Baloxavir
Jeneng merek: Xofluza
Kelas obat:
Agen Antineoplastik , Agen Antineoplastik
Panganggone Baloxavir
Pengobatan Infèksi Virus Influenza A lan B Musiman
Pengobatan influenza akut, ora rumit sing disebabake dening virus influenza A utawa B ing wong diwasa lan remaja ≥12 taun sing wis gejala kanggo ≤48 jam, kalebu wong sing sehat lan sing duwe risiko dhuwur kanggo komplikasi sing ana hubungane karo influenza. Khasiat yen diwenehake>48 jam sawise muncule gejala ora dievaluasi.
Data ora kasedhiya nganti saiki babagan panggunaan kanggo perawatan influenza sing abot utawa rumit ing pasien rawat inap utawa rawat rawat.
Kanggo perawatan sing dicurigai utawa dikOnfirmasi influenza musiman sing akut lan ora rumit ing pasien rawat jalan sing sehat, CDC, IDSA, lan liya-liyane nyatakake yen antivirus influenza sing cocog karo umur (oseltamivir oral, zanamivir inhalasi, marboxil baloxavir oral, peramivir IV) bisa digunakake yen ora ana kontraindikasi. Negara-negara CDC bisa uga nimbang perawatan antivirus empiris awal ing pasien rawat omah sing dicurigai influenza (contone, penyakit kaya influenza kayata mriyang kanthi watuk utawa tenggorokan) adhedhasar pertimbangan klinis yen perawatan kasebut bisa diwiwiti sajrone 48 jam wiwit penyakit.
Kanggo perawatan sing dicurigai utawa dikonfirmasi influenza musiman ing pasien rawat inap utawa pasien rawat rawat kanthi penyakit sing abot, rumit, utawa progresif (contone, radhang paru-paru, exacerbation saka kondisi medis kronis sing ndasari), CDC nyatakake oseltamivir minangka antivirus influenza sing disenengi amarga kurang data babagan panggunaan antivirus influenza liyane ing pasien kasebut. CDC nyatakake Baloxavir marboxil ora dianjurake kanggo perawatan influenza ing pasien sing dirawat ing rumah sakit.
Pertimbangake manawa influenza lan penyakit koronavirus 2019 (COVID-19) sing disebabake dening sindrom pernapasan akut parah coronavirus 2 (SARS-CoV-2) duwe tumpang tindih. pratandha lan gejala lan koinfeksi karo virus influenza A utawa B lan SARS-CoV-2 bisa kedadeyan. Sanajan tes laboratorium bisa mbantu mbedakake antarane infeksi virus influenza lan infeksi SARS-CoV-2, CDC nyaranake miwiti perawatan influenza empiris ing pasien sing dicurigai influenza sing dirawat ing rumah sakit, duwe penyakit sing abot, rumit, utawa progresif, utawa beresiko dhuwur kanggo komplikasi influenza. tanpa ngenteni asil tes influenza, tes SARS-CoV-2, utawa tes molekuler multiplex sing ndeteksi virus influenza A lan B lan SARS-CoV- 2.
Pertimbangake data pengawasan virus sing kasedhiya saka kesehatan lokal lan negara. departemen lan CDC nalika milih antivirus kanggo perawatan influenza musiman. Galur virus influenza sing sirkulasi lan kerentanan antivirus saka galur kasebut terus berkembang, lan munculé galur sing tahan bisa nyuda efektifitas antivirus influenza. Sanajan virus influenza A lan B sing nyebar ing taun-taun pungkasan wis rentan marang baloxavir, goleki informasi paling anyar babagan kerentanan virus sing nyebar nalika milih antivirus kanggo perawatan influenza.
CDC ngetokake rekomendasi babagan panggunaan antivirus kanggo perawatan influenza, lan rekomendasi kasebut dianyari yen perlu ing saben musim influenza. Informasi babagan pengawasan influenza lan rekomendasi sing dianyari kanggo perawatan influenza musiman kasedhiya saka CDC ing [Web].
Nyegah Infèksi Virus Influenza A lan B Musiman
Profilaksis posteksposure infeksi virus influenza A utawa B ing wong diwasa lan remaja ≥12 taun sing kena kontak karo wong sing kena influenza.
Vaksinasi taunan nganggo vaksin virus influenza musiman, kaya sing disaranake dening Komite Penasehat CDC babagan Praktek Imunisasi (ACIP), minangka cara utama kanggo nyegah influenza musiman lan komplikasi sing abot. Profilaksis kanthi antivirus aktif sing cocog marang galur influenza sing sirkulasi dianggep minangka tambahan kanggo vaksinasi kanggo ngontrol lan nyegah influenza ing individu tartamtu.
