Somatrogon (Systemic)
Jeneng merek: Ngenla
Kelas obat:
Agen Antineoplastik
Panganggone Somatrogon (Systemic)
Somatrogon-ghla nduweni kegunaan ing ngisor iki:
Somatrogon-ghla dituduhake kanggo perawatan pasien bocah-bocah umur 3 taun utawa luwih sing duwe gagal pertumbuhan amarga sekresi hormon pertumbuhan endogen sing ora nyukupi.
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- Co-trimoxazole
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- Cromolyn (EENT)
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- Crotalidae Polyvalent Immune Fab
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- Cysteamine Bitartrate
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- Cytomegalovirus Immune Globulin IV
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- Bacitracin (EENT)
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- Brivaracetam
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- Caffeine/Caffeine and Sodium Benzoate
- Calcitonin
- Calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate
- Calcium Salts
- Calcium, magnesium, potassium, and sodium oxybates
- Candida Albicans Skin Test Antigen
- Cantharidin (Topical)
- Capmatinib (Systemic)
- Carbachol
- Carbamide Peroxide
- Carbamide Peroxide
- Carmustine
- Castor Oil
- Catapres
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- Catapres-TTS-1
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- Ceftolozane/Tazobactam (Systemic)
- Cefuroxime
- Centruroides Immune F(ab′)2
- Cetirizine (EENT)
- Charcoal, Activated
- Chloramphenicol
- Chlorhexidine (EENT)
- Chlorhexidine (EENT)
- Cholera Vaccine Live Oral
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- Ciclesonide (EENT)
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- Ciprofloxacin (EENT)
- Citrates
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- Dapsone (Systemic)
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- Daridorexant
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- Dengue Vaccine Live
- Dexamethasone (EENT)
- Dexamethasone (Systemic)
- Dexmedetomidine
- Dexmedetomidine
- Dexmedetomidine
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- Dexmedetomidine (Oromucosal)
- Dexmedetomidine buccal/sublingual
- Dexmedetomidine injection
- Dextran 40
- Diclofenac (Systemic)
- Dihydroergotamine
- Dimethyl Fumarate (Systemic)
- Diphenoxylate
- Diphtheria and Tetanus Toxoids
- Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
- Diroximel Fumarate (Systemic)
- Docusate Salts
- Donislecel-jujn (Systemic)
- Doravirine, Lamivudine, and Tenofovir Disoproxil
- Doxepin (Systemic)
- Doxercalciferol
- Doxycycline (EENT)
- Doxycycline (Systemic)
- Doxycycline (Systemic)
- Doxylamine
- Duraclon
- Duraclon injection
- Dyclonine
- Edaravone
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- Efgartigimod Alfa (Systemic)
- Eflornithine
- Eflornithine
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- Fenofibric Acid/Fenofibrate
- Fibrinogen (Human)
- Flunisolide (EENT)
- Fluocinolone (EENT)
- Fluorides
- Fluorouracil (Systemic)
- Flurbiprofen (EENT)
- Flurbiprofen (EENT)
- Flurbiprofen (EENT)
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- Fluticasone and Vilanterol (Oral Inhalation)
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- Haemophilus b Vaccine
- Hepatitis A Virus Vaccine Inactivated
- Hepatitis B Vaccine Recombinant
- Hetlioz
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- Ipratropium (EENT)
- Ipratropium (EENT)
- Ipratropium (Systemic, Oral Inhalation)
- Ismelin
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- Ivermectin (Systemic)
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- Ixazomib Citrate (Systemic)
- Japanese Encephalitis Vaccine
- Kapvay
- Ketoconazole (Systemic)
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- Ketotifen
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- Measles, Mumps, and Rubella Vaccine
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- Mechlorethamine
