Faricimab
Jeneng merek: Vabysmo
Kelas obat:
Agen Antineoplastik
Panganggone Faricimab
Faricimab-svoa nduweni kegunaan ing ngisor iki:
Faricimab-svoa minangka faktor pertumbuhan endothelial vaskular (VEGF) lan inhibitor angiopoietin-2 (Ang-2) sing dituduhake kanggo perawatan pasien neovaskular (wetan). ) age-related macular degeneration (nAMD) utawa diabetic macular edema (DME).
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Carane nggunakake Faricimab
Umum
Faricimab-svoa kasedhiya ing wangun dosis lan kekuatan:
Injeksi kanggo panggunaan intravitreal: 120 mg/mL solusi ing vial dosis siji.
Dosis
Penting panyedhiya label pabrikan kudu dikonsultasi kanggo informasi sing luwih rinci babagan dosis lan administrasi obat iki. Ringkesan dosis:
Dewasa
Dosis lan AdministrasiKanggo injeksi intravitreal. Faricimab kudu ditindakake dening dokter sing mumpuni. Saben vial kudu digunakake mung kanggo perawatan mripat siji.
Dosis sing disaranake kanggo faricimab-svoa yaiku 6 mg (0,05 mL saka 120 mg/mL solusi) sing diwenehake kanthi injeksi intravitreal saben 4 minggu (kira-kira saben 28 ± 7 dina, saben wulan) kanggo 4 dosis pisanan, banjur koherensi optik. tomografi lan evaluasi ketajaman visual 8 lan 12 minggu sabanjure kanggo menehi informasi manawa menehi dosis 6 mg liwat injeksi intravitreal ing salah siji saka telung regimen ing ngisor iki: 1) Minggu 28 lan 44; 2) Minggu 24, 36 lan 48; utawa 3) Minggu 20, 28, 36 lan 44. Senajan khasiat tambahan ora dituduhake ing umume pasien nalika faricimab-svoa disedhiyakake saben 4 minggu dibandhingake saben 8 minggu, sawetara pasien mbutuhake saben 4 minggu (saben wulan) dosis sawise pisanan. 4 dosis. Pasien kudu ditaksir sacara reguler.
Faricimab-svoa disaranake kanggo dosis kanthi nderek siji saka rong regimen dosis iki: 1) 6 mg (0,05 mL saka 120 mg / mL solusi) diterbitake dening injeksi intravitreal saben 4 minggu (kira-kira saben 28 dina ± 7 dina, saben wulan) kanggo paling 4 dosis. Yen sawise paling sethithik 4 dosis, resolusi edema adhedhasar ketebalan subfield tengah (CST) makula sing diukur kanthi tomografi koherensi optik wis diraih, banjur interval dosis bisa diowahi kanthi ekstensi nganti 4 minggu interval tambahan utawa pengurangan. nganti 8 minggu tambahan interval adhedhasar CST lan evaluasi ketajaman visual liwat minggu 52; utawa 2) 6 mg dosis faricimab-svoa bisa diterbitake saben 4 minggu kanggo 6 dosis pisanan, ngiring dening 6 mg dosis liwat injeksi intravitreal ing interval saben 8 minggu (2 sasi) liwat 28 minggu sabanjuré. Sanajan khasiat tambahan ora dituduhake ing umume pasien nalika faricimab-svoa dosis saben 4 minggu dibandhingake saben 8 minggu, sawetara pasien mbutuhake dosis saben 4 minggu (saben wulan) sawise 4 dosis pisanan. Pasien kudu ditaksir kanthi rutin.
Pènget
Kontraindikasi
Pènget/PanandhapEndophthalmitis lan Detasemen Retina
Injeksi intravitreal wis digandhengake karo endophthalmitis lan detasemen retina. Teknik injeksi aseptik sing tepat kudu tansah digunakake nalika ngatur faricab-svoa. Pasien kudu didhawuhi nglaporake gejala apa wae sing nuduhake endophthalmitis utawa ablasio retina tanpa wektu tundha, supaya bisa ditindakake kanthi cepet lan tepat.
