Aprepitant/Fosaprepitant
Jeneng merek: Emend
Kelas obat:
Agen Antineoplastik
Panganggone Aprepitant/Fosaprepitant
Mual lan Muntah-muntah sing disebabake dening Kemoterapi Kanker
Nyegah mual lan muntah sing akut lan telat sing digandhengake karo kursus awal lan ulangan saka kemoterapi kanker sing emetogenik banget, kalebu terapi cisplatin dosis dhuwur. Digunakake ing kombinasi karo agen antiemetik liyane.
Nyegah mual lan muntah sing digandhengake karo kursus awal lan ulang saka kemoterapi kanker sing cukup emetogenik. Digunakake ing kombinasi karo agen antiemetik liyane.
Kanggo nyegah mual lan muntah sing digandhengake karo rejimen kemoterapi sing emetogenik banget (kalebu antrasiklin ditambah cyclophosphamide), ASCO nyaranake regimen antiemetik 3-obat sing dumadi saka antagonis reseptor NK1 (contone, aprepitant oral utawa fosaprepitant IV. ), antagonis reseptor 5-HT3 (contone, dolasetron, granisetron, ondansetron, palonosetron), lan deksametason. ASCO nyatakake yen netupitant kombinasi tetep lan palonosetron plus dexamethasone minangka pilihan perawatan tambahan.
Kanggo rejimen kemoterapi sing cukup emetogenik, ASCO nyaranake regimen antiemetik 2-obat sing luwih disenengi yaiku palonosetron lan deksametason. Yen palonosetron ora kasedhiya, antagonis reseptor 5-HT3 generasi pisanan (luwih becik granisetron utawa ondansetron) bisa diganti. Bukti winates nuduhake yen aprepitant bisa ditambahake ing regimen iki; ing kasus kaya mengkono, nggunakake sembarang antagonis reseptor 5-HT3 cocok.
Kanggo regimen kemoterapi kanthi resiko emetogenik sing kurang, ASCO nyaranake administrasi deksametason dosis siji sadurunge kemoterapi.
Kanggo regimen kemoterapi kanthi resiko emetogenik minimal, ASCO nyatakake yen administrasi antiemetik rutin ora perlu.
Keamanan lan khasiat kanggo panggunaan kronis utawa kanggo perawatan mual lan muntah sing durung ditemtokake.
Mual lan Muntah Pasca Operasi
Nyegah mual lan muntah pasca operasi.
Aman lan khasiat kanggo panggunaan kronis utawa kanggo perawatan mual lan muntah sing durung ditemtokake.
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Carane nggunakake Aprepitant/Fosaprepitant
Administrasi
Dispensing lan Pancegahan Administrasi
Amarga podho ing ejaan lan/utawa lafal antarane Emend (jeneng dagang kanggo aprepitant) lan Amen (jeneng dagang mantan kanggo medroxyprogesterone acetate; ora kasedhiya kanggo komersial ing jeneng dagang iki ing AS) utawa Vfend (jeneng dagang). kanggo voriconazole), ngleksanani ekstra ati-ati kanggo njamin akurasi resep kanggo obat kasebut. (Deleng Kemungkinan Kesalahan Resep lan Dispensing miturut Awas.)
Administrasi Lisan
Atur aprepitant kanthi lisan tanpa preduli saka dhaharan.
Administrasi IV
Atur dimeglumine fosaprepitant kanthi infus IV.
Kanggo informasi kompatibilitas solusi lan obat, deleng Kompatibilitas ing Stabilitas.
Rekonstitusi lan PengenceranReconstitute bubuk kanggo injeksi karo 5 ml natrium klorida 0,9% kanggo injeksi; nyegah jetting saline menyang vial. Solusi swirl alon-alon; aja goyangake.
Busak kabeh volume saka vial lan transfer menyang tas infus sing ngemot 110 mL natrium klorida 0,9%, ngasilake volume total 115 mL (1 mg/mL). Nyampur solusi kanthi inversi lembut saka tas 2-3 kaping.
Tingkat AdministrasiInfuse liwat 15 menit.
Dosis
Dosis fosaprepitant dimeglumine ditulis ing istilah fosaprepitant.
Dewasa
Kanker Mual lan Muntah-muntah sing disebabake dening KemoterapiAtur minangka bagéan saka regimen sing kalebu antagonis reseptor 5-HT3 lan kortikosteroid.
