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News Release: For Medical Media Embargoed: 00:01 Monday, 17 March 2014 NEW IN-HOME INJECTION SERVICE IN ADVANCED PROSTATE CANCER SIMPLIFIES CARE PATHWAY FOR PATIENTS AND CLINICIANS Eligard® NurseCARE flagship initiative launched by new specialist uro-oncology entry, Tolmar Australia 17 March 2014 – The increasing numbers of Australian men living in the community with advanced prostate cancer will now have access to a unique in-home injection service. Eligard® NurseCARE is a national program providing the administration of Eligard® (leuprorelin acetate) and health checks in line with existing treatment plans performed by a qualified nurse, at a time and location that suits the patient. The service, run by AESIR Health on behalf of Tolmar Australia, is provided entirely freeof-charge to both patients and prescribers and underscores Tolmar’s commitment to improving quality of life in prostate cancer. The incidence of prostate cancer has increased over time, due to increasing numbers of men presenting for testing, changes in diagnostic practices and the ageing of the population.1 “Eligard® NurseCARE program is unique in Australia and was designed to integrate with existing treatment plans to simplify patients’ journey of care,” said Dieter Torheiden, General Manager of Tolmar Australia. “The service offers 24-hour telephone support for patients and regular reporting back to the supervising clinician. It is one of several important initiatives we are pleased to be able to provide to the urology and oncology communities.” Tolmar Australia is a new, specialist uro-oncology company that is focused on working collaboratively with healthcare professionals to improve outcomes for men with advanced prostate cancer. A member of the international Tecnofarma group, with access to other members’ support and resources, Tolmar Australia comprises a dedicated team of highly-trained people with extensive experience in urology and oncology, motivated and resourced to work directly with the local sector. Tolmar manufactures Eligard®, an established treatment for prostate cancer symptoms that has a ten-year history of safety and efficacy data in Australia.2 The company is also offering funding for research into the advancement of outcomes and palliation in prostate cancer, which, despite high survival rates compared to other cancers, still claims more than 3,000 lives a year.1 “We welcome the arrival of Tolmar in Australia – any additional support to help patients is welcome,” commented Associate Professor Anthony Lowe, Chief Executive Officer, Prostate Cancer Foundation of Australia. Page 1 of 3 “With improved diagnosis and treatment, more and more men are surviving longer with prostate cancer than in the past, and initiatives such as the NurseCARE program will help reduce the burden on specialist services that are often overloaded,” he said. Tolmar Australia is exhibiting at the Urological Society of Australia and New Zealand (USANZ) Annual Scientific Meeting in Brisbane, from 16-19 March 2014 (stand 44-46). About Eligard® Eligard® is indicated for the palliative treatment of advanced prostate cancer.2 Eligard® is a luteinising hormone-releasing hormone (LHRH) designed to reduce the amount of testosterone in the body; to help manage the symptoms of advanced prostate cancer.2 Reducing the amount of testosterone inhibits the growth of prostate cancers, which rely on testosterone to grow. Eligard® is an injectable subcutaneous gel that is available in four dose options – one, three, four or six monthly – providing flexibility to tailor a treatment regimen to suit men’s individual needs.2 Eligard® is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogues or any of the components of Eligard®. Anaphylactic reactions to synthetic GnRH or GnRH agonist analogues have been reported in the literature.2 Eligard® is contraindicated in women who are breastfeeding, pregnant or intending to become pregnant and in paediatric patients. Eligard® was not studied in women or children.2 Eligard®, like other LH-RH agonists, causes a transient increase in serum concentrations of testosterone during the first week of treatment. Patients may experience worsening of symptoms or onset of new signs and symptoms during the first few weeks of treatment, including bone pain, neuropathy, haematuria, or bladder outlet obstruction. Isolated cases of ureteral obstruction and/or spinal cord compression, which may contribute to paralysis with or without fatal complications, have been observed in the palliative treatment of advanced prostate cancer using LH-RH agonists.2 The most common side effects include: transient burning/stinging, skin reactions; pain, fatigue, dizziness, alopecia, pruritis, bruising, atrophy or pain of testes, decreased libido, ulceration, and induration.2 Tolmar Australia offers a dedicated toll-free number (1800-TOLMAR) to access medical information on Eligard® (including dosage and administration.) Page 2 of 3 About Tolmar Australia Tolmar Australia aims to be the country’s premier urology company, providing locally informed support to men with advanced prostate cancer as well as specialists and nurses working in urology and oncology. Headquarted in Pymble, Sydney, Tolmar operates in parallel with Tolmar Inc, the global entity that invented, developed and manufactures Eligard®. Tolmar has access to the global company’s resources and expertise to support the community in Australia. Both Tolmar Inc, US and Tolmar Australia are members of the Tecnofarma group. For more information about Tolmar Australia, visit www.tolmaraustralia.com.au PBS Information: Authority required (STREAMLINED) Locally advanced (equivalent to stage C) or or metastatic (equivalent to stage D) carcinoma of the prostate. Please review full Product Information before prescribing - available on request. Call: 1800 TOLMAR (865 627) or visit www.ebs.tga.gov.au Minimum Product Information: INDICATIONS: Palliative treatment of advanced prostate cancer. DOSAGE: One subcutaneous injection of Eligard® every one/three/four/six months. Do not inject in the arm. CONTRAINDICATIONS: Hypersensitivity to GnRH, GnRH agonist analogues or any excipients. Pregnancy (Category D) and lactation. Paediatric patients. PRECAUTIONS: Increase in serum testosterone causing bone pain, neuropathy, haematuria, urinary tract obstruction, spinal cord compression or renal impairment, metastatic vertebral lesions, diabetes, cardiovascular disease, QT interval, convulsions. INTERACTIONS: No reports. ADVERSE EFFECTS: Flare phenomenon, skin reactions; malaise, fatigue, dizziness, alopecia, pruritis, myalgia, arthralgia, atrophy, or pain of testes, decreased libido, gynaecomastia; nervous system disturbances, depression, hot flashes/sweats; haematologic disorders; urinary disorders; gastrointestinal disorders; decreased bone density, cardiovascular disorders, pituitary apoplexy. REFERENCE: 1. Eligard® Product Information. Eligard® is a registered trademark of Tolmar Therapeutics, Inc. Full Product Information is available from: Tolmar Australia Pty Ltd. ABN 53 162 640 708. Level 2/20 Bridge St, Pymble, NSW 2073. Ph: 1800 TOLMAR(865 627). February 2014. AM4989. Media enquiries: Rachel Harris 02 8345 4521, 0498 140 433 [email protected] Kayleigh Moore 02 8345 4520, 0481 281 689 [email protected] References 1. AIHW 2013. Prostate cancer in Australia. Cancer series 79. Cat. no. CAN 76. Canberra: AIHW. Accessed at https://www.aihw.gov.au/WorkArea/DownloadAsset.aspx?id=60129545133 2. ELIGARD® Product Information, https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP2014-PI-01463-2 Page 3 of 3