Tremelimumab
Jeneng merek: Imjudo
Kelas obat:
Agen Antineoplastik
Panganggone Tremelimumab
Karsinoma Hepatoseluler
Digunakake ing kombinasi karo durvalumab kanggo perawatan wong diwasa kanthi karsinoma hepatoseluler sing ora bisa ditindakake (uHCC). Ditunjuk minangka obat yatim piatu dening FDA kanggo perawatan kanker iki kanthi kombinasi durvalumab.
Pedoman AS saiki ora mbahas panggunaan tremelimumab kanggo perawatan HCC.
Kanker Paru Sel Non-cilik
Digunakake ing kombinasi karo durvalumab lan kemoterapi berbasis platinum kanggo perawatan wong diwasa kanthi kanker paru-paru sel non-cilik metastatik (NSCLC) tanpa reseptor faktor pertumbuhan epidermal sensitizing ( mutasi EGFR) utawa anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
Pembaruan paling anyar saka pedoman urip ASCO nyatakake yen dokter bisa menehi kemoterapi adhedhasar durvalumab lan tremelimumab plus platinum kanggo pasien karo karsinoma sel non-squamous utawa squamous, skor proporsi tumor PD-L1 0% - 49%, lan status kinerja 0-1.
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Carane nggunakake Tremelimumab
Umum
Skrining Pretreatment
Ngawasi Pasien
Dispensing lan Administrasi Pancegahan
Administrasi
IV Administrasi
Kasedhiya minangka konsentrasi injeksi ing vial dosis siji sing ngemot 25 mg/1,25 mL (20 mg/mL) utawa 300 mg/15 mL (20 mg/mL). Obat kasebut diwenehake minangka infus IV sawise diencerake.
PengenceranSadurunge pengenceran, priksa injeksi kanthi visual babagan partikel lan warna; Mbuwang vial yen solusi kasebut mendhung, wernane, utawa ana partikel sing katon. Aja goyangake vial.
Busak volume sing dibutuhake saka vial lan transfer menyang kantong IV sing ngemot natrium klorida 0,9% utawa dekstrosa 5%. Nyampur solusi sing diencerke kanthi inversi sing lembut; ora goyang. Konsentrasi pungkasan maksimal saka solusi sing diencerke kudu ora ngluwihi 10 mg / mL. Buang bokor tremelimumab sing sebagian digunakake utawa kosong.
Atur solusi sing diencerke langsung sawise disiapake; tremelimumab ora ngandhut pengawet. Aja goyangake utawa beku solusi sing diencerake.
Tingkat AdministrasiAdministrasi tremelimumab IV liwat 60 menit liwat saluran IV sing ngemot saringan 0,2 mikron utawa 0,22 mikron sing steril lan kurang protein.
Gunakake tas infus lan saringan sing kapisah kanggo saben obat. Aja coadminister obatan liyane liwat baris infus padha.
Yen tremelimumab digunakake ing kombinasi karo durvalumab, infuse tremelimumab liwat 60 menit, mirsani sabar kanggo 60 menit sawise rampung infus, banjur infuse durvalumab minangka infus kapisah. luwih saka 60 menit ing dina dosis sing padha.
Yen tremelimumab digunakake ing kombinasi karo durvalumab plus kemoterapi basis platinum/pemetrexed, infuse tremelimumab pisanan, ngiring dening durvalumab, banjur kemoterapi basis platinum/pemetrexed ing dina. saka dosis. Sajrone siklus 1, pisanan infuse tremelimumab liwat 60 menit; banjur, 1-2 jam sawise rampung infus tremelimumab, infus durvalumab liwat 60 menit; lan 1-2 jam sawise rampung infus durvalumab, infuse kemoterapi adhedhasar platinum. Kanggo siklus sabanjure, yen ora ana reaksi infus sajrone siklus 1, durvalumab bisa disuntik sanalika sawise tremelimumab, lan wektu antarane pungkasan infus durvalumab lan wiwitan kemoterapi bisa dikurangi dadi 30 menit.
Dosis
Wong diwasa
Karsinoma Hepatoseluler IVDosis sing disaranake adhedhasar bobot awak.