Kemoterapi Kanker Highly Emetogenic OralAdministrasi 125 mg aprepitant 1 jam sadurunge kemoterapi ing dina 1, lan tindakake karo 80 mg sapisan dina ing esuk ing dina 2 lan 3 saka regimen perawatan.
Ing studi klinis, aprepitant diwenehake karo IV ondansetron (32 mg 30 menit sadurunge kemoterapi ing dina 1) lan dexamethasone oral (12 mg 30 menit sadurunge kemoterapi ing dina 1, banjur 8 mg sapisan dina esuk ing dina 2. –4).
IVAdministrasi 115 mg fosaprepitant liwat 15 menit, 30 menit sadurunge kemoterapi minangka alternatif kanggo aprepitant oral (125 mg) ing dina 1 mung saka regimen 3 dina. Tindakake fosaprepitant karo aprepitant oral 80 mg sapisan dina ing wayah esuk ing dina 2 lan 3 saka regimen perawatan.
Kemoterapi Kanker Emetogenik Moderately OralAdministrasi 125 mg aprepitant 1 jam sadurunge kemoterapi ing dina 1, lan tindakake karo 80 mg sapisan dina esuk ing dina 2 lan 3 saka regimen perawatan.
Ing studi klinis, aprepitant diwenehake karo ondansetron oral (8 mg 30-60 menit sadurunge kemoterapi ing dina 1, banjur 8 mg 8 jam sawise dosis pisanan) lan deksametason oral (12 mg 30 menit). sadurunge kemoterapi ing dina 1).
IVAdministrasi 115 mg fosaprepitant liwat 15 menit, 30 menit sadurunge kemoterapi minangka alternatif kanggo aprepitant lisan (125 mg) ing dina 1 mung saka regimen 3 dina. Tindakake fosaprepitant kanthi aprepitant oral 80 mg sapisan dina ing wayah esuk ing dina 2 lan 3 saka regimen perawatan.
Mual lan Muntah Pascaoperasi OralAtur 40 mg aprepitant sajrone 3 jam sadurunge induksi anestesi.
Populasi Khusus
Gangguan Hepatik
Ora ana panyesuaian dosis sing dibutuhake ing pasien kanthi gangguan hepatik entheng nganti moderat. Ora ditliti kanthi cukup ing pasien kanthi gangguan hepatik sing abot (Skor Child-Pugh >9).
Gangguan Renal
Ora ana panyesuaian dosis sing dibutuhake kanggo pasien sing nandhang gagal ginjel utawa penyakit ginjel tahap pungkasan sing mbutuhake. hemodialisis.
Pasien Geriatrik
Ora ana pangaturan dosis sing dibutuhake.
Pènget
Kontraindikasi
Pènget/PanandhapReaksi Sensitivitas
Sindrom Stevens-Johnson dilapurake ing 1 pasien sing nampa aprepitant karo agen antineoplastik. Reaksi hipersensitivitas, kalebu anafilaksis, gatal-gatal, ruam, gatal, lan urtikaria, dilapurake ing pasien sing nampa aprepitant utawa fosaprepitant; bisa dadi serius lan bisa nyebabake angel ambegan utawa ngulu. Angioedema dilaporake ing 1 pasien.
Pancegahan Umum
Potensi Interaksi ObatPotensi interaksi obat bisa diowahi kanthi nggunakake kronis (pirsani Interaksi); safety saka nggunakake kronis ora ditetepake.
Kemungkinan Kesalahan Resep lan DispensingMesthekake akurasi resep; Kamiripan ing ejaan lan/utawa lafal Emend (jeneng dagang kanggo aprepitant) lan Amen (mantan jeneng dagang kanggo medroxyprogesterone acetate) utawa Vfend (jeneng dagang kanggo voriconazole) bisa nyebabake kesalahan.
Populasi Spesifik
KandhutanKategori B.
LaktasiAprepitant disebarake menyang susu ing tikus; ora dingerteni manawa disebarake menyang susu manungsa. Mungkasi nyusoni utawa obat kasebut.
Panggunaan PediatrikKeamanan lan khasiat fosaprepitant lan aprepitant ora ditetepake ing bocah-bocah <18 taun.
Panggunaan GeriatrikOra ana beda substansial ing safety, khasiat, utawa farmakokinetik saka aprepitant lisan relatif kanggo wong diwasa enom, nanging tambah sensitivitas ora bisa ditolak lewat.
Gangguan HepatikAprepitant lisan durung diteliti kanthi cukup ing pasien kanthi gangguan hepatik sing abot (Skor Anak-Pugh >9); ati-ati disaranake ing pasien kasebut.
