Selexipag
Jeneng merek: Uptravi
Kelas obat:
Agen Antineoplastik , Agen Antineoplastik
Panganggone Selexipag
Pulmonary Arterial Hypertension
Manajemen hipertensi arteri paru (PAH; WHO grup 1) kanggo nundha perkembangan penyakit lan nyuda resiko rawat inap. Khasiat ditetepake utamane ing pasien karo WHO kelas fungsional II-III PAH (idiopatik, diwarisake, utawa digandhengake karo penyakit jaringan ikat utawa penyakit jantung bawaan kanthi shunt sing didandani).
Pengobatan kanthi selexipag piyambak utawa dikombinasikake karo antagonis reseptor endothelin lan/utawa inhibitor phosphodiesterase (PDE) tipe 5 nyuda risiko progresi penyakit lan rawat inap ing pasien karo PAH, nanging durung ditampilake nyuda mortalitas. .
Pedoman konsensus ahli saka American College of Chest Physicians (ACCP) nyaranake supaya kabeh pasien diwasa sing duwe gejala PAH diobati nganggo obat-obatan khusus PAH. Pamilihan terapi obat kudu adhedhasar tingkat keruwetan penyakit (kelas WHO/NYHA) saliyane kondisi komorbid, obat-obatan bebarengan, efek sing ora becik, rute administrasi, biaya, lan preferensi pasien.
Panel pedoman ACCP ditemtokake yen ora ana bukti sing cukup kanggo menehi rekomendasi kanggo utawa nglawan panggunaan selexipag amarga watesan ing data uji klinis.
Wis ditunjuk minangka obat yatim piatu dening FDA kanggo perawatan PAH.
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Carane nggunakake Selexipag
Umum
Pantauan Pasien
Pantau pasien kanggo tandha-tandha lan gejala edema paru.
Administrasi
Administrasi oral utawa infus IV. Preparasi parenteral sing dimaksudake kanggo digunakake ing pasien sing ora bisa njupuk terapi lisan kanggo sementara.
Administrasi Oral
Administrasi oral kaping pindho saben dina tanpa preduli saka dhaharan; Tolerability bisa uga luwih apik nalika dijupuk karo panganan.
Aja pamisah, ngunyah, utawa ngremuk tablet.
Internasional IV
Administrasi kanthi infus kaping pindho saben dina. Gunakake set infus sing digawe saka polivinil klorida bebas DEHP, tabung microbore tanpa karet lateks alami sing dilindhungi saka cahya. Aja nggunakake saringan kanggo administrasi.
Reconstitute lan luwih diencerke sadurunge administrasi.
ReconstitutionCopot karton saka kulkas lan ngidini kanggo ngadeg watara 30-60 menit kanggo tekan suhu kamar ( 20–25°C). Nglindhungi vial saka cahya.
Reconstitute nggunakake syringe polypropylene karo 8,6 ml injeksi natrium klorida 0,9%; alon-alon nyuntikake diluent menyang vial kanggo entuk konsentrasi 225 mcg / mL. Dokumen tanggal lan wektu tusukan vial pisanan.
PengenceranEncer mung ing wadhah kaca. Transfer 100 ml injeksi natrium klorida 0,9% menyang wadhah kaca steril kosong. Copot volume sing dibutuhake saka solusi selexipag sing dikonstitusi kanthi nggunakake jarum suntik polipropilena siji lan ditambahake menyang wadhah kaca sing ngemot 100 ml injeksi natrium klorida 0,9% kanggo entuk dosis pungkasan sing dikarepake. Nemtokake kadaluwarsa 4 jam saka wektu tusukan vial pisanan; Bungkus wadhah kaca kanthi tutup pelindung sing entheng.
Infus lengkap sajrone 4 jam saka tusukan vial pisanan (kalebu wektu infus).
Tingkat AdministrasiAtur selexipag sing diencerke kanggo injeksi kanthi infus IV liwat 80 menit nggunakake set infus sing digawe saka polivinil klorida tanpa DEHP, tabung mikrobore tanpa karet alam sing dilindhungi saka cahya. Aja nggunakake saringan kanggo administrasi.
Sawise solusi kanggo wadah kaca infus kosong, terusake infus kanthi tingkat sing padha karo injeksi natrium klorida 0,9% kanggo ngosongake solusi sing isih ana kanggo infus ing jalur IV, kanggo mesthekake yen kabeh solusi kanggo infus wis diwenehake.
Dosis
Dewasa
PAH OralDosis individu adhedhasar tolerability.