Bobot <30 kg: Atur tremelimumab 4 mg/kg kanthi infus IV minangka dosis tunggal banjur durvalumab 20 mg/kg kanthi infus IV ing dina 1 siklus 1, banjur durvalumab 20 mg/kg kanthi infus IV minangka agen tunggal saben 4 minggu nganti perkembangan penyakit utawa keracunan sing ora bisa ditampa.
Bobot ≥30 kg: Atur tremelimumab 300 mg kanthi infus IV minangka dosis siji banjur durvalumab 1,500 mg kanthi infus IV ing dina 1 siklus 1, disusul durvalumab 1,500 mg kanthi infus IV minangka agen tunggal saben 4 minggu nganti perkembangan penyakit utawa keracunan sing ora bisa ditampa.
Kanker Paru Sel Non-cilik IVDosis tremelimumab sing disaranake adhedhasar histologi tumor lan bobot awak. Timbang pasien sadurunge saben infus. Regimen sing disaranake lan jadwal dosis kasedhiya ing Tabel 1 lan 2.
Konsultasi informasi resep lengkap kanggo informasi dosis.
Tabel 1. Regimen lan Dosis sing Disaranake kanggo Perawatan NSCLC1 MetastatikHistologi Tumor
Bobot Pasien
Dosis Treremelimumab
Dosis Durvalumab
p>Rejimen Kemoterapi Berbasis Platinum
Non-squamous
<30 kg
1 mg/kg
20 mg /kg
Carboplatin lan paclitaxel kaiket albumin UTAWA Carboplatin utawa cisplatin lan pemetrexed
≥30 kg
75 mg
1500 mg
Squamous
<30 kg
1 mg/kg
20 mg/kg
Carboplatin lan paclitaxel sing kaiket albumin UTAWA Carboplatin utawa cisplatin lan gemcitabine
≥30 kg
75 mg
1500 mg
Ganti interval dosis saka saben 3 minggu nganti saben 4 minggu wiwit siklus 5.
Infus IV liwat 60 menit.
Yen pasien nampa <4 siklus kemoterapi berbasis platinum, gunakake siklus tremelimumab sing isih ana (nganti total 5) sawise fase kemoterapi adhedhasar platinum, kanthi kombinasi durvalumab, saben 4 minggu.
Terusake durvalumab nganti kemajuan penyakit utawa keracunan sing ora bisa ditolerir.
Ing pasien karo penyakit non-skuamosa sing nampa perawatan karo pemetrexed lan carboplatin / cisplatin, terapi pemetrexed opsional bisa ditindakake wiwit minggu 12 nganti perkembangan penyakit utawa keracunan sing ora bisa ditoleransi.
Tabel 2. Jadwal Dosis sing Disaranake kanggo Perawatan NSCLC1 MetastatikWeeka
0
3
6
9
12
16
20
24
Siklus
1
2
3
4
5
6
7
8
Tremelimumab ,
X
X
X
X
X
Durvalumab ,
X
X
X
X
X
X
X
X
Kemoterapi
X
X
X
X
X
X
X
X
e Ing pasien karo penyakit non-squamous sing nampa perawatan karo pemetrexed lan carboplatin / cisplatin, terapi pemetrexed opsional bisa diwenehake saka minggu. 12 nganti progresi penyakit utawa keracunan sing ora bisa ditoleransi.
Modifikasi Terapi kanggo Toksisitas
Reaksi Saleh sing dimediasi kekebalanPengurangan dosis ora dianjurake. Umumé, nahan regimen perawatan kanggo reaksi salabetipun imun-mediated abot (kelas 3) lan ngatur terapi kortikosteroid sistemik.
Terapi kortikosteroid sistemik kasusun saka prednison 1-2 mg/kg saben dina utawa padha karo nganti paningkatan kelas. 1 utawa kurang. Sawise nambah kelas 1 utawa kurang, miwiti taper kortikosteroid lan terus taper liwat ≥1 sasi. Coba administrasi imunosupresan sistemik liyane yen reaksi saleh sing dimediasi kekebalan ora dikontrol karo terapi kortikosteroid.