Putusan dhasar babagan panggunaan antivirus kanggo profilaksis influenza musiman babagan risiko komplikasi sing gegandhengan karo influenza ing wong sing kena pengaruh, jinis lan suwene kontak, rekomendasi saka panguwasa kesehatan lokal utawa umum, lan keputusan klinis. Umumé, gunakake profilaksis antivirus influenza mung yen bisa diwiwiti sajrone 48 jam sawise paparan paling anyar.
CDC lan liya-liyane ora nyaranake nggunakake rutin antiviral influenza kanggo profilaksis pasca pajanan ing wong sing kena influenza; bisa uga nimbang profilaksis kasebut ing kahanan tartamtu ing wong sing kena pengaruh kanthi risiko dhuwur kanggo komplikasi sing ana hubungane karo influenza sing vaksin influenza dikontraindikasi, ora kasedhiya, utawa diduga nduweni khasiat sing sithik (contone, wong sing duwe kekebalan).
CDC ngetokake rekomendasi babagan panggunaan antivirus kanggo profilaksis influenza, lan rekomendasi kasebut dianyari yen perlu ing saben musim influenza. Informasi babagan pengawasan influenza lan rekomendasi sing dianyari kanggo nyegah influenza musiman kasedhiya saka CDC ing [Web].
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Carane nggunakake Baloxavir
Administrasi
Administrasi Lisan
Atur kanthi lisan tanpa preduli saka dhaharan.
Aja nganggo produk susu; omben-omben sing diperkaya kalsium; utawa antacids, laxatives, utawa multivitamin utawa suplemen diet sing ngemot kation polyvalent (aluminium, kalsium, wesi, magnesium, Selenium, utawa seng). (Deleng Obat Spesifik ing Interaksi.)
Disedhiyakake kanthi komersil minangka tablet utawa minangka granul kanggo suspensi lisan sing kudu dilebokake ing banyu sadurunge administrasi. Suspensi oral ditujokake kanggo pasien sing ora bisa gampang ngulu tablet utawa sing mbutuhake administrasi enteral.
Sadurunge dispensing, tambahake 20 ml banyu ngombe utawa steril menyang botol sing ngemot granula marboxil baloxavir lan putar botol menyang mesthekake granules roto-roto dilereni soko tugas; aja goyangake botol. Saben botol nyedhiyakake suspensi lisan sing ngemot 40 mg / 20 mL (2 mg / mL) obat kasebut. Gumantung saka dosis sing dibutuhake, nyiyapake 1 utawa 2 botol suspensi oral.
Ora ngemot pengawet lan kudu diwenehake sajrone 10 jam sawise persiapan. Bisa nyimpen suspensi lisan ing suhu kamar (20-25 ° C) nganti 10 jam sawise persiapan; Buang yen ora digunakake sajrone 10 jam utawa yen disimpen ing suhu> 25 ° C. Tandhani tanggal lan wektu kadaluwarsa ing botol nalika nyiapake.
Sedhiyakake piranti ukur (contone, jarum suntik oral, gelas ukur) kanthi suspensi oral.
Administrasi enteral (( i.e., feeding tube): Tarik dosis suspensi oral menyang syringe enteral; siram tabung pakan karo 1 mL banyu sadurunge lan sawise administrasi enteral dosis.
Dosis
Pasien Anak
Perawatan Infeksi Virus Influenza A lan B Musiman Akut, Infeksi Virus Influenza A utawa B sing Ora Komplikasi OralRemaja ≥12 taun kanthi bobot <80 kg: Dosis tunggal 40-mg diwenehake sajrone 48 jam sawise muncule gejala.
Remaja ≥12 taun bobote ≥ 80 kg: Dosis tunggal 80 mg sing diwenehake sajrone 48 jam sawise muncule gejala.
Nyegah Infeksi Virus Influenza A lan B Musiman OralRemaja ≥12 taun kanthi bobot <80 kg: Dosis tunggal 40 mg diwenehake sajrone 48 jam sawise kontak karo individu sing kena influenza.
Remaja ≥12 taun bobote ≥80 kg: Tunggal Dosis 80-mg diwenehake sajrone 48 jam sawise kontak karo wong sing kena influenza.
Dewasa
Perawatan Infeksi Virus Influenza A lan B Musiman Infeksi Virus Influenza A lan B Akut, Ora Rumit Infeksi Virus A utawa B OralWong diwasa sing bobote 80 kg: Dosis tunggal 40-mg diwenehake sajrone 48 jam sawise wiwitan gejala.
Wong diwasa kanthi bobot ≥80 kg: Dosis 80-mg tunggal diwenehake sajrone 48 jam sawise wiwitan gejala.
Nyegah saka Infeksi Virus Influenza A lan B Musiman OralWong diwasa sing bobote <80 kg: Dosis tunggal 40 mg diwènèhaké ing 48 jam sawisé kontak karo wong sing kena influenza.
