Elexacaftor, Tezacaftor, And Ivacaftor
Jeneng merek: Trikafta
Kelas obat:
Agen Antineoplastik
Panganggone Elexacaftor, Tezacaftor, And Ivacaftor
Fibrosis Kistik
Terapi kombinasi Elexacaftor/tezacaftor/ivacaftor: Perawatan fibrosis kistik ing pasien umur ≥6 taun sing duwe paling ora siji mUTAsi F508del ing gen CFTR utawa sing duwe paling ora siji mutasi ing gen CFTR sing responsif marang regimen obat kombinasi adhedhasar data in vitro.
Ditetepake obat yatim piatu dening FDA kanggo panggunaan iki.
Yen genotipe pasien ora dingerteni, gunakake tes mutasi cystic fibrosis sing disetujoni FDA kanggo kOnfirmasi ana paling ora siji mutasi F508del utawa mutasi sing responsif adhedhasar data in vitro.
Ana sawetara terapi sing disetujoni kanggo suBPOpulasi spesifik pasien fibrosis kistik; Nanging, efek perawatan ing sawetara mutasi (eg homozygous F508del) andhap asor. Elexacaftor / tezacaftor / ivacaftor nyedhiyakake pilihan terapi anyar kanggo pasien kanthi mutasi sing ora dilindhungi dening modulator CFTR liyane sing disetujoni.
Pedoman pulmonary Cystic Fibrosis Foundation 2018 khusus ngarahake panggunaan modulator CFTR ing pasien karo fibrosis kistik. Elexacaftor/tezacaftor/ivacaftor disetujoni sawise diterbitake pedoman, lan mulane ora ditangani.
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Carane nggunakake Elexacaftor, Tezacaftor, And Ivacaftor
Umum
Skrining Pretreatment
Pemantauan Pasien
Administrasi
Oral Administration
Administrasi oral karo panganan sing ngandhut lemak (contone, endhog , keju, kacang-kacangan, susu wutuh, daging, panganan sing disiapake nganggo mentega utawa lenga) kanggo nambah panyerepan sistemik obat kasebut.
Telan tablet wutuh.
Yen dosis elexacaftor/tezacaftor Terapi kombinasi /ivacaftor ora kejawab nganti ≤6 jam, dosis kudu dijupuk sanalika dieling-eling lan jadwal dosis asli kudu diterusake.
Yen dosis esuk ora kejawab nganti >6 jam, dosis kudu dijupuk sanalika bisa lan dosis sore ivacaftor entitas tunggal kudu diilangi; dosis kombinasi tetep esuk ing dina sabanjure kudu dijupuk ing wektu sing dijadwalake kanthi reguler.
Yen dosis sore saka ivacaftor entitas tunggal ora kejawab luwih saka 6 jam, dosis sore kudu diilangi lan Dosis kombinasi tetep esuk kudu dijupuk ing wektu sing dijadwalake kanthi rutin.
Aja njupuk dosis esuk lan sore bebarengan.
Dosis
Kasedhiya minangka kit sing kasusun saka 4 kertu blister mingguan 14 tablet sing ngemot tablet kombinasi tetep saka elexacaftor 100 mg, tezacaftor 50 mg, lan ivacaftor 75 mg sing dikemas bebarengan karo 7 tablet sing ngemot 150 mg ivacaftor entitas tunggal.
Uga kasedhiya minangka kit sing kasusun saka 4 kertu blister mingguan saka 14 tablet sing ngemot tablet kombinasi tetep saka elexacaftor 50 mg, tezacaftor 25 mg, lan ivacaftor 37,5 mg sing dikemas bebarengan karo 7 tablet sing ngemot 75 mg ivacaftor entitas tunggal.
Pasien Pediatrik
Cystic Fibrosis OralBocah 6 nganti <12 taun: Dosis sing disaranake adhedhasar bobot. Kanggo pasien <30 kg, dosis sing disaranake yaiku elexacaftor 100 mg / tezacaftor 50 mg / ivacaftor 75 mg (diwenehake minangka 2 tablet kombinasi tetep saben ngemot elexacaftor 50 mg, tezacaftor 25 mg, lan ivacaftor 37,5 mg) sapisan dina ing wayah esuk lan ivacaftor. 75 mg (diwenehake minangka tablet siji-entitas) sapisan dina ing wayah sore kira-kira 12 jam. Kanggo pasien ≥30 kg, dosis sing disaranake padha kanggo bocah ≥12 taun lan wong diwasa.