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- Melphalan (Systemic)
- Meningococcal Groups A, C, Y, and W-135 Vaccine
- Meprobamate
- Methoxy Polyethylene Glycol-epoetin Beta (Systemic)
- Methyldopa
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- MetroNIDAZOLE (Systemic)
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- Miltown
- Minipress
- Minocycline (EENT)
- Minocycline (Systemic)
- Minoxidil (Systemic)
- Mometasone
- Mometasone (EENT)
- Moxifloxacin (EENT)
- Moxifloxacin (Systemic)
- Nalmefene
- Naloxone (Systemic)
- Natrol Melatonin + 5-HTP
- Nebivolol Hydrochloride
- Neomycin (EENT)
- Neomycin (Systemic)
- Netarsudil Mesylate
- Nexiclon XR
- Nicotine
- Nicotine
- Nicotine
- Nilotinib (Systemic)
- Nirmatrelvir
- Nirmatrelvir
- Nitroglycerin (Systemic)
- Ofloxacin (EENT)
- Ofloxacin (Systemic)
- Oliceridine Fumarate
- Olipudase Alfa-rpcp (Systemic)
- Olopatadine
- Omadacycline (Systemic)
- Osimertinib (Systemic)
- Oxacillin
- Oxymetazoline
- Pacritinib (Systemic)
- Palovarotene (Systemic)
- Paraldehyde
- Peginterferon Alfa
- Peginterferon Beta-1a (Systemic)
- Penicillin G
- Pentobarbital
- Pentosan
- Pilocarpine Hydrochloride
- Pilocarpine, Pilocarpine Hydrochloride, Pilocarpine Nitrate
- Placidyl
- Plasma Protein Fraction
- Plasminogen, Human-tmvh
- Pneumococcal Vaccine
- Polymyxin B (EENT)
- Polymyxin B (Systemic, Topical)
- PONATinib (Systemic)
- Poractant Alfa
- Posaconazole
- Potassium Supplements
- Pozelimab (Systemic)
- Pramoxine
- Prazosin
- Precedex
- Precedex injection
- PrednisoLONE (EENT)
- PrednisoLONE (Systemic)
- Progestins
- Propylhexedrine
- Protamine
- Protein C Concentrate
- Protein C Concentrate
- Prothrombin Complex Concentrate
- Pyrethrins with Piperonyl Butoxide
- Quviviq
- Ramelteon
- Relugolix, Estradiol, and Norethindrone Acetate
- Remdesivir (Systemic)
- Respiratory Syncytial Virus Vaccine, Adjuvanted (Systemic)
- RifAXIMin (Systemic)
- Roflumilast (Systemic)
- Roflumilast (Topical)
- Roflumilast (Topical)
- Rotavirus Vaccine Live Oral
- Rozanolixizumab (Systemic)
- Rozerem
- Ruxolitinib (Systemic)
- Saline Laxatives
- Selenious Acid
- Selexipag
- Selexipag
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- Sirolimus (Systemic)
- Sirolimus, albumin-bound
- Smallpox and Mpox Vaccine Live
- Smallpox Vaccine Live
- Sodium Chloride
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- Sodium Nitrite
- Sodium oxybate
- Sodium Phenylacetate and Sodium Benzoate
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- Tedizolid
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- Terbinafine (Systemic)
- Tetrahydrozoline
- Tezacaftor and Ivacaftor
- Theophyllines
- Thrombin
- Thrombin Alfa (Recombinant) (Topical)
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- Timolol (Systemic)
- Tixagevimab and Cilgavimab
- Tobramycin (EENT)
- Tobramycin (Systemic)
- TraMADol (Systemic)
- Trametinib Dimethyl Sulfoxide
- Trancot
- Tremelimumab
- Tretinoin (Systemic)
- Triamcinolone (EENT)
- Triamcinolone (Systemic)
- Trimethobenzamide
- Tucatinib (Systemic)
- Unisom
- Vaccinia Immune Globulin IV
- Valoctocogene Roxaparvovec
- Valproate/Divalproex
- Valproate/Divalproex
- Vanspar
- Varenicline (Systemic)
- Varenicline (Systemic)
- Varenicline Tartrate (EENT)
- Vecamyl
- Vitamin B12
- Vonoprazan, Clarithromycin, and Amoxicillin
- Wytensin
- Xyrem
- Xywav
- Zaleplon
- Zirconium Cyclosilicate
- Zolpidem
- Zolpidem (Oral)
- Zolpidem (Oromucosal, Sublingual)
- ZolpiMist
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- 5-hydroxytryptophan, melatonin, and pyridoxine
Carane nggunakake Somatrogon (Systemic)
Umum
Somatrogon-ghla kasedhiya ing wangun dosis lan kekuatan ing ngisor iki:
Injeksi:
Dosis
Iku penting supaya labeling pabrikan takon kanggo informasi sing luwih rinci babagan dosis lan administrasi obat iki. Ringkesan dosis:
Pasien Pediatrik
Dosis lan AdministrasiPènget
Kontraindikasi
Sindrom Prader-Willi ing pasien sing lemu banget utawa duwe gangguan ambegan abot.
