Vaccinia Immune Globulin IV
Jeneng merek: CNJ-016
Kelas obat:
Agen Antineoplastik
Panganggone Vaccinia Immune Globulin IV
Komplikasi Vaksinasi Cacar
Pengobatan lan/utawa manajemen komplikasi tartamtu saka vaksinasi cacar, kalebu vaksinasi eksim, vaksinasi progresif, vaksinasi umum sing abot, infeksi Vaccinia ing individu sing duwe kondisi kulit tartamtu (contone, kobong, impetigo , infèksi virus varicElla zoster, poison ivy, lesi kulit eczematous aktif utawa ekstensif), lan infèksi vaccinia aberrant disebabake autoinoculation ora sengaja ing mripat (kajaba vaccinia keratitis terisolasi), tutuk, utawa wilayah liyane sing infèksi kuwi bakal dadi bebaya khusus. Ditunjuk minangka obat yatim piatu dening FDA kanggo panggunaan iki.
Dianggep minangka perawatan lini pertama kanggo komplikasi serius vaksinasi cacar. Contraindicated ing patients karo keratitis vaccinia terisolasi; ora dianjurake kanggo perawatan saka encephalitis postvaccinial.
Yen VIGIV mung ora cukup utawa yen VIGIV ora kasedhiya, bisa nimbang nggunakake antivirus tartamtu (contone, cidofovir, Tecovirimat, Brincidofovir) kanggo perawatan komplikasi vaksinasi cacar sawise konsultasi karo CDC.
Hubungi departemen kesehatan negara bagian utawa lokal utawa Pusat Operasi Darurat CDC ing 770-488-7100 kanggo pitulung babagan diagnosis lan manajemen komplikasi sing dicurigai saka vaksinasi cacar.
Monkeypox
Sanajan data khasiat ora kasedhiya, CDC nyatakake yen ana kahanan tartamtu nalika VIGIV bisa dianggep kanggo perawatan monkeypox abot† [off-label]. Kajaba iku, CDC nyatakake yen panggunaan VIGIV bisa dianggep minangka profilaksis postexposure cacar monkeypox† [off-label] ing wong sing ora bisa nampa vaksinasi pasca pajanan karo vaksin cacar amarga kekurangan fungsi sel T sing abot.
Virus monkeypox minangka virus orthopox sing ana hubungane karo agen penyebab cacar. Sanajan ora ana perawatan khusus kanggo infeksi monkeypox, CDC nyatakake yen wabah monkeypox bisa dikontrol kanthi nggunakake vaksin cacar, VIGIV, lan antivirus tartamtu (contone, cidofovir, tecovirimat, brincidofovir).
Yen ana wabah monkeypox ana ing AS, CDC bakal nggawe pedoman sing dianyari kanggo nggunakake vaksin cacar, VIGIV, utawa antivirus kanggo perawatan lan/utawa profilaksis pasca pajanan kanggo wong sing wis kapapar.
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Carane nggunakake Vaccinia Immune Globulin IV
Umum
Administrasi
Administrasi mung kanthi infus IV.
IV Infus
Administrasi liwat jalur IV khusus. Yen kateter sing wis ana sadurunge kudu digunakake, siram garis karo injeksi natrium klorida 0,9% sadurunge menehi VIGIV.
Sadurunge administrasi, ngidini vial VIGIV teka ing suhu kamar. Cairan bokor beku kanthi dilebokake ing kulkas (2–8°C) nganti thawed (kira-kira 14 jam) utawa dilebokake ing suhu kamar suwene 1 jam banjur disiram banyu (37°C) nganti thawed rampung. Aja nyawiji ing gelombang mikro.
Katon kaya cairan bening nganti opalescent; aja digunakake yen mendhung, bundhas, utawa ngandhut partikel.
Bisa ditindakake tanpa diencerake utawa bisa diencerake nganti ora luwih saka 1:2 nggunakake injeksi natrium klorida 0,9%. Data ora kasedhiya babagan kompatibilitas karo solusi infus liyane.
Pasti miwiti infus IV ing 4 jam sawise vial dilebokake. Buang bokor sing sebagian wis digunakake.
Aja goyangake bokor amarga goyang bisa nyebabake umpluk.