Wong diwasa kanthi bobot ≥80 kg: Tunggal 80- dosis mg diwenehake sajrone 48 jam sawise kontak karo individu sing kena influenza.
Populasi Khusus
Ora ana rekomendasi dosis populasi khusus sing diwenehake dening pabrikan kanggo individu geriatrik utawa pasien sing duwe fungsi ati utawa ginjel cacat. .
Pènget
Kontraindikasi
Pènget/PanandhapReaksi Sensitivitas
Reaksi alergi sing serius, kalebu reaksi anafilaksis, anafilaksis utawa anafilaktoid, angioedema (wajah, kelopak mata, ilat, lambe), urtikaria, lan eritema multiforme, dilapurake sajrone pengalaman pasca pemasaran. Ruam uga dilapurake.
Miwiti perawatan sing cocog yen ana reaksi kaya alergi utawa dicurigai.
Infeksi Bakteri
Nalika nggawe keputusan perawatan ing pasien sing dicurigai influenza, pikirake kemungkinan infeksi bakteri primer utawa bebarengan.
Infeksi bakteri sing serius bisa diwiwiti kanthi gejala kaya influenza utawa bisa uga. urip bebarengan karo utawa kedadeyan minangka komplikasi influenza. Ora ana bukti yen baloxavir nyegah komplikasi kasebut. Yen ana infèksi bakteri, nambani sing cocog.
Ora ana bukti yen baloxavir efektif kanggo penyakit sing disebabake dening organisme liyane kajaba virus influenza.
Individu sing Imunokompromi
Data ora kasedhiya babagan khasiat lan keamanan baloxavir marboxil kanggo perawatan influenza ing individu kanthi imunosupresi abot. Munculé resistensi kanggo baloxavir bisa uga dadi kuwatir amarga durasi replikasi virus influenza bisa uga saya suwe ing pasien kasebut.
CDC ora nyaranake monoterapi marboxil baloxavir kanggo perawatan influenza ing individu kanthi imunosupresi abot.
Vaksinasi Influenza
Antivirus influenza dudu pengganti vaksinasi taunan kanthi vaksin influenza musiman (vaksin virus influenza ora aktif, rekombinan vaksin influenza, vaksin influenza intranasal urip).
Sanajan antivirus influenza, kalebu baloxavir marboxil, bisa digunakake bebarengan karo utawa sawayah-wayah sadurunge utawa sawise vaksin virus influenza ora aktif utawa rekombinan vaksin influenza, antivirus kasebut bisa nyegah virus vaksin sing ana ing vaksin influenza intranasal urip lan nyuda. khasiat saka vaksin urip. (Deleng Obat Spesifik ing Interaksi.)
Populasi Tertentu
KandhutanOra ana studi sing nyukupi lan dikontrol kanthi apik nggunakake baloxavir marboxil ing wanita ngandhut kanggo ngandhani risiko sing ana hubungane karo obat kanggo asil pangembangan sing ora becik.
Ora ana efek embriofetal sing ala. diamati ing studi reproduksi ing tikus lan terwelu.
Wanita meteng tambah risiko ngalami komplikasi sing abot saka influenza, sing bisa nyebabake meteng lan/utawa asil janin kalebu pati ibu, lair mati, cacat lair, lair prematur. , bobot lair kurang, lan ukuran cilik kanggo umur gestational.
CDC nyatakake baloxavir marboxil ora dianjurake kanggo perawatan influenza ing wanita ngandhut amarga kurang data safety lan khasiat ing pasien kasebut. Oseltamivir minangka antivirus sing disenengi kanggo perawatan influenza sing dicurigai utawa dikonfirmasi lan nyegah influenza ing wanita sing ngandhut utawa ≤2 minggu postpartum.
LaktasiOra dingerteni manawa nyebar menyang susu manungsa, mengaruhi produksi susu, utawa duweni pengaruh marang bayi sing disusu. Disebarake menyang susu ing tikus.
Produsen negara nganggep keuntungan saka nyusoni lan pentinge baloxavir marboxil kanggo wanita; uga nimbang potensial efek saru ing anak sing disusui saka obat utawa kondisi ibu sing ndasari.
CDC nyatakake baloxavir marboxil ora dianjurake kanggo perawatan influenza ing wanita sing nyusoni amarga kurang data safety ing pasien kasebut.
Panggunaan PediatrikKeamanan lan khasiat ora ditetepake ing pasien pediatrik <12 taun.
Pengobatan influenza akut, tanpa komplikasi ing remaja ≥12 taun bobote ≥40 kg: Keamanan lan khasiat ditetepake ing phase 3, randomized, pindho wuta, sinau placebo-kontrol. Profil safety padha karo sing dilapurake ing wong diwasa.
