Interferon Beta
Kelas obat: Agen Antineoplastik
Panganggone Interferon Beta
Multiple Sclerosis (MS)
Manajemen bentuk MS sing kambuh, kalebu sindrom terisolasi klinis (CIS), penyakit relapsing-remitting, lan penyakit progresif sekunder aktif, ing wong diwasa.
Akademi Neurologi Amerika (AAN) nyaranake supaya terapi modifikasi penyakit ditawakake kanggo pasien MS sing relapsing-remitting sing wis kambuh lan / utawa aktivitas MRI. Klinisi kudu nimbang efek salabetipun, toleransi, cara administrasi, safety, khasiat, lan biaya obat saliyane pilihan pasien nalika milih terapi sing cocog.
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Carane nggunakake Interferon Beta
Umum
Pantauan Pasien
Premedikasi lan Profilaksis
Dispensing and Administration Precaution
Pertimbangan Umum Liyane
Administrasi
Administrasi dening IM utawa sub-Q injeksi gumantung saka persiapan.
Interferon beta-1a kasedhiya kanthi komersial minangka injeksi IM sapisan minggu (Avonex) utawa injeksi sub-Q 3 kali seminggu (Rebif). Interferon beta-1b kasedhiya kanthi komersial minangka injeksi sub-Q alternatif dina (Betaseron, Extavia); 2 preparat interferon beta-1b sing saiki kasedhiya identik kajaba sawetara komponen kemasan (contone, ukuran jarum).
Administrasi Sub-Q sing digandhengake karo tingkat reaksi ing situs injeksi sing luwih dhuwur tinimbang administrasi IM. Jarum suntik sing wis diisi lan injektor otomatis mung kanggo panggunaan siji; aja nganggo maneh.
Administrasi IM
Interferon Beta-1a (Avonex)Administrasi Avonex sapisan saben minggu kanthi injeksi IM menyang paha utawa lengen ndhuwur. Atur Avonex Pen sapisan saben minggu menyang paha ndhuwur njaba. Puter situs injeksi lan aja nyuntikake menyang situs sing katon iritasi, abang, bruised, infèksi, utawa tatu. Priksa situs injeksi apa wae abang, bengkak, utawa nyeri 2 jam sawise administrasi.
Disedhiyakake sacara komersial minangka jarum suntik sing wis diisi utawa injektor otomatis sing wis diisi sadurunge (yaiku, Pen Avonex).
Jarum suntik sing wis diisi sadurunge. dikemas nganggo jarum 23-gauge, 1¼-inch sing diwenehake dening pabrikan; jarum 25-gauge, 1-inch kanggo injeksi IM bisa diganti dening dokter yen cocok. Injektor otomatis sing wis diisi kudu digunakake karo jarum 25-gauge, (5/8)-inch sing diwenehake; aja diganti karo jarum liyane.
Copot jarum suntik sing wis diisi lan injektor otomatis saka kulkas udakara 30 menit sadurunge digunakake kanggo ngidini solusi tekan suhu kamar; aja nggunakake sumber panas njaba (umpamane, banyu panas) kanggo anget solusi.
Administrasi Sub-Q
Interferon Beta-1a (Rebif)Administrasi kaping 3 saben minggu kanthi injeksi sub-Q menyang weteng (nyingkiri garis pinggang utawa wilayah ing 2 inci saka pusar), pupu, lengen ndhuwur, utawa bokong. Atur ing 3 dina sing padha (contone, Senin, Rebo, lan Jumuah) paling sethithik 48 jam saben minggu lan ing wektu sing padha (luwih becik ing wayah sore utawa sore) saben dina.
Puter situs injeksi lan aja nyuntikake menyang situs sing katon iritasi, abang, bruised, infèksi, utawa ora normal ing sembarang cara.
Busak obat saka kulkas 30 menit sadurunge digunakake.
Kasedhiya sacara komersial minangka jarum suntik sing wis diisi utawa injektor otomatis sing wis diisi sadurunge (yaiku, Rebidose).
Interferon Beta-1b (Betaseron, Extavia)Administrasi kanthi injeksi sub-Q saben dina menyang weteng (kajaba wilayah sing cedhak karo pinggul lan pusar), pupu, lengen ndhuwur, utawa bokong.