Kaping pisanan, 200 mcg kaping pindho saben dina. Nambah dosis kanthi nambah 200 mcg kaping pindho saben dina (biasane ing interval mingguan) nganti dosis sing paling ditoleransi (maksimal 1600 mcg kaping pindho saben dina).
Efek salabetipun cenderung kedadeyan luwih kerep sajrone fase titrasi dosis lan bisa ditindakake. kanthi analgesik, antidiare, lan antiemetik.
Yen dosis ora kejawab, njupuk sanalika iku eling; Yen dosis sabanjure kudu ditindakake sajrone 6 jam, lewati dosis sing ora kejawab lan njupuk dosis sabanjure ing wektu sing wis dijadwalake kanthi rutin.
IVAdministrasi kanthi dosis sing cocog karo dosis lisan pasien saiki (pirsani Tabel 1).
p> Tabel 1: Dosis Seleksipag IV Adhedhasar Dosis Seleksipag Oral Saiki.1Dosis tablet Selexipag (mcg) kanggo dosis kaping pindho saben dina
Selexipag IV sing cocog dosis (mcg) kanggo dosis kaping pindho saben dina
Volume transfer reconstituted (mL) kanggo pengenceran
200
225
1
400
450
2
600
675
3
800
900
4
1000
1125
5
1200
1350
6
1400
1575
7
1600
1800
8
Modifikasi Dosis kanggo Co-administrasi Inhibitor CYP2C8 ModeratNgurangi interval dosis selexipag nganti sapisan saben dina nalika digunakake bebarengan karo inhibitor CYP2C8 moderat (contone, clopidogrel, deferasirox, lan Teriflunomide).
Batesan Resep
Dewasa
PAH OralMaksimum 1600 mcg kaping pindho saben dina.
IVMaksimum 1800 mcg kaping pindho saben dina.
Populasi Khusus
Gangguan Hepatik
Gangguan Hepatik Ringan (Child-Pugh kelas A): Ora perlu panyesuaian dosis.
Gangguan ati moderat (Child-Pugh kelas B): Kaping pisanan, 200 mcg tablet sapisan dina; nambah dosis kanthi nambah 200 mcg sapisan saben dina kanthi interval mingguan kaya sing ditoleransi.
Gangguan ati sing abot (Child-Pugh kelas C): Aja nggunakake.
Gagal ginjal
Pasien kanthi eGFR >15 mL/menit saben 1,73 m2: Ora perlu pangaturan dosis.
Pasien kanthi eGFR <15 mL/menit saben 1,73 m2 utawa sing lagi dialisis: Ora diteliti.
Panganggone Geriatrik
Saiki ora ana rekomendasi dosis khusus.
Pènget
Kontraindikasi
Pènget/PanandhapOedema Pulmonary karo Penyakit Veno-Oklusif Pulmonary
Pertimbangake kemungkinan penyakit veno-occlusive paru (PVOD) sing gegandhengan lan mungkasi selexipag yen ana manifestasi edema paru.
Populasi Tertentu
KandhutanOra ana studi sing nyukupi lan dikontrol kanthi apik ing wanita ngandhut. Selexipag ora mengaruhi perkembangan embriofetal lan kaslametané ing studi kewan.
LaktasiDistribusi menyang susu ing tikus; ora dingerteni manawa disebarake menyang susu manungsa. Mungkasi nyusoni utawa obat kasebut.
Panggunaan PediatrikKeslametan lan khasiat durung ditetepake.
Panggunaan GeriatrikOra ana bedane sakabèhé ing safety lan khasiat sing diamati ing antarane pasien geriatrik lan luwih enom; Nanging, tambah sensitivitas ing sawetara wong tuwa ora bisa ditolak.
Gangguan HepatikPaparan sistemik kanggo selexipag mundhak ing pasien kanthi gangguan hepatik entheng (kelas Anak-Pugh A); paparan sistemik kanggo obat lan metabolit aktif tambah ing pasien kanthi gangguan hepatik moderat (kelas Child-Pugh B).
Ora diteliti ing pasien kanthi gangguan hepatik abot (kelas Child-Pugh C); supaya ora digunakake.
Gagal ginjelPaparan sistemik kanggo selexipag mundhak ing pasien kanthi gangguan ginjel sing abot (eGFR 15-29 mL / menit saben 1,73 m2).
Ora diteliti ing pasien ing dialisis utawa ing wong kanthi eGFR <15 mL/menit saben 1,73 m2.
