Peginterferon Beta-1a (Systemic)
Jeneng merek: Plegridy
Kelas obat:
Agen Antineoplastik
Panganggone Peginterferon Beta-1a (Systemic)
Multiple Sclerosis (MS)
Manajemen wangun MS sing kambuh, kalebu sindrom terisolasi klinis, penyakit relapsing-remitting, lan penyakit progresif sekunder aktif, ing wong diwasa.
Peginterferon beta-1a minangka salah siji saka sawetara terapi modifikasi penyakit sing digunakake ing manajemen bentuk MS sing kambuh. Sanajan ora kuratif, terapi iki kabeh wis ditampilake kanggo ngowahi sawetara ukuran aktivitas penyakit, kalebu tingkat kambuh, lesi MRI anyar utawa nambah, lan kemajuan cacat.
Akademi Neurologi Amerika (AAN) nyaranake supaya terapi modifikasi penyakit ditawakake kanggo pasien kanthi bentuk MS sing kambuh 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 Peginterferon Beta-1a (Systemic)
Umum
Pantauan Pasien
Premedikasi lan Profilaksis
Pertimbangan Umum Liyane
Administrasi
Administrasi kanthi injeksi IM utawa sub-Q. Bioequivalence wis dituduhake ing antarane 2 rute administrasi.
Injeksi subkutan sing kasedhiya kanthi komersial diwenehake dening pabrikan minangka pena utawa jarum suntik sing wis diisi sadurunge nganggo jarum sing dipasang, lan injeksi IM sing kasedhiya kanthi komersial diwenehake minangka prefilled. jarum suntik nganggo jarum sing kapisah.
Sadurunge administrasi, ngidini pena injeksi lan jarum suntik sing wis diisi sadurunge tekan suhu kamar (udakara 30 menit); aja nggunakake sumber panas njaba (contone, banyu panas) kanggo anget solusi.
Ngalih antarane administrasi IM lan sub-Q ora dievaluasi; Nanging, pabrikan nyatakake yen rute administrasi diowahi (IM dadi sub-Q utawa kosok balene), ora samesthine yen titrasi dosis bola-bali perlu.
Plapen injeksi lan jarum suntik sing wis diisi kanggo panggunaan siji. mung; Mbuwang bagean sing ora digunakake.
Administrasi IM
Administrasi kanthi injeksi IM saben 14 dina menyang paha. Puterake injeksi ing antarane pupu kiwa lan tengen kanggo nyuda resiko reaksi ing situs injeksi.
Administrasi Sub-Q
Administrasi kanthi injeksi sub-Q saben 14 dina menyang weteng, mburi lengen ndhuwur , utawa pupu. Puterake situs injeksi kanggo nyuda resiko reaksi ing situs injeksi.
Dosis
Dewasa
Multiple Sclerosis Sub-QKanggo nyuda kedadeyan lan keruwetan gejala kaya flu , titrasi kanthi bertahap nganti dosis pangopènan sing disaranake 125 mcg saben 14 dina miturut jadwal ing Tabel 1.
Tabel 1. Peginterferon Beta-1a Jadwal Titrasi Dosis1Dina
Dosis
1 (dina pisanan terapi)
63 mcg
15 (14 dina sabanjure)
94 mcg
29 lan saben 14 dina sabanjure
125 mcg
Kanggo sub- Injeksi Q, Plegridy utawa Plegridy Pen Starter Pack, sing ngemot pena injeksi utawa jarum suntik sing wis diisi 63-mcg lan pena injeksi utawa jarum suntik sing wis diisi 94-mcg, dirancang kanggo digunakake sajrone titrasi dosis.
IMKanggo nyuda kedadeyan lan keruwetan gejala kaya flu, titrasi kanthi bertahap menyang dosis pangopènan sing disaranake 125 mcg saben 14 dina miturut jadwal ing Tabel 2.