Tarif AdministrasiKanggo infus IV kanthi kecepatan ≤2 mL/menit.
Pasien sing bobote <50 kg: Produsen nyaranake tingkat infus IV maksimal 0,04 mL/kg per menit (133,3 unit/kg per menit). cedera ginjel akut, trombosis, utawa kakehan volume: Gunakake konsentrasi minimal lan tingkat infus IV sing bisa ditindakake. Aja ngluwihi tingkat infus sing disaranake lan tindakake jadwal infus kanthi rapet.
Yen efek saru sing relatif cilik (contone, flushing), tingkat infus alon. Yen reaksi sing luwih serius (contone, anafilaksis, hipotensi), mandhegake infus lan miwiti terapi sing cocog.
Dosis
Pasien Anak
Komplikasi Vaksinasi Cacar Remaja ≥16 Taun Umur IV6000 unit/kg dosis tunggal. Menehi sanalika gejala katon lan komplikasi sing gegandhengan karo vaccinia abot didiagnosis.
Gumantung saka keruwetan gejala lan respon kanggo perawatan, bisa nimbang menehi dosis kapindho 6000 unit/kg; data klinis babagan dosis ulang VIGIV ora kasedhiya.
Yen ora ana respon kanggo dosis awal, bisa nimbang dosis sing luwih dhuwur (contone, 9000 unit / kg).
Dewasa
Komplikasi Vaksinasi Cacar Dewasa ≤65 Taun Umur IV6000 unit/kg minangka dosis tunggal. Menehi sanalika gejala katon lan komplikasi sing gegandhengan karo vaccinia abot didiagnosis.
Gumantung saka keruwetan gejala lan respon kanggo perawatan, bisa nimbang menehi dosis kapindho 6000 unit/kg; data klinis babagan dosis ulang VIGIV ora kasedhiya.
Yen ora ana respon kanggo dosis awal, bisa nimbang dosis sing luwih dhuwur (contone, 9000 unit / kg). Ing uji klinis ing wong diwasa sing sehat, dosis nganti 24.000 unit / kg bisa ditoleransi kanthi apik.
Watesan Resep
Pasien Anak
IVPasien kanthi faktor risiko trombosis : Dosis maksimal 12.000 unit/kg saben dina.
Dewasa
IVPasien kanthi faktor risiko trombosis: Dosis maksimal 12.000 unit/kg saben dina.
Populasi Khusus
Gangguan Hepatik
Ora ana rekomendasi dosis khusus.
p>Gangguan Ginjal
Ora ana rekomendasi dosis khusus. Gunakake kanthi ati-ati ing pasien sing nandhang gagal ginjel lan ing wong sing duwe risiko disfungsi ginjel. (Deleng Gagal Ginjal ing Caution.)
Pènget
Kontraindikasi
Pènget / PancegahanReaksi Sensitivitas
Reaksi Hipersensitivitas
Reaksi hipersensitivitas langsung sing abot kanggo produk sing asale saka plasma bisa kedadeyan.
Sanajan reaksi alergi sistemik akut ora dilapurake ing uji klinis VIGIV, mung ditrapake ing setelan. yen kasedhiya peralatan lan personel sing dilatih ing manajemen anafilaksis akut.
Yen ana hipotensi utawa reaksi alergi utawa anafilaksis, langsung mandhegake infus IV VIGIV lan miwiti perawatan dhukungan sing cocog yen perlu.
Kekurangan IgAIndividu sing kekurangan IgA bisa ngembangake antibodi kanggo IgA; anafilaksis bisa kedadeyan sawise administrasi produk asale saka plasma sing ngemot IgA.
VIGIV ngemot jumlah IgA (≤40 mcg/mL).
Efek Ginjal
Disfungsi ginjal, gagal ginjal akut, nefropati osmotik, nefropati tubulus proksimal, lan pati sing dilaporake ing pasien sing nampa immunoglobulin IV (IGIV).
Kasus sing paling akeh dilaporake Gagal ginjel sawise administrasi IGIV kedadeyan ing pasien sing nampa persiapan IGIV sing ngemot sukrosa ing dosis saben dina ≥400 mg / kg. VIGIV ora ngemot sukrosa.
