Tretinoin (Systemic)
Jeneng merek: Vesanoid
Kelas obat:
Agen Antineoplastik
Panganggone Tretinoin (Systemic)
Leukemia Promyelocytic Akut
Digunakake kanggo ngindhuksi remisi ing leukemia promyelocytic akut (APL), klasifikasi Prancis-Amerika-Inggris M3 kalebu varian M3, ditondoi dening anané tandha genetik tartamtu (yaiku, 15; 17 translokasi kromosom lan / utawa gen PML / RAR-α) ing pasien kanthi penyakit kambuh utawa refrakter sawise kemoterapi adhedhasar antrasiklin utawa ing pasien sing terapi antrasiklin dikontraindikasi.
Umume dokter nyaranake tambahan tretinoin kanggo kombinasi kemoterapi induksi (basis antrasiklin) minangka perawatan awal† [off-label] kanggo APL ing pasien sing nandhang penyakit sing sadurunge ora diobati.
Bisa miwiti terapi tretinoin adhedhasar diagnosis morfologis APL, nanging nindakake evaluasi sitogenetik kanggo konfirmasi anané translokasi 15;17, lan yen ora ana, nindakake tes diagnostik molekuler kanggo protein fusi PML/RAR-α. .
Mungkin ora efektif nalika tandha-tandha genetik iki ora ana; nimbang terapi alternatif.
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Carane nggunakake Tretinoin (Systemic)
Umum
Administrasi
Administrasi Lisan
Administrasi oral ing 2-dosis sing dipérang merata.
Produsen ora menehi rekomendasi khusus babagan administrasi karo dhaharan; Nanging, panganan wis nambah panyerepan saka retinoids liyane. (Deleng Penyerapan ing Farmakokinetik.)
Dosis
Nyetop tretinoin lan nimbang perawatan alternatif yen ana 15;17 translokasi kromosom lan/utawa gen PML/RAR-α ora dikonfirmasi lan penyakit ora nanggapi.
Kajaba contraindicated, ngatur konsolidasi lan/utawa kemoterapi pangopènan kanggo kabeh pasien sawise terapi induksi tretinoin.
Elinga penghentian sementara yen konsentrasi transaminase serum >5 kaping ULN . (Waca Efek Hepatik ing Ati-ati.)
Coba mandhekake sauntara ing pasien sing ngalami sindrom asam retinoat-APL moderat utawa abot. (Deleng Sindrom RA-APL ing Ati-ati.)
Pasien Anak
Leukemia Promyelocytic Akut Oral45 mg/m2 saben dina ing 2 dosis sing dibagi rata.
Terus nganti 30 dina sawise remisi lengkap digayuh, utawa total 90 dina, endi wae sing luwih dhisik. Sawetara dokter nyaranake supaya diterusake nganti remisi lengkap tekan, utawa total 90 dina (mana wae sing kedadeyan luwih dhisik).
Coba nyuda dosis yen keracunan obat sing serius utawa ora bisa ditoleransi; Nanging, safety lan khasiat dosis <45 mg/m2 saben dina durung ditetepake.
Dewasa
Leukemia Promyelocytic Akut Oral45 mg/m2 saben dina ing 2 dosis dibagi merata.
Terus nganti 30 dina sawise remisi lengkap entuk, utawa total 90 dina, endi sing luwih dhisik. Sawetara dokter nyaranake supaya terus nganti remisi lengkap, utawa total 90 dina (mana wae sing kedadeyan luwih dhisik).
Watesan Resep
Pasien Pediatrik
Leukemia Promyelocytic Akut OralAman lan khasiat dosis <45 mg/m2 saben dina durung ditetepake.
Durasi maksimal: 30 dina sawise remisi lengkap, nganti 90 dina terapi.
Dewasa
Leukemia Promyelocytic Akut OralDurasi maksimal: 30 dina sawise remisi lengkap, nganti 90 dina terapi.
Pènget
Kontraindikasi
Pènget/PanandhapPènget
Morbiditas lan Mortalitas Janin/Neonatal
Bisa nyebabake cilaka janin; teratogenicity lan embriotoxicity dituduhake ing kéwan.
Pengalaman winates ing wanita ngandhut, nanging retinoid liyane digandhengake karo tambah aborsi spontan lan abnormalitas janin sing gedhe lan kadhangkala fatal (contone, kelainan CNS, sistem muskuloskeletal, kuping njaba, mripat, timus, lan pembuluh gedhe. Dysmorphia rai, langit-langit sumbing, kekurangan hormon paratiroid, skor IQ sing kurang (yaiku <85), kanthi utawa tanpa kelainan CNS sing jelas.
Risiko dhuwur kanggo bayi cacat banget ing wanita ngandhut; digunakake nalika meteng mung ing kahanan sing ngancam nyawa, utawa kanggo penyakit abot sing obat sing luwih aman ora bisa digunakake utawa ora efektif. Saiki ora ana cara antepartum kanggo nemtokake manawa janin kena pengaruh.
