Rozanolixizumab (Systemic)
Jeneng merek: Rystiggo
Kelas obat:
Agen Antineoplastik
Panganggone Rozanolixizumab (Systemic)
Rozanolixizumab-noli nduweni kegunaan ing ngisor iki:
Rozanolixizumab-noli dituduhake kanggo perawatan myasthenia gravis (gMG) umum ing pasien diwasa sing reseptor anti-acetylcholine (AChR) utawa anti-otot- antibodi spesifik tyrosine kinase (MuSK) positif.
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Carane nggunakake Rozanolixizumab (Systemic)
Umum
Rozanolixizumab-noli kasedhiya ing wangun dosis lan kekuatan:
Injeksi: 280 mg/2 mL (140 mg/mL) ing vial dosis siji kanggo subkutan. infus.
Dosis
Iku penting panyedhiya labeling pabrikan dikonsultasi kanggo informasi sing luwih rinci babagan dosis lan administrasi obat iki. Ringkesan dosis:
Dewasa
Dosis lan AdministrasiBobot Badan Pasien
Dosis
Volume sing arep Infus
Kurang saka 50 kg
420 mg
3 mL
50 kg nganti kurang saka 100 kg
560 mg
4 mL
100 kg lan ndhuwur
840 mg
6 mL
Pènget
Kontraindikasi
Ora ana.
Pènget / PancegahanInfeksi
Rozanolixizumab-noli bisa nambah risiko infeksi. Tundha administrasi ing pasien kanthi infèksi aktif nganti infeksi wis rampung. Sajrone perawatan karo obat kasebut, ngawasi pratandha klinis lan gejala infeksi. Yen infèksi serius ana, ngatur perawatan sing cocok lan nimbang nahan rozanolixizumab-noli nganti infèksi wis rampung.
ImunisasiImunisasi karo vaksin nalika perawatan rozanolixizumab-noli durung diteliti. Keamanan imunisasi kanthi vaksin urip utawa sing dilemahkan lan respon kanggo imunisasi karo vaksin apa wae ora dingerteni. Amarga rozanolixizumab-noli nyebabake nyuda tingkat IgG, vaksinasi kanthi vaksin urip utawa vaksin urip ora dianjurake sajrone perawatan karo obat kasebut. Evaluasi kabutuhan kanggo nyedhiyakake vaksin sing cocog karo umur miturut pedoman imunisasi sadurunge miwiti siklus perawatan anyar karo rozanolixizumab-noli.
Meningitis Aseptik
Reaksi salabetipun serius saka meningitis aseptik (uga disebut meningitis aseptik sing disebabake obat) wis dilapurake ing pasien sing diobati karo rozanolixizumab-noli. Yen gejala sing cocog karo meningitis aseptik berkembang, pemeriksaan diagnostik lan perawatan kudu diwiwiti miturut standar perawatan.
Reaksi Hipersensitivitas
Reaksi hipersensitivitas, kalebu angioedema lan ruam, diamati ing pasien sing diobati karo rozanolixizumab-noli. Manajemen reaksi hipersensitivitas gumantung saka jinis lan keruwetan reaksi kasebut. Ngawasi pasien sajrone perawatan karo rozanolixizumab-noli lan 15 menit sawise administrasi lengkap kanggo tandha klinis lan gejala reaksi hipersensitivitas. Yen reaksi hipersensitivitas kedadeyan, profesional kesehatan kudu ngetrapake langkah-langkah sing cocog yen perlu utawa pasien kudu njaluk perawatan medis.
Populasi Tertentu
KandhutanAna data winates babagan panggunaan rozanolixizumab-noli ing wanita ngandhut kanggo ngandhani risiko sing ana gandhengane karo obat-obatan saka cacat lair utama, keguguran, utawa asil ibu utawa janin sing ala. Sawise administrasi rozanolixizumab-noli menyang kethek sing ngandhut ing dosis sing luwih gedhe tinimbang sing digunakake sacara klinis, mundhak ing pati embrio, bobot awak sing suda, lan fungsi kekebalan sing ora bisa ditemokake yen ora ana keracunan ibu.
Kabeh meteng duweni risiko latar mburi cacat lair, mundhut, utawa asil salabetipun liyane. Tingkat latar mburi cacat lair utama lan keguguran ing populasi sing dituduhake ora dingerteni. Ing populasi umum AS, kira-kira risiko latar mburi cacat lair utama lan keguguran ing kandhutan sing diakoni sacara klinis yaiku 2% nganti 4% lan 15% nganti 20%.
LaktasiOra ana data babagan ngarsane rozanolixizumab-noli ing susu manungsa, efek ing bayi sing nyusoni, utawa efek ing produksi susu. IgG ibu dikenal ana ing susu manungsa.
Manfaat pangembangan lan kesehatan saka nyusoni kudu dianggep bebarengan karo kabutuhan klinis ibu kanggo rozanolixizumab-noli lan efek samping potensial kanggo bocah sing disusui saka obat kasebut. utawa saka kondisi ibu sing ndasari.
Panggunaan PediatrikSafe lan efektifitas ing pasien pediatrik durung ditetepake.
Panggunaan GeriatrikStudi klinis rozanolixizumab-noli ora kalebu jumlah pasien sing cukup 65 taun lan luwih lawas kanggo nemtokake manawa dheweke nanggapi beda karo pasien diwasa sing luwih enom.
Efek Samsaya Awon
Reaksi salabetipun sing paling umum (≥10%) ing pasien kanthi myasthenia gravis umum yaiku sirah, infeksi, diare, pyrexia, reaksi hipersensitivitas, lan mual.
Apa obatan liyane bakal mengaruhi Rozanolixizumab (Systemic)
Obat Spesifik
Pancen penting panyedhiya label pabrikan kudu dikonsultasi kanggo informasi sing luwih rinci babagan interaksi karo obat iki, kalebu kemungkinan pangaturan dosis. Sorotan interaksi:
Disclaimer
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