Gunakake VIGIV kanthi ati-ati ing pasien sing duwe gangguan ginjel sing wis ana sadurunge lan ing pasien sing duwe risiko ngalami gangguan ginjel (contone, diabetes mellitus, kurang volume, paraproteinemia, utawa sepsis lan sing umure luwih saka 65 taun utawa lagi nampa obat nefrotoksik).
Data ora kasedhiya nganti saiki kanggo ngenali dosis maksimal, konsentrasi, lan/utawa tingkat infus IV sing aman kanggo nggunakake VIGIV ing pasien kanthi risiko ngembangake. gangguan ginjel. Yen VIGIV digunakake ing pasien kasebut, gunakake kanthi nggunakake tingkat infus minimal sing bisa ditindakake.
Sadurunge administrasi, priksa manawa pasien sing duwe gangguan ginjel sing wis ana sadurunge lan pasien kanthi risiko tambah gagal ginjal ora nyuda volume.
Kaji fungsi ginjel (BUN lan Scr) sadurunge lan ing interval sing cocog sawise VIGIV. Ngawasi fungsi ginjel lan output urin kanthi periodik, utamane ing pasien sing dianggep tambah risiko ngalami gagal ginjal akut.
Yen fungsi ginjel saya rusak, coba mandhegake VIGIV.
Interferensi karo Tes Laboratorium
Ngandhut maltosa sing bisa nyebabake asil palsu ing penentuan glukosa getih sing nggunakake glukosa dehidrogenase pyrroloquinolinequinone (GDH-PQQ) utawa metode glukosa-pewarna-oxidoreductase. Tekad glukosa sing salah bisa nyebabake administrasi insulin sing ora cocog lan hipoglikemia sing ngancam nyawa lan ana risiko yen kasus hipoglikemia sing bener ora bisa diobati. Gunakake metode tes khusus glukosa (monitor lan jalur tes) sing ora kena pengaruh maltosa. Yen ana kahanan sing durung mesthi, hubungi pabrikan sistem tes glukosa kanggo nemtokake manawa sistem kasebut bakal menehi tes glukosa getih sing akurat kanggo pasien sing nampa VIGIV.
Ngandhut antibodi sing bisa ngganggu sawetara tes serologis. Pasien sing nampa globulin imun kayata VIGIV bisa uga ngalami paningkatan sementara ing macem-macem antibodi sing dipikolehi kanthi pasif sing bisa nyebabake asil tes serologis positif palsu (contone, tes Coombs). (Deleng Hemolisis ing Caution.)
Trombosis
Acara trombotik sing dilapurake ing pasien sing nampa IGIV.
Pasien sing duwe risiko trombosis kalebu sing duwe riwayat faktor risiko kardiovaskular, umur lanjut, gangguan output jantung, hiperkoagulasi. kelainan, wektu imobilisasi sing suwe, riwayat trombosis arteri utawa vena, panggunaan persiapan sing ngemot estrogen, kateter vaskular pusat sing ana ing njero, lan/utawa hiperviskositas sing dikawruhi utawa dicurigai.
Pertimbangake risiko potensial lan keuntungan saka VIGIV lan timbang karo terapi alternatif.
Amarga bisa nambah risiko trombosis, nimbang penilaian awal viskositas getih ing pasien sing duwe risiko hiperviskositas (contone, sing duwe cryoglobulins, kilomikronemia pasa / triacyglycerols sing dhuwur banget [trigliserida] , gammopathies monoklonal).
Yen manfaat VIGIV luwih gedhe tinimbang risiko potensial trombotik lan tromboemboli, gunakake VIGIV kanthi konsentrasi minimal sing kasedhiya lan tingkat infus IV minimal bisa ditindakake lan monitor tandha-tandha lan gejala trombosis. Kajaba iku, mesthekake hidrasi sing nyukupi sadurunge administrasi VIGIV.
Data calon ora kasedhiya kanggo ngenali dosis maksimal, konsentrasi, lan/utawa tingkat infus IV yen VIGIV digunakake ing pasien karo trombosis/tromboembolisme. Produsen nyatakake ora ngluwihi dosis VIGIV 12.000 unit / kg saben dina ing pasien kanthi faktor risiko trombotik.