Mungkasi regimen perawatan kanthi permanen kanggo reaksi salabetipun sing ngancam nyawa (kelas 4), reaksi sing dimediasi kekebalan sing abot (kelas 3), sing mbutuhake perawatan imunosupresif sistemik, utawa ora bisa nyuda dosis kortikosteroid nganti ≤ 10 mg prednison saben dina (utawa padha karo) ing 12 minggu miwiti kortikosteroid.
Tabel 3 ngringkes modifikasi perawatan sing disaranake kanggo reaksi salabetipun tartamtu.
Resume ing pasien kanthi resolusi lengkap utawa parsial. (kelas 0 nganti 1) sawise taper kortikosteroid. Mungkasi kanthi permanen yen ora ana resolusi lengkap utawa parsial sajrone 12 minggu sawise miwiti kortikosteroid utawa ora bisa nyuda dosis kortikosteroid dadi ≤10 mg prednison saben dina (utawa padha karo) sajrone 12 minggu miwiti kortikosteroid.
Endokrinopati kalebu jinis 1 diabetes, hipofisis, hipotiroidisme, hipertiroidisme, lan insufisiensi adrenal.
Tabel 3. Modifikasi Pangobatan sing Disaranake kanggo Reaksi Saleh1Reaksi Saleh
Keparahan
Modifikasi Perawatan
p>Reaksi Saru sing dimediasi kekebalan
Kolitis
Kelas 2
Ditahan
Kelas 3 utawa 4
Stop permanen
Endokrinopati
Kelas 3 utawa 4
Tahan nganti klinis stabil utawa mandheg kanthi permanen gumantung saka keruwetan
Kondisi dermatologis eksfoliatif
Sing dicurigai sindrom Stevens-Johnson ( SJS), nekrolisis epidermis beracun (TEN), utawa Ruam Obat kanthi Eosinofilia lan Gejala Sistemik (DRESS)
Nahan
Dikonfirmasi SJS, TEN, utawa DRESS
Stop permanen
Hepatitis tanpa keterlibatan tumor ing ati
ALT utawa AST mundhak dadi >3 lan nganti 8 kali ULN, utawa total bilirubin mundhak >1,5 lan nganti 3 kali ULN
Tahan
ALT utawa AST mundhak >8 kali ULN utawa total bilirubin mundhak >3 kaping ULN
Stop permanen
Hepatitis kanthi tumor ing ati
AST lan ALT kurang saka utawa padha karo ULN ing awal.
Nahan utawa nyetop permanen durvalumab adhedhasar rekomendasi kanggo hepatitis tanpa keterlibatan ati
AST utawa ALT >1 lan nganti 3 kaping ULN ing awal lan mundhak dadi >5 lan nganti 10 kaping ULN, utawa AST utawa ALT >3 lan nganti 5 kaping ULN ing awal lan mundhak dadi >8 lan nganti 10 kaping ULN
Nahan
ALT utawa AST mundhak >10 kaping ULN utawa total bilirubin mundhak dadi >3 kaping ULN
Stop permanen
Perforasi usus
Sembarang kelas
Stop permanen
Miokarditis
Kelas 2, 3, utawa 4
Stop permanen
Nefritis karo disfungsi ginjel
Grade 2 utawa 3 nambah kreatinin getih
Nahan
Grade 4 nambah kreatinin getih
Stop permanen
Toksisitas neurologis
Kelas 2
Ditahan
Kelas 3 utawa 4
Stop permanen
Pneumonitis
Grade 2
Turun
Grade 3 utawa 4
Turunake kanthi permanen
Reaksi salabetipun liyane
Reaksi sing gegandhengan karo infus
Kelas 1 utawa 2
Ngganggu utawa alon tingkat infus
Kelas 3 utawa 4
Stop permanen
Populasi Khusus
Gangguan Hepatik
Ora ana rekomendasi dosis khusus ing wektu iki.
Gangguan Ginjal
Ora ana rekomendasi dosis khusus ing wektu iki.
Panganggone Geriatrik
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Kontraindikasi
Pènget/PanandhapReaksi Saru sing dimediasi kekebalan sing abot lan fatal
Tremelimumab duweni potensi kanggo induksi reaksi sing dimediasi kekebalan.