Pènget/PanandhapPeningkatan Kematian ing Patients Kanthi Penyakit Kritis Akut
Peningkatan mortalitas ing pasien sing nandhang penyakit kritis akut amarga komplikasi sawise operasi jantung mbukak, operasi abdomen utawa sawetara trauma sing ora disengaja, utawa sing gagal ambegan akut wis dilaporake. karo somatropin. Keamanan saka perawatan somatrogon-ghla terus kanggo indikasi sing disetujoni ing pasien sing ngalami penyakit kasebut bebarengan durung ditetepake.
Hipersensitivitas abot
Reaksi hipersensitivitas sistemik sing abot kalebu anafilaksis lan angioedema wis dilapurake karo somatropin. Ngandhani pasien lan/utawa pengasuh yen reaksi kasebut bisa kedadeyan lan yen ana reaksi alergi. Somatrogon-ghla dikontraindikasi ing pasien kanthi hipersensitivitas sing dikenal kanggo somatrogon-ghla utawa bahan bantu apa wae ing produk kasebut.
Risiko Tambah Neoplasma
Ana tambah risiko progresi malignancy karo perawatan somatropin ing pasien kanthi malignancy aktif. Sembarang ganas sing wis ana sadurunge kudu ora aktif, lan perawatan kasebut kudu rampung sadurunge miwiti terapi karo somatrogon-ghla. Mungkasi somatrogon-ghla yen ana bukti keganasan sing terus-terusan.
Ing bocah-bocah sing slamet kanker, sing diobati kanthi radiasi menyang otak/sirah kanggo neoplasma pisanan lan sing ngalami kekurangan hormon pertumbuhan (GHD) sabanjure lan padha diobati karo somatropin, tambah risiko neoplasma kapindho wis dilaporake. Tumor intrakranial, utamane meningioma, sing paling umum saka neoplasma kapindho iki. Ngawasi kabeh pasien kanthi riwayat GHD sekunder kanggo neoplasma intrakranial nalika terapi somatrogon-ghla kanggo kemajuan utawa kambuh tumor.
Amarga bocah-bocah sing duwe panyebab genetik langka tartamtu sing cendhek duwe risiko tambah akeh. malignancies, sak tenane nimbang risiko lan keuntungan saka miwiti somatrogon-ghla ing patients iki. Yen perawatan karo somatrogon-ghla diwiwiti, ngawasi pasien kasebut kanthi teliti kanggo pangembangan neoplasma.
Pantau pasien kanthi terapi somatrogon-ghla kanthi ati-ati kanggo nambah wutah utawa owah-owahan ganas potensial saka nevi sing wis ana. Anjurake pasien lan/utawa pengasuh kanggo nglaporake owah-owahan ing prilaku, wiwitan sirah, gangguan penglihatan lan/utawa owah-owahan pigmentasi kulit utawa owah-owahan ing tampilan nevi sing wis ana.
Intoleransi Glukosa lan Diabetes Mellitus
Pengobatan kanthi hormon pertumbuhan bisa nyuda sensitivitas insulin, utamane ing dosis sing luwih dhuwur. Diabetes mellitus jinis 2 anyar wis dilaporake ing pasien sing nampa hormon pertumbuhan. Pasien karo pra-diabetes lan diabetes mellitus sing ora didiagnosis bisa ngalami kontrol glikemik sing luwih elek lan dadi gejala. Ngawasi tingkat glukosa sacara periodik ing kabeh pasien sing nampa somatrogon-ghla, utamane ing wong sing duwe faktor risiko diabetes mellitus, kayata obesitas, sindrom Turner, utawa riwayat kulawarga diabetes mellitus. Pasien karo diabetes mellitus jinis 1 utawa jinis 2 utawa pra-diabetes kudu dipantau kanthi teliti. Dosis agen antidiabetik mbutuhake pangaturan nalika somatrogon-ghla diwiwiti.
