Monitori GBS. Aegros aestimare neuropathiam periphericam exhibere pro GBS. Considera curationem GBS cum mensuris adminiculis et in coniunctione cum immunoglobulis et plasmatis permutationis, secundum severitatem GBS.
Periphericum Neuropathum: Sex aegris in CARTITUDO-1 periphericis neuropathia evoluta. Hae neuropathiae offeruntur sensoriis, motoriis vel sensorimotis neuropathiis. Medium tempus accessionis symptomatis erat 62 dierum (range 4-136 dierum), duratio mediana neuropathiae peripheriae erat 256 dierum (range 2-465 dierum), inter quae cum neuropathia permanenti. Aegroti, qui neuropathiam periphericam experti sunt, etiam nervorum cranialium paralyticorum experti sunt vel GBS in aliis iudiciis permanentibus ciltacabtageni autoleucelis.
Nervus paralyticus cranialis: Tres aegroti (3.1%) periti nervorum cranialium paralyticorum in CARTITUDE-1. Omnes tres aegris habebat 7th nervorum cranialium
paralyticus; unus aeger habebat 5th cranialis nervus paralyticus. Medus tempus aggrediendi erat 26 dierum (range 21-101 dies) sequens infusionem
ciltacabtagen autoleucel. Eventum 3 et 6 nervi paralytici, 7 nervi cranialis bilateralis, nervorum cranialium paralysi post emendationem peiorationem, et neuropathiae peripheriae eventum in patientibus nervo craniali paralytico etiam in iudiciis permanentibus relatum est.
of ciltacabtagen autoleucel. Aegri monitoris sunt signa et indicia nervorum cranialium paralyticorum. Considera administrationem cum corticosteroideis systemicis, secundum gravitatem et progressionem signorum et symptomatum. Hemophagocytica lymphohistiocytosis (HLH)/Macrophage Syndrome Activationis (MAS: Fatal HLH in uno passo occurrit (1%), 99
dies post ciltacabtagen autoleucel. The HLH event was preceded by CRS diuturna 97 dierum. Manifestationes HLH/MAS
hypotensia, hypoxia cum damno diffusa alveolaris, coagulopathy, cytopenia, et multi- organi dysfunctiones, inclusa dysfunctione renum. HLH condicio vitae imminens est cum magna mortalitatis rate, nisi mature cognoscitur et tractatur. Curatio HLH/MAS administranda est per signa institutionalia. CARVYKTI™ REMS: Propter periculum CRS et toxicitates neurologicae, CARVYKTI> nonnisi per strictum propositum sub periculo Aestimationis et Mitigatio Strategy (REMS) vocantur CARVYKTI™ REMS.
Praeterea notitia praesto est apud www.CARVYKTIrems.com vel 1-844-672-0067.
Prolonged and Recurrent Cytopenias: Patients may exhibit prolonged and recurrent cytopenias following lymphodepleting chemotherapy and CARVYKTI™ infusion. One patient underwent autologous stem cell therapy for hematopoietic reconstitution due to prolonged thrombocytopenia.
In CARTITUDO-1, 30% (29/97) aegrorum periti longi Gradus 3 vel 4 neutropenia et 41% (40/97) aegrorum periti longi Gradus 3 vel 4 thrombocytopenia quae ante diem 30 sequentis ciltacabtageni autoleucelis infusione non resolvuntur.
Gradus recurrentes 3 vel 4 neutropenia, thrombocytopenia, lymphopenia et anemia in 63% (61/97), 18% (17/97), 60% (58/97) visi sunt;
et 37% (36/97) post recuperationem ab initio Gradus 3 vel 4 cytopenia sequenti infusione. Post diem LX sequentes ciltacabtagen autoleucel
infusio, 31%, 12% et 6% aegrorum recursum Gradus 3 vel superior lymphopenia, neutropenia et thrombocytopenia, respective, post primam receptam Gradus 3 vel 4 cytopenia. Octoginta septem centesimas (84/97) aegrorum unum, duo, tres vel plures habebant
recursus Gradus 3 vel 4 cytopenias post recuperationem initialem Gradus 3 vel 4 cytopenia. Sex et 11 aegroti Gradus 3 vel 4 neutropenia et thrombocytopenia respective tempore mortis habuerunt.
Monitor sanguinis numerat prior et post CARVYKTI™ infusionem. Cytopenias curo cum factores incrementi et transfusio sanguinis producti subsidii secundum normas institutionales locales.
Infectiones: CARVYKTI aegris cum infectio activa vel perturbationes inflammatoriae ministrari non debent. Gravis, vita-minaces vel pestiferas contagiones post CARVYKTI™ infusionem aegris evenerunt.
