Search

Retinal vein occlusion (RVO) is one of the most common causes of vision loss. Anti-vascular endothelial growth factor (anti-VEGF) drugs, ranibizumab and aflibercept, and corticosteroid implants are approved treatment options for RVO-related macular edema (ME) in Turkey. To the best of our knowledge, there is no data regarding the off-label use of these drugs for RVO in English literature. We aimed to evaluate the clinical and demographic characteristics of off-label drug use applications in Turkey for RVO.Applications made to the Turkish Medicines and Medical Devices Agency between January 1 and December 31, 2018, for the use of off-label drugs (ranibizumab, aflibercept, dexamethasone implant) for the diagnosis of RVO from hospitals across Turkey were retrospectively analysed. Data of the applications, such as demographic characteristics, previous treatment regimens, reasons for applications, applicant hospitals and their regions, were recorded.There were 291 approved applications for RVO. The mean age of the patients was 64.88 ± 10.78 years, 48.8% were male, and 51.2% were female. Of these applications, 44.7% were for aflibercept, 35.7% for ranibizumab and 19.6% for dexamethasone implant. No application was made for bevacizumab since it could be used without needing for an application. The most common reasons for applications were due to dose limitations, failure to complete loading doses, and glaucoma, respectively. In terms of the distribution of the applicant hospitals, public university hospitals ranked first with 72.5%, training and research hospitals ranked second with 14.7% and foundation university hospitals ranked third with 13.1% rates.The practice of drug use in RVO in Turkey has changed as of the beginning of 2019. Stepwise therapy has been accepted by the drug regulatory agency Turkish Medicines and Medical Devices Agency. Utilization of licensed drugs, aflibercept, ranibizumab and dexamethasone has been allowed only after administration of 3 doses of intravitreal bevacizumab. After 3 doses of bevacizumab, the physician may continue either with bevacizumab again or a dexamethasone implant. If there is a reason such as the presence of glaucoma, the physician may skip dexamethasone and switch to aflibercept and ranibizumab, but in this case, dexamethasone cannot be administered to the patient for life. The evaluation of the off-label treatments of RVO, which is one of the most frequently followed diseases in retina clinics, not only contributes to the literature but also provides information regarding the most frequently applied treatments and the physicians' off-label drug preferences for RVO.

Objective The use of biological agents in the treatment of ocular Behcet’s disease has recently become more frequent. The use of two agents, infliximab (IFX) and adalimumab (ADA), for the treatment of Behcet’s disease requires prior approval by the Turkish Medicines and Medical Devices Agency. We report on a review of such applications with a view to informing on how such agents are used off-label in Turkey. Methods Prescriptions for off-label use of IFX or ADA sent from hospitals in Turkey to the Turkish Medicines and Medical Devices Agency in 2018 were evaluated. Demographic data, previous treatment regimens and reasons for referral were extracted from the files of the cases. Results A total of 662 patients were considered for off-label use of IFX or ADA for the treatment of ocular Behcet’s disease. The mean age of the patients was 35.7±10.8 years (range 12–76); 61.5% of patients were men and 38.5% were women. Of the applications, 345 (52.1%) were for IFX and 317 (47.9%) for ADA. Among the referring hospitals, the public university hospitals ranked first, accounting for 77.9% of IFX and 88.6% of ADA prescriptions. Most applications were made after the failure of conventional therapy, which included steroids and immunosuppressive agents. Conclusion IFX and ADA are rarely used as initial therapy. Stepwise treatment is still preferred in the treatment of ocular Behcet’s disease in Turkey. Our report informs on the management of this difficult-to-treat condition.

