Axicabtagene (Systemic)
Jeneng merek: Yescarta
Kelas obat:
Agen Antineoplastik
Panganggone Axicabtagene (Systemic)
Axicabtagene ciloleucel minangka produk seluler individu sing disiapake saka sel T autologous sing diduweni dening leukapheresis; sel sing dikirim menyang laboratorium komersial ngendi padha gen dipunéwahi kanggo nyebut reseptor antigen chimeric (CAR) lan banjur infused bali menyang sabar. Axicabtagene ciloleucel minangka terapi sel T CAR kanthi indikasi kanggo limfoma sel B gedhe lan limfoma folikel.
Terapi sel T CAR bisa digandhengake karo keracunan sing abot; American Society of Clinical Oncology (ASCO) wis nerbitake pedoman kanggo menehi tuntunan babagan diagnosis, evaluasi lan manajemen keracunan kasebut.
Limfoma sel B gedhe
Axicabtagene ciloleucel minangka terapi sel T CAR sing dituduhake kanggo perawatan wong diwasa kanthi limfoma sel B gedhe sing refrakter kanggo kemoimunoterapi lini pertama utawa sing kambuh sajrone 12 wulan. kemoimunoterapi lini pertama.
Axicabtagene ciloleucel uga digunakake kanggo perawatan wong diwasa kanthi limfoma sel B gedhe sing kambuh utawa refraktori sawise loro utawa luwih terapi sistemik, kalebu limfoma sel B gedhe sing nyebar (DLBCL) sing ora ditemtokake, utamane. limfoma sel B mediastinal gedhe, limfoma sel B kelas dhuwur, lan DLBCL sing muncul saka limfoma folikel. Axicabtagene ciloleucel ditetepake minangka obat yatim piatu dening FDA kanggo perawatan DLBCL lan limfoma sel B mediastinal primer.
Axicabtagene ciloleucel ora dituduhake kanggo perawatan pasien karo limfoma CNS primer.
Khasiat axicabtagene ciloleucel ing perawatan limfoma sel B gedhe sing kambuh utawa refraktori wis ditetepake ing studi multicenter label terbuka kanthi acak (ZUMA-7). Sawise kemoterapi lymphodepleting, pasien nampa axicabtagene ciloleucel (diwenehake minangka infus IV tunggal) utawa perawatan baris kapindho standar. Kaslametané tanpa acara (EFS) luwih dawa ing pasien sing nampa axicabtagene ciloleucel versus terapi standar (median 8.3 versus 2 sasi). Perkiraan tingkat EFS ing 18 sasi yaiku 41,5% ing klompok axicabtagene ciloleucel lan 17% ing klompok terapi standar. saka infus tunggal axicabtagene ciloleucel ing pasien diwasa kanthi limfoma non-Hodgkin sel B sing kambuh utawa refraktori. Sawise kemoterapi lymphodepleting, axicabtagene ciloleucel diwenehake minangka infus IV tunggal. Antarane 101 pasien sing nampa axicabtagene ciloleucel, 73 (72%) nduweni respon objektif lan 52 (51%) nduweni respon lengkap; rata-rata suwene respon yaiku 9,2 sasi.
Follicular Lymphoma
Axicabtagene ciloleucel minangka terapi sel T CAR sing dituduhake kanggo perawatan wong diwasa kanthi limfoma folikular (FL) kambuh utawa refraktori sawise rong utawa luwih terapi sistemik. Indikasi iki disetujoni miturut persetujuan cepet adhedhasar tingkat respon. Persetujuan terus kanggo indikasi iki bisa uga gumantung saka verifikasi lan katrangan babagan keuntungan klinis ing uji coba konfirmasi.
Axicabtagene ciloleucel ditunjuk minangka obat yatim piatu dening FDA kanggo perawatan limfoma folikel.
