Goserelin
Jeneng merek: Zoladex
Kelas obat:
Agen Antineoplastik
Panganggone Goserelin
Kanker Prostat
Pengobatan paliatif kanker prostat lanjut. Dianggep salah siji saka sawetara pilihan pisanan-line kanggo therapy hormonal; opsi liyane kalebu orchiectomy, estrogens, lan antiandrogens.
Ing studi klinis, goserelin (3,6 mg saben 4 minggu) efektif minangka orchiectomy. Hasil klinis ing pasien sing nampa goserelin 10,8 mg saben 12 minggu samesthine padha karo pasien sing nampa goserelin 3,6 mg saben 4 minggu.
Uga digunakake minangka tambahan kanggo terapi radiasi ing pasien kanker prostat stadium III [C]).
Pengobatan kanker prostat stadium T2b-T4 (B2-C) sing dikurung sacara lokal bebarengan karo terapi flutamide lan radiasi.
Endometriosis
Pengobatan paliatif endometriosis. Pengalaman karo goserelin diwatesi kanggo wanita ≥18 taun sing nampa terapi berturut-turut (3,6 mg saben 4 minggu) sajrone 6 wulan.
Kanker Payudara
Pengobatan paliatif kanker payudara lanjut ing wanita premenopausal lan perimenopausal.
Panganggone suppression ovarium ing kombinasi karo terapi endokrin (yaiku, anastrozole, exemestane, letrozole, tamoxifen)† [off-label] minangka terapi adjuvant† [off-label] ing wanita premenopausal kanthi hormon tahap awal kanker payudara reseptor-positif† [off-label] bisa dianggep minangka pilihan sing cukup (ditampa).
Perdarahan Uterine Disfungsional
Digunakake minangka agen penipisan endometrium sadurunge prosedur ablasi endometrium kanggo perawatan pendarahan uterus sing disfungsional.
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Carane nggunakake Goserelin
Umum
Temtokake konsentrasi testosteron serum sacara periodik ing pasien kanker prostat sing respon klinis utawa biokimia sing diantisipasi kanggo goserelin durung bisa ditindakake.
Panyurangan konsentrasi antigen spesifik prostat (PSA) serum bisa menehi informasi babagan durasi. status tanpa kemajuan ing wong kanthi kanker prostat. Aja mung ngandelake konsentrasi PSA kanggo ngawasi respon amarga nyuda konsentrasi PSA bisa uga ora gumantung saka respon tumor.
Administrasi
Sub-Q
Diwenehake minangka a implan biodegradable menyang tembok weteng anterior ing ngisor garis pusar.
Implan sing ngandhut goserelin 3,6 mg diwenehake saben 4 minggu.
Implan sing ngandhut goserelin 10,8 mg diwenehake saben 12 minggu.
Ketaatan jadwal sing disaranake; wektu tundha sawetara dina diijini.
Implan bisa ditemokake kanthi ultrasonik yen perlu dicopot.
Konsultasi label pabrikan kanggo cara administrasi sing tepat lan pancegahan sing gegandhengan.
Dosis
Kasedhiya minangka goserelin acetate; dosis ditulis ing syarat-syarat goserelin.
Dewasa
Kanker Prostat Sub-Q Kanker Prostat LanjutSiji implan sing ngandhut 3,6 mg saben 4 minggu utawa siji implan sing ngandhut 10,8 mg saben 12 minggu. Disaranake kanggo administrasi jangka panjang kajaba sacara klinis ora cocog.
Tahap III [C]) kanker prostat (minangka tambahan kanggo terapi radiasi): Siji implan sing ngemot 3,6 mg saben 4 minggu; miwiti terapi ing dina pisanan radiasi utawa sajrone minggu pungkasan radiasi.
Tahap B2-C Kanker Prostat Sub-QSiji implan sing ngemot 3,6 mg saben 4 minggu wiwit 8 minggu sadurunge terapi radiasi lan terus nganti total 4 dosis sing disaranake dening pabrikan. Utawa, siji implan sing ngemot 3.6 mg ditanem 8 minggu sadurunge terapi radiasi lan disusul siji implan sing ngemot 10.8 mg ing dina 28 (4 minggu sawise dosis awal 3.6 mg) sing disaranake dening pabrikan.
Endometriosis Sub-QSawijining implan sing ngemot 3,6 mg saben 4 minggu suwene 6 wulan berturut-turut. Retreatment karo kursus tambahan saiki ora dianjurake; safety mung ditetepake kanggo terapi 6 sasi; ana uneg-uneg babagan efek long-term potensial ing Kapadhetan balung. Netepake kapadhetan balung yen perawatan mundur kanggo kambuh dianggep. (Deleng Efek Muskuloskeletal ing Ati-ati.)
Kanker Payudara Lanjut Kanker Payudara Sub-QSawijining implan sing ngemot 3,6 mg saben 4 minggu. Tambah dosis dadi 7.2 mg (3.6 mg ditanem ing 2 situs sing beda) saben 4 minggu ing wanita sing konsentrasi estradiol serum ora suda nganti tingkat postmenopause sawise 8 minggu. Disaranake kanggo administrasi jangka panjang kajaba sacara klinis ora cocog.