Bocah ≥12 taun: Elexacaftor 200 mg/tezacaftor 100 mg/ivacaftor 150 mg (diwenehake minangka 2 Tablet kombinasi tetep saben ngemot elexacaftor 100 mg, tezacaftor 50 mg, lan ivacaftor 75 mg) sapisan dina ing wayah esuk lan ivacaftor 150 mg (diwenehake minangka tablet siji-sijine) sapisan dina ing wayah sore kira-kira 12 jam.
Panyesuaian dosis perlu yen digunakake bebarengan karo inhibitor CYP3A moderat utawa kuwat. (Deleng Obat-obatan sing Ngaruhi utawa Dimetabolisme dening Enzim Mikrosomal Hepatik ing Interaksi.)
Dewasa
Fibrosis Cystic OralElexacaftor 200 mg/tezacaftor 100 mg/ivacaftor 150 mg (diwenehake minangka 2 kombinasi tetep saben tablet ngemot elexacaftor 100 mg, tezacaftor 50 mg, lan ivacaftor 75 mg) sapisan dina ing wayah esuk lan ivacaftor 150 mg (diwenehake minangka tablet siji-sijine) sapisan dina ing wayah sore kira-kira 12 jam.
Penyesuaian dosis perlu nalika digunakake bebarengan karo inhibitor CYP3A moderat utawa kuwat. (Deleng Obat-obatan sing Ngaruhi utawa Dimetabolisme dening Enzim Mikrosomal Hepatik ing Interaksi.)
Populasi Khusus
Gangguan Hepatik
Gangguan Hepatik Ringan (Child-Pugh kelas A): Penyesuaian dosis ora perlu.
Gagal ati moderat (kelas Anak-Pugh B): Gunakake kanthi ati-ati ing dosis suda 2 tablet kombinasi tetep ing wayah esuk ing dina 1 lan siji tablet kombinasi tetep ing esuk ing dina 2; terus dosis karo 2 tablet elexacaftor / tezacaftor / ivacaftor lan siji tablet ivacaftor ing dina sulih ing esuk. Aja menehi dosis sore ivacaftor ing pasien kasebut.
Gangguan ati sing abot (Child-Pugh kelas C): Gunakake ora dianjurake.
Gangguan Ginjal
Gagal ginjel entheng nganti sedheng: Ora perlu nyetel dosis.
Gagal ginjel abot (eGFR <30 mL/menit saben 1,73 m2) utawa penyakit ginjel tahap pungkasan (ESRD): Disaranake ati-ati.
p>Pasien Geriatrik
Saiki ora ana rekomendasi dosis khusus.
Pènget
Kontraindikasi
Pènget / PancegahanEfek Hepatik
Konsentrasi aminotransferase (ALT utawa AST) lan bilirubin sing luwih dhuwur dilaporake.
Kaji konsentrasi ALT, AST, lan bilirubin serum sadurunge miwiti terapi, saben 3 wulan sajrone taun pisanan terapi, lan saben taun sabanjure. Ing pasien sing duwe riwayat penyakit hepatobiliary utawa tes fungsi ati sing dhuwur, nimbang pemantauan sing luwih kerep.
Interupsi terapi ing pasien kanthi kenaikan ALT utawa AST> 5 kaping ULN utawa ing pasien kanthi peningkatan ALT utawa AST>3 kaping ULN nalika digandhengake karo konsentrasi bilirubin sing dhuwur> 2 kaping ULN; ngawasi pasien kanthi rapet nganti ora normal rampung. Sawise resolusi tes fungsi ati mundhak, nimbang keuntungan lan risiko nerusake terapi.
Interaksi karo Inducers CYP3A
Penggunaan bebarengan elexacaftor/tezacaftor/ivacaftor lan inducers CYP3A kuat (contone, rifampisin, rifabutin, phenobarbital, Carbamazepine, phenytoin, [St. paparan sistemik saka ivacaftor lan bisa nyuda paparan elexacaftor lan tezacaftor; nyuda eksposur bisa nyuda khasiat terapeutik. Panggunaan bebarengan karo inducers CYP3A kuat ora dianjurake.