Khasiat axicabtagene ciloleucel ing perawatan limfoma folikel sing kambuh utawa refraktori wis ditetepake ing siji-lengen, label terbuka, studi multisenter (ZUMA-5). Sawise kemoterapi lymphodepleting, axicabtagene ciloleucel diwenehake minangka infus IV tunggal. Ing analisis khasiat utama sing kalebu 81 pasien, 74 (91%) entuk respon objektif lan 49 (60%) entuk respon lengkap. Durasi rata-rata nanggepi ora bisa ditaksir nalika tindak lanjut rata-rata 14,5 sasi.
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Carane nggunakake Axicabtagene (Systemic)
Umum
Axicabtagene ciloleucel kasedhiya ing wangun dosis lan kekuatan ing ngisor iki:
Dosis
Pancen penting panyedhiya label pabrik kudu takon kanggo informasi sing luwih rinci babagan dosis lan administrasi obat iki. Ringkesan dosis:
Dewasa
Dosis lan AdministrasiMung kanggo panggunaan autologous. Kanggo nggunakake IV mung.
Pènget
Kontraindikasi
Pènget/PanandhapSindrom Pelepasan Sitokin
CRS, kalebu reaksi fatal utawa sing ngancam nyawa, kedadeyan sawise perawatan karo axicabtagene ciloleucel. CRS dumadi ing 90% (379/422) pasien karo limfoma non-Hodgkin (NHL) sing nampa axicabtagene ciloleucel, kalebu ≥ Grade 3 (Lee grading system1) CRS ing 9%. CRS dumadi ing 93% (256/276) pasien karo limfoma sel B gedhe (LBCL), kalebu ≥ Grade 3 CRS ing 9%. Antarane pasien LBCL sing tilar donya sawise nampa axicabtagene ciloleucel, papat duwe acara CRS sing terus-terusan nalika mati. Kanggo pasien karo LBCL ing sinau ZUMA-1, wektu rata-rata wiwitan CRS yaiku 2 dina sawise infus (kisaran: 1 nganti 12 dina) lan durasi rata-rata CRS yaiku 7 dina (kisaran: 2 nganti 58 dina). Kanggo pasien LBCL ing studi ZUMA-7, wektu rata-rata wiwitan CRS yaiku 3 dina sawise infus (kisaran: 1 nganti 10 dina) lan durasi rata-rata yaiku 7 dina (kisaran: 2 nganti 43 dina).
CRS dumadi ing 84% (123/146) pasien karo limfoma non-Hodgkin indolent (iNHL) ing studi ZUMA-5, kalebu ≥ Grade 3 CRS ing 8%. Antarane pasien karo iNHL sing tilar donya sawise nampa axicabtagene ciloleucel, siji pasien duwe acara CRS sing terus-terusan nalika mati. Wektu rata-rata wiwitan CRS yaiku 4 dina (kisaran: 1 nganti 20 dina) lan durasi rata-rata yaiku 6 dina (kisaran: 1 nganti 27 dina) kanggo pasien karo iNHL.
Manifestasi utama CRS ( ≥ 10%) ing kabeh pasien gabungan kalebu mriyang (85%), hipotensi (40%), tachycardia (32%), hawa adhem (22%), hipoksia (20%), sirah (15%), lan lemes (12% ). Acara serius sing bisa digandhengake karo CRS kalebu aritmia jantung (kalebu fibrilasi atrium lan takikardia ventrikel), insufisiensi ginjel, gagal jantung, gagal ambegan, serangan jantung, sindrom bocor kapiler, gagal multi-organ, lan sindrom limfositositosis hemophagocytic/aktivasi makrofag (HLH). / MAS).
