Apremilast (Systemic)
Jeneng merek: Otezla
Kelas obat:
Agen Antineoplastik
Panganggone Apremilast (Systemic)
Psoriatic Arthritis
Manajemen psoriatic arthritis aktif ing wong diwasa.
Maneka warna obat lan kelas obat digunakake kanggo ngobati arthritis psoriatik. Apremilast dianggep minangka molekul cilik lisan (OSM), yaiku salah siji saka sawetara kelas perawatan modifikasi penyakit kanggo kondisi iki.
Pedoman American College of Rheumatology (ACR)/National Psoriasis Foundation kanthi kondisional nyaranake panggunaan kasebut. agen pamblokiran TNF liwat OSM ing pasien naif perawatan karo arthritis psoriatik aktif; Nanging, OSM kayata apremilast bisa dianggep ing pasien naif perawatan tanpa psoriasis abot utawa arthritis psoriatik, ing wong sing luwih seneng oral tinimbang terapi parenteral, lan sing duwe kontraindikasi kanggo terapi pamblokiran TNF (contone, CHF, infeksi serius sadurunge, infeksi berulang. , penyakit demielinasi).
Ing pasien sing ora nanggapi perawatan karo OSM, ngalih menyang OSM liyane umume dianjurake tinimbang nambah OSM liyane menyang regimen saiki kajaba ing kasus apremilast amarga bukti entuk manfaat saka obat iki. biasane karo terapi kombinasi. Ngalih menyang monoterapi apremilast bisa uga dianggep tinimbang terapi kombinasi apremilast yen pasien duwe efek samping sing ora bisa ditoleransi karo OSM saiki.
Rekomendasi kanggo nggunakake lan milih terapi modifikasi penyakit ing arthritis psoriatik beda-beda adhedhasar anané karakteristik penyakit tartamtu (contone, spondylitis psoriatic/penyakit aksial, enthesitis) lan komorbiditas (contone, penyakit radang usus, diabetes).
Psoriasis Plak
Manajemen psoriasis plak ing wong diwasa sing calon kanggo fototerapi utawa terapi sistemik.
Maneka warna obat lan kelas obat digunakake kanggo nambani psoriasis kalebu terapi biologis lan nonbiologis sistemik; apremilast minangka pilihan nonbiologis kanggo perawatan kondisi iki.
Pedoman umume nyaranake apremilast kanggo perawatan wong diwasa kanthi psoriasis moderat nganti abot; uga bisa digunakake kanggo nambah khasiat agen biologi tartamtu (contone, adalimumab, etanercept, infliximab, ustekinumab).
Rekomendasi kanggo nggunakake lan milih terapi psoriasis beda-beda adhedhasar umur pasien, karakteristik penyakit (contone, keruwetan, lokasi, anané psoriatic arthritis), lan komorbiditas (contone, penyakit radang usus).
Ulcer Oral sing Gegandhèngan karo Penyakit Behçet
Manajemén ulkus oral sing gegandhèngan karo penyakit Behçet ing wong diwasa.
Pengobatan penyakit Behçet ditemtokake dening organ sing melu, keruwetan lan durasi penyakit, umur, jender, frekuensi serangan, lan preferensi pasien. Pedoman European Alliance of Associations for Rheumatology (EULAR) nyaranake perawatan topikal (kayata steroid) lan colchicine kanggo lesi mucocutaneous. Apremilast bisa dianggep minangka alternatif kanggo colchicine ing pasien sing dipilih sing duwe lesi berulang sanajan nggunakake colchicine.
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Carane nggunakake Apremilast (Systemic)
Umum
Skrining Pretreatment
Ngawasi Pasien
Pantau pasien yen diare, mual, lan muntah.
Administrasi
Administrasi Lisan
Administrasi oral tanpa preduli saka dhaharan .
Tablet ngulu utuh. Aja ngremuk, dibelah, utawa dikunyah.
Dosis
Dewasa
Psoriatic Arthritis OralMulai kanthi dosis 10 mg saben dina lan titrasi kaya ing ngisor iki (luwih saka 5 dina kanthi tambahan 10 mg saben dina) kanggo nyuda risiko gejala GI:
Dosis pangopènan: 30 mg kaping pindho saben dina.
Psoriasis Plak OralMulai kanthi dosis 10 mg saben dina lan titrasi kaya ing ngisor iki (luwih saka 5 dina kanthi nambah 10 mg saben dina) kanggo nyuda risiko gejala GI:
Dosis pangopènan: 30 mg kaping pindho saben dina.
> Ulkus Oral sing Gegandhengan karo Penyakit Behçet OralMiwiti kanthi dosis 10 mg saben dina lan titrasi kaya ing ngisor iki (luwih saka 5 dina kanthi nambah 10 mg saben dina) kanggo nyuda risiko gejala GI.
<10 mg ing wayah esuk ing dina 1
10 mg ing wayah esuk lan 20 mg ing wayah sore ing dina kaping 3
Dosis pangopènan: 30 mg kaping pindho saben dina.
Populasi Khusus
Gagal Hepatik
Ora ana pangaturan dosis sing dibutuhake.
Gangguan Ginjal
Gangguan ginjel abot (Clcr <30 mL/menit): Dosis pangopènan 30 mg sapisan dina. Diwiwiti kanthi dosis 10 mg saben dina lan titrasi kaya ing ngisor iki kanggo nyuda risiko gejala GI:
Pasien Geriatrik
Produsen ora menehi rekomendasi dosis tartamtu.