Profilaksis postexposure influenza ing remaja ≥12 taun: Keamanan lan khasiat sing didhukung dening uji coba kontrol plasebo kanthi acak, buta kaping pindho, sing ditindakake ing Jepang sing kalebu 12 wong umur 12-17 taun sing nampa obat kasebut. Efek saleh padha karo sing dilapurake ing wong diwasa sing nampa obat kasebut.
Panggunaan GeriatrikKeamanan lan khasiat ing wong diwasa ≥65 taun kanggo perawatan influenza akut, tanpa komplikasi sing ditetepake lan didhukung kanthi acak, buta kaping pindho. , uji coba terkontrol sing nyakup 209 wong diwasa ing klompok umur iki kanthi risiko komplikasi sing gegandhengan karo influenza sing diobati nganggo obat kasebut. Profil safety ing wong diwasa ≥65 taun padha karo sing dilaporake ing populasi uji coba sakabèhé, kajaba mual (kacarita ing 6% wong diwasa ≥65 taun dibandhingake karo 1% saka 18-64 taun). .
Efek Umum sing Sabar
Efek GI (mual, diare), bronkitis, sinusitis, sirah.
Apa obatan liyane bakal mengaruhi Baloxavir
Metabolit aktif baloxavir marboxil, baloxavir, dimetabolisme utamane dening UGT1A3 lan, ing tingkat cilik, dening CYP3A4.
Baloxavir marboxil lan baloxavir ora nyandhet CYP1A2, 2B6, 2C8, 2C9, 2C9, utawa 2D6 lan ora nyebabake CYP1A2, 2B6, utawa 3A4 in vitro.
Baloxavir marboxil lan baloxavir ora nyandhet UGT1A1, 1A3, 1A4, 1A6, 1A9, 2B7, utawa 2B15 in vitro. Baloxavir ora nyandhet polypeptide transport anion organik (OATP) 1B1, OATP1B3, transporter kation organik (OCT) 1, OCT2, transporter anion organik (OAT) 1, OAT3, multidrug and toxin extrusion (MATE) 1, utawa MATE2K.
Baloxavir marboxil lan baloxavir minangka substrat P-glikoprotein (P-gp) in vitro.
Obat Spesifik
Obat
Interaksi
Komentar
Antacid, aluminium, kalsium, utawa magnesium
Bisa nyuda konsentrasi baloxavir lan nyuda khasiat
Aja nggunakake bebarengan karo baloxavir marboksil
Suplemen kalsium
Bisa nyuda konsentrasi baloxavir lan nyuda khasiat
Aja nggunakake bebarengan karo baloxavir marboxil
Digoxin
Ora ana efek ing farmakokinetik digoxin
Vaksin influenza
Vaksin virus influenza sing ora aktif (IIV) lan rekombinan vaksin influenza (RIV): Baloxavir ora samesthine bakal mengaruhi khasiat vaksin; ora ana studi khusus
Vaksin influenza intranasal urip (LAIV): Baloxavir bisa nyandhet virus vaksin lan nyuda khasiat vaksin urip; ora ana studi khusus; adhedhasar umur paruh sing dawa, ACIP nyatakake marboxil baloxavir bisa ngganggu LAIV yen diwenehi saka 17 dina sadurunge nganti 2 minggu sawise vaksin urip
IIV utawa RIV: Bisa ditrapake bebarengan karo utawa kapan wae sadurunge utawa sawise. baloxavir
LAIV: Yen baloxavir marboxil diwenehake saka 17 dina sadurunge nganti 2 minggu sawise LAIV, ACIP nyaranake vaksinasi maneh nggunakake IIV utawa RIV sing cocog karo umur
Persediaan wesi
Bisa ngurangi konsentrasi baloxavir lan ngurangi khasiat
Aja nggunakake bebarengan karo baloxavir marboxil
Itraconazole
Ora ana efek ing farmakokinetik baloxavir marboxil utawa baloxavir
Laksatif sing ngandhut kation polivalen
Bisa nyuda konsentrasi baloxavir lan nyuda khasiat
Aja nggunakake bebarengan karo baloxavir marboxil
Midazolam
Ora ana pengaruh ing farmakokinetik midazolam
Multivitamin
Muga nyuda konsentrasi baloxavir lan nyuda khasiat
Aja nggunakake bebarengan karo baloxavir marboxil
Oseltamivir
Ora ana efek ing farmakokinetik saka oseltamivir, baloxavir marboxil, utawa baloxavir
Probenecid
Ora ana pengaruh ing farmakokinetik baloxavir marboxil utawa baloxavir
Rosuvastatin
Ora ana efek ing farmakokinetik rosuvastatin
Disclaimer
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