Dampak tocilizumab lan / utawa kortikosteroid ing kedadeyan lan keruwetan CRS ditaksir ing rong kohort sabanjure pasien LBCL ing ZUMA-1. Antarane pasien sing nampa tocilizumab lan / utawa kortikosteroid kanggo acara Grade 1, CRS dumadi ing 93% (38/41), kalebu 2% (1/41) karo Grade 3 CRS; ora ana pasien sing ngalami acara kelas 4 utawa 5. Wektu rata-rata wiwitan CRS yaiku 2 dina (kisaran: 1 nganti 8 dina) lan durasi rata-rata CRS yaiku 7 dina (kisaran: 2 nganti 16 dina).
Pengobatan prophylactic karo kortikosteroid diwenehake kanggo kohort saka 39 pasien sajrone 3 dina wiwit dina infus axicabtagene ciloleucel. Telung puluh siji saka 39 pasien (79%) ngembangake CRS ing ngendi pasien kasebut diobati karo tocilizumab lan / utawa dosis terapi kortikosteroid tanpa pasien sing ngalami Grade 3 utawa CRS sing luwih dhuwur. Wektu rata-rata kanggo wiwitan CRS yaiku 5 dina (kisaran: 1 nganti 15 dina) lan durasi rata-rata CRS yaiku 4 dina (kisaran: 1 nganti 10 dina). Sanajan ora ana panjelasan mekanis sing dikawruhi, nimbang risiko lan mupangat saka kortikosteroid profilaksis ing konteks komorbiditas sing wis ana kanggo pasien individu lan potensial risiko Grade 4 lan keracunan neurologis sing berpanjangan.
Pesthekake yen 2 dosis tocilizumab kasedhiya sadurunge infus axicabtagene ciloleucel. Monitor pasien paling ora saben dina suwene 7 dina ing fasilitas kesehatan sing disertifikasi sawise infus kanggo tandha lan gejala CRS. Ngawasi pasien kanggo tandha utawa gejala CRS sajrone 4 minggu sawise infus. Konsultasi pasien supaya njaluk perhatian medis langsung yen tandha utawa gejala CRS kedadeyan kapan wae. Ing tandha pisanan saka CRS, institute perawatan kanthi perawatan sing ndhukung, tocilizumab, utawa tocilizumab lan kortikosteroid kaya sing dituduhake.
Toksisitas Neurologis
Toksisitas neurologis (kalebu ICANS) sing fatal utawa ngancam nyawa kedadeyan sawise perawatan karo axicabtagene ciloleucel. Toksisitas neurologis dumadi ing 78% (330/422) pasien karo NHL sing nampa axicabtagene ciloleucel, kalebu ≥ kasus Grade 3 ing 25%.
Toksisitas neurologis dumadi ing 87% (94/108) pasien karo LBCL ing ZUMA-1, kalebu ≥ kasus Grade 3 ing 31% lan ing 74% (124/168) pasien ing ZUMA-7 kalebu ≥ kasus Grade 3 ing 25%. Wektu rata-rata wiwitan yaiku 4 dina (kisaran: 1 nganti 43 dina) lan durasi rata-rata yaiku 17 dina ing pasien karo LBCL ing ZUMA-1. Wektu rata-rata kanggo keracunan neurologis yaiku 5 dina (kisaran: 1 nganti 133 dina) lan durasi rata-rata yaiku 15 dina ing pasien karo LBCL ing ZUMA-7. Toksisitas neurologis dumadi ing 77% (112/146) pasien karo iNHL, kalebu ≥ Grade 3 ing 21%. Wektu rata-rata wiwitan yaiku 6 dina (kisaran: 1 nganti 79 dina) lan durasi rata-rata yaiku 16 dina. Sembilan puluh wolu persen kabeh keracunan neurologis ing pasien karo LBCL lan 99% kabeh keracunan neurologis ing pasien karo iNHL dumadi ing 8 minggu pisanan saka infus axicabtagene ciloleucel. Toksisitas neurologis dumadi ing 7 dina pisanan infus axicabtagene ciloleucel ing 87% pasien sing kena pengaruh LBCL lan 74% pasien sing kena pengaruh iNHL.
