DaTscan (Ioflupane I 123 Injection) Now Available at Saint Clare's Health System
First FDA-approved imaging agent of its kind in the United States will help physicians differentiate Parkinsonian Syndromes from Essential Tremors
DENVILLE, NJ – June 11, 2012 – Saint Clare’s Health System announced today announced today the availability of DaTscan™, the first FDA-approved radiopharmaceutical adjunct imaging agent to help physicians evaluate patients with suspected parkinsonian syndromes (PS), such as Parkinson’s disease (PD). DaTscan gives physicians adjunctive diagnostic capability that may help lead to timely and appropriate diagnosis and treatment.
Saint Clare’s Health System is equipped with an infrastructure dedicated to quality control, handling and dispensing of Drug Enforcement Administration (DEA) Schedule II, radioactive drugs, such as DaTscan.
“Saint Clare’s is pleased to work with GE Healthcare to bring this advanced and state-of-the-art technology to patients in our community,” said Dr Jeffrey Wexler, Medical Director of Radiology, Saint Clare’s Health System. “Both patients and their physicians will benefit from having access to DaTscan and the advanced care offered by our diagnostic imaging team at Saint Clare’s Health System.”
An accurate diagnosis for patients with neurodegenerative movement disorders, such as PD, can take up to six years. PD, which currently affects one million people in the US, is one of several types of PS. *
“This new imaging agent is a step in the right direction for timely and accurate diagnosis for patients with parkinsonian syndromes, which includes Parkinson’s disease,” said Dr Jeffrey Plutchok, a board-certified radiologist at Saint Clare’s Health System. “The challenge for physicians is how to differentiate parkinsonian syndromes from other conditions that mimic it, such as essential tremor. While the symptoms are similar, treatment and management greatly differ. Having another diagnostic tool to help rule out one of these conditions will be tremendously helpful in reaching an appropriate and timely diagnosis for patients.”
PS occurs when the brain does not get enough dopamine to perform certain functions. This affects the ability of the brain to control movement and other muscle functions. DaTscan is an adjunct to other diagnostic evaluations that help differentiate essential tremor (ET) – a common movement disorder – from tremors due to PS. The effectiveness of DaTscan as a screening or confirmatory test for monitoring disease progression or response to therapy has not been established.
In the United States, 50,000 to 60,000 new cases of PD are diagnosed each year. It is estimated that as many as 10 million people around the world suffer from the condition.** A timely and correct diagnosis will help patients and their families overcome the fears and frustrations associated with the process of getting an accurate diagnosis so they can move on with their lives.***, ****
Movement disorders are primarily diagnosed through clinical examinations. Clinical exams alone, particularly early in the disease, are often inconclusive and can result in misdiagnosis.
Patients and caregivers should discuss their symptoms with their primary care physician to determine the best way forward. To learn more about DaTscan, visit www.datscan.com.
Saint Clare’s Health System offers an advanced diagnostic imaging program, staffed by 13 radiologists, each board-certified by the American Board of Radiology and specialize in neuroradiology, abdominal imaging, interventional radiology, breast, nuclear medicine, orthopedic radiology, and pediatric radiology. The department also works with licensed radiology technologists who are certified by the American Registry of Radiologic Technologists. To schedule an appointment, please call 1-888-808-1234.
About Saint Clare’s Health System
Saint Clare’s Health System, which has served the healthcare needs of northwestern New Jersey residents since 1895, is the region’s premier provider of community-based healthcare and behavioral health services. Saint Clare’s operates hospitals in Boonton Township, Denville, Dover and Sussex Borough and other facilities located throughout Morris and Sussex counties.
Saint Clare’s is part of Catholic Health Initiatives (CHI), a national nonprofit health organization with headquarters in Denver, Colorado. The faith-based system operates in 19 states and includes 73 hospitals; 40 long-term care, assisted- and residential-living facilities; two community health-services organizations; and home health agencies.
About GE Healthcare:
GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems.
