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Episil ® Product Information Brochure

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Episil ® Product Information Brochure ORAL LIQUID NEW to Australia Introducing Episil® Oral Liquid A barrier to oral pain Information for healthcare professionals Introducing episil® oral liquid Rapid pain relief within 5 minutes1,2 Long-lasting effect for up to 8 hours1 Ready-to-use, pocket-sized, multidose pump device3 Demonstrated safety, with no systemic side effects1 Improves patients’ quality of life during cancer therapy2 Established use in 9 other countries, including the US and UK Oral mucositis is a serious complication of cancer therapies Oral mucositis (OM) is one of the most common and debilitating side effects of cancer therapies.4 Risk of OM by cancer therapy Risk of OM by selected targeted therapy High-dose radiotherapy (HNC) – up to 100%5 Everolimus – up to 70%9 High-dose chemotherapy (BMT) – up to 100%6 Afatinib – 71%10 Standard chemotherapy – up to 75%7,8 Sunitinib – up to 58%11 HNC, head and neck cancers; BMT, bone marrow transplant Advantages of effective OM pain management12,13 Increases compliance with cancer treatment Lowers rates of hospitalisation Maintains the ability to eat, drink, swallow and speak Lessens the need for total parenteral nutrition Prevents dehydration and malnutrition Decreases the use of opioid analgesics Reduces weight loss Improves patients’ quality of life episil® oral liquid — an innovative solution for oral mucositis pain episil® liquid is an innovative treatment for the intraoral pain associated with OM, providing clinically demonstrated, rapid and long-lasting pain relief.1,2 episil® liquid is recommended for use in Cancer Group guidelines in both Europe and UK14,15 for the management and relief of pain in the oral cavity in oral mucositis which may be caused by chemotherapy and/or radiotherapy. Patented and award-winning technology16 episil® liquid was developed in Sweden based on the award-winning FluidCrystal® technology.16 The product contains a patented mixture of phospholipids and glycerol dioleate.16 Within minutes of administration, and in contact with only small quantities of saliva, the lipid mixture self-assembles into a protective film that strongly adheres to the oral mucosa.17 Without producing a numbing effect, episil® liquid soothes painful oral lesions. Lipids converge upon saliva and Spheres connect and rapidly transition Technologically advanced, bioadhesive self-assemble to form spheres into a micro-thin gel matrix barrier coats, soothes and protects No known side effects episil® liquid has demonstrated good local and systemic tolerability in pre-clinical and clinical studies, and has no known risks or side effects with use.1,15 Convenient and ready to use episil® oral liquid is supplied in a convenient, pocket-sized, multidose pump device. It is ready to use and can be applied just before meals.3 Recommended dose: 1–3 pump strokes, 2–3 times per day or as needed. episil® liquid is intended for continuous use for up to 30 days. Content: Glycerol dioleate, phosphatidylcholine (soy lecithin), ethanol,* propylene glycol, polysorbate 80 and peppermint oil. *<100 mg of ethanol per dose (3 pump strokes) Efficacy proven in clinical studies67.5 In a multicentre, randomised, double-blind, crossover, A large observational study involving 44 physicians and single-dose trial with 38 head and neck cancer patients more than 150 cancer patients (e.g. breast, head and undergoing radiotherapy, and with oral mucositis Grades neck, gastrointestinal and other solid cancer tumour 2–3 (World Health Organization scale), episil® liquid patients) was conducted to confirm the efficacy and provided an immediate and long-lasting reduction of safety of episil® liquid. Some of the key study results for intraoral pain.1 The effect was clinically proven with the entire patient population were that episil® liquid a 40% mean reduction in pain (Likert scale) and provided on average a 60% decrease in oral pain when a long-lasting effect for up