Peningkatan Tekanan Intraokular
Peningkatan transien tekanan intraokular (IOP) wis katon ing 60 menit injeksi intravitreal, kalebu karo IOP faricimab-svoa lan perfusi saka sirah saraf optik kudu dipantau lan diatur kanthi bener.
Kedadeyan Thromboembolic
Sanajan ana tingkat cilik saka acara thromboembolic arteri (ATE) diamati ing uji klinis faricimab-svoa, ana risiko potensial ATE sawise nggunakake intravitreal inhibitor VEGF. ATE ditetepake minangka stroke nonfatal, infark miokard nonfatal, utawa pati vaskular (kalebu kematian sing ora dingerteni sababe). ) ing pasien sing diobati karo faricimab-svoa dibandhingake karo 1% (6 saka 662) ing pasien sing diobati karo aflibercept. saka 1,262) ing pasien sing diobati karo faricimab-svoa dibandhingake karo 2% (14 saka 625) ing pasien sing diobati karo aflibercept.
Populasi Tertentu
KandhutanOra ana studi sing nyukupi lan dikontrol kanthi apik babagan administrasi faricimab-svoa ing wanita ngandhut.
Administrasi faricimab-svoa kanggo kethek sing ngandhut sajrone periode organogenesis nyebabake peningkatan insiden aborsi ing dosis intravena (IV) 158 kaping paparan manungsa (adhedhasar konsentrasi plasma puncak) saka dosis maksimal sing disaranake manungsa. Adhedhasar mekanisme tumindak inhibitor VEGF lan Ang-2, ana risiko potensial kanggo kapasitas reproduksi wanita, lan pangembangan embrio-janin. Faricimab-svoa ora bisa digunakake nalika meteng kajaba keuntungan potensial kanggo pasien ngluwihi risiko potensial kanggo janin.
LaktasiOra ana informasi babagan anané faricimab ing susu manungsa, efek saka obat kasebut. ing bayi sing disusui, utawa efek obat kasebut ing produksi susu. Akeh obat sing ditransfer ing susu manungsa kanthi potensial kanggo nyerep lan reaksi salabetipun ing bayi sing disusui.
Mupangat pangembangan lan kesehatan saka nyusoni kudu dianggep bebarengan karo kabutuhan klinis ibu kanggo faricimab- svoa lan potensial efek samping ing bocah sing disusui saka faricimab-svoa.
Wanita lan Lanang Potensi ReproduksiWanita kanthi potensial reproduksi disaranake nggunakake kontrasepsi sing efektif sadurunge dosis awal, sajrone perawatan lan kanggo paling sethithik 3 sasi sawise dosis pungkasan faricimab-svoa.
Ora ana studi babagan efek faricimab ing kesuburan manungsa sing ditindakake lan ora dingerteni manawa faricimab bisa mengaruhi kapasitas reproduksi. Adhedhasar mekanisme tumindak, perawatan karo faricimab-svoa bisa nyebabake risiko kanggo kapasitas reproduksi.
Panggunaan PediatrikAman lan khasiat faricimab-svoa ing pasien pediatrik durung ditetepake.
Geriatrik GunakakeIng papat studi klinis, kira-kira 60% pasien kanthi acak kanggo perawatan karo faricimab-svoa umure ≥ 65 taun. Ora ana bedane sing signifikan ing khasiat utawa safety saka faricimab sing katon kanthi umur tambah ing panliten kasebut. Ora ana panyesuaian dosis sing dibutuhake kanggo pasien 65 taun lan luwih.
Efek Samsaya Awon
Reaksi salabetipun sing paling umum (≥ 5%) sing dilapurake ing pasien sing nampa faricimab-svoa yaiku pendarahan conjunctival (7%).
Apa obatan liyane bakal mengaruhi Faricimab
Obat Spesifik
Pancen penting panyedhiya label pabrikan kudu dikonsultasi kanggo informasi sing luwih rinci babagan interaksi karo obat iki, kalebu kemungkinan pangaturan dosis. Sorotan interaksi:
Deleng label produk kanggo informasi interaksi obat.
Disclaimer
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