Pènget
Kontraindikasi
Pènget/PanandhapHipersensitivitas
Reaksi hipersensitivitas kalebu kasus angioedema lan anafilaksis kacarita. Aja nggunakake ing pasien kanthi hipersensitifitas sing dikenal kanggo obat apa wae saka eksipien kasebut.
Tundha yen ana tandha utawa gejala reaksi hipersensitivitas sing serius lan miwiti terapi sing cocog.
Efek GI
Diare parah, mual, lan muntah kacarita.
Ngawasi pasien sing luwih rentan kanggo komplikasi, kayata pasien ≥65 taun lan sing njupuk obat sing bisa nyebabake nyuda volume utawa hipotensi.
Kurangi dosis apremilast utawa nundha terapi yen pasien ngalami diare, mual, utawa muntah sing abot.
Depresi lan Suicidality
Depresi, swasana ati depresi, lan ide / prilaku bunuh diri dilaporake.
Timbang kanthi ati-ati risiko lan keuntungan sadurunge nggunakake apremilast ing pasien sing duwe riwayat depresi lan/ utawa pikiran utawa prilaku suicidal. Evaluasi kanthi ati-ati risiko lan keuntungan saka terapi terus yen efek kasebut kedadeyan.
Bobot Mundhut
Bobot mundhut ≥5–10% saka bobot awak dilaporake.
Awasi bobote pasien kanthi rutin. Yen ana bobot mundhut sing ora dijelasake utawa penting sacara klinis, evaluasi bobote bobote lan nimbang nyetop apremilast.
Interaksi
Panganggo bareng induksi CYP kuat (contone, carbamazepine, fenobarbital, fenitoin, rifampisin) ora dianjurake.
Populasi Tertentu
KandhutanRegistrasi meteng ing [Web]877-311-8972 utawa .
Peningkatan aborsi spontan lan pati embriofetal dilaporake ing studi reproduksi kewan.
LaktasiDistribusi menyang susu ing tikus; ora dikawruhi manawa disebarake menyang susu manungsa.
Pirsani mupangat nyusoni lan pentinge apremilast kanggo pasien bebarengan karo potensial efek samping ing bayi sing disusui saka obat utawa kondisi ibu sing ndasari.
Panggunaan PediatrikKeamanan lan khasiat ora ditetepake ing pasien pediatrik <18 taun.
Panggunaan GeriatrikOra ana prabédan sakabèhé ing safety sing diamati antarane wong diwasa geriatrik lan luwih enom karo arthritis psoriatik.
Ora ana prabédan sakabèhé ing khasiat lan safety sing diamati ing antarane wong diwasa geriatrik lan luwih enom karo psoriasis plak.
Pantau pasien ≥65 taun kanthi rapet kanggo nyuda volume utawa hipotensi amarga diare, mual, utawa muntah.
Gagal HepatikGagal ati sing moderat utawa abot (kelas B utawa C Anak-Pugh) ora ngowahi farmakokinetik apremilast. Ora ana panyesuaian dosis sing dibutuhake.
Gagal GinjalPaparan sistemik mundhak ing pasien kanthi gangguan ginjel abot (Clcr <30 mL/menit). Disaranake nyuda dosis.
Efek Umum sing Sabar
Kedadeyan ala sing dilapurake ing ≥5% pasien arthritis psoriatik: Diare, mual, lan sirah.
Kedadeyan ala sing dilapurake ing ≥5% pasien psoriasis: Diare, mual, infeksi saluran napas ndhuwur, lan sirah (kalebu sirah tegang).
Efek ala sing dilapurake ing ≥10% pasien sing nandhang penyakit Behçet: Diare, mual, sirah, lan infeksi saluran napas ndhuwur.
Apa obatan liyane bakal mengaruhi Apremilast (Systemic)
Ngalami metabolisme oksidatif (utamane ditengahi dening CYP3A4, kanthi kontribusi cilik saka CYP1A2 lan CYP2A6) kanthi glukuronidasi sabanjure; uga ngalami hidrolisis non-CYP-mediated.
Ora nyandhet CYP isoenzyme 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, utawa 3A4 in vitro; ora ngindhuksi isoenzim CYP 1A2, 2B6, 2C9, 2C19, utawa 3A4 in vitro.
A substrate nanging ora inhibitor P-glikoprotein (P-gp) in vitro; dudu substrat utawa inhibitor transporter anion organik (OAT) 1 lan 3, polipeptida pengangkut anion organik (OATP) 1B1 lan 1B3, transporter kation organik (OCT) 2, utawa protein tahan kanker payudara (BCRP) in vitro.
Obat-obatan sing Ngaruhi Enzim Mikrosomal Hepatik
Inducer CYP sing kuat: Ngurangi paparan sistemik lan kemungkinan ilang khasiat apremilast; ora dianjurake kanggo nggunakake bebarengan.
Obat Spesifik
Obat
Interaksi
Komentar
Anticonvulsants (carbamazepine, phenobarbital , fenitoin)
Paparan sistemik lan khasiat apremilast bisa dikurangi
Panganggone bebarengan ora dianjurake
Estrogen/progestin
Kontrasepsi sing ngandhut etinil estradiol lan norgestimate: Ora ana interaksi farmakokinetik sing substansial
Ketoconazole
Ora ana efek klinis penting ing paparan apremilast
Methotrexate
Ora ana efek substansial ing farmakokinetik saka salah siji obat
Rifampisin
AUC apremilast suda lan konsentrasi plasma puncak; bisa ilang efektifitas apremilast
Panganggo bareng ora dianjurake
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