Amaç: Türkiye’de retinal ven tıkanıklığı (RVT) olan hastalarda endikasyon dışı ilaç kullanımı için yapılan başvuruların demografik özelliklerini değerlendirmek. Gereç ve Yöntem: 1 Ocak ile 31 Aralık 2013 tarihleri arasında Türkiye İlaç ve Tıbbi Cihaz Kurumu Başkanlığına, Türkiye genelindeki hastanelerden RVT tanısı ile endikasyon dışı ilaç kullanımı (deksametazon implant, ranibizumab, bevasizumab, aflibersept) için yapılan başvurular geriye dönük olarak incelendi. Olguların dosyaları demografik veriler, önceki tedavi rejimleri, başvuru gerekçeleri, ilacın istenilen doz ve kullanımı açısından değerlendirildi. Bulgular: Çalışmaya RVT tanısı ile endikasyon dışı ilaç kullanımı başvurusu kabul edilen 30 hasta dâhil edildi. Hastaların ortalama yaşı 64,43 ± 9,48 yıldı ve % 56,7’si erkek, % 43,3’ü kadındı. Bu başvuruların % 70’ini deksametazon implant, % 30’unu ise ranibizumab oluşturmaktaydı. Başvuruların bölgelere göre dağılımında ilk iki sırada, İç Anadolu (% 66,6) ve Ege (% 23,3) bölgesi yer almaktaydı. Başvuru yapan hastanelerin dağılımında ise % 80 oranıyla devlet üniversitesi 1. sırada, %13,3 oranıyla eğitim ve araştırma hastanesi 2. sırada, % 6,7 oranıyla ise vakıf üniversitesi 3. sırada bulunmaktaydı. Başvuru yapan hastaların 5’i (% 16,7) önceden aldığı tedavi rejimi olmayan naif hastalardan oluşmakta iken, 11’i (% 36,7) başvuru öncesinde ranibizumab tedavisi almaktaydı. Sonuç: Ciddi görme kaybına neden olabilen RVT tedavisinde Türkiye’de endikasyon dışı ilaç kullanımı başvuru bilgilerinin değerlendirilmesi, literatüre katkısının yanı sıra, tedavi seçeneklerimizi belirleme açısından yol gösterici olacaktır.

Amac: Turkiye’de diyabetik retinopatisi olan hastalarda endikasyon disi ilac kullanimi icin yapilan basvurularin demografik ozelliklerini degerlendirmek. Gerec ve Yontem: 1 Ocak ile 3 1 Aralik 2013 tarihleri arasinda Turkiye Ilac ve Tibbi Cihaz Kurumu Baskanligina Turkiye genelindeki hastanelerden diyabetik retinopati (DRP) tanisi ile endikasyon disi ilac kullanimi (bevacizumab, ranibizumab, deksametazon implant, aflibercept) icin yapilan basvurular geriye donuk olarak incelendi. Olgularin dosyalari demografik veriler, onceki tedavi rejimleri, basvuru gerekceleri, ilacin istenilen doz ve kullanimi acisindan degerlendirildi. Bulgular: Calismaya DRP tanisi ile endikasyon disi ilac kullanimi basvurusu kabul edilen 320 hasta dahil edildi. Hastalarin ortalama yasi 63,05 ± 9,32 yildi ve % 51,9’u erkek, % 48,1’i kadindi. Bu basvurularin % 95,31’ini deksametazon implant, % 4,06’sini ranibizumab, % 0,63’unu bevacizumab, % 0 ise aflibersept olusturmaktaydi. Basvurularin bolgelere gore dagiliminda ilk uc sirada; Ege (%28,75), Ic Anadolu (%26,69) ve Marmara Bolgesi (%21,56) yer almaktaydi. Basvuru yapan hastanelerin dagiliminda ise % 55,9 oraniyla devlet universitesi birinci sirada, %22,2 oraniyla vakif universitesi ikinci sirada, % 21,3 oraniyla egitim ve arastirma hastanesi ise ucuncu sirada bulunmaktaydi. Basvuru yapan hastalarin %9,7’si (31 kisi) onceden aldigi tedavi rejimi olmayan naif hastalardan olusmaktaydi. Sonuc: Ulkemizde sik gorulen DRP’nin tedavisinde endikasyon disi ilac kullanimi basvuru bilgilerinin degerlendirilmesi, literature katkisinin yani sira, Turkiye’deki tedavi seceneklerimizi belirleme acisindan yol gosterici olacaktir.