Tabel 2. Peginterferon Beta-1a Jadwal Titrasi Dosis1Dina
Dosis
1 (dina pisanan terapi)
63 mcg
15 (14 dina sabanjure)
94 mcg
29 lan saben 14 dina sabanjure
125 mcg
Kanggo injeksi IM , Kit Titrasi Plegridy, sing ngemot 2 klip titrasi warna, dirancang kanggo digunakake karo jarum suntik sing wis diisi kanggo panggunaan IM sajrone titrasi dosis. Klip kuning digunakake kanggo dosis 1 kanggo nyedhiyakake 63 mcg obat lan klip ungu digunakake kanggo dosis 2 kanggo nyedhiyakake 94 mcg obat.
Populasi Khusus
Gagal Hepatik
Ora ana rekomendasi dosis khusus.
Gagal ginjal
Produsen ora menehi rekomendasi dosis tartamtu; asil panaliten farmakokinetik nyaranake pangaturan dosis ora dibutuhake.
Pasien Geriatri
Ora ana rekomendasi dosis khusus.
Populasi Khusus Liyane
Dosis pangaturan adhedhasar bobot awak, jender, utawa umur ora dibutuhake.
Pènget
Kontraindikasi
Pènget/PanandhapHepatotoksisitas
Kemungkinan peningkatan konsentrasi aminotransferase hepatik (ALT lan AST) lan ciloko ati.
Hepatitis, hepatitis otoimun, lan kasus gagal hepatik sing jarang dilapurake kanthi terapi interferon beta.
Ngawasi pasien kanggo manifestasi cedera hepatik; uga ngawasi tes fungsi ati. Coba mandhegake obat yen ana ciloko ati.
Depresi lan Bunuh Diri
Depresi, ide bunuh diri, lan upaya bunuh diri bisa uga. Yen depresi utawa gejala psikiatri serius liyane, coba mandhegake terapi.
Reaksi Situs Injeksi lan Nekrosis
Reaksi situs injeksi sing abot, kalebu nekrosis, abses ing situs injeksi lan selulitis, dilaporake. Rumah sakit kanggo drainase bedah lan antibiotik IV dibutuhake ing sawetara kasus.
Reaksi ing situs injeksi lokal (contone, eritema, nyeri, pruritus, edema) umume sawise administrasi sub-Q.
Evaluasi sacara periodik pangerten pasien lan nggunakake teknik aseptik lan prosedur sing tepat kanggo administrasi mandiri, utamane yen nekrosis situs injeksi wis kedadeyan.
Apa kanggo mungkasi terapi sawise siji situs nekrosis gumantung saka tingkat nekrosis. Yen terapi diterusake, aja injeksi ing cedhak situs sing kena pengaruh nganti lesi wis mari. Yen ana pirang-pirang lesi, ganti situs injeksi utawa mandhegake obat nganti pulih.
Efek Kardiovaskular
Kamungkinan gagal jantung kongestif lan kardiomiopati; ngawasi pasien sing nandhang penyakit jantung sing saya tambah parah sajrone wiwitan lan perawatan terus.
Efek Hematologis
Nurunake jumlah sel getih perifer ing kabeh garis sel, kalebu kasus pansitopenia sing jarang lan trombositopenia abot, dilapurake karo terapi interferon beta.
Pantau CBC, kalebu diferensial WBC lan jumlah trombosit, sajrone terapi. Kajaba iku, ngawasi pasien kanggo infeksi, pendarahan, lan gejala anemia. Pasien karo myelosuppression mbutuhake pemantauan sing luwih intensif.
Trombotic Microangiopathy
Thrombotic microangiopathy (TMA), kalebu thrombotic thrombocytopenic purpura lan hemolytic uremic syndrome, dilapurake karo terapi interferon beta lan wis fatal ing sawetara kasus.
Yen manifestasi klinis lan/utawa temuan laboratorium sing konsisten karo TMA kedadeyan, mungkasi terapi lan atur pasien kaya sing dituduhake sacara klinis.
Hipertensi Arteri Pulmonal
Hipertensi Arteri Pulmonal (PAH) dilapurake yen ora ana faktor kontributor liyane. Akeh kasus mbutuhake rumah sakit; siji pasien ngalami transplantasi paru-paru. PAH bisa kedadeyan ing wektu sing beda-beda kalebu pirang-pirang taun sawise wiwitan perawatan.