Interaksi karo Inhibitor CYP3A
Panganggone bebarengan elexacaftor/tezacaftor/ivacaftor lan inhibitor CYP3A kuat utawa moderat (contone, ketokonazol, itrakonazol, posaconazole, vorikonazol, telitromisin, klaritromisin) nambah paparan sistem saka elexacaftor, tezacaftor, lan ivacaftor. Ngurangi dosis elexacaftor/tezacaftor/ivacaftor nalika digunakake bebarengan karo inhibitor CYP3A moderat utawa kuwat.
Efek Okular
Kekeruhan lensa okuler (ora ana alam bawaan) dilaporake ing pasien pediatrik sing nampa regimen obat sing ngemot ivacaftor. Sanajan faktor risiko liyane ana ing sawetara kasus (contone, panggunaan kortikosteroid, paparan radiasi), kemungkinan risiko sing disebabake dening terapi ivacaftor ora bisa diilangi. Pemeriksan ophthalmologic dhasar lan tindak lanjut dianjurake kanggo pasien pediatrik.
Populasi Tertentu
KandhutanData winates kasedhiya babagan panggunaan terapi kombinasi elexacaftor/tezacaftor/ivacaftor utawa komponen individu ing wanita ngandhut. Bukti teratogenisitas utawa efek samping ing perkembangan janin sing ora diamati ing kewan sing nampa elexacaftor, tezacaftor, utawa ivacaftor. Ora ana data kewan sing kasedhiya kanthi nggunakake elexacaftor, tezacaftor, lan ivacaftor bebarengan. Transfer plasenta saka komponen individu sing diamati ing kewan.
LaktasiDistribusi menyang susu ing tikus; ora dingerteni manawa disebarake menyang susu manungsa. Coba keuntungan pangembangan lan kesehatan saka nyusoni lan pentinge klinis terapi kanggo wanita nalika mutusake manawa kudu ati-ati utawa mandheg nyusoni. Efek elexacaftor/tezacaftor/ivacaftor ing bayi sing nyusoni utawa produksi susu ora dingerteni.
Panggunaan PediatrikKeamanan lan khasiat ora ditetepake ing pasien pediatrik <6 taun.
Panggunaan GeriatrikUji klinis ditindakake ora kalebu pasien ≥65 taun.
Gangguan HepatikGangguan ati sing entheng (kelas Child-Pugh A): Penyesuaian dosis ora perlu. Ngawasi tes fungsi ati kanthi rapet.
Gagal ati moderat (kelas Anak-Pugh B): Tambah cahya; nggunakake kanthi ati-ati lan ing dosis suda sawise nimbang risiko lan keuntungan saka therapy. Ngawasi tes fungsi ati kanthi rapet. Ing panaliten klinis saka 11 subyek kanthi gangguan hepatik moderat (kelas Child-Pugh B), siji subyek ngalami peningkatan total lan bilirubin langsung>2 kaping ULN lan siji subyek ngembangake peningkatan bilirubin langsung>4,5 kaping ULN.
Gangguan hepatik sing abot (kelas Anak-Pugh C): Efek ing farmakokinetik sing ora diteliti, nanging tambah akeh paparan. Gunakake ora dianjurake.
Gagal ginjelGagal ginjel entheng utawa moderat: Penyesuaian dosis ora perlu.
Gagal ginjel abot (eGFR <30 mL/menit saben 1,73 m2) utawa ESRD: Gunakake karo ati-ati.
Disfungsi Paru ParahKeamanan lan khasiat ing 18 pasien kanthi garis dasar FEV1 <40% saka prediksi sing nampa terapi kombinasi elexacaftor/tezacaftor/ivacaftor ing salah sawijining studi khasiat utama bisa dibandhingake karo populasi sinau sakabèhé.
p>Efek Samsaya Awon
Efek salabetipun sing dumadi ing ≥5% pasien: Sakit sirah, infeksi saluran napas ndhuwur, nyeri abdomen, diare, ruam, tambah konsentrasi ALT, hidung tersumbat, tambah konsentrasi CK, tambah konsentrasi AST, rhinorrhea, rhinitis, influenza, sinusitis, tambah konsentrasi bilirubin.