to 8 hours. eating, swallowing or speaking, and that over 85% of patients reported improvement in their quality of life.2 8 8 80 80 7 7 59% 59% 60 60 6 6 56% 56% 5 5 0 0 4 4 0 0 17% 17% 3 3 1% 15% 15% 1%1% 15% 1% 15% 1% 1% uality of life improvement % improvement life of uality 0 % improvement life of uality 0 Mean pain intensity (iert scale) (iert pain intensity Mean 2 scale) (iert pain intensity Mean 2 0 1 0 1 5 6 7 5 8 6 7 8 None SlightNone ModerateSlight StrongModerate Strong Time (Hours) Time (Hours) Reported improvementReported improvement episil® episil® hysician feedbac, hysiciann16 feedbac,Patient feedbac, n16 n1Patient feedbac, n1 Average pain score before and after administration of a single dose of episil® (n=32) All patients: Quality of life improvement with episil® References 1. Hadjieva, T., Cavallin-Ståhl, E., Linden, M. and Tiberg, F. (2014) Treatment of oral mucositis pain following radiation therapy for head-and-neck cancer using a bioadhesive barrier-forming lipid solution. Support Care Cancer, 22(6):1557–1562. 2. Seidenspinner, I., Adamietz, I. A., Strohm, G. L. and Tiberg, T. (2015) Effects of episil® oral liquid in cancer patients with oral mucositis: an observational study. Poster presented at the Multinational Association of Supportive Care in Cancer, 25–27 June 2015, Copenhagen, Denmark. 3. Camurus. (2015) episil® package leaflet. 4. Sonis, S. T. (2004) Oral mucositis in cancer therapy. J Support Oncology, 2(3):3–8. 5. Trotti, A., Bellm, L. A., Epstein, J. B., et al. (2003) Mucositis incidence, severity and associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: a systematic literature review. Radiother Oncol, 66(3):253–262. 6. Wardley, A. M., Jayson, G. C., Swindell, R., et al. (2000) Prospective evaluation of OM in patients receiving myeloablative conditioning regimens and haemopoietic progenitor rescue. Br J Haematol, 110(2):292–299. 7. Fulton, J. S., Middleton, G. J., McPhail, J. T. (2002) Management of oral complications. Semin Oncol Nurs, 18(1):28–35. 8. Dodd, M. J., Miaskowski, C., Dibble, S. L., et al. (2000) Factors influencing OM in patients receiving chemotherapy. Cancer Pract, 8(6):291–297. 9. Novartis Pharmaceuticals Corporation (2012) Everolimus (Afinitor®) Prescribing information. 10. Boehringer Ingelheim (2017) Afatinib (Giotrif®) prescribing information. 11. Pfizer Laboratories (2019) Sunitinib (Sutent®) prescribing information. 12. Vera-Llonch, M., Oster, G., Hagiwara, M., et al. (2006) Oral mucositis in patients undergoing radiation treatment for head and neck carcinoma. Cancer, 106(2):329–336. 13. Murphy, B. A. (2007) Clinical and economic consequences of mucositis induced by chemotherapy and/or radiation therapy. J Support Oncol, 5(9 Suppl 4):13–21. 14. UK Oral Mucositis in Cancer Group Oral Mucositis Guidelines. Mouth Care guidance and support in cancer and palliative care, June 2015. http://www.ukomic.co.uk/documents/UK_OM_Guidelines.pdf. 15. European Oral Care in Cancer Group Guidelines. http://www.cancernurse.eu/documents/EOCCGuidelinesv7.pdf. 16. FluidCrystal® was awarded the “Best innovation in formulation” prize at the CPhI Worldwide in 2013. 17. Joabsson, F., Linden, M., Thuresson, K. and Tiberg, F. (2010) Patent EP1848403. Topical Bioadhesive Formulations. 18. Barauskas, J., Christerson, L., Wadsäter, M., et al. (2014) Bioadhesive Lipid Compositions: Self-Assembly Structures, Functionality, and Medical Applications. Mol. Pharmaceutics, 11(3):895−903. https://www.prnewswire.com/news-releases/cphi-pharma-awards-showcase-industry-drivers-229079101.html episil® oral liquid is a registered trademark and is developed by Camurus AB, Ideon Science Park, SE-223 70, Lund, Sweden. episil® oral liquid is distributed by BTC Speciality Health Pty Ltd (a wholly owned company of BTC Health) under licence from Camurus AB. BTC Specialty Health, Suite 201, 697 Burke Road, Camberwell VIC 3124, Australia. Website: btchealth.com.au, Queries: [email protected]. Phone: Australia 1800 100 282 | New Zealand 0800 567 370. Etal 8181BTC. .
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