Assess onset dyspnea anyar utawa tambah lemes kanggo pangembangan potensial PAH. Yen panyebab alternatif ora ana lan diagnosis PAH dikOnfirmasi, mungkasi terapi lan atur miturut indikasi klinis.
Penyakit otoimun
Penyakit otoimun, kalebu idiopatik thrombocytopenic purpura (ITP), hipertiroidisme, hipotiroidisme, lan hepatitis otoimun, dilapurake kanthi terapi interferon beta.
Yen kelainan otoimun anyar berkembang , nimbang mungkasi terapi.
Kejang
Kejang kacarita; nggunakake kanthi ati-ati ing pasien karo kelainan kejang sing wis ana.
Imunogenisitas
Kamungkinan pangembangan antibodi netralake kanggo peginterferon beta-1a utawa PEG. Anane antibodi anti-PEG katon ora mengaruhi paparan sakabèhé utawa respon farmakodinamik kanggo obat sawise administrasi sub-Q.
Imunogenisitas peginterferon beta-1a sing diwenehake dening injeksi IM ora dievaluasi.
Reaksi Sensitivitas
HipersensitivitasAnafilaksis lan reaksi alergi serius liyane (contone, angioedema, urtikaria) kacarita arang banget.
Banjur terapi yen ana reaksi alergi sing serius.
Sensitivitas LateksTutup jarum suntik sing wis diisi kanggo injeksi IM ngandhut lateks karet alam. Keamanan nggunakake jarum suntik sing wis diisi kanggo injeksi IM ora dievaluasi ing individu sing sensitif marang lateks.
Populasi Spesifik
KandhutanData saka studi kohort sing akeh adhedhasar populasi uga studi liyane sing diterbitake sajrone pirang-pirang dekade ora nuduhake risiko cacat lair utama sing ana gandhengane karo obat kanthi nggunakake interferon beta. sak meteng. Panemuan babagan risiko potensial kanggo bobote lair kurang utawa keguguran kanthi nggunakake interferon beta nalika meteng ora konsisten.
Studi reproduksi kewan sing durung ditindakake nganti saiki karo peginterferon beta-1a; Nanging, studi nggunakake beta interferon nonconjugated ing kethek ngandhut nuduhake sawetara aktivitas abortif, nanging ora ana bukti efek salabetipun ing perkembangan embriofetal.
LaktasiInformasi winates sing diterbitake nuduhake yen interferon beta-1a disebarake menyang susu manungsa kanthi konsentrasi sing sithik. Ora dikawruhi apa peginterferon beta-1a mengaruhi produksi susu.
Pirsani keuntungan pangembangan lan kesehatan saka nyusoni bebarengan karo kabutuhan klinis ibu kanggo peginterferon beta-1a lan potensial efek samping ing bayi sing disusui. saka obat utawa kondisi ibu sing ndasari.
Panggunaan PediatrikKeamanan lan khasiat ora ditetepake ing pasien pediatrik.
Panggunaan GeriatrikData sing ora cukup kanggo nemtokake manawa pasien geriatrik ≥65 taun nanggapi kanthi beda. peginterferon beta-1a tinimbang wong diwasa sing luwih enom.
Gagal GinjalAmarga kemungkinan tambah pajanan obat, ngawasi pasien sing nandhang gagal ginjel abot kanggo efek samping.
Paparan sistemik ora kena pengaruh ing pasien kanthi endoskopi. - tahap penyakit ginjel sing ngalami hemodialisis.
Efek Sabar sing Umum
Eritema ing situs injeksi, gejala kaya flu, pyrexia, sirah, myalgia, menggigil, nyeri ing situs injeksi, asthenia, pruritus ing situs injeksi, artralgia.
Apa obatan liyane bakal mengaruhi Peginterferon Beta-1a (Systemic)
Ora ana studi interaksi obat resmi nganti saiki.
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