Fosaprepitant dimetabolisme dening jaringan ekstrahepatik; insufficiency hepatic ora samesthine kanggo ngowahi konversi fosaprepitant dadi aprepitant.
Efek Umum sing Sabar
Kapsul aprepitant: Asthenia lan/utawa lemes, pusing, hypoesthesia, mual, anorexia, diare, constipation, heartburn, nyeri weteng, rasa ora nyaman ing epigastric, dyspepsia, gastritis, stomatitis, nyeri pharyngolaryngeal, cegukan, ulkus duodenum perforating, enterocolitis, neutropenia, dehidrasi, hot flush, pruritus, hipotensi, hipertensi, sinus tachycardia, neutropenic sepsis, pneumonia, alopecia, bradikardia.
Injeksi fosaprepitant: Reaksi situs infus (contone, nyeri, indurasi), sirah. Amarga dimeglumine fosaprepitant kanggo injeksi diowahi dadi aprepitant, efek ala sing ana gandhengane karo aprepitant uga bisa kedadeyan nalika injeksi.
Apa obatan liyane bakal mengaruhi Aprepitant/Fosaprepitant
Interaksi obat sawise administrasi fosaprepitant bisa kedadeyan karo agen sing berinteraksi karo aprepitant.
Aprepitant dimetabolisme sacara ekstensif, utamane dening CYP3A4 lan luwih sithik dening CYP1A2 lan CYP2C19. Obat kasebut minangka inhibitor sing gumantung karo dosis sing lemah nganti moderat lan inducer CYP3A4; uga inducer saka CYP2C9.
Obat-obat sing Dimetabolisme dening Enzim Mikrosomal Hepatik
Substrat CYP3A4: Metabolisme sing bisa diowahi saka substrat CYP3A4. Aprepitant bisa nyandhet utawa ngindhuksi CYP3A4. Inhibisi CYP3A4 gumantung karo dosis lan moderat kanthi regimen aprepitant 125-mg / 80-mg lan lemah karo regimen dosis tunggal, 40-mg. Konsentrasi plasma sing bisa tambah saka obat-obatan sing disedhiyakake bebarengan, utamane bisa ditindakake kanthi dosis aprepitant sing luwih dhuwur (yaiku, ing regimen sing dumadi saka 125 mg ing dina 1 diikuti karo 80 mg ing dina 2 lan 3) utawa kanthi administrasi ulang ing sembarang dosis aprepitant. Aprepitant (ing tingkat dosis 125 mg ing dina 1 diikuti 80 mg ing dina 2 lan 3) bisa nambah konsentrasi plasma saka substrat CYP3A4 nganti luwih cilik nalika substrate diwenehi IV tinimbang lisan. Gunakake kanthi ati-ati; pangaturan dosis saka substrat CYP3A4 bisa uga dibutuhake.
Substrat CYP2C9: Bisa nambah metabolisme lan nyuda konsentrasi plasma saka substrat CYP2C9.
Obat-obatan sing Ngaruhi Enzim Mikrosomal Hepatik
Inhibitor CYP3A4: Kemungkinan metabolisme aprepitant mudhun, nyebabake konsentrasi aprepitant plasma mundhak. Gunakake kanthi ati-ati.
Inducer CYP3A4: Bisa nambah metabolisme aprepitant. Potensi nyuda khasiat aprepitant kanthi inducer CYP3A4 sing kuwat.
