Benralizumab (Systemic)
Jeneng merek: Fasenra
Kelas obat:
Agen Antineoplastik
Panganggone Benralizumab (Systemic)
Asma
Terapi pangopènan tambahan ing pasien ≥12 taun kanthi asma eosinofilik abot.
Nyuda tingkat eksaserbasi asma, nyuda syarat dosis kortikosteroid oral, lan nambah FEV1 saka awal.
Ora dituduhake kanggo perawatan kondisi eosinofilik liyane.
Ora dituduhake kanggo ngilangi bronkospasme akut utawa status asma.
Sawetara pedoman praktik klinis babagan manajemen asma kasedhiya , kalebu pedoman Global Initiative for Asma (GINA). Ing GINA, pendekatan bertahap kanggo perawatan dianjurake ing ngendi obat-obatan tartamtu ditambahake utawa disetel munggah utawa mudhun liwat seri langkah (1 nganti 5) kanggo entuk kontrol gejala nalika njaga pasien ing perawatan sing paling efektif.
Agen biologis kayata Benralizumab umume dianjurake minangka terapi tambahan kanggo asma sing abot.
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Carane nggunakake Benralizumab (Systemic)
Umum
Skrining Pretreatment
Monitoring Pasien
Pertimbangan Umum Liyane
Administrasi
Administrasi Sub-Q
Atur kanthi injeksi sub-Q menyang lengen ndhuwur, pupu, utawa weteng.
Kasedhiya sacara komersial ing jarum suntik sing wis diisi lan injektor otomatis. Jarum suntik sing wis diisi kanggo administrasi dening dokter. Pena autoinjector bisa diwenehake dening pasien utawa pengasuh sawise latihan sing tepat lan panyedhiya kesehatan nemtokake manawa cocok.
Copot jarum suntik utawa autoinjector saka kulkas lan ngidini kanggo njagong ing suhu kamar watara 30 menit sadurunge injeksi; nggunakake ing 24 jam utawa discard.
Ora ana pengawet; mung kanggo panggunaan siji.
Nyuntikake kabeh isi jarum suntik sing wis diisi (1 mL nyedhiyakake 30 mg).
Dosis
Pasien Anak
Asma Sub -QRemaja ≥12 taun: Kaping pisanan, 30 mg saben 4 minggu kanggo 3 dosis banjur 30 mg saben 8 minggu.
Dewasa
Asma Sub-QKaping pisanan , 30 mg saben 4 minggu kanggo 3 dosis banjur 30 mg saben 8 minggu.
Watesan Resep
Populasi Khusus
Pasien Geriatrik
Produsen ora menehi rekomendasi dosis khusus kanggo pasien geriatrik.
Gangguan Hepatik
Produsen ora menehi rekomendasi dosis khusus kanggo pasien sing duwe gangguan hepatik.
Gagal ginjal.
Produsen ora menehi rekomendasi dosis khusus kanggo pasien sing duwe gangguan ginjel.
Pènget
Kontraindikasi
Pènget/PanandhapReaksi Sensitivitas
Hipersensitivitas
Reaksi hipersensitivitas (contone, anafilaksis, angioedema, urtikaria, ruam) dilaporake, umume kedadeyan sajrone sawetara jam utawa bisa uga sawetara dina sawise administrasi. Yen ana reaksi hipersensitivitas, mungkasi benralizumab.
Pemburukan Penyakit lan Episode Akut
Ora dituduhake kanggo perawatan gejala asma akut utawa eksaserbasi, bronkospasme akut, utawa status asma.
Panyurangan Dosis Kortikosteroid
Aja nyetop terapi kortikosteroid sistemik utawa inhalasi nalika miwiti terapi benralizumab. Yen perlu, ngurangi dosis kortikosteroid kanthi bertahap lan ngawasi pengurangan kasebut kanthi teliti.
Infeksi Parasit
Tanggepan kekebalan marang sawetara infèksi parasit (helminth) bisa uga diowahi. Ora diteliti ing pasien sing duwe infeksi parasit sing dikenal. Nambani pasien kanthi infeksi parasit (helminth) sing wis ana sadurunge miwiti benralizumab. Yen infèksi parasit dumadi lan ora nanggapi perawatan anthelmintik, interupsi terapi benralizumab nganti infeksi rampung.
Imunogenisitas
Potensi imunogenisitas. Pangembangan antibodi anti-benralizumab sing dideteksi ing 13% pasien lan digandhengake karo tambah reresik obat lan tambah konsentrasi eosinofil getih; pangembangan antibodi netralisasi uga dideteksi. Bukti asosiasi antarane antibodi anti-benralizumab lan khasiat utawa safety obat sing ora diamati.
Populasi Tertentu
KandhutanOra ana bukti cilaka janin ing kethek sawise IV benralizumab nalika meteng. Efek potensial saka antibodi monoklonal (contone, benralizumab) ing janin luwih cenderung kedadeyan ing trimester katelu.
Informasi registri kasedhiya kanthi nelpon 1-877-311-8972 utawa ngunjungi [Web].
LaktasiOra dingerteni manawa disebarake menyang susu manungsa. Wiwit IgG nyebar menyang susu ing manungsa, benralizumab samesthine bakal disebarake menyang susu manungsa.
Coba manfaatake nyusoni lan pentinge obat kanggo wanita; uga nimbang potensial efek salabetipun ing anak sing disusui saka tamba utawa kondisi ibu sing ndasari.
Panggunaan PediatrikKeamanan lan khasiat ora ditetepake ing bocah-bocah <12 taun.
Dievaluasi ing 62 pasien remaja 12-17 taun kanthi asma; profil efek salabetipun umume padha karo sing diamati ing wong diwasa.
Panggunaan GeriatrikOra ana beda sakabèhé ing safety lan khasiat ing patients ≥65 taun relatif kanggo wong diwasa enom, nanging tambah sensitivitas ora bisa ditolak lewat.
Gagal HepatikFarmacokinetik ora diteliti ing pasien sing duwe gangguan hepatik.
Gagal GinjalFarmacokinetik ora diteliti ing pasien sing duwe gangguan ginjel.
Efek Sabar sing Umum
Efek Sampah sing umum (≥5%): nyeri sirah, faringitis.
Apa obatan liyane bakal mengaruhi Benralizumab (Systemic)
Ora ana studi interaksi obat resmi nganti saiki.
Obat sing dimetabolisme dening Enzim Mikrosomal Hepatik
Substrat CYP: Interaksi farmakokinetik ora mungkin.
Obat sing Dipengaruhi dening Efflux Transport Sistem
Substrat sistem transportasi efluks: Interaksi farmakokinetik ora mungkin.
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