Reaksi sing disebabake dening kekebalan sing abot utawa fatal bisa kedadeyan ing organ apa wae. sistem utawa jaringan. Bisa kedadeyan kapan wae sawise miwiti tremelimumab ing kombinasi karo durvalumab; reaksi kasebut biasane diwujudake sajrone perawatan nanging bisa uga katon sawise mandheg perawatan.
Identifikasi awal lan manajemen reaksi saleh sing dimediasi kekebalan penting kanggo njamin keamanan perawatan. Ngawasi pratandha lan gejala sing bisa dadi manifestasi klinis saka reaksi salabetipun sing dimediasi kekebalan. Evaluasi kimia klinis, kalebu enzim ati, kreatinin, tingkat hormon adrenokortikotropik, lan fungsi tiroid, ing awal lan sadurunge saben dosis. Atur sacara medis reaksi salabetipun sing dimediasi kekebalan kanthi cepet, lan hubungi konsultasi khusus sing cocog
Nahan utawa nyetop tremelimumab lan durvalumab kanthi permanen gumantung saka keruwetan; deleng Tabel 3 kanggo modifikasi perawatan dianjurake kanggo reaksi salabetipun imun-mediated tartamtu. Umumé, yen interupsi utawa penghentian perawatan dibutuhake, gunakake terapi kortikosteroid sistemik (prednison 1 nganti 2 mg / kg saben dina utawa sing padha) nganti paningkatan kelas 1 utawa kurang. Sawise nambah kelas 1 utawa kurang, miwiti taper kortikosteroid lan terus taper liwat ≥1 sasi. Coba administrasi immunosuppressants sistemik liyane yen reaksi salabetipun-mediated imun ora dikontrol karo terapi kortikosteroid.
Reaksi salabetipun imun-mediated sing kapacak ing ngisor iki bisa uga ora kalebu kabeh reaksi imun-mediated bisa.
Immun-mediated Pneumonitis: Immune-mediated pneumonitis (kalebu kelas 3 lan acara fatal) wis kacarita ing pasien sing nampa tremelimumab kanthi kombinasi karo durvalumab lan/utawa kemoterapi adhedhasar platinum. Kabeh pasien nampa kortikosteroid sistemik kanggo ngobati pneumonitis sing dimediasi kekebalan; sawetara mbutuhake immunosuppressants liyane. Nalika pneumonitis dirampungake ing pirang-pirang kasus, iki nyebabake penghentian perawatan ing sawetara pasien.
Kolitis sing dimediasi kekebalan: Tremelimumab kanthi kombinasi durvalumab bisa nyebabake kolitis sing dimediasi kekebalan (kalebu kelas 3). acara) sing kerep digandhengake karo diare. Ing studi klinis, kabeh pasien nampa kortikosteroid sistemik kanggo ngatur kolitis lan kortikosteroid dosis dhuwur sing paling dibutuhake (paling ora 40 mg prednison utawa padha karo saben dina); sawetara pasien uga nampa imunosupresan liyane. Nalika kedadeyan wis rampung ing umume pasien, kedadeyan kasebut nyebabake penghentian permanen ing sawetara pasien.
Infeksi / reaktivasi cytomegalovirus sing dilapurake ing pasien karo kolitis sing dimediasi kekebalan kortikosteroid-refraktori. Ing kasus kolitis corticosteroid-refractory, nimbang mbaleni workup infèksius kanggo ngilangi etiologi alternatif. Perforasi usus diamati ing studi liyane saka tremelimumab ing kombinasi karo durvalumab.
Hepatitis sing dimediasi kekebalan:Hepatitis sing dimediasi kekebalan (kalebu kelas 3 lan 4 lan kedadeyan fatal) wis kedadeyan karo tremelimumab ing kombinasi karo durvalumab. Ing studi klinis, kortikosteroid sistemik digunakake kanggo ngatur hepatitis sing dimediasi kekebalan ing kabeh pasien lan kabeh pasien mbutuhake terapi kortikosteroid dosis dhuwur (paling ora 40 mg prednison utawa padha karo saben dina); sawetara pasien mbutuhake immunosuppressants liyane. Hepatitis ditanggulangi ing kurang saka setengah pasien nanging nyebabake mandheg permanen ing sawetara pasien.