Obat Spesifik
Obat
Interaksi
Komentar
Antiemetik, antagonis reseptor 5-HT3 (contone, dolasetron, granisetron, ondansetron)
Ora ana efek klinis sing penting ing farmakokinetik antagonis reseptor 5-HT3
Anti jamur, azoles (contone, itraconazole, ketokonazol)
Konsentrasi aprepitant plasma sing bisa meningkat
Gunakake kanthi ati-ati
Agen antineoplastik (contone, etoposide, ifosfamide, imatinib, irinotecan, paclitaxel, vinblastine, vincristine)
Kamungkinan nambah konsentrasi plasma agen antineoplastik sing dimetabolisme dening CYP3A4
Ngati-ati; ngawasi kanthi ati-ati dibutuhake
Astemizole (ora kasedhiya kanggo komersial maneh ing AS)
Konsentrasi astemizol plasma mundhak; potensial kanggo reaksi serius utawa ngancam nyawa
Kontraindikasi panggunaan bebarengan
Benzodiazepines (contone, alprazolam, midazolam, triazolam)
Konsentrasi plasma benzodiazepin sing bisa dimetabolisme dening CYP3A4 bisa tambah
Pertimbangake efek potensial saka paningkatan konsentrasi benzodiazepine ing plasma
IV midazolam: Penyesuaian dosis bisa uga dibutuhake nalika diwènèhaké bebarengan karo regimen aprepitant oral 125 mg ing dina 1 banjur 80 mg ing dina 2 lan 3
Interaksi ora penting sacara klinis nalika midazolam diwenehake kanthi dosis tunggal fosaprepitant 100 mg utawa dosis tunggal 40-mg saka aprepitant
Carbamazepine
Konsentrasi plasma sing bisa mudhun lan efektifitas aprepitant sing mudhun
Cisapride (kasedhiya sacara komersial ing AS mung ing watesan winates. -protokol akses)
Nambah konsentrasi cisapride plasma; potensial kanggo reaksi serius utawa ngancam nyawa
Kontraindikasi panggunaan bebarengan
Kontrasepsi, oral
Konsentrasi steroid plasma bisa mudhun lan efektifitas kontrasepsi suda
Gunakake metode kontrasepsi alternatif utawa tambahan sajrone perawatan fosaprepitant utawa aprepitant lan suwene 1 wulan sawise dosis pungkasan
Kortikosteroid (contone, dexamethasone, methylprednisolone)
Konsentrasi plasma kortikosteroid sing bisa dimetabolisme dening CYP3A4, utamane kanthi regimen aprepitant oral 125 mg ing dina 1 banjur 80 mg ing dina kaping 2 lan 3
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Turunake dosis kortikosteroid oral lan IV yen perlu. Ngurangi dosis dexamethasone oral lan methylprednisolone kanthi 50% lan IV methylprednisolone kanthi 25% ing pasien sing nampa regimen aprepitant oral 125 mg ing dina 1 diikuti 80 mg ing dina 2 lan 3; pangaturan dosis ora dianjurake kanggo pasien sing nampa regimen 40 mg dosis tunggal
Digoxin
Mungkin interaksi farmakokinetik
Diltiazem
Mungkin tambah konsentrasi plasma aprepitant lan diltiazem; ora ana owah-owahan klinis penting ing ECG, denyut jantung, utawa BP diamati
Cilik, nanging sacara klinis migunani, nyuda DBP, lan bisa uga SBP, dilapurake kanthi terapi fosaprepitant bebarengan; ora ana owah-owahan klinis penting ing denyut jantung utawa interval PR sing diamati
Gunakake kanthi ati-ati
Docetaxel
Ora ana efek ing farmakokinetik docetaxel kanthi regimen aprepitant oral 125 mg saben dina. 1 banjur 80 mg ing dina 2 lan 3
Inhibitor protease HIV (nelfinavir, ritonavir)
Konsentrasi aprepitant plasma sing bisa tambah
Gunakake kanthi ati-ati
Antibiotik macrolide (contone, clarithromycin, troleandomycin)
Konsentrasi aprepitant plasma bisa tambah
Gunakake kanthi ati-ati
Nefazodone
Konsentrasi aprepitant plasma bisa tambah
Gunakake kanthi ati-ati
Paroxetine
Konsentrasi aprepitant plasma lan paroxetine bisa mudhun
p>Fenitoin
Konsentrasi plasma bisa mudhun lan efektifitas aprepitant; bisa ngurangi konsentrasi phenytoin plasma
Pimozide
Nambah konsentrasi pimozide plasma; potensial kanggo reaksi serius utawa ngancam nyawa
Kontraindikasi panggunaan bebarengan
Rifampin
Konsentrasi plasma bisa mudhun lan efektifitas aprepitant mudhun
Terfenadine (ora kasedhiya kanggo komersial maneh ing AS)
Konsentrasi terfenadine plasma mundhak; potensial kanggo reaksi serius utawa ngancam nyawa
Kontraindikasi panggunaan bebarengan
Tolbutamide
Konsentrasi tolbutamide plasma bisa mudhun
Vinorelbine
Ora ana efek ing farmakokinetik vinorelbine kanthi regimen aprepitant oral 125 mg ing dina 1 banjur 80 mg ing dina 2 lan 3
Warfarin
Konsentrasi S-warfarin plasma bisa mudhun lan nyuda PT
Monitor PT kanthi rapet sajrone 2 minggu (utamane 7-10 dina) sawise wiwitan fosaprepitant diikuti karo aprepitant, regimen utawa administrasi oral aprepitant 3 dina. saka regimen aprepitant dosis tunggal
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