Puter situs injeksi lan aja nyuntikake menyang situs sing katon abang, bruised, infèksi, utawa ora normal kanthi cara apa wae.
Kasedhiya minangka bubuk lyophilized sing kudu reconstituted sadurunge digunakake. Injektor otomatis opsional (Betaconnect) kasedhiya kanthi komersial lan bisa dipikolehi liwat program dhukungan pasien pabrikan kanthi nelpon 1-800-788-1467.
Reconstitution of Betaseron and Extavia Lyophilized PowderReconstitute vial containing 0.3 mg bubuk lyophilized interferon-beta-1b (Betaseron, Extavia) kanthi nempelake jarum suntik sing wis disedhiyakake pabrikan sing ngemot 1,2 mL natrium klorida 0,54% menyang vial; alon-alon nyuntikake kabeh isi jarum suntik kanggo nyedhiyakake solusi sing ngemot 0,25 mg interferon beta-1b saben 1 ml.
Alon-alon swirl vial kanggo mesthekake pembubaran lengkap; ora goyang.
Solusi sing dikonstitusi ora ngandhut pengawet; solusi luwih kudu disiapake langsung sadurunge digunakake. Vials mung kanggo nggunakake siji; mbuang solusi sing isih ana.
Dosis
Kasedhiya minangka interferon beta-1a utawa interferon beta-1b; dosis ditulis ing syarat-syarat mg.
Potensi interferon beta uga wis dituduhake ing unit internasional. Saben mg interferon beta-1a padha karo kira-kira 200 yuta unit (kanggo Avonex) lan 270 yuta unit (kanggo Rebif); saben mg interferon beta-1b padha karo kira-kira 32 yuta unit (kanggo Betaseron lan Extavia).
Dewasa
Multiple Sclerosis Interferon beta-1a (Avonex) IM30 mcg sapisan saben minggu. Kanggo nyuda kedadeyan lan keruwetan gejala kaya flu, miwiti kanthi dosis kurang 7,5 mcg sapisan saben minggu, banjur tambah 7,5 mcg saben minggu kanggo 3 minggu sabanjure nganti dosis sing disaranake.
Interferon beta-1a (Rebif) ) Sub-QTitrasi dosis kanthi bertahap sajrone periode 4 minggu dadi 22 utawa 44 mcg 3 kali saben minggu nggunakake jadwal ing Tabel 1. Nalika titrasi menyang dosis 22-mcg, gunakake mung jarum suntik sing wis diisi (ora injeksi otomatis). ).
Tabel 1. Jadwal Titrasi Dosis Rebif20Minggu
Rebif 22 mcg Dosis Target
Rebif 44 mcg Dosis Target
Minggu 1–2
4,4 mcg (nggunakake ½ saka jarum suntik 8,8 mcg)
8,8 mcg (nggunakake jarum suntik 8,8 mcg utawa injektor otomatis)
Minggu 3-4
11 mcg (nggunakake ½ saka jarum suntik 22-mcg)
22 mcg (nggunakake jarum suntik 22-mcg utawa injektor otomatis)
Minggu 5+
22 mcg (nggunakake jarum suntik 22-mcg utawa injektor otomatis)
44 mcg (nggunakake jarum suntik 44-mcg utawa injektor otomatis)
Interferon beta-1b (Betaseron, Extavia ) Sub-QTitrasi dosis kanthi bertahap sajrone periode 6 minggu nganti 0,25 mg saben dina nggunakake jadwal ing Tabel 2.
Tabel 2. Jadwal Titrasi Dosis Betaseron lan Extavia16170Persentase Dosis Target
Dosis Betaseron lan Extavia
Volume
Minggu 1–2
25%
0,0625 mg
0,25 ml
Minggu 3-4
50%
0,125 mg
0,5 mL
Minggu 5-6
75%
0,1875 mg
0,75 mL
Minggu 7+
100%
0,25 mg
1 mL
Yen dosis ora kejawab, gunakake sanalika bisa; dosis sing dijadwalake sabanjure kira-kira 48 jam mengko. Aja ngurus 2 dina berturut-turut.