Tahap awal† [off-label] Sub-Q Kanker PayudaraDosis siji implan sing ngemot 3,6 mg saben 4 minggu wis digunakake ing kombinasi karo terapi endokrin† [off-label]. (Deleng Kanker Payudara ing Panggunaan.)
Pendarahan Uterus Disfungsional Sub-QSawijining implan sing ngemot 3,6 mg 4 minggu sadurunge ablasi endometrium. Utawa, dosis awal 3.6-mg goserelin bisa diterusake kanthi dosis 3.6-mg kapindho 4 minggu sawise dosis pisanan; operasi kudu ditindakake 2-4 minggu sawise dosis kapindho.
Watesan Resep
Dewasa
Endometriosis Sub-QMaksimum 3,6 mg saben 4 minggu kanggo 6 berturut-turut sasi.
Populasi Khusus
Gangguan Hepatik
Panyesuaian dosis ora dibutuhake ing pasien kanthi gangguan hepatik entheng nganti moderat. Ora diteliti ing pasien kanthi insufisiensi ati sing abot.
Gangguan Ginjal
Panyesuaian dosis ora dibutuhake. (Deleng Populasi Khusus miturut Farmakokinetik.)
Pasien Geriatrik
Panyesuaian dosis ora dibutuhake.
Pènget
Kontraindikasi
Pènget / PancegahanReaksi Sensitivitas
Reaksi Hipersensitivitas
Pembentukan antibodi lan reaksi anafilaksis akut sing dilapurake karo agonis GnRH, kalebu goserelin.
Morbiditas lan Mortalitas Fetal/Neonatal
Owah-owahan hormonal sing diarepake nambah risiko mundhut meteng lan cilaka janin nalika diwenehake marang wanita ngandhut; tambah risiko mundhut meteng dituduhake ing kéwan.
Wanita sing bisa nglairake anak kudu ngindhari meteng lan nggunakake metode kontrasepsi nonhormonal sing efektif sajrone terapi lan 12 minggu sawise dosis terakhir goserelin. Panggunaan goserelin sing terus-terusan biasane nyegah ovulasi lan mungkasi menstruasi; Nanging, nyegah kandhutan ora bisa ditindakake.
Singkirake meteng sadurunge miwiti terapi ing wanita kanthi kondisi ginekologi sing entheng. Yen pasien endometriosis utawa ngalami penipisan endometrium dadi ngandhut sajrone terapi, mandhegake obat kasebut lan menehi saran marang pasien babagan kemungkinan bahaya janin.
Yen digunakake nalika meteng ing wanita sing duwe kanker payudara sing luwih maju, bisa uga ana bebaya kanggo janin.
Efek Endokrin
Mungkin tandha-tandha lan/utawa gejala kanker prostat utawa kanker payudara (contone, nyeri balung sing tambah) lan/utawa manifestasi anyar amarga mundhake testosteron serum (ing wong). utawa konsentrasi estrogen (ing wanita) sajrone minggu wiwitan terapi. Terapi bebarengan karo antiandrogen (contone, bicalutamide, flutamide, nilutamide) 1 minggu sadurunge lan sajrone sawetara minggu pisanan terapi goserelin bisa nyuda suar penyakit ing wong sing kena kanker prostat.
Kompresi sumsum balung mburi lan/utawa obstruksi ureter sing dilapurake ing wong sing kena kanker prostat. Yen komprèsi sumsum balung mburi utawa gangguan ginjel sekunder kanggo alangan ureter berkembang, institute perawatan standar kanggo komplikasi kasebut; nimbang orchiectomy langsung ing kasus nemen. Ati-ati ing pasien kanthi risiko tartamtu ngembangake kompresi sumsum tulang belakang utawa alangan ureter; mirsani rapet sak sasi pisanan therapy. Nambani kompresi sumsum tulang belakang utawa alangan ureter sadurunge miwiti goserelin.
Kamungkinan hiperglikemia lan tambah risiko diabetes ing pasien sing nampa agonis GnRH kanggo perawatan kanker prostat. Pasinaon sing ngevaluasi risiko diabetes ing wanita lan bocah-bocah sing nampa agonis GnRH sing durung ditindakake nganti saiki. Evaluasi pasien kanggo faktor risiko diabetes lan kanthi ati-ati nimbang keuntungan lan risiko terapi agonis GnRH sadurunge milih perawatan kanggo kanker prostat. Ngawasi glukosa getih lan / utawa HbA1c kanthi periodik ing pasien sing nampa agonis GnRH kanggo perawatan kanker prostat. Ngatur hiperglikemia utawa diabetes miturut standar perawatan saiki.
Mungkin mundhake resistensi serviks. Tindakake dilatasi serviks kanthi ati-ati sawise nggunakake goserelin minangka agen tipis endometrium.
