Lumasiran Sodium
Kelas obat: Agen Antineoplastik
Panganggone Lumasiran Sodium
Primary Hyperoxaluria Type 1
Digunakake kanggo perawatan saka hyperoxaluria primer tipe 1 (PH1) ing pasien diwasa lan bocah kanggo ngedhunake tingkat oksalat urin lan plasma.
Wis ditetepake minangka obat yatim piatu dening FDA kanggo perawatan PH1.
Pedoman Eropa babagan manajemen hiperoksaluria primer umume nyaranake lumasiran lan agen interfering RNA liyane minangka perawatan lini kedua PH1 ing pasien sing dipilih sawise manajemen konservatif kanthi hiperhidrasi, kalium sitrat, lan suplemen piridoksin.
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Carane nggunakake Lumasiran Sodium
Administrasi
Administrasi Sub-Q
Administrasi kanthi injeksi sub-Q dening profesional kesehatan. Kasedhiya kanthi komersial minangka solusi sing siap digunakake ing vial dosis siji sing ora mbutuhake rekonstitusi utawa pengenceran sadurunge administrasi.
Nalika nyiapake administrasi, dibagi volume injeksi dadi pirang-pirang jarum suntik yen> 1,5 ml. Gunakake jarum suntik steril 0,3-mL kanggo volume <0,3 mL. Yen nggunakake jarum suntik insulin 0,3 ml kanggo administrasi, tandha 1 unit nuduhake 0,01 ml.
Atur sub-Q menyang weteng, pupu, utawa sisih utawa mburi lengen ndhuwur; supaya administrasi menyang jaringan parut, inflamed utawa abuh, utawa sak area navel. Puter situs injeksi lan misahake saben situs injeksi paling sethithik 2 cm yen luwih saka 1 injeksi dibutuhake kanggo dosis siji. Sawise administrasi, mbuwang bagean obat sing ora digunakake.
Yen dosis ora kejawab, gunakake sanalika bisa; nerusake dosis saben wulan utawa seprapat saka wektu dosis sing paling anyar diwenehake.
Dosis
Kasedhiya minangka natrium lumasiran; dosis ditulis lumasiran.
Pasien Anak
Hyperoxaluria Primer Tipe 1 Sub-QAdministrasi minangka 3 dosis loading saben wulan ngiring dening dosis pangopènan wiwit 1 sasi sawise loading dosis pungkasan. Regimen dosis adhedhasar bobot awak nyata (pirsani Tabel 1).
Tabel 1. Regimen Dosis Lumasiran sing Disaranake Adhedhasar Bobot Badan Aktual1Bobot Badan (kg)
Dosis Muatan
Dosis Pangopènan
<10
6 mg/kg sapisan saben wulan kanggo 3 dosis
3 mg/kg sapisan saben wulan, wiwit 1 sasi sawise dosis loading pungkasan
10 nganti <20
6 mg/kg sapisan saben wulan kanggo 3 dosis
6 mg/kg sapisan saben 3 sasi, diwiwiti 1 sasi sawise dosis loading pungkasan
≥20
3 mg/kg sapisan saben wulan kanggo 3 dosis
3 mg/kg sapisan saben 3 sasi, diwiwiti 1 sasi sawise dosis loading pungkasan
Dewasa
Hyperoxaluria Primer Tipe 1 Sub-QAdministrasi minangka 3 dosis loading saben wulan banjur dosis pangopènan wiwit 1 sasi sawise dosis loading pungkasan.
Rejimen dosis adhedhasar bobot awak sing nyata (Deleng Tabel 1).
Populasi Khusus
Gangguan Hepatik
Ora ana panyesuaian dosis sing dianjurake kanggo pasien sing entheng (total bilirubin >ULN nganti 1,5 kaping ULN utawa AST ing ndhuwur ULN) utawa moderat (total bilirubin>1,5-3 kaping ULN kanthi AST) gangguan hepatik.
Ora diteliti ing pasien kanthi gangguan hepatik abot (total bilirubin > 3 kaping ULN karo AST).
Gangguan ginjel
Panyesuaian dosis ora perlu kanggo pasien. kanthi gangguan ginjel, kalebu pasien sing diobati hemodialisis.
Ing pasien sing nampa hemodialisis, gunakake sawise dialisis yen diwenehi dina dialisis. Ora diteliti ing pasien dialisis peritoneal.
Pasien Geriatri
Ora ana rekomendasi dosis khusus.
Pènget
Kontraindikasi
Pènget/PanandhapImunogenisitas
Antibodi anti-narkoba (ADA) dideteksi; ora ana bedane klinis sing signifikan babagan safety, farmakokinetik, utawa farmakodinamik lumasiran ing pasien sing dites positif ADA.
Populasi Tertentu
KandhutanOra ana data sing kasedhiya kanggo netepake risiko cacat lair utama, keguguran, utawa asil sing ora becik kanggo ibu utawa janin nalika nggunakake lumasiran nalika meteng.
LaktasiOra dingerteni manawa tamba utawa metabolite disebarake menyang susu manungsa; efek ing bayi sing disusui utawa ing produksi susu uga ora dingerteni. Coba manfaatake pangembangan lan kesehatan saka nyusoni karo kabutuhan ibu kanggo lumasiran lan reaksi salabetipun potensial kanggo anak sing disusui saka obat utawa kondisi ibu sing ndasari.
Panggunaan PediatrikKeamanan lan khasiat sing ditetepake ing pasien pediatrik wiwit lair. .
Panggunaan GeriatrikOra dingerteni manawa pasien geriatri nanggapi beda karo pasien sing luwih enom amarga jumlah pasien sing umure ≥65 taun ora cukup ing uji klinis.
Gangguan HepatikOra ana bedane klinis sing signifikan ing lumasiran farmakokinetik / farmakodinamik ing pasien kanthi gangguan hepatik entheng utawa moderat; efek saka gangguan hepatik abot ora dingerteni.
Gagal GinjalOra ana prabédan sing signifikan sacara klinis ing farmakokinetik/farmakodinamik lumasiran ing pasien kanthi gangguan ginjel utawa ing hemodialisis; safety lan khasiat ora ditetepake ing pasien sing nampa dialisis peritoneal.
Efek Sabar sing Umum
Reaksi saru sing paling umum (≥20%) yaiku reaksi ing situs injeksi.
Apa obatan liyane bakal mengaruhi Lumasiran Sodium
Ora ana studi interaksi obat. Lumasiran dudu substrat, inhibitor, utawa inducer enzim CYP lan ora modulasi aktivitas transporter obat.
Obat Spesifik
Obat
Interaksi
p>Pyridoxine
Panganggone bebarengan ora mengaruhi farmakokinetik utawa farmakodinamika lumasiran
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