Toksisitas neurologis sing paling umum (≥ 10%) ing kabeh pasien gabungan kalebu encephalopathy (50%), sirah (43%), tremor (29%), pusing (21%), afasia (17%), delirium (15%), lan insomnia (10%). Encephalopathy sing dawa nganti 173 dina kacathet. Acara serius kalebu aphasia, leukoencephalopathy, dysarthria, lesu, lan kejang dumadi kanthi axicabtagene ciloleucel. Kasus edema serebral lan encephalopathy sing fatal lan serius, kalebu encephalopathy onset pungkasan, wis kedadeyan ing pasien sing diobati karo axicabtagene ciloleucel.
Dampak tocilizumab lan/utawa kortikosteroid ing kedadeyan lan keruwetan keracunan neurologis ditaksir. ing rong kohort sabanjure pasien LBCL ing ZUMA-1. Antarane pasien sing nampa kortikosteroid nalika wiwitan keracunan Grade 1, keracunan neurologis dumadi ing 78% (32/41) lan 20% (8/41) duwe keracunan neurologis Grade 3; ora ana pasien sing ngalami acara kelas 4 utawa 5. Wektu rata-rata kanggo wiwitan keracunan neurologis yaiku 6 dina (kisaran: 1 nganti 93 dina) kanthi durasi rata-rata 8 dina (kisaran: 1 nganti 144 dina). Pangobatan prophylactic karo kortikosteroid diwenehake menyang kelompok 39 pasien sajrone 3 dina wiwit dina infus axicabtagene ciloleucel. Saka 39 pasien kasebut, 85% (33/39) ngembangake keracunan neurologis; 8% (3/39) ngembangake Grade 3 lan 5% (2/39) ngembangake keracunan neurologis Grade 4. Wektu rata-rata kanggo wiwitan keracunan neurologis yaiku 6 dina (kisaran: 1 nganti 274 dina) kanthi durasi rata-rata 12 dina (kisaran: 1 nganti 107 dina). Kortikosteroid profilaksis kanggo manajemen CRS lan keracunan neurologis bisa nyebabake tingkat keracunan neurologis sing luwih dhuwur utawa prolongation saka keracunan neurologis, tundha wiwitan lan nyuda durasi CRS.
Ngawasi pasien paling ora saben dina suwene 7 dina ing papan kasebut. fasilitas kesehatan sing disertifikasi sawise infus kanggo pratandha lan gejala keracunan neurologis. Ngawasi pasien kanggo tandha utawa gejala keracunan neurologis sajrone 4 minggu sawise infus lan nambani kanthi cepet.
Program REMS
Amarga risiko CRS lan keracunan neurologis, axicabtagene ciloleucel mung kasedhiya liwat program sing diwatesi miturut Risk Evaluation and Mitigation Strategy (REMS) sing diarani YESCARTA lan TECARTUS REMS Program. Komponen sing dibutuhake saka Program REMS yaiku:
Reaksi Hipersensitivitas
Reaksi alergi bisa kedadeyan kanthi infus axicabtagene ciloleucel. Reaksi hipersensitivitas sing serius, kalebu anafilaksis, bisa uga amarga dimethyl sulfoxide (DMSO) utawa gentamicin residual ing axicabtagene ciloleucel.
Infeksi Serius
Infeksi sing abot utawa ngancam nyawa dumadi ing pasien sawise infus axicabtagene ciloleucel. Infèksi (kabeh gelar) dumadi ing 45% pasien NHL. Infeksi kelas 3 utawa luwih dumadi ing 17% pasien, kalebu infeksi Grade 3 utawa luwih kanthi patogen sing ora ditemtokake ing 12%, infeksi bakteri ing 5%, infeksi virus ing 3%, lan infeksi jamur ing 1%. Axicabtagene ciloleucel ora kudu diwenehake marang pasien kanthi infeksi sistemik aktif sing signifikan sacara klinis. Ngawasi pasien kanggo tandha lan gejala infeksi sadurunge lan sawise infus axicabtagene ciloleucel lan nambani kanthi tepat. Atur antimikroba prophylactic miturut pedoman lokal.
