Doxercalciferol
Jeneng merek: Hectorol
Kelas obat:
Agen Antineoplastik
Panganggone Doxercalciferol
Hiperparatiroidisme Sekunder kanggo Penyakit Ginjal Kronis
Pengobatan hiperparatiroidisme sekunder ing pasien penyakit ginjel kronis (CKD) sing ngalami dialisis.
DoxerCalciferol oral uga digunakake kanggo perawatan hiperparatiroidisme sekunder ing pasien CKD tahap 3 utawa 4 sing durung mbutuhake dialisis pangopènan (pasien predialisis). konsentrasi hormon (PTH) sing ana gandhengane karo hiperparatiroidisme sekunder ing pasien CKD. Produksi metabolit vitamin D sing ora aktif sacara biologis nyebabake hiperparatiroidisme sekunder, sing nyebabake pangembangan penyakit balung metabolik.
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Carane nggunakake Doxercalciferol
Administrasi
Administrasi
Administrasi kanthi lisan tanpa preduli saka dhaharan utawa kanthi injeksi IV langsung.
Dosis
Dosis doxercalciferol individu adhedhasar konsentrasi serum utawa plasma utuh PTH (iPTH), kanthi ngawasi serum kanthi teliti. konsentrasi kalsium lan fosfor.
Ing pasien dialisis, ukur konsentrasi iPTH serum, kalsium, lan fosfor sadurunge wiwitan obat lan saben minggu sajrone terapi 12 minggu pisanan. Ukur konsentrasi serum iPTH, kalsium, fosfor, lan fosfatase alkalin kanthi periodik.
Ing pasien predialisis, monitor konsentrasi kalsium serum, fosfor serum, lan plasma iPTH paling sethithik saben 2 minggu suwene 3 sasi sawise wiwitan terapi utawa sawise owah-owahan dosis sabanjure, banjur saben wulan suwene 3 wulan (sawise dosis stabil. ), lan saben 3 sasi sabanjure.
Titrasi dosis doxercalciferol kanggo nyuda konsentrasi iPTH ing kisaran target; kisaran target tartamtu sing disaranake dening pabrikan adhedhasar tingkat gangguan ginjel.
Rekomendasi pabrikan adhedhasar Pedoman Praktek Klinis KDOQI 2003 Yayasan Ginjal Nasional kanggo Metabolisme Tulang lan Penyakit ing Penyakit Ginjal Kronis.
Produsen- Rekomendasi Rentang Target Plasma Utuh PTH miturut Tahap CKD1Tahap CKD
GFR (mL/menit/1,73 m2)
Target iPTH (pg/mL)
3
30–59
35–70
4
15–29
70–110
5
<15 (utawa dialisis)
150-300
Pakar nefrologi saiki nyatakake yen konsentrasi iPTH optimal kanggo pasien predialisis kanthi tahap 3a (eGFR 45- 59 ml / menit saben 1,73 m2) nganti tahap 5 CKD ora dingerteni, nanging elevasi sing sithik bisa uga minangka respon adaptif sing cocog kanggo nyuda fungsi ginjel.
Kanggo pasien CKD tahap 5 sing ngalami dialisis, sawetara ahli nyaranake njaga konsentrasi iPTH ing kisaran kira-kira 2-9 kaping ULN tes (bisa cocog karo kisaran kira-kira 130-600 pg/mL kanggo tes komersial. ). PTH assays nuduhake variasi substansial; kisaran sadurunge dianjurake saka 150-300 pg / ml kanggo patients karo tataran 5 CKD mbutuhake dialisis adhedhasar assay sing ora kasedhiya maneh. Ngindhari oversuppression saka PTH, sing bisa nambah risiko penyakit balung adynamic.
Pakar nefrologi saiki nyaranake nggunakake nilai individu kanggo kalsium serum lan fosfor (dievaluasi bebarengan) tinimbang konstruk matematika produk kalsium kaping fosfor kanggo nuntun praktik klinis.
