BO Y TE CONG HOA XA H 0 I CHU NGHIA V I E T NAM CUC QUAN L Y DlTOC Doc lap - T u do - Hanh phuc

So: /QLD-TT V/v cung cap thong tin lien quan den tinh an

toan cua thudc tranh thai khan cap chha levonorgestrel, thuoc khang vi rut tac dong true tiep (DAA) dieu tr i viem gan sieu v i C,

thuoc chha warfarin

Kmh giri:

Ha Noi, ngdy nam 2017

E "sk .L.Zm"

So Y te cac tinh, thanh pho true thub<?!rungTft^^ D^Ty ftL - Cac benh vien, vien co giubng benh true thupc Bo Y te. ^ fa Ct7

Ngay 13/01/2017, Hoi dong Tu van cap So dang ky luu hanh thuoc - Bo Y te da hop xet duyet dot 157 - dbi vbi thubc trong nubc va dot 96 - dbi vbi thuoc nubc ngoai da thong nhat cap nhat cac thong tin ve tmh an toan cua: thuoc tranh thai khan cap chura levonorgestrel tuong tac vbi cac thuoc cam ung enzym CYP3A4, thubc khang vi rut tac dong true tiep (DAA) dieu tri viem gan sieu vi C, thubc chtra warfarin.

De dam bao su dung thubc an toan, hop ly, Cue Quan ly Dugc yeu c&u So Y te cac tinh, thanh phb true thubc Trung uong, cac benh vien, vien cb giubng benh true thubc Bo Y te:

1. Thong bao cho cac ca sa kham benh, chua benh, cac ca sa kinh doanh dirge tren dia ban cac thong tin lien quan den tlnh an toan, hieu qua cua cac thubc neu tren dugc ghi trong Phu luc "Cap nhat thong tin lien quan den tmh an toan thubc" dlnh kem trong cbng van nay, dbng thbi dugc dang tai tren cbng thong tin dien tu cua Cue Quan ly Dugc theo dia chi http://www.dav.gov.vn trong muc "Thong tin thubc" de cac can bo y te co the tra cum, cap nhat thong tin.

2. Hubng d in cac ca sa kham benh, chua benh tren dia ban tang cubng theo doi, phat hien va xu tr i cac trubng hgp xay ra phan umg cb hai cua cac thubc neu tren (neu cb). Gui bao cao phan bng cb hai cua thubc vb: Trung tarn qubc gia v6 Thong tin thubc va Theo dbi phan ung cb hai cua thubc (13-15 Le Thanh Tbng, Quan Hoan Kiem, Ha NOi) hoac Trung tarn khu vuc ve thong tin thubc va theo dbi phan ung cb hai cua thubc TP. Hb Chi Minh (20IB Nguyen Chi Thanh, Quan 5, TP. Ho Chi Minh).

Cue Quan ly Dugc se tiep tuc cap nhlt cac thong tin lien quan tmh an toan va hubng d in xu" tri dbi vbi cac ADR cua cac thubc neu tren de yeu cau cac ca sa dang ky thubc cap nhat vao nhan va tb hubng d in su dung thubc trong thbi gian tbi.

Cue Quan ly Dugc thong bao de cac dan vi biet va thuc hien./.

Noi nhan: K X C U C T R U I N G

^ C t r l l B p Y t e C d ^ b / c ) ; PHO C U C TRLr6NG - Cac T M truong Bo Y te (de b/c) ; - Cue Quan ly Kham chira benh; - Cue Quan Y - Bo Qubc phong ; - Cue Y te - Bo Cbng an ; - Cue Y te - Bb Giao thong van tai; - Trung tarn DI & ADR Qubc gia; ^ - Trung tarn DI & ADR khu vuc TP. HCM; - Website Cue Quan ly Duqc; - Phong DKT, QLKD, QLCL - Cue Quan ly Duqc; - Luu : VT, TT.

iyen Tat Dat

(

PHU L U C Cap nhat thong tin lien quan den tinh an toan ciia thubc

(Dinh kem theo Cbng van s6\A()ttf) /QLD-TT ngay 33 thang 3 nam 2017)

