ite, 6-AV » i » = me yar, na a “gue REMDERSIVIR Dang bao ché: : Lo bot d6ng khé chtra 100mg remdesivir hoac dung dich dam dic ding dé jie truyén Looe ml (Smg/ml)Bon vj Duege lm sang ~ Thong tin thude, Khoa Diege, Bénh vién Bach Mai F/ REMDESIVIR Dang bao ché: Lo bot dong khé chita 100mg remdesivir hose dung dich ding dé pha truyén 100mg/20 ml (Smg/ml) CHi DINH ~ Nguéii bénh ni tra, mite d6 nhe va cé it nhat mét yéu t6 nguy co tién trién nang; mie 46 trung binh va nang, khéi phat bénh chua qua 10 ngay c6 suy hé hap phai thé oxy, tho HENC, thé may khdng xam nhap. - Nén phéi hyp voi corticoid (wu tién dexamethason) - Voi cée tring hop di duge digu tri bing remdesivir true khi thé may xm nhap hofic ECMO thi c@ thé tiép tuc dang remdesivir cho dit ligu trinh CHONG CHi BINH Bing chitng lam sang: Co quan quén thyec phd Hoa ki (FDA) da phé duyét chi dinh remdesivir cho cée bénh nhén ngoai tri dua trén két qua thie nghiém lam sang mit déi voi 562 bénk nhdn ngueéi lin diéu tri ngoai tri, dicong tinh voi SARS-CoV-2, ¢6 ede trigu ching COVID-19 trong ving 7 ngdy trrde dé vi cb it nhdt mot yéu t6 nguy co tién trién nding (bénh nhin 260 tudi, béo phi, ting huyét dp, dai théo dieing). Céc bénh nan duce diéu tri ngdu nhién bang remdesivir hole gid diege trong 3 ngdy, liéu remdesivir ngdy déu 200mg, cde ngdy sau 100 mg méi 24 gid. Ti If bénk nhin nhgp vign do COVID-19 ngdy tit 28 it hon c6 J nghia thing ké 6 nhém diing remdesivir so v6i nhém ding gid diroc (0.7% so voi 5.3%: HR 0.13 [95% CI 0.03-0.59]; NNT 21.8). Khong c6 ‘bénk nhén tie vong ngdy thit 28 6 ed hat mhém. - Tién str qua man véi bat ky thanh phan nao trong céng thite thudc. - Tang enzyme gan ALT > 5 lin gid tri giéi han trén cia khoang gia trj binh thudng LIEU DUNG| Ngw0i lon vi tré em > 12 tudi, céin niing > 40kg - Ngay dau tién: liu nap 200mg truyén tinh mach trong vong 30 ~ 120 phut, nhiing ngay sau ligu duy tri: 100mg truyén tinh mach, 1 lin/ngay, trong 2 — 5 ngay. Tré em < 12 tuéi va can nding > 40 kg: ap dung gidng liéu cia ngudi in Tré em < 12 tuéi, céin niing tie 3,5 dén 40kg - Ngay dau tién: liu nap Smg/kg, nhiing ngay sau ligu duy tri: 2,5mg/kg/ngay, truyén tinh mach trong 2 — 5 ngay. Déi véi bénh nhan khong ghi nhfn cai thign vé mat lam sing sau 5 ngay diéu tri c6 thé can nhac digu tr tiép dén 10 ngay. Thing tin ip at 03/2022Bon vj Duge lm sang ~ Thong tin thude, Khoa Duege, Bénh vién Bach Mai HIEU CHINH LIEU BENH NHAN SUY GIAM CHUC NANG GAN - THAN Thude cha dige dinh gid trén bénh nhdn Igc | Suy than mau, Khdng Khuyén céo sie dung cho bénh nhan | - eGFR > 30 ml/phut: khdng cdn higu ngueéi lan va tré em (> 28 ngay tdi tro lén) cé | chinh ligu eGER <30 mLiphiit hodec tré so sinh di thing (27 ngay va < 28 ngay) cé creatinin huyét thanh > 88,4 mol/L do té duoc sulfobutylether-B-cyclodextrin | Suy gan (SBECD) tich ly 6: nhiing bgnh nhin suy gidm chire | - Chua c6 dit ligu danh gid trén bénh ning than. Tuy nhién, rong 100 mg remdesivir dang | phan suy gan ot ding khé hoje dung dich truyén c6 3g hode 6g | -—- = SBECD, SBECD cé nguing an toin 1a 250 ||CACH DUNG mg/kgingay. Mii dit di iu an toan arén bénh nhan | ~ Bn han nb ti 3.5kg dén dues 6 eGER <30 mLphit cdn thiéw, du ti 3-10 ngay | 4g: chi ding dang bt déng kho remdesivir cho thay néng d6 SBECD thdp, goi ¥ loi A a ich cé thé viegt trdi hon nguy co. Hon nita SBECD | ~ Khong str dung dung dich dam dic dove tht tnt qua Toe mi ngét quang vd loc mau | 100mg/20ml (Smg/ml) cho tré em < lién tue (J Am Soc Nephrol 2020;31:1384). 