Dewasa
Pasien Dialisis Hiperparatiroidisme Sekunder kanggo Penyakit Ginjal Kronis Oral Produsen-Rekomendasi Regimen Dosis Doxercalciferol Oral ing Pasien Dialisis1Dosis Awal
Konsentrasi iPTH
Dosis
>400 pg/mL
10 mcg 3 kali seminggu ing dialisis (kira-kira saben dina)
Titrasi Dosis
Konsentrasi iPTH
Dosis
>300 pg/mL
Tambah 2,5 mcg kanthi interval 8 minggu yen perlu; dosis maksimal sing disaranake yaiku 20 mcg kaping telu saben minggu (60 mcg saben minggu)
150–300 pg/mL
Njaga dosis
<100 pg/mL
p>Nahan 1 minggu, miwiti maneh kanthi dosis paling sethithik 2,5 mcg luwih murah tinimbang dosis pungkasan
Yen hiperkalsemia, hiperfosfatemia, utawa kalsium serum (ing mg/dL) kaping fosfor serum (ing mg/dL) produk >55 mg2/dL2, suda dosis utawa nolak terapi lan/utawa setel dosis saka pengikat fosfat bebarengan.
Yen konsentrasi kalsium serum >1 mg/dL ndhuwur ULN, mandhegake obat kasebut kanthi cepet , institute diet kurang kalsium, mbatalake suplemen kalsium, lan ngukur konsentrasi kalsium serum paling sethithik saben minggu; nalika normocalcemia dumadi (umume ing 2-7 dina), reinstitute doxercalciferol ing dosis suda (paling 2,5 mcg luwih murah tinimbang dosis sadurunge).
Konsentrasi iPTH
Dosis
> 400 pg/mL
4 mcg 3 kali seminggu ing pungkasan dialisis (kira-kira saben dina liyane)
Titrasi Dosis
Konsentrasi iPTH
p>Dosis
Turunake <50% lan ngluwihi 300 pg/mL
Tambah dosis sing diwenehake kaping 3 saben minggu kanthi 1-2 mcg kanthi interval 8 minggu yen perlu ; Dosis IV ngluwihi 18 mcg saben minggu durung diteliti
Muda >50% lan ngluwihi 300 pg/mL
Njaga dosis
150–300 pg/mL
Njaga dosis
<100 pg/mL
Tahan 1 minggu, ulangi dosis paling sethithik 1 mcg luwih murah tinimbang dosis pungkasan
Yen hiperkalsemia, hiperfosfatemia, utawa kalsium serum (ing mg/dL) kaping serum fosfor (ing mg/dL) produk >55 mg2/dL2, ngurangi dosis utawa nahan terapi lan/utawa nyetel dosis saka pengikat fosfat bebarengan.
Yen konsentrasi kalsium serum> 1 mg/dL ing ndhuwur ULN, mandhegake obat kasebut kanthi cepet, tindakake diet rendah kalsium, mundurake suplemen kalsium, lan ngukur konsentrasi kalsium serum paling sethithik saben minggu; nalika normocalcemia ana (umume ing 2-7 dina), reinstitute doxercalciferol ing dosis suda (paling 1 mcg luwih murah tinimbang dosis sadurunge).
Pasien Predialisis Hiperparatiroidisme Sekunder kanggo Penyakit Ginjal Kronis Oral Produsen-Recommended Dosis Doxercalciferol Oral Regimen. ing Pasien Predialisis1Dosis Awal
Konsentrasi iPTH
Dosis
>70 pg/mL (Tahap 3) lan >110 pg/mL (Tahap 4 )
1 mcg sapisan dina
Titrasi Dosis
Konsentrasi iPTH
Dosis
> 70 pg/mL (Tahap 3) lan >110 pg/mL (Tahap 4)
p>Tambah 0,5 mcg ing interval 2 minggu yen perlu; dosis maksimal sing disaranake yaiku 3,5 mcg sapisan dina
35–70 pg/mL (Tahap 3) lan 70–110 pg/mL (Tahap 4)
Njaga dosis
<35 pg/mL (Tahap 3) lan <70 pg/mL (Tahap 4)
Tahan 1 minggu, miwiti maneh ing dosis sing paling sethithik 0,5 mcg luwih murah tinimbang dosis pungkasan
p>Yen hiperkalsemia, hiperfosfatemia, utawa kalsium serum (ing mg/dL) kaping fosfor (ing mg/dL) produk >55 mg2/dL2, suda dosis utawa nolak terapi lan/utawa atur dosis pengikat fosfat bebarengan.