Neutropenia febrile diamati ing 36% pasien NHL sawise infus axicabtagene ciloleucel lan bisa bebarengan karo CRS. Yen neutropenia febrile, evaluasi infeksi lan atur kanthi antibiotik spektrum sing amba, cairan, lan perawatan dhukungan liyane kaya sing dituduhake sacara medis.
Ing pasien immunosupresi, kalebu sing wis nampa axicabtagene ciloleucel, sing ngancam nyawa. lan infèksi oportunistik fatal kalebu infèksi jamur sing disebarake (umpamane, infeksi candida sepsis lan aspergillus) lan reaktivasi virus (umpamane, virus herpes manungsa-6 [HHV-6] encephalitis lan virus JC leukoencephalopathy multifokal progresif [PML]) wis dilaporake. Kemungkinan encephalitis HHV-6 lan PML kudu dianggep ing pasien immunosuppressed kanthi acara neurologis lan evaluasi diagnostik sing cocok kudu ditindakake.
Reaktivasi Virus Hepatitis BReaktivasi virus Hepatitis B (HBV), ing sawetara kasus nyebabake hepatitis fulminant, gagal hepatik, lan pati, wis dumadi ing pasien sing diobati karo obat-obatan sing diarahake marang sel B, kalebu axicabtagene ciloleucel. Tindakake skrining kanggo HBV, HCV, lan HIV, lan atur miturut pedoman klinis sadurunge koleksi sel kanggo manufaktur.
Sitopenia sing Berpanjangan
Pasien bisa nuduhake sitopenia sajrone sawetara minggu sawise kemoterapi limfodepleting lan infus axicabtagene ciloleucel. Sitopenia kelas 3 utawa luwih sing ora ditanggulangi ing Dina 30 sawise infus axicabtagene ciloleucel dumadi ing 39% kabeh pasien NHL lan kalebu neutropenia (33%), trombositopenia (13%), lan anemia (8%). Monitor jumlah getih sawise infus axicabtagene ciloleucel.
Hypogammaglobulinemia
Aplasia sel B lan hypogammaglobulinemia bisa kedadeyan ing pasien sing nampa perawatan karo axicabtagene ciloleucel. Hypogammaglobulinemia kacarita minangka reaksi salabetipun ing 14% kabeh pasien karo NHL. Ngawasi tingkat immunoglobulin sawise perawatan karo axicabtagene ciloleucel lan ngatur nggunakake pancegahan infeksi, profilaksis antibiotik, lan panggantos immunoglobulin.
Keamanan imunisasi karo vaksin virus urip sajrone utawa sawise perawatan axicabtagene ciloleucel durung diteliti. Vaksinasi nganggo vaksin virus urip ora dianjurake kanggo paling sethithik 6 minggu sadurunge wiwitan kemoterapi lymphodepleting, sajrone perawatan axicabtagene ciloleucel, lan nganti pemulihan kekebalan sawise perawatan karo axicabtagene ciloleucel.
Keganasan Sekunder
Pasien sing diobati karo axicabtagene ciloleucel bisa ngalami ganas sekunder. Ngawasi seumur hidup kanggo keganasan sekunder. Yen kedadeyan ganas sekunder, hubungi Kite ing 1-844-454-KITE (5483) kanggo njaluk instruksi babagan sampel pasien sing kudu dikumpulake kanggo dites.
Efek ing Kemampuan kanggo Nyopir lan Gunakake Mesin
Amarga potensial kanggo acara neurologis, kalebu status mental utawa kejang sing diowahi, pasien sing nampa axicabtagene ciloleucel beresiko kanggo owah-owahan utawa nyuda kesadaran utawa koordinasi ing 8 minggu sawise infus axicabtagene ciloleucel. Pitutur marang pasien supaya ora nyopir lan nglakoni pakaryan utawa aktivitas sing mbebayani, kayata ngoperasikake mesin sing abot utawa bisa mbebayani, sajrone periode wiwitan iki.