Populasi Khusus
Gangguan Hepatik
Produsen Rebif nyatakake kanggo nimbang pengurangan dosis ing pasien sing konsentrasi ALT serum mundhak > 5 kaping ULN. Bisa mboko sithik maneh dosis nalika konsentrasi ALT serum wis bali menyang normal.
Genal Gagal
Ora ana rekomendasi dosis tartamtu.
Pasien Geriatrik
Ora ana pangaturan dosis khusus sing dibutuhake; Nanging, pilih dosis kanthi ati-ati, biasane miwiti terapi ing pungkasan dosis sing paling sithik amarga bisa nyuda fungsi ati, ginjel, lan/utawa sing ana hubungane karo umur lan penyakit bebarengan lan terapi obat.
Pènget
Contraindications
Pènget/PanandhapHepatotoksisitas
Cedera hepatik serius kalebu hepatitis otoimun lan bisa uga gagal hepatik fulminan sing abot sing mbutuhake transplantasi ati.
Gunakake kanthi ati-ati ing pasien kanthi penyakit ati sing aktif, penyalahgunaan alkohol, konsentrasi ALT serum tambah (>2,5 kaping ULN), utawa riwayat penyakit ati sing penting sacara klinis. Coba risiko potensial nalika interferon beta digunakake bebarengan karo obat liyane sing ana gandhengane karo ciloko ati (kalebu alkohol) utawa nalika obat liyane ditambahake menyang regimen perawatan beta interferon sing wis ana.
Monitor kanggo manifestasi cedera hepatik. Nindakake tes fungsi ati kanthi interval reguler (contone, 1, 3, lan 6 sasi) sawise wiwitan terapi lan banjur sacara periodik sawise ora ana gejala klinis.
Sawetara pabrikan nyaranake mungkasi terapi yen ana peningkatan substansial ing konsentrasi aminotransferase serum utawa manifestasi klinis disfungsi ati (contone, jaundice).
Peningkatan asimtomatik ing konsentrasi aminotransferase serum (utamane ALT) dilapurake kanthi umum karo terapi interferon beta.
Sensitivitas Lateks
Sawetara komponen kemasan saka formulasi tartamtu (contone, tutup pena jarum suntik sing wis diisi Avonex, tutup jarum suntik diluent sing wis diisi Extavia) ngemot lateks karet alam; individu sing sensitif lateks ngirim ora nangani komponen packaging iki. Safety of Extavia digawe maneh nggunakake jarum suntik pengencer sing wis diisi sadurunge ing individu sing sensitif lateks sing ora dievaluasi.
Reaksi Hipersensitivitas
Kamungkinan reaksi anafilaksis utawa anafilaktoid.
Yen reaksi hipersensitivitas sing akut lan serius, mandheg langsung lan miwiti terapi sing cocog.
Depresi lan Bunuh Diri
Kemungkinan depresi, ide bunuh diri, lan bunuh diri.
Sawetara pabrikan nyatakake yen nggunakake kanthi ati-ati ing pasien depresi utawa gangguan swasana ati liyane. Ngawasi pasien kanthi rapet kanggo bukti depresi utawa gejala kejiwaan liyane; nimbang mandheg terapi yen ana gejala kasebut.
Amarga prevalensi gangguan swasana ati sing dhuwur ing pasien MS, riwayat depresi dudu kontraindikasi mutlak kanggo nggunakake interferon beta. Bisa uga angel misahake gejala neuropsikiatri sing ana gandhengane karo terapi beta interferon saka sing ana gandhengane karo MS.
Gagal Jantung Kongestif
Gagal jantung kongestif (CHF), kardiomiopati (kanthi utawa tanpa CHF), palpitasi, lan tachycardia, dilapurake karo sawetara persiapan beta interferon sajrone pengawasan pasca pemasaran. Ing sawetara kasus, acara kasebut ana hubungane karo administrasi interferon beta-1b; Kambuh nalika rechallenge diamati ing sawetara pasien.
Pantau pasien sing duwe CHF sing wis ana sadurunge kanggo elek klinis sajrone terapi. Sawetara pabrikan nyatakake yen ora diterusake terapi yen CHF sing saya tambah ora ana etiologi liyane.
Nekrosis
Nekrosis situs injeksi sing abot dilapurake sawise administrasi sub-Q lan IM, kadhangkala mbutuhake debridement kulit utawa grafting kulit. Biasane kedadeyan ing 3-4 wulan pisanan terapi.