1. Thubc chua levonorgestrel su dung trong tranh thai khan cap tu'omg tac vol cac thubc cam ung enzym CYP3A4:

7.7. Cap nhat thong tin cua cdc nude tren The gicfi: - Thang 9/2016, Co quan Quan ly Dirge va cac san phlm y te cua Anh (MHRA)

da dira ra khuyen cao ve tirong tac cua cac thubc tranh thai khln cap chira levonorgestrel vbi cac chat g ly cam umg enzym gan. Theo do, cac thubc hoac cac thao dirge gay cam irng cac enzym CYP3A4 se lam giam nbng do trong mail ciia levonorgestrel. tir do d in den giam hieu qua tranh thai kh ln cap. M H R A da dua ra khuyen cao cho cac can bo y te nhu sau:

- Phu nir dang c ln sir dung bien phap tranh thai khan cap ma da sir dung cac chat gay cam irng enzym gan trong vbng 4 tuan tnrbc do:

+ Tot hon het la su dung bien phap tranh thai kh ln cap khbng cb hormon, vi dir. dung cu dat tir cung chira dbng.

+ Neu phiro'ng an tren khbng phai la mot lira chgn, can gap dbi lieu cua levonorgestrel tir l,5mg lbn 3 mg.

- Dbi vbi cac phu nu nay, cac can bo y te can: + Cung cap tu v l n ve cac bien phap tranh thai lien tuc cb hieu qua cao khbng bi

tac dbng boi cac thubc gay cam umg enzym gan. + Tu van hg tien hanh test thu thai de loai trur kha nang mang thai sau khi sir

dung thubc tranh thai kh ln cap chba levonorgestrel. + Tu van hg trong trubng hgp cb thai c ln tham van y kien chuyen gia y te ngay

lap tire. * Khuyen cao nay ciia M H R A xua't phap tir khuyen cao cua Co quan Quan ly

Dirge Chau Au vao ngay 01/8/2016. 7.2. Tinh hinh cap so clang ky chephdm thuoc chua Levonorgestrel dViet Nam: Hien nay, o Viet Nam cb 25 thubc nubc ngoai chua hoat chat Levonorgestrel

dugc cap SDK va 40 thubc trong nubc chira hoat chit Levonorgestrel dirge cap SDK.

2, Thubc khang vi rut tac dong true tiep (DAA) dieu tri viem gan sieu vi C: 7.7. Cap nhcit thong tin cua ccic nude tren The gidi: - Ngay 02/12/2016, Uy ban Danh gia nguy co Canh giac dirge (PRAC) cua Co

quan Quan ly Dugc Chau Au (EMA) da khang dinh benh nhan dugc dibu tri vbi thuoc khang vi nit tac dbng true tiep de dieu tri viem gan sieu vi C cb the cb nguy ca tai hoat viem gan sieu vi B. PRAC khuyen cao ring: trubc khi b i t dau dibu tri , tat ca cac benh nhan nen dirge sang lgc vi nit viem gan B; nhirng benh nhan dbng nhibm vbi vi nit viem gan B va C phai dugc giam sat va quan ly theo cac hubng d in dieu tri lam sang hien thbi.

Ngay 16/12/2016, Co quan Quan ly Dirge Chau Au (EMA) da phe chuan khuyen cao neu tren.

- Ngay 01/12/2016, sau khi xem xet, Co quan Quan ly Y te Canada (Health Canada) da ket l u l n r ing cb the cb mbi lien quan giua nguy ca tai hoat viem gan sieu vi B a nhirng benh nhan nhibm ca HBV va HCV dang dugc dieu tri vbi cac DAA.

Health Canada khuyen cao thong tin an toan cua tat ca cac D A A can cap nhat ve nguy co nay nhir mot than trong. Hon nua, mot thong bao cap nhat thong tin se dirge cbng bb rbng rai tbi ngu'bi dan va cac can bo y te.

- Ngay 04/10/2016, Co quan Quan ly Dirge va Thuc pham Hoa Ky (US FDA) dira ra canh bao ve nguy co tai hoat viem gan sieu vi B b nhung benh nhan hien tai hoac tru'bc day da bi nhibm HBV va hibn dang sir dung cac thubc D A A de dieu tri vibm gan sieu vi C. Trong mot so trirong hgp, vibe tai hoat HBV b bbnh nhan dang dieu tri vbi cac thubc D A A da d in den cac van de nghibm trgng ve gan hoac tir vong.

FDA ybu cau bb sung box canh bao (Boxed Warnings - dang canh bao manh nhat) ve nguy ca nbu trbn vao nhan cac thubc D A A ybu c lu cac can bo y te sang lgc va giam sat HBV b tat ca cac bbnh nhln dang sit dung cac thubc DAA. Canh bao nay cung dugc cap nhat vao tb thong tin cho bbnh nhan hoac cac hubng d in dieu tri ciia cac thubc nay.