Hemolisis
VIGIV bisa uga ngemot antibodi golongan getih sing bisa tumindak minangka hemolisin lan ngindhuksi lapisan sel darah merah in vivo karo globulin imun, nyebabake reaksi antiglobulin langsung positif lan hemolisis.
Akut. hemolisis, konsisten karo hemolisis intravaskular, dilapurake karo IGIV; anemia hemolitik bisa berkembang sakbanjure terapi IGIV amarga sekuestrasi eritrosit sing luwih apik.
Faktor risiko sing bisa digandhengake karo perkembangan hemolisis sawise administrasi IGIV kalebu dosis dhuwur (diwenehake minangka dosis siji utawa dibagi dosis sajrone sawetara dina). ) lan golongan getih non-O. Senajan faktor pasien individu liyane uga hipotesis kanggo nambah risiko hemolisis sawise administrasi IGIV (contone, kahanan inflamasi sing ndasari kaya sing dibayangke, contone, protein C-reaktif sing dhuwur utawa tingkat sedimentasi eritrosit), peran faktor kasebut ora mesthi. p>
Pantau kanthi rapet kanggo tandha-tandha klinis lan gejala hemolisis, utamane sing duwe faktor risiko hemolisis. Ing pasien sing dianggep beresiko luwih dhuwur, nimbang tes laboratorium sing cocog, kalebu pangukuran hemoglobin utawa hematokrit sadurunge infus IV VIGIV lan kira-kira 36-96 jam sawise rampung infus. Tindakake tes laboratorium kOnfirmasi tambahan yen tandha lan/utawa gejala hemolisis utawa penurunan hemoglobin utawa hematokrit sing signifikan sawise infus VIGIV.
Yen transfusi getih dituduhake kanggo pasien sing ngalami hemolisis kanthi anemia sing mbebayani sacara klinis sawise nampa VIGIV, nindakake cross-matching sing cukup kanggo ngindhari hemolisis sing terus-terusan.
Sindrom Meningitis Aseptik
Sindrom meningitis aseptik dilapurake ing pasien sing nampa IGIV.
Dicirikan kanthi nyeri sirah abot, kaku nuchal, ngantuk, mriyang, fotofobia, gerakan mripat sing nyeri, mual, lan muntah; biasane katon ing sawetara jam nganti 2 dina sawise administrasi IGIV.
Analisis CSF kerep nuduhake pleositosis (nganti sawetara ewu sel per mm3), utamane saka seri granulocytic, lan konsentrasi protein nganti pirang-pirang atus mg / dL; Kultur CSF negatif.
Ing pasien sing nampa IGIV, sindrom meningitis aseptik paling kerep dilapurake ing wong sing nampa dosis total dhuwur (2 g/kg). Dibandhingake, kanthi dosis VIGIV sing disaranake 6000 unit / kg, pasien bisa kena nganti 0,18 g / kg protein.
Sindrom meningitis aseptik umume pulih sajrone sawetara dina tanpa sekuele sawise mandhegake IGIV.
Yen ana pratandha lan gejala sindrom meningitis aseptik ing pasien sing diobati karo VIGIV, tindakake pemeriksaan neurologis sing lengkap (kalebu studi CSF) kanggo ngilangi panyebab liyane meningitis.
Cedera paru-paru akut sing gegandhengan karo transfusi
Cedera paru-paru akut sing gegandhengan karo transfusi (TRALI; edema paru nonkardiogenik) sing dilapurake ing pasien sing nampa IGIV.
Biasane kedadeyan sajrone 1-6 jam sawise Infus IGIV lan ditondoi kanthi gangguan ambegan sing abot, edema paru, hipoksemia, fungsi ventrikel kiri normal, lan demam.
Monitor reaksi paru-paru sing ala. Yen TRALI dicurigai, tindakake tes sing cocog kanggo nemtokake manawa ana antibodi antiNeutrofil ing produk utawa ing serum pasien.
Atur nggunakake terapi oksigen kanthi dhukungan ventilasi sing cukup.