Yen konsentrasi kalsium serum> 10,7 mg/dL, langsung mandhegake obat kasebut, tindakake diet rendah kalsium, mundurake suplemen kalsium, lan ngukur konsentrasi kalsium serum paling sethithik saben minggu; nalika normocalcemia ana (umume ing 2-7 dina), reinstitute doxercalciferol ing dosis suda (paling 0,5 mcg luwih murah tinimbang dosis sadurunge).
Watesan Resep
Dewasa
OralMaksimum: 20 mcg 3 kali seminggu (60 mcg saben minggu).
IVDosis >18 mcg saben minggu durung diteliti.
Pènget
Kontraindikasi
Kecenderungan hiperkalsemia.
Bukti keracunan vitamin D.
Injeksi Doxercalciferol: Hipersensitivitas sing dikenal kanggo doxercalciferol utawa bahan apa wae ing formulasi. (Deleng Reaksi Hipersensitivitas ing Cautions.)
Pènget/PanandhapReaksi Sensitivitas
Reaksi Hipersensitivitas
Reaksi hipersensitivitas sing serius, kadhangkala fatal, dilapurake ing pasien hemodialisis sing nampa injeksi doxercalciferol. Reaksi kalebu anafilaksis karo angioedema (nyangkut pasuryan, lambe, ilat, lan saluran napas), hipotensi, ora responsif, rasa ora nyaman ing dada, sesak ambegan, lan penahanan kardiopulmoner.
Pantau pasien kanggo reaksi hipersensitivitas nalika miwiti IV. perawatan doxercalciferol. Yen reaksi hipersensitivitas kedadeyan, mandhegake obat kasebut lan menehi perawatan sing cocog sacara klinis.
Hiperkalsemia
Risiko keracunan analog vitamin D; bisa uga mbutuhake langkah darurat.
Hiperkalsemia akut bisa nambah risiko aritmia jantung, kejang, lan uga efek inotropik lan beracun sinergis ing ngarsane glikosida jantung.
Hiperkalsemia kronis nambah risiko kalsifikasi jaringan alus, kalebu kalsifikasi vaskular.
Yen hiperkalsemia berkembang sawise wiwitan terapi doxercalciferol, ngurangi dosis doxercalciferol lan/utawa pengikat fosfat sing ngandhut kalsium.
Gunakake evaluasi radiografi saka wilayah sing dicurigai kanggo deteksi awal kalsifikasi.
Aja nggunakake vitamin D lan analoge sajrone terapi doxercalciferol; efek aditif bisa.
Hiperfosfatemia
Bisa kedadeyan kanthi keracunan analog vitamin D.
Ing pasien CKD, gunakake pengikat fosfat sing ngandhut kalsium utawa liyane sing ora ngemot aluminium lan diet kurang fosfat kanggo ngontrol konsentrasi fosfat serum.
Yen hiperfosfatemia berkembang sawise wiwitan terapi doxercalciferol, ngurangi dosis doxercalciferol lan/utawa nambah dosis pengikat fosfat.
Hipermagnesemia
Aja nggunakake antacid sing ngandhut magnesium bebarengan karo doxercalciferol.
Kekurangan Vitamin D
Aja nggunakake doxercalciferol kanggo perawatan kekurangan vitamin D nutrisi.
Evaluasi pasien kanggo kekurangan vitamin D sadurunge miwiti terapi doxercalciferol; yen dituduhake, kekurangan vitamin D kudu diobati sadurunge miwiti doxercalciferol.