Singkirake meteng nggunakake tes kehamilan getih utawa urine sing dipercaya kanthi sensitivitas ≥50 mIU/mL sajrone 1 minggu sadurunge miwiti tretinoin; tundha wiwitan tretinoin (saben bisa) nganti tes meteng negatif; yen wektu tundha ora bisa ditindakake, pasangake 2 bentuk kontrasepsi sing bisa dipercaya. Baleni tes meteng lan konseling kontrasepsi saben wulan sajrone terapi.
Kabeh wanita (kalebu sing duwe riwayat infertilitas utawa menopause) kudu nggunakake 2 kontrasepsi sing bisa dipercaya bebarengan sajrone terapi lan sajrone 1 wulan sawise mandheg, kajaba histerektomi. wis dileksanakake. Preparat mung progestin (yaiku, minipill) bisa uga minangka cara kontrasepsi sing ora nyukupi sajrone terapi tretinoin.
Konfirmasi Diagnosis SitogenetikBisa miwiti terapi adhedhasar diagnosis morfologis APL. Nanging, konfirmasi diagnosis kanthi nindakake evaluasi cytogenetic kanggo konfirmasi anané translokasi 15;17; yen ora ana, tindakake tes diagnostik molekuler kanggo protein fusi PML/RAR-α.
Pilih terapi alternatif nalika tandha genetik iki ora ana; khasiat ora ditetepake ing subtipe leukemia myelogenous akut (AML) kajaba APL.
Sindrom RA-APLSindrom RA-APL sing mungkin (sindrom diferensiasi APL), ditondoi dening demam, dyspnea, gangguan ambegan akut, tambah bobot, infiltrasi paru, efusi pleura lan perikardial, edema, lan hepatik, ginjal, lan gagal multiorgan sok-sok diiringi kontraktilitas miokardium lan hipotensi episodik; bisa kedadeyan kanthi utawa tanpa leukositosis bebarengan. Onset umume dumadi ing sasi pisanan perawatan, nanging bisa kedadeyan sawise dosis pisanan. (Waca Retinoic Acid-APL [RA-APL] Syndrome in Boxed Warning.)
Hipoksemia progresif sing mbutuhake intubasi endotrakeal lan ventilasi mekanik bisa kedadeyan ing kasus sing abot; kematian sing dilapurake sekunder amarga hipoksemia progresif lan gagal multiorgan.
Yen tandha utawa gejala sindrom kasebut (contone, demam, dyspnea, bobot awak, temuan auskultasi dada sing ora normal, kelainan radiografi), langsung menehi kortikosteroid dosis dhuwur. perawatan (contone, dexamethasone 10 mg IV saben 12 jam paling sethithik 3 dina utawa nganti gejala rampung), preduli saka jumlah leukosit; bisa nyuda morbiditas lan mortalitas. Yen sindrom kambuh, miwiti perawatan kortikosteroid liyane.
Penghentian tretinoin ora dibutuhake ing umume pasien sajrone perawatan sindrom RA-APL; Nanging, nimbang interupsi sementara terapi ing kasus moderat lan abot.
LeukositosisKamungkinan leukositosis sing berkembang kanthi cepet; bisa uga digandhengake karo tambah risiko komplikasi sing ngancam nyawa.
Pengelolaan leukositosis sing optimal durung ditemtokake, nanging miwiti perawatan kortikosteroid dosis dhuwur kanthi cepet yen leukositosis lan tandha utawa gejala sindrom RA-APL berkembang bebarengan.
Insidens sindrom RA-APL sing luwih murah dilapurake kanthi tambahan agen kemoterapi rutin kanggo tretinoin nalika jumlah leukosit dhasar> 5000/mm3, utawa nalika leukopenia wiwitan ana lan nambah jumlah leukosit kanthi cepet.
Coba tambahake kemoterapi dosis lengkap (kalebu antrasiklin, kajaba kontraindikasi) kanggo terapi tretinoin ing dina 1 utawa 2 yen jumlah leukosit dhasar > 5000/mm3.
Langsung miwiti kemoterapi yen awal. Jumlah leukosit <5000/mm3 banjur mundhak dadi >6000/mm3 ing dina 5, 10.000/mm3 ing dina 10, utawa 15.000/mm3 ing dina 28.
Pseudotumor CerebriPosibel pseudotumor cerebrinial hipertensi , utamane ing pasien pediatrik. Tambah risiko bisa uga kanthi nggunakake agen liyane sing bisa nyebabake pseudotumor cerebri utawa hipertensi intrakranial. (Deleng Obat Spesifik ing Interaksi.)
Evaluasi kanggo pseudotumor cerebri yen ana pratandha utawa gejala (contone, papilledema, sirah, mual, muntah, gangguan visual); yen ana, nambani kanthi tepat (kalebu penilaian neurologis). Analgesik opiate, kortikosteroid, lan tusukan lumbar bisa uga dibutuhake.
LipidHiperkolesterolemia lan/utawa hipertrigliseridemia sing bisa dibalikake.
Kepentingan klinis kenaikan lipid transien ora dingerteni, nanging trombosis vena lan MI kacarita ing pasien sing beresiko rendah.
Efek HepatikKamungkinan tes fungsi ati sing luwih dhuwur; kelainan tes biasane ditanggulangi sajrone utawa sawise perawatan.