Hipertensi Intrakranial
Hipertensi Intrakranial (IH) kanthi papilledema, owah-owahan visual, sirah, mual, lan / utawa muntah wis dilaporake ing pasien sing diobati karo somatropin. Gejala biasane dumadi ing wolung (8) minggu pisanan sawise wiwitan terapi somatropin. Ing kabeh kasus sing dilapurake, pratandha lan gejala sing gegandhengan karo IH kanthi cepet ditanggulangi sawise mandheg terapi utawa ngurangi dosis somatropin.
Nindakake pemeriksaan fundoskopi sadurunge miwiti perawatan karo somatrogon-ghla kanggo ngilangi papilledema sing wis ana lan sacara periodik sakwise. Yen papilledema diidentifikasi sadurunge wiwitan, evaluasi etiologi lan nambani sabab sing ndasari sadurunge miwiti somatrogon-ghla. Somatrogon-ghla kudu dihentikan sementara ing pasien kanthi bukti klinis utawa fundoskopi IH. Yen IH dikonfirmasi, miwiti maneh perawatan karo somatrogon-ghla kanthi dosis sing luwih murah sawise pratandha lan gejala sing ana gandhengane karo IH wis rampung.
Retensi Cairan
Retensi Cairan sajrone terapi somatrogon-ghla bisa kedadeyan. Manifestasi klinis saka retensi cairan (umpamane edema lan sindrom kompresi saraf kalebu sindrom carpal tunnel/paresthesia) biasane transient lan gumantung dosis.
Hipoadrenalisme
Pasien sing nampa terapi hormon pertumbuhan sing duwe utawa beresiko kekurangan hormon hipofisis bisa uga ana risiko nyuda tingkat kortisol serum lan / utawa mbukak tutup hipoadrenalisme pusat (sekunder). Kajaba iku, pasien sing diobati karo panggantos glukokortikoid kanggo hypoadrenalism sing wis didiagnosis sadurunge bisa mbutuhake paningkatan dosis pangopènan utawa stres sawise miwiti perawatan somatrogon-ghla. Ngawasi pasien kanggo nyuda tingkat kortisol serum lan/utawa perlu kanggo nambah dosis glukokortikoid ing wong sing duwe hypoadrenalism sing dikenal.
Hypothyroidism
Hypothyroidism sing ora didiagnosa / ora diobati bisa nyegah respon optimal kanggo terapi somatrogon-ghla. Ing pasien sing kurang GH, hipotiroidisme tengah (sekunder) bisa uga katon utawa saya parah sajrone perawatan karo terapi hormon pertumbuhan. Mula, pasien kudu nganakake tes fungsi tiroid berkala lan terapi penggantian hormon tiroid kudu diwiwiti utawa diatur kanthi tepat yen dituduhake.
Slipped Capital Femoral Epiphysis
Slipped Capital Femoral Epiphysis bisa kedadeyan luwih kerep ing pasien sing ngalami wutah kanthi cepet. Evaluasi pasien pediatrik kanthi wiwitan limp utawa keluhan nyeri pinggul utawa lutut sing terus-terusan.
Kemajuan Scoliosis sing wis ana sadurunge
Somatrogon-ghla ningkatake tingkat pertumbuhan, lan kemajuan scoliosis sing wis ana bisa kedadeyan ing pasien sing ngalami pertumbuhan kanthi cepet. Pangobatan hormon pertumbuhan durung ditampilake kanggo nambah kedadeyan scoliosis. Ngawasi pasien kanthi riwayat scoliosis kanggo kemajuan penyakit.
Pankreatitis
Kasus pankreatitis wis dilaporake ing pasien sing nampa somatropin. Resiko bisa luwih gedhe ing pasien pediatrik dibandhingake karo wong diwasa. Coba pankreatitis ing pasien sing ngalami nyeri abdomen sing terus-terusan.
