Antithrombin alfa
Jeneng merek: ATryn
Kelas obat:
Agen Antineoplastik , Agen Antineoplastik
Panganggone Antithrombin alfa
Defisiensi Antitrombin III Kongenital
Nyegah tromboembolisme perioperatif lan peripartum ing pasien kanthi kekurangan antitrombin III kongenital; ditunjuk minangka obat yatim piatu dening FDA kanggo digunakake ing kahanan kasebut.
Tromboprofilaksis jangka pendek kanthi antikoagulan sing cocog sing disaranake ing pasien kanthi kekurangan antitrombin III kongenital sajrone kahanan sing beresiko dhuwur (contone, operasi, meteng, periode postpartum); Konsentrasi antitrombin III bisa digunakake nalika terapi antikoagulan ora bisa ditindakake (contone, amarga ana risiko pendarahan) utawa ora cukup.
Ora dituduhake kanggo perawatan acara thromboembolic.
Resistensi Heparin
Wis digunakake kanggo ngatur resistensi heparin sajrone bypass kardiopulmoner (CPB)† [off-label].
Bisa nyuda kabutuhan plasma beku seger lan heparin tambahan sajrone CPB.
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Carane nggunakake Antithrombin alfa
Administrasi
IV Administrasi
Administrasi kanthi infus IV nggunakake saringan inline 0,22-µm.
RekonstitusiIdini vial bubuk antitrombin alfa (antitrombin [rekombinan]) kanggo injeksi tekan suhu kamar (20–25°C) ≤3 jam sadurunge rekonstitusi.
Reconstitute vial sing ngemot kira-kira 1750 unit obat kanthi 10 ml banyu steril kanggo injeksi sadurunge digunakake; ora goyang. Bisa luwih diencerake (contone, kanggo entuk konsentrasi 100 unit / mL) kanggo administrasi IV. Copot isi 1 utawa luwih vial sing wis dikonstitusi (gumantung dosis sing diwilang) menyang jarum suntik steril utawa ditambahake menyang tas infus sing ngemot injeksi natrium klorida 0,9%. saka preparation. Bisa disimpen ing suhu kamar nganti administrasi. Mbuwang bagean sing ora digunakake.
Tingkat AdministrasiAdministrasi dosis pengisian IV awal luwih saka 15 menit banjur terus infus pangopènan IV.
Dosis
Potensi ditulis ing internasional unit (IU, unit) sing diuji marang aktivitas standar referensi WHO. Saben vial ngemot kira-kira 1750 unit.
Gunakake rumus dosis sing beda kanggo perawatan pasien sing ngandhut lan ora ngandhut. (Deleng Distribusi: Populasi Khusus, miturut Farmakokinetik lan deleng Eliminasi: Populasi Khusus, miturut Farmakokinetik.)
Dewasa
Kekurangan Antitrombin III Kongenital Wanita Ngandhut IVWanita meteng sing nglakoni prosedur bedah kudu diobati miturut rumus dosis kanggo pasien sing ngandhut. Miwiti perawatan sadurunge nglairake utawa kira-kira 24 jam sadurunge operasi; terus nganti antikoagulasi tindak lanjut ditetepake.
Loading dose (unit) = [ (100 − baseline antithrombin III level activity) / 1.3] × bobot awak ing kg
Dosis pangopènan (unit/jam) = [ (100 − tingkat aktivitas antitrombin III baseline) / 5.4] × bobot awak ing kg
Setel dosis adhedhasar pemantauan serial tingkat aktivitas antitrombin III serum (ditulis minangka persentase normal). Ngawasi tingkat aktivitas antithrombin III serum sadurunge miwiti terapi lan kanthi interval reguler (yaiku, sepisan utawa kaping pindho saben dina) sajrone terapi kanggo nggayuh tingkat aktivitas antitrombin III terapeutik ing kisaran 80-120% saka normal.
Pasien Bedah Non Pregnant IVMiwiti perawatan kira-kira 24 jam sadurunge operasi; terus nganti antikoagulasi tindak lanjut ditetepake.
Loading dose (unit) = [ (100 − baseline antithrombin III level activity) / 2.3] × bobot awak ing kg
Dosis pangopènan (unit/jam) = [ (100 − tingkat aktivitas antitrombin III awal) / 10.2] × bobot awak ing kg
Sesuaikan dosis adhedhasar pemantauan serial tingkat aktivitas antitrombin III serum (ditulis minangka persentase normal). Ngawasi tingkat aktivitas antithrombin III serum sadurunge miwiti terapi lan kanthi interval reguler (yaiku, sepisan utawa kaping pindho saben dina) sajrone terapi kanggo nggayuh tingkat aktivitas antitrombin III terapeutik ing kisaran 80-120% saka normal.