Apa obatan liyane bakal mengaruhi Elexacaftor, Tezacaftor, And Ivacaftor
Elexacaftor minangka substrat isoenzim CYP3A (contone, CYP3A4, 3A5) lan transportasi P-glikoprotein (P-gp). In vitro, elexacaftor wis nuduhake potensial kurang kanggo nyandhet CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4, lan P-gp. In vitro, elexacaftor lan metabolit M23 nyandhet penyerapan polipeptida pengangkut anion organik (OATP) 1B1 lan 1B3.
Tezacaftor minangka substrat saka isoenzim CYP3A (contone, CYP3A4, 3A5), transportasi P-gp, Protein tahan kanker payudara (BCRP), lan OATP1B1. In vitro, tezacaftor wis nuduhake potensial kurang kanggo nyandhet CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4, P-gp, BCRP, transporter kation organik (OCT) 2, transporter anion organik, lan OAT3 1. /p>
Ivacaftor minangka substrat sensitif CYP3A (contone, CYP3A4, 3A5). In vitro, ivacaftor wis nuduhake potensial kanggo nyandhet CYP3A lan P-gp, lan uga bisa nyandhet CYP2C8 lan CYP2C9.
Obat sing Ngaruhi utawa Dimetabolisme dening Enzim Mikrosomal Hepatik
Inhibitor CYP3A sing kuat (contone. , klaritromisin, itrakonazol, ketokonazol, posakonazol, telitromisin, vorikonazol): Kemungkinan eksposur elexacaftor, tezacaftor, lan ivacaftor sing tambah. Disaranake nyuda dosis. Dosis kombinasi tetep elexacaftor/tezacaftor/ivacaftor (minangka 2 tablet kombinasi tetep) sapisan dina esuk kaping pindho saben minggu (kira-kira 3-4 dina). Aja menehi dosis sore ivacaftor entitas tunggal.
Inhibitor CYP3A moderat (contone, flukonazol, eritromisin): Kemungkinan tambah eksposur elexacaftor, tezacaftor, lan ivacaftor. Disaranake nyuda dosis. Nyedhiyakake dosis kombinasi tetep sing cocog saka elexacaftor/tezacaftor/ivacaftor (minangka 2 tablet kombinasi tetep) sapisan dina esuk ing dina 1 lan dosis ivacaftor sing cocog (diwenehake minangka tablet siji-entitas) sapisan dina esuk ing dina 2 ; salajengipun, terus dosis karo 2 tablet elexacaftor / tezacaftor / ivacaftor lan siji tablet ivacaftor ing dina sulih. Aja menehi dosis sore saka ivacaftor entitas tunggal.
Inducer CYP3A sing kuat: Kemungkinan nyuda paparan ivacaftor; nyuda eksposur elexacaftor lan tezacaftor samesthine. Panggunaan bebarengan ora dianjurake.
Obat sing Dipengaruhi Transport P-glikoprotein
Substrat P-gp: Kemungkinan tambah cahya, efek terapeutik sing suwe, utawa tambah risiko efek samping obat substrat. Gunakake substrat P-gp kanthi indeks terapeutik sing sempit bebarengan kanthi ati-ati; ngawasi pasien kanthi tepat.
Obat-obatan sing kena pengaruh Polipeptida 1B1 lan 1B3 Organik Anion-transporting
Substrat OATP1B1 lan 1B3: Kemungkinan tambah paparan, efek terapeutik sing suwe, utawa tambah risiko efek samping saka obat substrate. Gunakake substrat saka transporter kasebut kanthi ati-ati; ngawasi pasien kanthi tepat.
Obat Spesifik
Obat
Interaksi
Komentar
Anticonvulsants (carbamazepine, phenobarbital, phenytoin)
Bisa ngurangi eksposur elexacaftor, tezacaftor, lan ivacaftor lan ngurangi khasiat elexacaftor/tezacaftor/ivacaftor
Ora disaranake nggunakake bebarengan
Agen antidiabetik, sulfonylureas (Glimepiride, Glipizide, glyburide, Nateglinide, repaglinide)
Kamungkinan tambah paparan glimepiride, glipizide, glyburide, nateglinide
, repaglinide >Gunakake kanthi ati-ati lan ngawasi pasien kanthi tepat
Anti jamur, azoles (flukonazol, itrakonazol, ketokonazol, posaconazole, vorikonazol)
Itrakonazol: Panggunaan bebarengan karo tezacaftor/ivacaftor nyebabake 4- lan 15,6 kaping tambah tezacaftor lan ivacaftor AUCs, mungguh; nggunakake bebarengan karo dosis siji saka elexacaftor lan tezacaftor nambah AUC saka elexacaftor lan tezacaftor dening 2,8- lan 4- kanggo 4,5-fold, mungguh
Ketoconazole: nggunakake bebarengan karo dosis 150-mg saka ivacaftor siji asil ing 8,5 -lipat tambah AUC saka ivacaftor
Fluconazole: Panggunaan bebarengan karo ivacaftor nyebabake 2,9 kali lipat AUC saka ivacaftor; nggunakake bebarengan karo elexacaftor lan tezacaftor bisa nambah AUC saka elexacaftor lan tezacaftor kanthi 1,9- nganti 2,3- lan 2,1 kaping, mungguh
Itraconazole, ketoconazole, posaconazole, vorikonazol: Suda dosis elexacaftor//tezacaftor Deleng Obat-obatan sing Ngaruhi utawa Dimetabolisme dening Enzim Mikrosomal Hepatik ing Interaksi.)