Lipoatrophy
Yen somatrogon-ghla diwenehake kanthi subkutan ing situs sing padha sajrone wektu sing suwe, bisa nyebabake lipoatrofi. Puterake situs injeksi nalika menehi somatrogon-ghla kanggo nyuda resiko iki.
Pati Dadakan ing Pasien Anak Kanthi Sindrom Prader-Willi
Ana laporan babagan kematian dadakan sawise miwiti terapi karo somatropin ing pasien pediatrik karo sindrom Prader-Willi sing duwe siji utawa luwih faktor risiko ing ngisor iki. : obesitas abot, riwayat obstruksi saluran napas ndhuwur utawa apnea turu, utawa infeksi pernapasan sing ora dingerteni. Pasien lanang sing duwe siji utawa luwih faktor kasebut bisa uga duwe risiko luwih gedhe tinimbang wanita. Somatrogon-ghla ora diwènèhaké kanggo perawatan pasien pediatrik sing gagal pertumbuhan amarga sindrom Prader-Willi sing dikonfirmasi sacara genetis.
Tes Laboratorium
Kadar fosfor, alkali fosfatase, lan hormon paratiroid ing serum bisa nambah kanthi terapi somatrogon-ghla. Yen pasien ditemokake duwe tes laboratorium sing ora normal, monitor sing cocog.
Populasi Tertentu
KandhutanOra ana data sing kasedhiya babagan panggunaan somatrogon-ghla ing wanita ngandhut kanggo ngevaluasi risiko sing gegandhengan karo obat kanggo cacat lair utama, keguguran, utawa asil sing ora becik kanggo ibu utawa janin. Ing studi reproduksi karo tikus ngandhut, ora ana bukti keracunan embrio-janin sawise administrasi somatrogon-ghla subkutan sajrone organogenesis kanthi dosis nganti 45 kaping dosis maksimum sing disaranake manungsa adhedhasar pajanan.
Risiko 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%, masing-masing.
LaktasiOra ana data babagan ngarsane saka somatrogon-ghla ing susu manungsa utawa kewan, efek ing bayi sing nyusoni, utawa efek ing produksi susu. Mupangat pangembangan lan kesehatan saka nyusoni kudu dianggep bebarengan karo kabutuhan klinis ibu kanggo somatrogon-ghla lan efek samping sing potensial kanggo bayi sing disusui saka somatrogon-ghla utawa saka kondisi ibu sing ndasari.
Wanita lan Lanang Potensi ReproduksiSanajan somatrogon-ghla ora ngganggu tes meteng hCG ing sawetara tes komersial sing winates, gangguan karo tes meteng getih lan urin hCG ing pasien sing nampa somatrogon-ghla bisa uga, nyebabake asil positif palsu utawa negatif palsu. Cara alternatif (yaiku, ora gumantung ing hCG) dianjurake kanggo nemtokake meteng.
Panggunaan PediatrikAman lan efektifitas somatrogon-ghla wis ditetepake kanggo perawatan gagal pertumbuhan amarga sekresi hormon pertumbuhan endogen sing ora nyukupi. (GH) ing pasien pediatrik umur 3 taun lan luwih. Panggunaan somatrogon-ghla kanggo indikasi iki didhukung dening bukti saka 52 minggu, multi-pusat, acak, open-label, aktif-kontrol, paralel-kelompok fase 3 sinau ing 224 perawatan-naif, subyek pediatrik prepubertal kanthi wutah kurang hormon.
Risiko ing pasien pediatrik sing gegandhèngan karo panggunaan hormon pertumbuhan kalebu:
Efek Samsaya Awon
Reaksi salabetipun sing dilapurake ing ≥5% pasien sing diobati karo somatrogon-ghla kalebu reaksi ing situs injeksi, nasofaringitis, sirah, pyrexia, anemia, batuk, muntah, hipotiroidisme, nyeri weteng. , ruam, lan nyeri orofaringeal.
Apa obatan liyane bakal mengaruhi Somatrogon (Systemic)
Obat Spesifik
Iku penting panyedhiya label pabrikan dikonsultasi kanggo informasi sing luwih rinci babagan interaksi karo obat iki, kalebu kemungkinan pangaturan dosis. Sorotan interaksi:
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