Faktor-faktor sing bisa digandhengake karo pangembangan nekrosis kulit kalebu teknik injeksi nonsteril, administrasi solusi beta interferon kadhemen, ora bisa muter situs injeksi, lan paparan situs injeksi anyar menyang sinar UV.
Reaksi ing situs injeksi
Reaksi situs injeksi sing entheng nganti moderat (contone, pendarahan, hipersensitivitas, inflamasi, massa, nyeri, edema, atrofi, abang, indurasi) dilaporake ing sawetara pasien sawise sub-Q utawa administrasi IM.
Abses situs injeksi utawa selulitis, bisa uga mbutuhake intervensi bedhah, arang dilapurake sajrone pengawasan pasca pemasaran. Reaksi lokal sawise injeksi IM utawa sub-Q umume luwih abot kanthi dosis interferon beta sing luwih kerep lan luwih dhuwur.
Efek Hematologis
Turunan jumlah sel getih perifer ing kabeh garis sel, kalebu pansitopenia langka, leukopenia, trombositopenia, dilaporake.
Ngawasi pasien kanggo tandha lan gejala nyuda jumlah getih. Nindakake CBC, jumlah trombosit, lan tes kimia getih sing cocok sadurunge miwiti terapi lan sacara periodik sakwise. Pasien karo myelosuppression mbutuhake pemantauan sing luwih intensif.
Trombotic Microangiopathy
Thrombotic microangiopathy (TMA), kalebu kadhangkala fatal thrombotic thrombocytopenic purpura lan hemolytic uremic syndrome, kacarita. Onset wiwit sawetara minggu nganti pirang-pirang taun sawise obat kasebut diwiwiti. Yen TMA kedadeyan, mandhegake perawatan lan atur miturut indikasi klinis.
Sindrom kaya flu
Sindrom kaya flu biasane kedadeyan. Senajan ana variasi interindividual sing cukup akeh, gejala kasebut paling kerep kedadeyan sajrone wiwitan terapi (contone, sajrone jam utawa dina sawise injeksi) lan biasane mudhun sajrone sawetara sasi.
Pertimbangake premedikasi kanthi agen analgesik lan/utawa antipiretik.
Kejang
Kamungkinan kejang, kalebu ing pasien sing ora ana riwayat kejang; ora dikawruhi manawa ana hubungane karo kelainan kejang sing wis ana, efek MS wae, panggunaan beta interferon, utawa faktor risiko potensial liyane (contone, demam). Gunakake kanthi ati-ati ing pasien sing duwe kelainan kejang sing wis ana.
Yen pasien sing ora duwe riwayat kejang ngalami kejang sajrone terapi, gawe basis etiologis lan gawe terapi antikonvulsan sing cocog sadurunge nimbang terapi maneh.
Lupus Erythematosus sing Disebabake Narkoba
Gangguan otoimun saka pirang-pirang organ target, kalebu trombositopenia idiopatik, hipertiroidisme, hipotiroidisme, lan hepatitis otoimun, dilapurake.
Mungkasi terapi beta interferon yen ana kelainan otoimun anyar, utawa yen pasien ngalami manifestasi lupus (contone, ruam, serositis, polyarthritis, nefritis, fenomena Raynaud).
Hipertensi Arteri Pulmonal
Hipertensi arteri paru (PAH) dilapurake sanajan ora ana faktor kontributor liyane. Akeh kasus mbutuhake rumah sakit; siji pasien ngalami transplantasi paru-paru. Bisa kedadeyan ing wektu sing beda-beda sajrone terapi kalebu sawetara taun sawise wiwitan perawatan.
Assess pasien sing ngalami dyspnea onset anyar utawa tambah lemes kanggo PAH. Yen panyebab alternatif wis diilangi lan diagnosis PAH dikonfirmasi, mandhegake terapi beta interferon lan atur kaya sing dituduhake sacara klinis.
Imunogenisitas
Potensi imunogenisitas. Kemungkinan pangembangan antibodi naleni utawa netralake menyang interferon beta sawise terapi jangka panjang.