Our "healthymagination" vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing costs, increasing access and improving quality and efficiency around the world. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our web site at www.gehealthcare.com.
Important Risk and Safety Information about DaTscan
INDICATIONS AND USAGE - DaTscan is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS). DaTscan may be used to help differentiate essential tremor from tremor due to PS (idiopathic Parkinson’s disease, multiple system atrophy and progressive supranuclear palsy). DaTscan is an adjunct to other diagnostic evaluations. CONTRAINDICATIONS - DaTscan is contraindicated in patients with known hypersensitivity to the active substance, any of the excipients, or iodine. WARNINGS AND PRECAUTIONS - Hypersensitivity Reactions - Hypersensitivity reactions, generally consisting of skin erythema and pruritis, have been reported following DaTscan administration. Thyroid Accumulation - The DaTscan injection may contain up to 6% of free iodide (iodine 123 or I-123). To decrease thyroid accumulation of I-123, block the thyroid gland at least 1 hour before administration of DaTscan; failure to do so may increase the long term risk for thyroid neoplasia. ADVERSE REACTIONS - In clinical trials, headache, nausea, vertigo, dry mouth or dizziness of mild to moderate severity were reported. In post marketing experience, hypersensitivity reactions and injection site pain have been reported. DRUG INTERACTIONS - Drugs that bind to the dopamine transporter with high affinity may interfere with the DaTscan image. The impact of dopamine agonists and antagonists upon DaTscan imaging results has not been established. SPECIFIC POPULATIONS - Pregnancy - It is unknown whether DaTscan can cause fetal harm or increase risk of pregnancy loss in pregnant women. DaTscan should be given to pregnant women only if clearly needed. Like all radiopharmaceuticals, DaTscan may cause fetal harm depending on the stage of fetal development, and the magnitude of the radionuclide dose. Radioactive iodine products cross the placenta and can permanently impair fetal thyroid function. Nursing Mothers - It is not known whether DaTscan is excreted into human milk, however, I-123 is excreted into human milk. Because many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of DaTscan or not to administer DaTscan. Nursing women may consider interrupting nursing and pump and discard breast milk for 6 days after DaTscan administration to minimize risks to a nursing infant. Pediatric Use - The safety and efficacy of DaTscan have not been established in pediatric patients. Geriatric Use - There were no differences in responses between the elderly and younger patients that would require a dose adjustment. Renal and Hepatic Impairment - The effect of renal or hepatic impairment upon DaTscan imaging has not been established. DaTscan is excreted by the kidney; patients with severe renal impairment may have increased radiation exposure and altered DaTscan images. DRUG ABUSE AND DEPENDENCE - Ioflupane I 123 Injection is a DEA Schedule II controlled substance. A DEA license is required for handling or administering this controlled substance. OVERDOSAGE - It is unknown whether or not ioflupane is dialyzable. The major risks of overdose relate to increased radiation exposure and long-term risk for neoplasia. In case of radioactivity overdosage, frequent urination and defecation should be encouraged to minimize radiation exposure to the patient. PROCEDURE - Radiation Safety - DaTscan emits radiation and must be handled with safety measures to minimize radiation exposure to clinical personnel and patients.
Prior to DaTscan administration, please read the full prescribing Information.
* Statistics on Parkinson’s. Parkinson’s Disease Foundation Web site. http://www.pdf.org/en/parkinson_statistics. Accessed August 25, 2010.
** Statistics on Parkinson’s. Parkinson’s Disease Foundation Web site. http://www.pdf.org/en/parkinson_statistics. Accessed August 25, 2010.
*** Emotional Responses to PD. National Parkinson Foundation Web site. http://www.parkinson.org/Parkinson-s-Disease/PD-101/Emotional-Responses-to-PD. Accessed March 7, 2011.
**** What Does "Newly Diagnosed" Mean? Multiple Sclerosis Association of America Web site. http://www.msassociation.org/about_multiple_sclerosis/newlydiagnosed/. Accessed March 8, 2011.