Infectiones (omnes gradus) anno 57 (59%) facta sunt. Gradus 3 vel 4 infectiones factae sunt in 23% (22/97) aegrorum; Gradus 3 vel 4 contagio cum pathogeni non specificata facta sunt in 17%, infectiones virales in 7%, infectiones bacteriales in 1%, et infectiones fungalales in 1% aegrorum.
Super quattuor aegros Gradus 5 infectiones habuit: abscessus pulmonis (n=1), sepsis (n=2) et pneumonia (n=1).
Monitor aegros signa et indicia contagionis ante et post CARVYKTI™ infusionem et aegros tractat tur. Administrare prophylacticos, prae-emptivos et/vel antimicrobiales medicinales secundum normas normas institutionales. Neutropenia febrilis erat
observed in 10% of patients after ciltacabtagene autoleucel infusion, and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids and other supportive care, as medically indicated.
Reactivatio Viralis: Hepatitis B virus (HBV) reactivatio, in quibusdam casibus resultantibus in hepatitis, hepatis, defectione et morte hepatis, fieri potest in aegris cum hypogammaglobulinemia. Praestare protegendo pro Cytomegalovirus (CMV), HBV, hepatitis C virus (HCV), et virus immuno- rum humanorum (HIV), vel quaevis agentia infectiosa, si secundum normas clinicas ante collectionem cellularum fabricandis amet indicatis. Considera therapiam antiviralem ad reactivationem viralem per normas institutionales locales / praxim clinicam.
Hypogammaglobulinemia in 12% aegrorum (12/97) eventum adversam relatum est; laboratorium Igg gradus infra 500 mg/dL incidit post infusionem 92% (89/97) aegrorum. Monitor gradus immunoglobulinorum post curationem CARVYKTI™ et IVIG administrandam pro Igg
<400 mg/dL. Curo per normas institutionales locales, inter infectio cautiones et prophylaxem antibioticam vel antiviralem.
Usus vitae Vaccines: Salus immunizationis cum vaccina virali viva durante vel sequenti CARVYKTI curationis™ investigata non est.
Vaccinatio cum vaccino virus vivo non commendatur pro ante sex septimanas saltem ante initium chymographiae lymphaticae, in curatione CARVYKTI, et usque ad immunem recuperationem sequentem curationem cum CARVYKTI™.
Hypersensitivity Reactiones in 5% (5/97) aegrorum sequentes infusionem ciltacabtageni autoleucelis factae sunt. Gravis hypersensitatis motus, anaphylaxis exceptus, esse potest propter dimethyl sulfoxidi (DMSO) in CARVYKTI™. Aegroti diligenter viverra debent post infusionem signa et indicia gravis reactionis pro II horis. Prompte tracta et apte secundum hypersensilitatis reactionem severitatem administrare.
Secundae malignitatis: Aegroti secundas malignitates explicari possunt. Monitor vitalem desiderare secundas malignitates. In eventu quod secundaria malignitas incidit, contactum Janssen Biotech, Inc., ad 1-800-526-7736 pro nuntiandis et obtinendis instructionibus collectionis
exempla patientis ad tentationem secundae malignitatis cellae originis T.
Effectus de facultate depellendi et utendi Machinis: Ob potentialem eventorum neurologicorum, incluso status mentis mutatus, invasiones, declinationes neurocognitivae, vel neuropathiae, aegroti periclitantur pro conscientia vel coordinatione alteratae vel diminutae in 8 septimanis sequentibus.
CARVYKTI™ infusio. Aegris mone ut abstineant a pulsis et susceptis occupationibus vel activitate ancipitibus, ut gravia vel potentialiter periculosa machinatione operandi durante hoc initiali tempore, et in eventu novorum incursionum quarumlibet toxicitatum neurologicarum.
adversa reactiones
Frequentissima non-laboratoriae motus adversae (incidentia maior quam 20%) sunt pyrexia, cytokina syndrome emissio, hypogammaglobulinemia, hypotension, dolor musculoskeletalis, lassitudo, infectiones pathogenis non specificati, tussis, frigora, diarrhoea, nausea, encephalopathy, appetitus decrescentes, superiores. tractus respiratorii contagio, capitis, tachycardia, vertigo, dyspnoea, hydropicus, infectiones virales, coagulopathy, constipatio, vomitus. Frequentissima laboratorium reactiones adversae (incidentiam maiorem quam vel aequalem ad 50%) includunt thrombocytopenia, neutropenia, anemia, elevatio aminotransferase, et hypoalbuminemia.
Please read plena praescribens Information including Boxed Admonitio pro CARVYKTI™.