Risiko Agen Infèksi sing Bisa Ditular ing Preparasi sing Diturunake Plasma
Amarga VIGIV disiapake saka plasma manungsa sing dikumpulake, iki minangka kendaraan potensial kanggo transmisi virus manungsa lan sacara teoritis bisa nggawa risiko nularake agen penyebab. saka penyakit Creutzfeldt-Jakob (CJD).
Sanajan sumbangan plasma sing digunakake kanggo nyiapake VIGIV dites kanggo virus tartamtu (umpamane, HIV, HBV, HCV) lan VIGIV ngalami prosedur tartamtu (yaiku, inaktivasi virus pelarut/deterjen. , filtrasi virus, kromatografi kolom pertukaran anion) sing nyuda potensial infèksi virus, risiko panularan agen infèksius, kalebu agen infèksi sing ditularaké getih sing ora diakoni, isih tetep sanajan ana langkah-langkah kasebut.
Lapokake infeksi sing diyakini wis ditularake VIGIV menyang pabrikan ing 800-768-2304.
Panyimpenan lan Penanganan sing ora bener
Panyimpenan utawa penanganan globulin imun sing ora bener bisa mengaruhi khasiat.
Priksa kabeh globulin kekebalan nalika dikirim lan monitor sajrone panyimpenan kanggo mesthekake yen suhu sing cocog dijaga. .
Aja menehi VIGIV sing salah ditangani utawa ora disimpen ing suhu sing disaranake. (Deleng Panyimpenan ing Stabilitas.)
Yen ana keprihatinan babagan penanganan sing salah, hubungi pabrikan utawa departemen imunisasi utawa kesehatan negara utawa lokal kanggo panuntun babagan apa VIGIV bisa digunakake.
Populasi Tertentu
KandhutanStudi reproduksi kewan ora ditindakake. Data ora kasedhiya babagan panggunaan VIGIV ing wanita ngandhut kanggo ngandhani risiko sing gegandhengan karo obat.
ACIP nyatakake ora ana risiko sing dikawruhi karo panggunaan globulin imun ing wanita ngandhut.
CDC negara. VIGIV ora dituduhake kanggo profilaksis ing wanita ngandhut sing ora sengaja divaksinasi karo vaksin cacar; Nanging, aja nyegah VIGIV yen wanita ngandhut ngalami komplikasi vaksinasi cacar (umpamane, vaksinasi eksim).
LaktasiOra dingerteni manawa VIGIV disebarake menyang susu manungsa, mengaruhi produksi susu, utawa mengaruhi sing disusui. bayi.
Panggunaan PediatrikKeslametan lan khasiat ora ditetepake ing pasien pediatrik <16 taun.
Panggunaan GeriatrikKeamanan lan khasiat ora ditetepake ing wong diwasa geriatrik > 65 taun.
p> Gagal GinjalGunakake kanthi ati-ati lan diwènèhaké ing tingkat infus IV minimal sing bisa ditindakake ing pasien kanthi gangguan ginjel sing wis ana lan ing wong sing duwe risiko ngalami gangguan ginjel. Iki kalebu, nanging ora diwatesi, kanggo wong sing nandhang diabetes mellitus, nyuda volume, paraproteinemia, utawa sepsis lan wong-wong sing umure luwih saka 65 taun† [off-label] utawa lagi nampa obat nefrotoksik.
Efek Umum sing Sabar
Sakit sirah, mual, kaku, pusing.
Apa obatan liyane bakal mengaruhi Vaccinia Immune Globulin IV
Vaksin lan Toksoid sing ora aktif
Vaksin utawa toksoid sing ora aktif bisa ditindakake bebarengan karo (ing situs sing beda-beda) utawa ing interval apa wae sadurunge utawa sawise persiapan globulin imun, kalebu VIGIV.
Vaksin Urip
Antibodi sing ana ing VIGIV bisa ngganggu respon imun kanggo sawetara vaksin virus urip, kalebu vaksin campak, gondok, lan virus rubella urip (MMR) lan vaksin virus varicella urip. Aja menehi vaksin urip lan persiapan globulin imun, kalebu VIGIV, bebarengan. Nundha vaksin virus urip nganti kira-kira 3 sasi sawise VIGIV; vaksinasi maneh karo vaksin urip sing dituduhake yen VIGIV diwenehake sakcepete sawise vaksin urip.
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