Telotristat
Jeneng merek: Xermelo
Kelas obat:
Agen Antineoplastik
Panganggone Telotristat
Diare Sindrom Carcinoid
Digunakake (ing kombinasi karo terapi analog somatostatin) kanggo perawatan diare sindrom carcinoid sing ora bisa dikontrol kanthi terapi analog somatostatin piyambak (ditunjuk minangka obat yatim piatu dening FDA kanggo perawatan sindrom carcinoid ing pasien. karo tumor neuroendokrin).
Sindrom carcinoid, sawijining kondisi sing ana hubungane karo produksi serotonin sing berlebihan, ditondoi kanthi flushing, diare, wheezing, kadhangkala gagal jantung kongestif, lan macem-macem manifestasi liyane. Senajan analog somatostatin (contone, octreotide, lanreotide) minangka perawatan standar kanggo sindrom carcinoid lan efektif ing wiwitane akeh pasien, sawetara pasien bisa uga ora nanggapi kanthi cukup utawa bisa ngalami gejala sing terus-terusan, kalebu diare, sanajan terapi.
Ing studi klinis, telotristat etil nyuda frekuensi gerakan usus saben dina ing pasien karo diare sindrom carcinoid. Pengurangan gejala sindrom carcinoid liyane (umpamane, nyeri abdomen, flushing) ora diamati.
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Carane nggunakake Telotristat
Umum
Distribusi Watesan
Administrasi
Administrasi Lisan
Administrasi kanthi lisan 3 kali saben dina. karo panganan. (Deleng Panganan ing Pharmacokinetics.)
Dosis
Kasedhiya minangka telotristat etiprate (garam hippurate saka telotristat etil); dosis sing dituduhake ing syarat-syarat telotristat etil (basa gratis).
Dewasa
Sindrom Carcinoid Diare Oral250 mg 3 kali dina; digunakake ing kombinasi karo analog somatostatin.
Dosis sing luwih dhuwur (contone, 500 mg 3 kali dina) wis diteliti ing sawetara pasien, nanging nambah risiko efek sing ora dikarepake (cons, konstipasi abot) tanpa menehi terapi tambahan. entuk manfaat.
Interupsi Terapi kanggo Efek GI Keracunan OralYen konstipasi abot utawa nyeri weteng sing terus-terusan utawa saya tambah parah, leren terapi.
Batesan Resep
Dewasa
Carcinoid Syndrome Diare OralDosis >250 mg 3 kali dina ora dianjurake.
Populasi Khusus
Gangguan Hepatik
Saiki ora ana rekomendasi dosis khusus. (Deleng Kerusakan Hepatik ing Ati-ati.)
Gangguan Ginjal
Ora ana rekomendasi dosis khusus ing wektu iki. (Deleng Kerusakan Renal ing Cautions.)
Pasien Geriatrik
Ora ana rekomendasi dosis khusus ing wektu iki. (Deleng Panggunaan Geriatrik ing Caution.)
Pènget
Kontraindikasi
Pènget/PanandhapSembelit
Nyuda frekuensi gerakan usus; constipation kacarita. Konstipasi parah sing nyebabake obstruksi GI utawa perforasi dilaporake ing pasien sing nampa dosis sing luwih dhuwur tinimbang sing disaranake (500 mg 3 kali dina).
Amarga integritas tembok saluran GI bisa uga rusak ing pasien kanthi tumor karsinoid metastatik, ngawasi pasien kanggo pangembangan konstipasi lan / utawa nyeri weteng sing terus-terusan utawa saya tambah parah. Yen manifestasi kasebut kedadeyan, mandhegake terapi.
Populasi Tertentu
KandhutanData sing nyukupi ing wanita ngandhut ora kasedhiya.
Embriotoxicity (yaiku, mundhut sawise implantasi, bobot janin mudhun), keracunan ibu (yaiku, mortalitas, cacat gain bobot), lan mundhak ing kematian pup ing postnatal dina 0-4 diamati ing kéwan ing dosis dites.
LaktasiOra dingerteni apa telotristat etil nyebar menyang susu manungsa. Efek obat kasebut ing bayi sing nyusoni lan produksi susu uga ora dingerteni. Kajaba iku, efek saka GI lokal lan paparan sistemik kanggo obat kasebut ing bayi sing disusui ora dingerteni.
Pikirake keuntungan saka nyusoni kanggo bayi bebarengan karo kabutuhan klinis wanita kanggo obat kasebut lan kemungkinan efek samping. efek ing bayi sing disusui saka obat utawa saka kondisi ibu sing ndasari. Ngawasi bayi sing disusui kanggo gejala konstipasi. (Deleng Konstipasi ing Ati-ati.)
Panggunaan PediatrikKeslametan lan khasiat durung ditetepake.