Populasi Tertentu
KandhutanOra ana data sing kasedhiya babagan panggunaan axicabtagene ciloleucel ing wanita ngandhut. Ora ana studi keracunan reproduksi lan perkembangan kewan sing ditindakake kanthi axicabtagene ciloleucel kanggo netepake apa bisa nyebabake cilaka janin nalika diwenehake marang wanita ngandhut. Ora dingerteni yen axicabtagene ciloleucel duweni potensi kanggo ditransfer menyang janin. Adhedhasar mekanisme tumindak, yen sel transduksi ngliwati plasenta, bisa nyebabake keracunan janin, kalebu limfositopenia sel B. Mulane, axicabtagene ciloleucel ora dianjurake kanggo wanita sing ngandhut, lan meteng sawise infus axicabtagene ciloleucel kudu dirembug karo dokter sing nambani.
Ing populasi umum AS, kira-kira risiko latar mburi cacat lair utama lan keguguran. ing kandhutan sing diakoni sacara klinis yaiku 2% - 4% lan 15% - 20%. efek ing produksi susu. Mupangat pangembangan lan kesehatan saka nyusoni kudu dianggep bebarengan karo kabutuhan klinis ibu kanggo axicabtagene ciloleucel lan efek samping potensial ing bayi sing disusui saka axicabtagene ciloleucel utawa saka kondisi ibu sing ndasari.
Wanita lan Lanang Potensi ReproduksiStatus meteng wanita kanthi potensial reproduksi kudu diverifikasi. Badhak wadon aktif seksual potensial reproduksi kudu duwe tes meteng sadurunge miwiti perawatan karo axicabtagene ciloleucel.
Deleng informasi resep kanggo fludarabine lan cyclophosphamide kanggo informasi babagan perlu kanggo kontrasepsi efektif ing pasien sing nampa kemoterapi lymphodepleting.
Ora ana data pajanan sing cukup kanggo menehi rekomendasi babagan durasi kontrasepsi sawise perawatan karo axicabtagene ciloleucel.
Ora ana data babagan efek axicabtagene ciloleucel ing kesuburan.
Panggunaan PediatrikKeamanan lan khasiat axicabtagene ciloleucel durung ditetepake ing pasien pediatrik.
Panggunaan GeriatrikSaka 422 pasien NHL sing nampa axicabtagene ciloleucel ing uji klinis, 127 pasien (30%) yaiku 65 taun lan luwih. Ora ana bedane klinis penting ing safety utawa efektifitas sing diamati antarane pasien 65 taun lan luwih lawas lan pasien sing luwih enom.
Efek Samsaya Awon
Reaksi salabetipun sing paling umum (kajadian ≥ 30%), ora kalebu kelainan laboratorium, ing pasien karo limfoma non-Hodgkin yaiku CRS, demam, hipotensi, encephalopathy, lemes, takikardia , sirah, mual, neutropenia febrile, diare, nyeri muskuloskeletal, infèksi karo patogen sing ora ditemtokake, kedinginan, lan nyuda napsu.
Kelainan laboratorium kelas 3-4 sing paling umum (≥ 30%) yaiku leukopenia, limfopenia, neutropenia, anemia, thrombocytopenia, lan hypophosphatemia.
Apa obatan liyane bakal mengaruhi Axicabtagene (Systemic)
Obat Spesifik
Iku penting panyedhiya label pabrik dikonsultasi kanggo informasi sing luwih rinci babagan interaksi karo obat iki, kalebu kemungkinan pangaturan dosis. Sorotan interaksi:
Deleng label produk kanggo informasi interaksi obat.
Disclaimer
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