40kg hoje bénh nhan suy thin cé Liéu ding remdesivir dige ste dung trong cée | eGFR< 30 ml/phat nghién citu trén bénh nhn suy than €6 loc mau ngat quing hot loc lién ue: liu nap 200mg, lidu duy tri 100mg/ngay. - eGFR < 30 ml/phiit va loc mau - Khong truyén chung véi cae thude khae, tring duéng truyén bing NaCl 0,9% sau khi két thiie truyén Hoan nguyén Ig bot dong kho - Lay 19 ml nude cat pha tiém dé pha vao lg thuéc Remdesivir 100mg duge 20 ml dung dich thude c6 nding 49 Smg/ml Pha loang - Ding dung dich NaCI 0,9% logi thé tich 100ml hoge 250ml dé pha loang, trude khi pha can rat bét NaCl 0,9% véi lugng thé tich tuong duong thé tich thude sé pha vao. - Trwéng hop bénh nhén la ngudi lon va tré em > 12 tuoi, can nang > 40kg: Pha long lo thuéc di duge hoan nguyén thém véi NaCl 0,9%, truyén tinh mach trong vong 30 — 120 phit. - Truéng hop bénh nhén ld tré em < 12 tudi, can nding tie 3,5 dén 40kg: Lay s6 lugng thude di hoan nguyén sau khi tinh theo cn nang, pha loing v6i NaCl 0,9% dé duge néng 46 remdesivir 1,25 mg/mL, truyén tinh mach trong 30 — 120 phat BAO QUAN Dung dich sau khi pha lodng cé thé bio quan trong 24 gid 6 20 — 25 46 C hode 48 gid 6 2-8 d6C Thing tin ip at 03/2022Bon vj Duge lm sang ~ Thong tin thude, Khoa Diege, Bénh vién Bach Mai PHU NU CO THAI - CHO CON BU - Phy nit c6 thai va cho con bit: Chua cé dit ligu day di. Khong khuyén céo trir trudng hop loi ich vuot tri so véi nguy co. - Khong nén sit dung remdesivir cho phy nit c6 thai trong trudng hgp cho chi dinh khac TAC DUNG KHONG MONG MU - Cae trigu chimg dung tiéu hoa (budn nén ...), tang transaminase, ting thoi gian prothrombin (khéng kém theo ting INR), cae phan img qua man, Nén truyén cham trong vong 120 phat dé han ché cdc tac dung khéng mong muén. - Xét nghigm enzym gan va thdi gian prothrombin nén duge lam true va trong qué trinh diéu tri bang remdesivir. Nén dimg thuéc néu ALT > 5 lin gidi han trén hodc néu ALT tang va cé cdc dau higu ciia ton thong gan, TUONG TAC THUOC Chloroquin hoe hydroxychloroquin c6 thé kam hoat tinh eta remdesivir. TAL LIEU THAM KHAO BO Y té (2022). Vé vide sira déi, bé sung mé ém cla Huéng din chan doin va digu trj COVID-19 Huéng dan chin doan va diéu trj Covid-19 ban hanh kém theo Quyét dinh sé 437/QD-BYT ngay 27/02/2022 2. BO Y 16 (2022). Cong van sé 6573/BYT-KCB ngay 12/8/2021 vé viée huéng din trién khai sir dung thudc diéu tri COVID — 19 do Vingroup hé tro 3. FDA. Fact sheet for health care providers. Emergency Use Authorization (EUA) of Veklury (remdesivir) for the treatment of coronavirus disease 2019 (COVID- 19) in pediatric patients, January 2022. https://www. fda. gov/media/137566/download. Truy cp 21/3/2022. 4. Pettit NN et al (2020). Remdesivir Use in the Setting of Severe Renal Impairment: A Theoretical Concer or Real Risk? Clin Infect Dis 2021 Dec 6;73(1 1):€3990-€3995 5. Thakare S, Gandhi C et al (2020). Safety of Remdesivir in Patients With Acute Kidney Injury or CKD. Kidney Int Rep (2021) 6, 206 ~ 210 6. hitps://www.covid 9treatmentguidelines.nih. gov/therapies/antiviral- therapy/remdesivir/. Truy cap ngay 24/8/2021 7. hitps://dailymed.nim.nih.gov/dailymed/druginfo.ctm?setid=98b7e6bf-2668- 4a61-a874-194eb674b 5c. Truy cap ngay 24/8/2021 8._https://www.ema.europa.eu/en/documents/product-information/veklury-epar- product-information_en.pdf. Truy cp ngay 24/8/2021 Thing tin ip at 03/2022