7.2. Tinh hinh cap so dang ky ccic thuoc khang vi nit tdc dong true tiep (DAA) dieu tri viem gan sieu vi C:

Hibn nay, b Viet Nam cb 06 thubc khang vi nit tac dpng true tiep (DAA) dibu tri vibm gan sibu vi C nubc ngoai va 01 thubc trong nubc dirge cap SDK.

Cue Quan ly Dugc - Bp Y te se cb cbng van giri cac dan vi dang ky, san xuat thubc yeu cau va hubng d in vibe cap nhat cac thong tin canh bao nay vao nhan va to hubng din sir dung cua cac thubc cb lien quan.

3. Thubc chira warfarin: 5.7. Cap nhat thong tin cua ede nude tren Thegioi: - Trong an pham Drug Safety Update ra thang 7 nam 2016, Co quan Quan ly

Dirge pham va San pham y te Anh (MHRA) cb canh bao vb nguy ca xay ra chfrng calci hba mach mau va hoai tu da lien quan den vibe sir dung warfarin.

- Mot cube ra soat trbn toan chau Au da dugc thuc hibn gan day dua trbn nhirng du lieu hibn cb cho thay vibe su dung warfarin cb thb gby ra chii'ng calci hba mach mau va hoai tir da (calciphylaxis) vbi ty lb hib'm gap. Day la mot tinh trang rat nghibm trgng vbi ty lb tir vong cao, thudng dugc ghi nhan trbn bbnh nhan cb bbnh than giai doan cubi hoac trbn nhirng bbnh nhan cb cac yeu tb nguy ca nhu thieu hut protein C hoac S, tang phosphat mau; tang calci mau hoac ha albumin mau. Cac tnrbng hgp calci hba mach mau va hoai tir da da dirge bao cao trbn bbnh nhan sir dung warfarin, bao gbm ca nhung bbnh nhan cb chu'c nang than binh thubng.Tb thong tin san pham va tb thong tin cho bbnh nhan cua warfarin se dugc cap nhat cac khuybh cao nbu trbn cung nhir canh bao bbnh nhan ve nguy ca cua chii'ng calci hba mach mau va hoai tir da.

- Nhan thubc va tb hubng d in su' dung thubc cho bbnh nhan sir dung warfarin da dugc MHRA cap nhat thong tin ve nguy ca xay ra chii'ng calci hba mach mau va hoai tu da.

- Ngay 17/11/2016, Cue Quan ly Dugc nhan dugc alert (canh bao) tu' He thong giam sat hau mai (PMAS) cua ASEAN thong bao: Cue Quan ly Dugc Qubc gia (NPCB) Malaysia thong bao da ybu cau cap nhat cac thong tin mbi ve nguy ca xay ra chii'ng calci hba mach mau va hoai tu da (calciphylaxis) lien quan den vibe sir dung warfarin vao muc Canh bao va Than trgng, Tac dung phu trbn m l u nhan tat ca cac thubc chii'a warfarin.

- Tra ctfu thong tin tai cac nhan thubc da dugc sua doi tai Anh, My, Canada, nguy co' xay ra chirng calci hba mach mau va hoai tir da deu dugc phan loai a mire

"Chira ro tan suit xay ra phan ung". Ngoai ra, nhan thubc tai Phap, Australia chua dugc cap nhat thong tin ve nguy ca nay. Co so du lieu cua To chuc Y te the gibi (WHO) ve phan ung cb hai (Vigilize) da ghi nhan 212 bao cao ve chirng calci hba mach mau va hoai tir da trong tbng so 60.788 bao cao phan irng cb hai lien quan den warfarin trong giai doan tir 01/01/2005 - 28/02/2017.

3.2. Tinh hinh cap so clang ky ccic thuoc chua Warfarin: - Hien nay, a Viet Nam cb 02 thubc nubc ngoai va 07 thubc trong nubc chira

hoat chit Warfarin dugc d p SDK. Cue Quan ly Dugc - Bp Y te se cb cbng van giri cac dan vi dang ky, san x u l l

thubc yeu cau va hubng d in viec cap nhat cac thong tin canh bao nay vao nhan va to huong din sir dung ciia cac thubc cb lien quan.