Inclisiran (Systemic)
Jeneng merek: Leqvio
Kelas obat:
Agen Antineoplastik
Panganggone Inclisiran (Systemic)
Hiperlipidemia Primer
Digunakake minangka tambahan kanggo diet lan terapi statin kanggo perawatan wong diwasa kanthi hiperlipidemia primer, kalebu hiperkolesterolemia familial heterozygous (HeFH), kanggo nyuda kolesterol lipoprotein kapadhetan rendah (LDL-C) .
Pedoman manajemen kolesterol AHA/ACC nyatakake yen modifikasi gaya urip minangka dhasar nyuda resiko penyakit kardiovaskular aterosklerotik (ASCVD).
Yen terapi farmakologis dibutuhake, statin minangka obat lini pertama. pilihan.
Klompok pasien tartamtu bisa entuk manfaat saka tambahan obat nonstatin kayata inclisiran yen terapi statin sing ditoleransi kanthi maksimal ora cukup kanggo nggayuh tujuan nyuda konsentrasi kolesterol LDL.
Dhukungan pedoman panggunaan inclisiran ing pasien sing nampa terapi statin maksimal sing mbutuhake terapi penurun LDL tambahan sanajan perawatan karo ezetimibe lan / utawa inhibitor proprotein convertase subtilisin kexin tipe 9 (PCSK9).
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- Diphenoxylate
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Carane nggunakake Inclisiran (Systemic)
Umum
Pengawasan Pasien
Administrasi
Administrasi Sub-Q
Administrasi kanthi injeksi sub-Q.
Kasedhiya minangka jarum suntik prefilled dosis siji sing ngemot 284 mg/1,5 mL (189 mg/mL).
Administrasi dening profesional kesehatan. Atur injeksi sub-Q menyang weteng, lengen ndhuwur, utawa paha; aja nyuntikake ing wilayah sing aktif penyakit kulit utawa ciloko (contone, sunburns, rashes kulit, inflammation, infèksi kulit).
Dosis
Kasedhiya minangka inclisiran sodium; dosis ditulis ing syarat-syarat inclisiran. Saben jarum suntik 1,5-mL ngemot padha karo 284 mg inclisiran.
Dewasa
Hiperlipidemia Primer Sub-Q284 mg minangka injeksi siji, maneh ing 3 sasi, banjur saben 6 sasi ; digunakake ing kombinasi karo terapi statin.
Yen dosis sing direncanakake ora kejawab nganti <3 sasi, aturake inclisiran lan njaga dosis miturut jadwal asli pasien.
Yen dosis sing direncanakake ora kejawab. kanthi >3 sasi, miwiti maneh karo jadwal dosis anyar kanthi menehi inclisiran ing wiwitan, maneh ing 3 sasi, banjur saben 6 sasi.
Watesan Resep
Populasi Khusus
< h4>Gangguan HepatikOra ana pangaturan dosis sing dibutuhake kanggo gangguan hepatik entheng utawa moderat. Ora dievaluasi ing pasien kanthi gangguan hepatik sing abot.
Gangguan Ginjal
Ora ana panyesuaian dosis sing dibutuhake kanggo gangguan ginjel sing entheng, moderat, utawa abot. Ora dievaluasi ing pasien kanthi penyakit ginjel tahap pungkasan.
Panganggone Geriatrik
Saiki ora ana rekomendasi dosis khusus.
Pènget
Kontraindikasi
Ora ana.
Pènget/PanandhapPènget
Imunogenisitas
Potensi imunogenisitas karo kabeh oligonukleotida, kalebu inclisiran. Ing studi klinis, antibodi anti-inclisiran dideteksi. Ora ana bukti manawa anané antibodi pengikat anti-obat mengaruhi khasiat, safety, utawa farmakodinamika; Nanging, akibat jangka panjang saka perawatan inclisiran sing terus-terusan nalika ana antibodi pengikat anti-narkoba ora dingerteni.
Populasi Tertentu
KandhutanOra ana data sing kasedhiya babagan panggunaan ing wanita ngandhut kanggo netepake risiko sing ana gandhengane karo obat kanggo cacat lair utama, keguguran, utawa asil sing ora becik kanggo ibu utawa janin. Adhedhasar mekanisme tumindak, bisa nyebabake cilaka janin nalika ditindakake nalika meteng. Nyetop inclisiran nalika meteng diakoni utawa, minangka alternatif, nimbang kabutuhan terapi sing terus-terusan saka pasien individu. Perawatan hiperlipidemia umume ora perlu nalika meteng.
LaktasiOra dingerteni manawa inclisiran disebar ing susu manungsa; efek obat kasebut ing bayi sing disusui utawa ing produksi susu uga ora dingerteni. Inclisiran dideteksi ing susu tikus lactating; mulane, kamungkinan sing tamba bakal ana ing susu manungsa. Coba keuntungan pangembangan lan kesehatan saka nyusoni bebarengan karo kabutuhan klinis ibu kanggo inclisiran lan efek samping sing potensial kanggo bayi sing disusui saka obat utawa kondisi ibu sing ndasari.
Panggunaan PediatrikAman lan khasiat ora ditetepake ing pasien pediatrik.
Panggunaan GeriatrikIng studi klinis, ora ana bedane sakabèhé ing safety utawa khasiat sing diamati antarane pasien ≥65 taun lan pasien sing luwih enom; Nanging, sensitivitas sing luwih gedhe kanggo reaksi salabetipun ing sawetara wong tuwa ora bisa ditolak.
Gangguan HepatikOra ana panyesuaian dosis sing dibutuhake kanggo pasien kanthi gangguan hepatik entheng nganti moderat. Ora diteliti ing pasien kanthi gangguan ati sing abot.
Gagal GinjalOra ana panyesuaian dosis sing dibutuhake kanggo pasien kanthi gangguan ginjel entheng, moderat, utawa abot. Ora diteliti ing pasien kanthi penyakit ginjel tahap pungkasan.
Efek Samsaya Awon
Reaksi salabetipun umum (≥3%): reaksi ing situs injeksi, artralgia, bronkitis.
Apa obatan liyane bakal mengaruhi Inclisiran (Systemic)
Ora ana studi interaksi obat formal. Ora substrat, inhibitor, utawa inducer saka enzim CYP450. Ora samesthine bakal nyebabake interaksi obat-obatan.
Obat Spesifik
Obat
Interaksi
Komentar
Atorvastatin
Ora ana pengaruh ing konsentrasi atorvastatin kanthi nggunakake bebarengan
Rosuvastatin
Ora ana pengaruh ing konsentrasi rosuvastatin kanthi nggunakake bebarengan
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