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Buy Defibrotide 200mg 10vials Oline

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Defitelio (defibrotide sodium) is indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome

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Aim To confirm that sterility is maintained for 72 hours for patient specific doses of defibrotide when compounded in syringes under aseptic conditions and stored at room temperature.BackgroundHepatic sinusoidal obstruction syndrome – previously termed hepatic veno-occlusive disease – is a major complication of haematopoietic stem cell transplantation and has a high mortality rate1. Defibrotide is used in both prevention and treatment of this complication. Defibrotide is dosed at 6.25mg/kg every 6 hours for a course of 14-30 days for prevention and 21-60 days for treatment1,2. Defibrotide 200mg/2.5mL solution is available in Australia through the Special Access Scheme at a cost of approximately $5870AUD per box of 10 vials. Defibrotide is physicochemically stable at room temperature and cannot be refrigerated2. In a paediatric setting, substantial cost savings can be made repackaging the defibrotide vial under aseptic conditions into individual doses. Over a 12 month period, repacking doses for individual paediatric patients by the pharmacy aseptic production unit (APU) saved the hospital approximately $500,000. For example, a 13.6kg patient prescribed an 85mg dose could be treated for three days using 12 vials odefibrotide reconstituted on the ward (cost = $7044) or prepared from six vials of defibrotide by the aseptic manufacturing unit(cost = $3522null). This represents a cost saving in product alone of $3522 for every three days of treatment and $35,220 for a treatment course of 30 days. Further labour cost savings result from efficiencies gained in preparing multiple doses in a batch. The new 2018 Australian Guidance on Compounding of Sterile Injectable Medicines mandates beyond use dating (expiry dates) must comply with “principles and procedures outlined in the United States Pharmacopeia–National Formulary (USP-NF) Chapter 797 —Sterile Preparations)”3. The USP-NF assigns expiry dates to aseptic manufactured products according to the complexity and storage of the product. Repackaged defibrotide syringes are considered a ‘medium’ risk product as the drug is withdrawn from multiple vials, diluted to prepare a stock solution and drawn into multiple doses. The maximum USP-NF shelf life for a medium risk product, stored at room temperature, is 24 hours. However, a longer expiry date can be assigned if the aseptic technique is validated and the sterility of the product is proven. The USP-NF does not specify how sterility is to be proven4.Prior to the introduction of the guidelines, the APU assigned a 72 hour expiry to defibrotide syringes based on stability data from the product information2. Rather than reduce the expiry to 24 hours, we aimed to prove the microbial stability of repackaged defibrotide and retain the extended expiry of72 hours. Testing was to be concluded prior to the enactment date of the new guidelines to enable continued repackaging of defibrotide.MethodThe sterility of 55 batches of repackaged defibrotide compounded at different times, days and by different operators was tested over four months. Patient batches of repackaged defibrotide were prepared under aseptic conditions according to standard operating procedures. Normal wastage or one dose from the patient batch (if wastage volume < 4mL) was retained for testing. Each sample was transferred into two syringes, capped, labelled (date of manufacture, compounding staff member (operator) initials), and stored at room temperature with the relevant batch sheet. After 24 hours, equal volumes from one syringe was aseptically transferred into two clear bottles of tryptone soy broth (TSB). The broth bottles were labelled with the original compounding date and operator; the transfer date and operator and planned analysis date for the sample. This process was repeated for the second syringe at 72 hours. Each broth sample was incubated in a fluid warmer at 30°C in an upright position for a period of 14 days. After 14 days of incubation, each broth sample was visually inspected. Non-turbid samples were passed by consensus from two independent pharmacists. Microbiological testing and isolation was performed on turbid samples. ResultsOf the 220 samples, no turbidity was observed in 216 samples. Of the four turbid samples, two were confirmed to have leaked during incubation (false positive). Samples sent for microbial testing cultured Corynebacterium; Bacillus andMicrococcus spp. The duplicate sample of each positive broth exhibited no growth. DiscussionThe sterility of compounded defibrotide syringes stored at room temperature was confirmed at 72 hours through robust local testing. Ongoing quality assurance has been conducted monthly, with consistently negative cultures. This study has detailed a reproducible, simple and cost-effective method that could be applied to sterility product testing for other products and in other facilities. If a product requires sterility extension to the expiry date mandated by the USP-NF guidelines the framework outlined in this study may offer assistance. References1. Corbacioglu S, Cesaro S, Faraci M, et al. Defibrotide for prophylaxis of hepatic veno-occlusive disease in paediatric haemopoietic stem-cell transplantation: an open-label, phase 3, randomised controlled trial. Lancet. 2012; 379:1301-13092. Defibrotide Summary of Product Characteristics [product information on the Internet]. Villa Guardia, Italy: Gentium SpA; 2013 [updated 2016 May 26; cited 2018 June]. Available

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