Penyesuaian DosisSesuaikan dosis adhedhasar tingkat aktivitas serum antitrombin III. Entuk pangukuran aktivitas antitrombin III 2 jam sawise wiwitan terapi. Yen tingkat aktivitas sing diukur <80%, tambahake tingkat infus kanthi 30%; yen tingkat aktivitas sing diukur yaiku> 120%, ngurangi tingkat infus nganti 30%. Priksa maneh tingkat aktivitas antitrombin III serum 2 jam sawise saben penyesuaian dosis.
Yen pangukuran awal aktivitas antitrombin III sawise miwiti terapi ana ing kisaran target 80-120%, njaga dosis sing padha lan mriksa tingkat aktivitas maneh sajrone 6 jam. Nindakake pangukuran tingkat aktivitas antithrombin III sakteruse 2 jam sawise saben pangaturan dosis utawa 6 jam sawise saben pangukuran sing ana ing kisaran target 80-120%.
Entuk tingkat aktivitas serum antitrombin III sanalika sawise operasi utawa pangiriman. Yen tingkat sing diukur <80%, bisa menehi dosis loading tambahan nggunakake rumus sing padha kanggo dosis loading awal (ngganti tingkat aktivitas antitrombin III serum pungkasan sing kasedhiya kanggo nilai awal); nerusake infus pangopènan ing tingkat sing diwènèhaké sadurungé.
Pènget
Kontraindikasi
Pènget/PanandhapPènget
Terapi Antikoagulan Koncomitant
Potensi efek antikoagulan sing luwih apik yen digunakake bebarengan karo heparin sing ora difraksinasi, heparin bobot molekul rendah, utawa obat liya sing nggunakake antitrombin III kanggo ngetrapake efek antikoagulan. (Deleng Interaksi.)
Nindakake tes koagulasi (contone, aPTT, aktivitas anti-faktor Xa) kanthi interval reguler lan kerep ing pasien sing nampa terapi antikoagulan bebarengan, utamane ing sawetara jam pisanan sawise wiwitan utawa mundur saka antitrombin. terapi alfa (antitrombin [rekombinan]). Ngawasi kanthi rapet kanggo getihen utawa trombosis.
Reaksi Sensitivitas
Reaksi HipersensitivitasPotensi reaksi hipersensitivitas tipe alergi, kalebu anafilaksis. Ngawasi kanthi rapet kanggo manifestasi hipersensitivitas (contone, gatal-gatal, urtikaria umum, sesak dada, wheezing, hipotensi, anafilaksis). Langsung mandhegake obat kasebut lan menehi perawatan darurat sing cocog yen ana hipersensitivitas.
ImunogenisitasPotensi pangembangan antibodi kanggo antitrombin alfa, antitrombin wedhus, utawa protein susu wedhus. Reaksi imunologi sing dikonfirmasi ora dilapurake nganti saiki.
Registry pasien wis digawe kanggo ngevaluasi potensial imunogenik antitrombin alfa. Dokter dianjurake kanggo melu kanthi nelpon Lundbeck Inc. ing 800-455-1141.
Populasi Tertentu
KandhutanKategori C.
Katon ora ana hubungane karo tambah risiko kelainan janin nalika diwenehake sajrone trimester katelu. Nanging, gunakake sajrone meteng mung yen dituduhake kanthi jelas.
LaktasiDistribusi menyang susu kanthi konsentrasi sing sithik. Gunakake kanthi ati-ati lan mung yen dituduhake kanthi jelas.
Panggunaan PediatrikKeamanan lan khasiat ora ditetepake ing pasien pediatrik <18 taun.
Panggunaan GeriatrikPengalaman sing ora cukup ing pasien umur ≥65 taun kanggo nemtokake manawa reaksi kasebut beda karo pasien sing luwih enom. Pilih dosis kanthi ati-ati, diwiwiti ing sawetara dosis sing sithik, amarga nyuda fungsi ati, ginjel, lan/utawa jantung sing gegandhengan karo umur lan penyakit bebarengan lan terapi obat.
Efek Samsaya Awon
Pendarahan, reaksi situs infus.
Apa obatan liyane bakal mengaruhi Antithrombin alfa
Obat Spesifik
Obat
Interaksi
Komentar
Antikoagulan (contone, heparin sing ora difraksinasi, heparin bobot molekul rendah, obat liya sing nggunakake antitrombin III kanggo menehi efek antikoagulan. )
Kamungkinan efek antikoagulan sing tambah
Separuh umur antitrombin alfa bisa diowahi amarga owah-owahan turnover antitrombin
Ngawasi pasien kanthi rapet (pirsani Terapi Antikoagulan Koncomitant ing ngisor iki. Waspada)
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