Panggunaan GeriatrikOra ana bedane sakabèhé ing safety lan khasiat sing diamati ing pasien ≥65 taun dibandhingake karo wong diwasa sing luwih enom , nanging tambah sensitivitas ora bisa ditolak lewat. (Deleng Populasi Khusus miturut Farmakokinetik.)
Kerusakan HepatikKerusakan hepatik entheng ora ngowahi farmakokinetik telotristat. Ora diteliti ing pasien kanthi gangguan hepatik moderat utawa abot. (Deleng Populasi Khusus miturut Farmakokinetik.)
Gagal GinjalGangguan ginjel entheng nganti moderat (Clcr 20–89 mL/menit) ora ngowahi farmakokinetik sacara substansial.
Ora diteliti ing pasien kanthi endoskopi. -tahap penyakit ginjel sing mbutuhake dialisis.
Efek Umum sing Sabar
Mual, sirah, tambah konsentrasi γ-glutamyltransferase (γ-glutamyltranspeptidase, GGT, GGTP), depresi, edema perifer, kembung, napsu suda, pyrexia, nyeri abdomen, konstipasi .
Apa obatan liyane bakal mengaruhi Telotristat
Dimetabolisme dening carboxylesterases dadi telotristat. Telotristat luwih dimetabolisme kanthi dekarboksilasi lan deaminasi, kalebu metabolit ora aktif utama; Nanging, potensial interaksi tamba metabolit iki ora dingerteni.
Etil telotristat utawa telotristat ora minangka substrat isoenzim CYP in vitro. Telotristat etil lan telotristat ora ditliti kanthi cukup ing vitro kanggo nunjukake manawa obat utawa metabolit aktif nyegah isoenzim CYP 2B6, 2C8, utawa 2C9 utawa ngindhuksi isoenzim CYP 1A2 utawa 2B6. Efek ing CYP3A4 durung ditetepake kanthi lengkap. (Deleng Obat Dimetabolisme dening Enzim Mikrosomal Hepatik ing Interaksi.)
In vitro, telotristat etil nyegah P-glikoprotein (P-gp) lan protein tahan kanker payudara (BCRP). In vitro, telotristat dudu inhibitor P-gp lan BCRP, nanging minangka substrat P-gp ing konsentrasi sing relevan sacara klinis.
Obat sing Dimetabolisme dening Enzim Mikrosomal Hepatik
Substrat CYP3A4: Kemungkinan interaksi farmakokinetik (mudhun paparan sistemik saka substrat CYP3A4 lan khasiat suboptimal). Ngawasi tandha-tandha nyuda khasiat substrat CYP3A4, utamane obat-obatan kanthi indeks terapeutik sing sempit, lan nimbang nambah dosis substrat CYP3A4, yen perlu. (Deleng Obat Spesifik ing Interaksi.)
Obat sing Dipengaruhi Sistem Transportasi
Interaksi farmakokinetik sing penting sacara klinis ora mungkin karo substrat P-gp, BCRP, transporter kation organik (OCT) 1, OCT2 , transporter anion organik (OAT) 1, OAT3, protein transport anion organik (OATP) 1B1, OATP1B3, utawa pompa ekspor uyah empedu (BSEP). (Deleng Obat Spesifik ing Interaksi.)
Obat sing Ngaruhi Keasaman Lambung
Kelarutan telotristat etil gumantung marang pH. Kemungkinan interaksi farmakokinetik karo obat sing nambah pH lambung. (Deleng Obat Spesifik ing Interaksi.)
Obat Spesifik
Obat
Interaksi
Komentar
Fexofenadine
Etil telotristat ora ngowahi AUC lan konsentrasi puncak fexofenadine ing wong sing sehat
Midazolam
Etil telotristat nyuda AUC lan konsentrasi puncak midazolam (substrat CYP3A4) kanthi 48 lan 25 %, mungguh; AUC lan konsentrasi puncak metabolit aktif midazolam mudhun 48 lan 34%, masing-masing
Monitor tandha-tandha nyuda khasiat substrat CYP3A4; nimbang kenaikan dosis substrat CYP3A4, yen perlu
Octreotide acetate
Short-acting octreotide acetate nyuda AUC lan konsentrasi puncak telotristat etil kanthi masing-masing 81 lan 86%; AUC lan konsentrasi puncak telotristat mudhun 68 lan 79%, masing-masing
Administrasi octreotide acetate short-acting ≥30 menit sawise administrasi telotristat etil
Inhibitor pompa proton (contone, omeprazole). )
Ora sinau; interaksi farmakokinetik sing mungkin
Ing studi khasiat utama, 42% pasien nampa terapi bebarengan karo telotristat etil lan obat-obatan sing mengaruhi kaasaman lambung
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