Anané antibodi netralisasi, utamané ing titer sing terus-terusan dhuwur, digandhengake karo nyuda khasiat radiografi lan klinis saka terapi interferon beta. Antibodi sing netralake umume berkembang 6-24 sasi sawise miwiti terapi.
Risiko pangembangan antibodi bisa beda-beda adhedhasar persiapan, frekuensi dosis, dosis total, lan rute administrasi.
Populasi Tertentu
KandhutanOra ana studi sing dikontrol kanthi apik ing wanita ngandhut; Nanging, data sing kasedhiya umume ora ngenali risiko cacat lair utama sing ana gandhengane karo obat. Temuan babagan risiko potensial kanggo bobot lair kurang utawa keguguran kanthi nggunakake beta interferon nalika meteng ora konsisten. Ing studi kewan, administrasi nalika meteng nyebabake tambah tingkat aborsi ing dosis sing luwih gedhe tinimbang sing digunakake sacara klinis; Nanging, ora jelas apa, minangka kelas produk, administrasi kanggo kewan ngandhut ing dosis luwih gedhe tinimbang sing digunakake sacara klinis nyebabake tingkat aborsi tambah. Gunakake nalika meteng mung yen keuntungan potensial mbenerake risiko sing bisa ditindakake kanggo janin.
LaktasiData winates nuduhake yen interferon beta-1a nyebar menyang susu manungsa. Ora ana data babagan anané interferon beta-1b ing susu manungsa. Ora dingerteni manawa interferon beta duweni efek ing bayi sing disusui utawa produksi susu.
Pirsani keuntungan pangembangan lan kesehatan saka nyusoni bebarengan karo kabutuhan klinis ibu kanggo interferon beta lan efek samping sing potensial kanggo bocah sing disusui saka obat utawa kondisi ibu sing ndasari.
Wanita lan Lanang Potensi ReproduksiStudi ora ditindakake kanggo nemtokake manawa interferon beta mengaruhi kesuburan ing manungsa. Penyimpangan menstruasi, anovulasi, lan penurunan konsentrasi progesteron serum sing diamati ing sawetara studi kewan kanthi dosis sing luwih dhuwur tinimbang sing disaranake kanggo manungsa.
Panggunaan PediatrikSanajan safety lan khasiat interferon beta ing bocah-bocah <18 taun durung ditemtokake. ditetepake, tamba wis digunakake karo asil variabel kanggo ngatur MS serangn kanak-kanak.
Panggunaan GeriatrikPengalaman sing ora cukup ing pasien ≥65 taun kanggo nemtokake manawa pasien geriatrik nanggapi beda karo wong diwasa sing luwih enom; pilih dosis kanthi ati-ati.
Gangguan HepatikKeamanan lan khasiat ora dievaluasi ing gangguan hepatik. Mungkasi yen tingkat ALT serum mundhak sacara signifikan.
Gagal GinjalKeamanan lan khasiat ora dievaluasi ing gangguan ginjel.
Efek Samsaya Awon
Interferon beta-1a (Avonex): Reaksi salabetipun sing paling umum (≥5%) ing studi klinis yaiku gejala kaya flu kayata menggigil, mriyang, myalgia, lan asthenia. .
Interferon beta-1a (Rebif): Reaksi salabetipun sing paling umum ing uji klinis sing dikontrol yaiku kelainan situs injeksi, gejala kaya influenza, nyeri weteng, depresi, paningkatan enzim ati, lan kelainan hematologi.
Interferon beta-1b (Betaseron): Reaksi salabetipun sing paling umum (≥5%) ing studi klinis yaiku reaksi ing situs injeksi, limfopenia, gejala kaya flu, myalgia, leukopenia, neutropenia, tambah enzim ati, sirah. , hipertonia, nyeri, ruam, insomnia, nyeri abdomen, lan asthenia.
Interferon beta-1b (Extavia): Reaksi saru sing paling umum (≥5%) ing studi klinis yaiku reaksi ing situs injeksi, limfopenia, gejala kaya flu, myalgia, leukopenia, neutropenia, tambah enzim ati, sirah, hipertonia, nyeri, ruam, insomnia, nyeri weteng, lan asthenia.
Apa obatan liyane bakal mengaruhi Interferon Beta
Ora ana studi interaksi obat resmi nganti saiki.
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