Insufisiensi Adrenal sing dimediasi kekebalan:Insufisiensi adrenal primer utawa sekunder, kalebu acara kelas 3, dilapurake karo tremelimumab kanthi kombinasi karo durvalumab. Kanggo insufficiency adrenal kelas 2 utawa luwih, miwiti perawatan simtomatik, kalebu panggantos hormon kaya sing dituduhake sacara klinis. Ing studi klinis, kortikosteroid sistemik dibutuhake ing kabeh pasien. Kedadean ditanggulangi ing sawetara pasien.
Hipofisitis sing dimediasi kekebalan: Tremelimumab kanthi kombinasi durvalumab bisa nyebabake hypophysitis sing dimediasi kekebalan (kalebu kedadeyan kelas 3). Hypophysitis bisa uga ana gejala akut sing ana gandhengane karo efek massa (umpamane, sirah, fotofobia, utawa potongan visual). Hypophysitis bisa nyebabake hypopituitarism. Miwiti perawatan simtomatik kalebu panggantos hormon kaya sing dituduhake sacara klinis. Ing studi klinis, umume pasien karo hypophysitis lan hypopituitarism sing dimediasi kekebalan mbutuhake kortikosteroid sistemik lan sawetara pasien uga mbutuhake terapi endokrin. Kedadeyan iki ditanggulangi ing sawetara pasien.
Gangguan Tiroid:Tremelimumab ing kombinasi karo durvalumab bisa nyebabake kelainan tiroid sing dimediasi kekebalan, kalebu tiroiditis (sing bisa ana utawa tanpa endokrinopati), hipertiroidisme (kalebu acara kelas 3), lan hipotiroidisme (sing bisa ngetutake hipertiroidisme). Miwiti terapi penggantian hormon kanggo hypothyroidism utawa institute manajemen medis hipertiroidisme kaya sing dituduhake sacara klinis. Ing uji klinis, kortikosteroid sistemik dibutuhake ing sawetara pasien kanthi hipertiroidisme, hipotiroidisme, utawa tiroiditis; kabeh utawa umume pasien mbutuhake terapi liyane (contone, terapi penggantian hormon, thiamazole, karbimazol, propylthiouracil, perchlorate, blocker saluran kalsium, beta-blocker). Hipertiroidisme ditanggulangi ing umume pasien, dene hipotiroidisme lan tiroiditis dirampungake ing sawetara pasien.
Diabetes Mellitus Tipe 1:Diabetes mellitus tipe 1 bisa nyebabake ketoacidosis diabetes. Ngawasi pasien kanggo hiperglikemia lan pratandha lan gejala diabetes liyane. Miwiti perawatan karo insulin kaya sing dituduhake sacara klinis.
Nefritis sing dimediasi kekebalan kanthi Disfungsi Renal:Nefritis sing dimediasi kekebalan kanthi disfungsi ginjel (kalebu acara kelas 3) sing dilapurake karo tremelimumab kanthi kombinasi durvalumab. Kortikosteroid sistemik dibutuhake ing kabeh pasien. Ing sawetara pasien, acara wis rampung; nefritis sing dimediasi kekebalan nyebabake penghentian permanen ing sawetara pasien.
Reaksi Dermatologis sing dimediasi kekebalan: Tremelimumab sing digabungake karo durvalumab bisa nyebabake ruam utawa dermatitis sing dimediasi kekebalan, kalebu kelas 3 lan 4 acara. Dermatitis eksfoliatif, kalebu Sindrom Stevens-Johnson (SJS), ruam obat kanthi eosinofilia lan gejala sistemik (DRESS), lan necrolysis epidermal beracun (TEN), wis kedadeyan karo inhibitor pos pemeriksaan kekebalan. Emolien topikal lan/utawa kortikosteroid topikal bisa uga cukup kanggo nambani ruam non-exfoliative entheng nganti moderat. Ing studi klinis, kabeh pasien nampa kortikosteroid sistemik kanggo ngatur ruam utawa dermatitis sing dimediasi kekebalan; immunosuppressants liyane dibutuhake arang. Kedadean dermatologis ditanggulangi ing umume pasien, sanajan mandheg permanen dibutuhake ing sawetara kasus.