Efek Sabar sing Umum
Efek sing ora becik (≥5% lan luwih kerep tinimbang plasebo): sirah, diare, nyeri rahang, mual, myalgia, mutahke, nyeri ing ekstremitas, lan flushing. p>
Reaksi ing situs infus (eritema ing situs infus / abang, nyeri lan bengkak) dilaporake karo selexipag kanggo injeksi.
Apa obatan liyane bakal mengaruhi Selexipag
Selexipag lan metabolit aktif dimetabolisme dening CYP2C8 (utamane) lan CYP3A4. Selexipag lan metabolit aktif ora nyandhet utawa ngindhuksi enzim CYP ing konsentrasi klinis sing relevan lan uga ora nyandhet protein transpor hepatik utawa ginjel.
Selexipag lan metabolit aktif minangka substrat saka protein transport anion organik (OATP) 1B1 lan 1B3. Selexipag minangka substrat P-glikoprotein (P-gp), lan metabolit aktif minangka substrat protein tahan kanker payudara (BCRP).
Obat sing Ngaruhi Enzim Mikrosomal Hepatik
Kuat inhibitor CYP2C8: Kemungkinan tambah paparan selexipag lan metabolit aktif; nggunakake concomitant contraindicated.
Inhibitor CYP2C8 moderat: Sanajan ora dievaluasi sacara khusus, tambah paparan selexipag lan metabolit aktif bisa uga. Coba regimen dosis sing kurang asring (contone, sapisan dina) nalika miwiti selexipag ing pasien sing nampa inhibitor CYP2C8 moderat. Ngurangi dosis selexipag nalika miwiti inhibitor CYP2C8 moderat.
Inducer CYP2C8: Kemungkinan ngurangi paparan metabolit aktif selexipag.
Inhibitor CYP3A4: Ora samesthine kanggo ngowahi farmakokinetik selexipag lan metabolit aktif ing tingkat klinis sing penting; pangaturan dosis saka selexipag katon ora perlu.
Obat sing Ngaruhi Protein Transport
Inhibitor OATP1B1, OATP1B3, lan P-gp: Ora samesthine kanggo ngowahi farmakokinetik selexipag lan aktif metabolit menyang ombone penting klinis; pangaturan dosis selexipag katon ora perlu.
Obat Spesifik
Obat
Interaksi
Komentar
Clopidogrel
Clopidogrel, inhibitor CYP2C8 moderat, nambah paparan metabolit aktif selexipag
Ngurangi interval dosis selexipag dadi sapisan dina
Deferasirox
Deferasirox, inhibitor moderat CYP2C8, bisa nambah paparan metabolit aktif selexipag
Pertimbangake regimen dosis selexipag sing kurang asring (contone, sapisan dina) nalika miwiti obat kasebut ing pasien sing wis ana. nampa deferasirox; nyuda dosis selexipag nalika deferasirox diwiwiti ing pasien sing wis nampa selexipag
Antagonis reseptor endothelin
Ora ana interaksi obat sing relevan sacara klinis
Ora ana penyesuaian dosis sing dibutuhake
Gemfibrozil
Gemfibrozil, inhibitor kuat CYP2C8, nambah paparan selexipag kaping pindho lan metabolit aktif 11 kali lipat
Kontraindikasi panggunaan bebarengan
Lopinavir lan ritonavir
Kombinasi tetep lopinavir lan ritonavir (lopinavir/ritonavir): Ora ana interaksi farmakokinetik sing relevan sacara klinis sing diamati
Ora ana pangaturan dosis sing dibutuhake
Inhibitor tipe 5 PDE
Ora Interaksi obat sing relevan sacara klinis diamati
Ora ana pangaturan dosis sing dibutuhake
Rifampisin
Bisa nyuda paparan metabolit aktif selexipag
Tambah dosis selexipag (nganti kaping pindho) nalika digunakake bebarengan karo rifampisin; nyuda dosis selexipag nalika rifampisin dihentikan
Teriflunomide
Teriflunomide, inhibitor moderat CYP2C8, bisa nambah paparan metabolit aktif selexipag
Coba dosis sing kurang asring. regimen selexipag (contone, sapisan dina) nalika miwiti obat ing pasien sing wis nampa teriflunomide; nyuda dosis selexipag nalika teriflunomide diwiwiti ing pasien sing wis nampa selexipag
Warfarin
Ora ana owah-owahan ing farmakokinetik warfarin utawa selexipag; ora ana pengaruh ing INR
Ora ana pangaturan dosis sing dibutuhake
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