Efek Metabolik
Risiko hiperkalsemia, hiperfosfatemia, hiperkalsiuria, lan penekanan konsentrasi iPTH sing berlebihan; ngawasi lan nyetel dosages ajeg kanggo nyilikake risiko efek kuwi.
Umume pasien mbutuhake titrasi dosis doxercalciferol uga pangaturan terapi bebarengan (contone, pengikat fosfat dietary) kanggo ngoptimalake suppression iPTH nalika njaga kalsium lan fosfor serum ing kisaran sing wis ditemtokake. (Deleng Dosis ing Dosis lan Administrasi.)
Populasi Tertentu
KandhutanKategori B.
LaktasiOra dingerteni yen doxercalciferol disebarake menyang susu; mungkasi nyusoni utawa obat amarga ana risiko potensial (umpamane, hiperkalsemia) ing bayi sing nyusoni.
Panggunaan PediatrikKeslametan lan khasiat ora ditetepake ing pasien pediatrik.
Panggunaan GeriatrikOra ana bedane signifikan ing safety lan khasiat relatif kanggo wong diwasa enom.
Gangguan HepatikGunakake kanthi ati-ati amarga doxercalciferol bisa uga ora dimetabolisme kanthi tepat. Ngawasi konsentrasi serum iPTH, kalsium, lan fosfor luwih kerep.
Efek Samsaya Awon
Ing pasien dialisis: Edema, sirah, malaise, mual/muntah, pusing, dyspnea, pruritus, bradikardia.
Ing pasien predialisis kanthi CKD tahap 3 utawa 4: Infèksi, nyeri dada, konstipasi, dyspepsia, anemia, dehidrasi, depresi, hipertonia, insomnia, paresthesia, tambah batuk, dyspnea, rhinitis.
Kakehan asupan vitamin D (manifestasi awal): Kekirangan, sirah, ngantuk, mual, mutahke, tutuk garing, konstipasi, nyeri balung, rasa metalik, anorexia.
Kakehan asupan vitamin D (manifestasi pungkasan): Poliuria, polydipsia anorexia, mundhut bobot awak, nokturia, konjungtivitis calcific, pankreatitis, fotofobia, rhinorrhea, pruritus, hipertermia, penurunan libido, BUN tambah, albuminuria, hiperkolesterolemia, tambah konsentrasi AST lan ALT serum, kalsifikasi ektopik, hipertensi, aritmia jantung, gangguan sensori, dehidrasi, apatis, penahanan pertumbuhan, infeksi saluran kemih.
Apa obatan liyane bakal mengaruhi Doxercalciferol
Obat sing Ngaruhi Enzim Mikrosomal Hepatik
Kamungkinan interaksi farmakokinetik karo induksi enzim hepatik (contone, glutethimide, fenobarbital) utawa inhibitor (contone, eritromisin, ketokonazol) sing mengaruhi hidroksilasi (aktivasi) doxercalciferol hepatik.
Obat Spesifik
Obat
Interaksi
Komentar
Glikosida jantung
Mungkin aritmia jantung
Cholestyramine
Panyerepan usus doxercalciferol oral bisa dikurangi
Eritromisin
Konsentrasi serum gugus aktif doxercalciferol bisa dikurangi
Glutethimide
Metabolisme doxercalciferol bisa diowahi
Panyesuaian dosis doxercalciferol bisa uga dibutuhake
Ketoconazole
Konsentrasi serum aktif bagean doxercalciferol bisa dikurangi
Antacid sing ngandhut magnesium
Kamungkinan hipermagnesemia
Mineral oil
Mungkin nyuda penyerapan doxercalciferol oral
p>
Orlistat
Kamungkinan nyuda penyerapan doxercalciferol oral
Vitamin D lan analoge
Potensi efek farmakologi aditif sing nyebabake tambah efek samping, kalebu hiperkalsemia
Phenobarbital
p>Metabolisme doxercalciferol bisa diowahi
Panyesuaian dosis doxercalciferol bisa uga dibutuhake
Disclaimer
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