Imun-mediated Pancreatitis: Tremelimumab ing kombinasi karo durvalumab bisa nyebabake pankreatitis sing dimediasi kekebalan, kalebu kelas 3 utawa 4 acara. Ing studi klinis, kabeh pasien mbutuhake manajemen karo kortikosteroid sistemik (terapi kortikosteroid dosis dhuwur perlu ing umume pasien); pankreatitis dirampungake ing umume pasien.
Reaksi Saleh sing dimediasi Kekebalan Liyane:Reaksi saleh sing dimediasi kekebalan sing signifikan sacara klinis ing ngisor iki kedadeyan kanthi insiden <1% saben pasien sing nampa tremelimumab ing kombinasi karo durvalumab utawa dilapurake kanthi nggunakake inhibitor imun-checkpoint liyane.
Jantung/vaskular: Miokarditis, perikarditis, vaskulitis.
Sistem saraf: Meningitis, encephalitis, mielitis lan demielinasi, sindrom miastenia/miastenia gravis (kalebu eksaserbasi), sindrom Guillain-Barré, paresis saraf, neuropati autoimun.
Okular: Uveitis, iritis, lan toksisitas inflamasi okular liyane sing diamati; sawetara kasus bisa digandhengake karo detasemen retina. Macem-macem derajat cacat visual, kalebu wuta, bisa kedadeyan. Yen uveitis dumadi ing kombinasi karo reaksi salabetipun imun-mediated liyane, nimbang sindrom Vogt-Koyanagi-Harada-kaya; kondisi iki mbutuhake terapi kortikosteroid sistemik kanggo ngurangi risiko mundhut penglihatan permanen.
GI: Gastritis, duodenitis.
Muskuloskeletal lan jaringan ikat. kelainan: Myositis/polimiositis, rhabdomyolysis lan sekuel sing gegandhengan kalebu gagal ginjal, arthritis, polymyalgia rheumatica.
Endokrin: Hipoparatiroidisme.
Liyane (hematologis/imun): Anemia hemolitik, anemia aplastik, limfohistiositosis hemophagocytic, sindrom respon inflamasi sistemik, limfadenitis necrotizing histiocytic (limfadenitis Kikuchi), sarcoidosis, trombositopenia imun.
Reaksi sing gegandhengan karo infus
Reaksi sing gegandhengan karo infus sing abot utawa ngancam nyawa sing dilapurake karo tremelimumab ing kombinasi karo durvalumab.
Monitor tandha lan gejala reaksi sing gegandhengan karo infus. Interrupt, alon tingkat saka, utawa permanen nyetop tremelimumab lan durvalumab adhedhasar keruwetan; deleng Tabel 3 kanggo rekomendasi tartamtu. Kanggo reaksi sing gegandhengan karo infus Grade 1 utawa 2, nimbang pre-medications karo dosis sakteruse.
Toksisitas Embrio-janin
Adhedhasar temuan saka studi kewan lan mekanisme tumindak tremelimumab, obat kasebut bisa nyebabake cilaka janin nalika diwenehake marang wanita ngandhut. Pasinaon kewan nemokake yen blokade CTLA-4 digandhengake karo kedadeyan mundhut meteng sing luwih dhuwur.
Anjurake wanita ngandhut lan wanita babagan potensial reproduksi babagan risiko potensial kanggo janin. Rekomendasi wanita sing duwe potensi reproduksi kanggo nggunakake kontrasepsi sing efektif sajrone perawatan karo tremelimumab lan 3 wulan sawise dosis pungkasan obat kasebut.
Immunogenicity
Ana potensial kanggo immunogenicity karo terapi tremelimumab. Ing studi HIMALAYA lan POSEIDON, antibodi anti-tremelimumab dideteksi ing 11 lan 14% pasien, masing-masing. Antibodi anti-tremelimumab iki ora duwe efek signifikan sacara klinis ing farmakokinetik utawa safety tremelimumab; Nanging, efek antibodi anti-narkoba lan antibodi netralake babagan khasiat obat kasebut ora dingerteni.