Pertimbangake mandheg sementara yen konsentrasi transaminase serum luwih saka 5 kaping ULN.
Pancegahan Umum
Tes LaboratoriumSing ngawasi profil hematologi, profil koagulasi, tes fungsi ati, lan konsentrasi kolesterol lan trigliserida serum, lan kanthi klinis netepake status jantung sajrone terapi tretinoin.
TrombosisTrombosis vena utawa arteri sing nglibatake sistem organ apa wae (umpamane, kacilakan serebrovaskular, MI, infark ginjal) dilaporake sajrone wulan pisanan perawatan. Ati-ati yen digunakake bebarengan karo agen antifibrinolitik. (Deleng Obat Spesifik ing Interaksi.)
Populasi Spesifik
KandhutanKategori D. (Deleng Morbiditas lan Mortalitas Janin/Neonatal miturut Ati-ati.)
LaktasiOra dingerteni manawa tretinoin disebarake menyang susu. Mungkasi nyusoni amarga ana potensial efek saleh serius ing bayi sing nyusoni.
Panggunaan PediatrikGunakake kanthi ati-ati ing pasien pediatrik; data klinis winates kanggo nggunakake ing bocah-bocah.
Keamanan lan khasiat ora ditetepake ing bayi <1 taun.
Nambah risiko sirah abot lan pseudotumor cerebri, sing mbutuhake perawatan analgesik lan tusukan lumbar. (Deleng Pseudotumor Cerebri ing Cautions.)
Pengurangan dosis bisa uga cocog yen ana efek samping sing abot, nanging safety lan khasiat dosis <45 mg/m2 saben dina durung ditetepake.
Panggunaan GeriatrikAman lan khasiat ing umur ≥60 taun padha karo wong diwasa sing luwih enom, nanging sensitivitas tambah ora bisa ditolak.
Efek Umum sing Sabar
Efek pernapasan (gangguan saluran napas ndhuwur, dyspnea, insufficiency ambegan), sirah, pusing, parestesia, kuatir, insomnia, depresi, bingung, kulit/membran mukosa garing, ruam , pruritus, tambah kringet, alopecia, owah-owahan kulit, efek GI (mual lan muntah, pendarahan GI, mucositis, nyeri abdomen, diare, konstipasi), nyeri balung, myalgia, edema perifer, rasa ora nyaman ing dada, edema, aritmia, flushing, hipotensi, hipertensi, phlebitis, insufficiency ginjel, kuping, krasa kebak ing kuping, gangguan visual, mriyang, malaise, ndredheg.
Apa obatan liyane bakal mengaruhi Tretinoin (Systemic)
Dimetabolisme dening isoenzim CYP.
Obat-obatan sing Ngaruhi Enzim Mikrosomal Hepatik
Panganggone obat bebarengan sing mengaruhi isoenzim CYP (contone, CYP3A4, CYP2C8, CYP2E) bisa ngowahi metabolisme tretinoin; ora dikawruhi manawa nggunakake obat-obatan bebarengan sing mengaruhi sistem enzim CYP ngowahi khasiat utawa keracunan tretinoin.
Induser isoenzim CYP: Potensi interaksi farmakokinetik (mudhun konsentrasi tretinoin plasma).
Inhibitor isoenzim CYP: Potensi interaksi farmakokinetik (konsentrasi tretinoin plasma mundhak).
Obat Spesifik
Obat
Interaksi
Komentar
Agen antifibrinolitik (contone, asam traneksamat, asam aminocaproic, aprotinin)
Komplikasi trombotik fatal sing dilapurake kanthi nggunakake bebarengan
Gunakake kanthi ati-ati
Cimetidine
Konsentrasi tretinoin plasma sing bisa mundhak
Kortikosteroid
Konsentrasi tretinoin plasma sing bisa mudhun
Cyclosporine
Konsentrasi tretinoin plasma sing bisa tambah
Diltiazem
Konsentrasi tretinoin plasma sing bisa tambah
Eritromisin
Konsentrasi tretinoin plasma sing bisa meningkat
Hydroxyurea
Penggunaan bebarengan bisa nyebabake efek sinergis sing nyebabake lisis sel gedhe
Nekrosis sumsum balung, kadhangkala fatal, wis dilaporake
Gunakake bebarengan karo ati-ati
Ketoconazole
Konsentrasi tretinoin plasma bisa tambah; administrasi ketoconazole 1 jam sadurunge dina 29 dosis tretinoin digandhengake karo kenaikan rata-rata tretinoin AUC 72%
Pentobarbital
Konsentrasi tretinoin plasma sing bisa mudhun
Phenobarbital
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Konsentrasi tretinoin plasma bisa mudhun
Rifampisin
Konsentrasi tretinoin plasma bisa mudhun
Tetrasiklin
Risiko tambah pseudotumor cerebri utawa hipertensi intrakranial
Verapamil
Konsentrasi tretinoin plasma bisa tambah
Vitamin A
Panganggone bebarengan bisa nambah gejala hipervitaminosis A
Aja nggunakake bebarengan
Disclaimer
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