Agen anti-infèksi, makrolida (clarithromycin, erythromycin)
Mungkin tambah elexacaftor, tezacaftor, lan ivacaftor
Clarithromycin, erythromycin, Telithromycin: Suda dosis elexacaftor/tezacaftor/ivacaftor sing disaranake (Deleng Obat-obatan sing Ngaruhi utawa Dimetabolisme dening Enzim Mikrosomal Hepatik ing Interaksi.)
Agen Antilipemik, HydroxyAmethylglutaryl-Comethyl ) inhibitor reduktase (yaiku, statin)
Kamungkinan tambah paparan statin
Gunakake kanthi ati-ati lan ngawasi pasien kanthi tepat
Antimycobacterial (rifabutin, rifampisin)
Rifabutin: Kemungkinan ngurangi eksposur elexacaftor, tezacaftor, lan ivacaftor lan ngurangi khasiat elexacaftor/tezacaftor/ivacaftor
Rifampisin: Ngurangi paparan ivacaftor nganti 89%, lan nyuda paparan elexacaftor lan tezacaftor uga dikarepake; bisa nyuda khasiat elexacaftor/tezacaftor/ivacaftor
Panganggone bebarengan ora dianjurake
Ciprofloxacin
Ora ana efek klinis penting ing eksposur elexacaftor, tezacaftor, utawa ivacaftor sing dikarepake
p>Panyesuaian dosis ora dibutuhake
Digoxin
Peningkatan paparan digoxin; kemungkinan efek terapeutik sing luwih dawa saka digoxin utawa tambah risiko efek samping sing ana gandhengane karo digoxin
Gunakake kanthi ati-ati lan ngawasi kanthi tepat
Estrogen lan progestin
Etinil estradiol lan levonorgestrel : Ora ana efek sing signifikan ing paparan etinil estradiol utawa levonorgestrel
Kontrasepsi hormonal: Panggunaan bebarengan ora samesthine kanggo mengaruhi khasiat kontrasepsi hormonal
Kontrasepsi hormonal sing bebarengan bisa nyebabake ruam sing ana gandhengane karo terapi elexacaftor/tezacaftor/ivacaftor
Pertimbangake gangguan saka elexacaftor /tezacaftor/ivacaftor ing pasien sing nampa kontrasepsi hormonal sing ngalami ruam; yen ruam wis rampung, nimbang nerusake elexacaftor / tezacaftor / ivacaftor tanpa kontrasepsi hormonal; yen ruam ora kambuh, coba nerusake kontrasepsi hormonal
Jus jeruk bali utawa jeruk bali
Bisa tambah eksposur elexacaftor, tezacaftor, lan ivacaftor
Aja nggunakake bebarengan
Imunosupresan (siklosporin, everolimus, sirolimus, tacrolimus)
Bisa tambah paparan imunosupresan, efek terapeutik sing suwe, utawa tambah risiko efek samping sing gegandhengan karo imunosupresan
Gunakake kanthi ati-ati. ; ngawasi pasien kanthi tepat
St. John's wort (Hypericum perforatum)
Kamungkinan nyuda eksposur elexacaftor, tezacaftor, lan ivacaftor lan nyuda khasiat elexacaftor/tezacaftor/ivacaftor
Panganggone bebarengan ora dianjurake
Warfarin
Mungkin warfarin sing tambah paparan
Pantau INR lan atur dosis warfarin yen perlu
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