Populasi Tertentu
KandhutanOra ana data babagan panggunaan tremelimumab ing wanita ngandhut. Nanging, adhedhasar temuan saka studi kewan lan mekanisme tumindake, tremelimumab bisa nyebabake cilaka janin nalika diwenehake marang wanita ngandhut. Ing model kandhutan murine, blokade CTLA-4 digandhengake karo tambah risiko penolakan sing dimediasi kekebalan marang janin sing berkembang lan pati janin.
IgG2 manungsa dikenal ngliwati alangan plasenta; mulane, tremelimumab bisa ditularake saka ibu menyang janin sing berkembang. Wenehi pitutur marang wanita ngandhut lan wanita babagan potensial reproduksi babagan risiko potensial kanggo janin.
LaktasiOra dingerteni manawa tremelimumab disebarake menyang susu manungsa; Efek obat kasebut ing bayi sing disusui utawa ing produksi susu uga ora dingerteni. IgG ibu dikenal ana ing susu manungsa. Efek paparan GI lokal lan paparan sistemik winates kanggo tremelimumab ing bocah sing disusui ora dingerteni. Amarga ana potensial reaksi salabetipun serius ing bocah sing disusui, menehi saran supaya wanita ora nyusoni sajrone perawatan karo tremelimumab lan 3 sasi sawise dosis pungkasan.
Wanita lan Lanang Potensi ReproduksiTremelimumab bisa nyebabake janin. gawe piala nalika ditrapake kanggo wanita ngandhut. Nindakake tes meteng ing wanita kanthi potensial reproduksi sadurunge miwiti tremelimumab.
Anjurake wanita sing duwe potensi reproduksi nggunakake kontrasepsi sing efektif sajrone perawatan karo tremelimumab lan suwene 3 sasi sawise dosis pungkasan.
Panggunaan PediatrikKeamanan lan khasiat tremelimumab ora ditetepake ing pasien pediatrik.
Panggunaan GeriatrikIng studi klinis pasien karo karsinoma hepatoseluler sing ora bisa ditindakake utawa kanker paru-paru non-sel cilik metastatik sing diobati karo tremelimumab ing kombinasi karo durvalumab, ora ana bedane safety sakabèhé. utawa khasiat tremelimumab diamati ing pasien umur ≥65 taun dibandhingake karo wong diwasa sing luwih enom.
Gangguan HepatikOra ana prabédan klinis sing signifikan ing farmakokinetik sing diamati ing pasien kanthi gangguan hepatik entheng nganti moderat (bilirubin <3 kaping ULN lan AST apa wae. ). Efek saka gangguan hepatik sing abot (bilirubin> 3 kaping ULN lan AST apa wae) ing farmakokinetik ora dingerteni.
Gagal GinjalOra ana prabédan klinis sing signifikan ing farmakokinetik sing diamati ing pasien kanthi gangguan ginjel entheng nganti moderat (Clcr 30-89 mL). / min). Efek saka gangguan ginjel abot (Clcr 15–29 mL/min) ing farmakokinetik ora dingerteni.
Efek Samsaya Awon
Efek salabetipun paling umum (≥20%) ing pasien karo karsinoma hepatoseluler sing ora bisa ditindakake: Ruam, diare, lemes, pruritus, nyeri muskuloskeletal, nyeri abdomen. Abnormalitas laboratorium sing paling umum (≥40%) pasien karo karsinoma hepatoseluler sing ora bisa diobati: Tambah AST, tambah ALT, hemoglobin mudhun, natrium mudhun, bilirubin tambah, fosfatase alkalin mundhak, limfosit mudhun.
Efek saru sing paling umum ( ≥20%) ing pasien NSCLC metastatik: Mual, lemes, nyeri muskuloskeletal, nyuda napsu, ruam, diare.
Apa obatan liyane bakal mengaruhi Tremelimumab
Produsen ora menehi informasi babagan interaksi obat karo tremelimumab ing informasi resep. Hubungi informasi resep kanggo interaksi obat saka agen sing digabungake karo tremelimumab.
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