Efek Kardiovaskular
Kamungkinan tambah risiko penyakit kardiovaskular (contone, MI, pati jantung dadakan, stroke) ing pasien sing nampa agonis GnRH kanggo perawatan kanker prostat. Pasinaon sing ngevaluasi risiko penyakit kardiovaskular ing wanita lan bocah-bocah sing nampa agonis GnRH sing durung ditindakake nganti saiki.
Evaluasi pasien kanggo faktor risiko kardiovaskular lan kanthi ati-ati nimbang keuntungan lan risiko terapi agonis GnRH sadurunge milih perawatan kanggo kanker prostat.
Pantau kanthi periodik pasien sing nampa agonis GnRH kanggo manifestasi penyakit kardiovaskular; ngatur penyakit kardiovaskular miturut standar perawatan saiki.
Kasus tromboembolisme vena lan arteri sing serius (umpamane, DVT, PE, MI, TIA, stroke) dilapurake ing wanita sing nampa agonis GnRH.
Kamungkinan owah-owahan transien ing BP (hipotensi utawa hipertensi ).
Mungkin nambah kolesterol total, kolesterol LDL, lan trigliserida lan nyuda kolesterol HDL.
Efek Muskuloskeletal
Penurunan kapadhetan mineral balung (BMD), osteoporosis, lan fraktur balung sing dilapurake ing wong; nyuda BMD sing dilaporake ing wanita. Data sing kasedhiya saiki nuduhake yen pemulihan balung mundhut kedadeyan sawise mandheg terapi umume wanita.
Kanggo manajemen endometriosis ing wanita, nggunakake terapi sulih hormon utawa bifosfonat bebarengan (contone, alendronate) bisa nyuda mundhut mineral balung. kanthi terapi agonis GnRH tanpa nyuda khasiat.
Kanggo perawatan kanker prostat ing wong, panggunaan bifosfonat bebarengan bisa nyuda mundhut mineral balung sing ana gandhengane karo terapi agonis GnRH.
Risiko mundhut BMD bisa uga tambah ing pasien kanthi riwayat terapi sadurunge sing nyebabake mundhut BMD lan/utawa pasien kanthi faktor risiko nyuda BMD (contone, penyalahgunaan alkohol kronis, penyalahgunaan rokok, riwayat kulawarga osteoporosis, nggunakake kronis anticonvulsants utawa kortikosteroid).
Hypercalcemia kacarita ing patients karo prostat utawa kanker payudara karo metastase balung. Miwiti perawatan sing cocog yen hiperkalsemia berkembang.
Prolongation saka QT Interval
Kamungkinan QT-interval prolonggation. Coba ngawasi ECG lan konsentrasi elektrolit serum kanthi periodik sajrone terapi. Mbenerake kelainan elektrolit.
Timbang keuntungan lan risiko terapi kekurangan androgen ing pasien sing duwe sindrom QT dawa kongenital, kelainan elektrolit, utawa CHF lan ing pasien sing nggunakake obat sing dikenal bisa nambah interval QT.
Reaksi Lokal
Cedera situs injeksi lan ciloko pembuluh darah (contone, nyeri, hematoma, pendarahan, kejut hemoragik) sing mbutuhake transfusi getih lan intervensi bedah dilaporake.
Atur kanthi ati-ati ing pasien kanthi BMI sing kurang lan/utawa sing nampa terapi antikoagulasi dosis lengkap.
Pituitary Apoplexy
Pituitary apoplexy, sindrom klinis asil saka infark kelenjar hipofisis, lan adenoma pituitary kacarita arang. Paling kasus dumadi ing 2 minggu saka dosis pisanan, kadhangkala ing jam pisanan. Yen ana manifestasi (umpamane, sirah dadakan, muntah, owah-owahan visual, ophthalmoplegia, status mental sing diowahi, kadhangkala ambruk kardiovaskular), perhatian medis langsung dibutuhake.
Populasi Tertentu
KandhutanBisa nyebabake cilaka janin. (Waca Fetal/Neonatal Morbidity and Mortality ing Cautions.)
LaktasiDistribusi menyang susu ing tikus; ora dingerteni manawa disebarake menyang susu manungsa. Mungkasi nyusoni utawa obat kasebut.
Panggunaan PediatrikKeslametan lan khasiat ora ditetepake.
Panggunaan GeriatrikStudi klinis kanggo kanker prostat wis ditindakake utamane ing pasien ≥65 taun. Pasinaon klinis ing wanita> 65 taun sing durung ditindakake nganti saiki.
Gagal GinjalKedadeyan efek samping ora mundhak ing pasien gagal ginjal sing nampa goserelin 10,8 mg.
Efek Umum sing Sabar
Pria: Hot flushes (kelip-kelip), disfungsi seksual, nyuda ereksi, gejala saluran kemih ngisor, nyeri (murah ing sasi kapisan).
Wanita: Hot flushes (kelip-kelip), vaginitis, sirah, labilitas emosi, suda/tambah libido, kringet, depresi, kukul, atrofi payudara, nggedhekake payudara.
Apa obatan liyane bakal mengaruhi Goserelin
Ora ana studi interaksi obat resmi nganti saiki.
Disclaimer
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